ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Metacam 5 mg/ml solution for injection for cattle and pigs
2.
One ml contains:
Active substance:
Meloxicam
5 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear yellow solution.
4.
Cattle (calves and young cattle) and pigs
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in
cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post operative pain associated with minor soft tissue surgery such as castration.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.
Treatment of piglets with Metacam before castration reduces post operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed.
2
To obtain the best possible pain relieving effect post surgery Metacam should be administered
30 minutes before surgical intervention.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight
transient swelling at the injection site following subcutaneous administration was observed in less than
10 % of the cattle treated in clinical studies.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Cattle:
Can be used during pregnancy and lactation.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant agents.
Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy,
as appropriate.
Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg
body weight). If required, a second administration of meloxicam can be given after 24 hours.
Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.
Particular care should be taken with regard to the accuracy of dosing including the use of an
appropriate dosing device and careful estimation of body weight.
Avoid introduction of contamination during use.
3
Pigs:
Can be used during pregnancy.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiods
Cattle:
Meat and offal:
15 days
Pigs:
Meat and offal:
5 days
5.
Pharmacotherapeutic group:Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic
and antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to
inhibit production of thromboxane B
2
induced by
E. coli
endotoxin administration in calves and pigs.
5.2 Pharmacokinetic particulars
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, C
max
values of 2.1 µg/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a C
max
value of 1.1 to 1.5 µg/ml was
reached within 1 hour in pigs.
Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are
to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle
and fat.
Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product
in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine
contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately
2.5 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.
6.1 List of excipients
-
Ethanol
4
-
Poloxamer 188
-
Sodium chloride
-
Sodium hydroxide
-
Glycofurol
-
Meglumine
-
Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/035 20 ml
EU/2/97/004/037 50 ml
EU/2/97/004/001 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml
9.
Date of first authorisation:
07.01.1998
Date of last renewal:
06.12.2007
5
-
Glycine
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
1.
Metacam 1.5 mg/ml oral suspension for dogs
2.
One ml contains:
Active substance:
Meloxicam
1.5 mg (equivalent to 0.05 mg per drop)
Excipient:
Sodium benzoate
1.5 mg (equivalent to 0.05 mg per drop)
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Yellowish viscous oral suspension with a green tinge.
4.
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.
7
Special precautions to be taken by the person administering the veterinary
medicinal product to
animals
People with known hypersensitivity to Non Steroidal Anti-inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These side effects occur generally within the
first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of
Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and
inflammation associated with chronic musculo-skeletal disorders may vary over time.
Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.
Dosing procedure using the drop dispenser of the bottle:
Initial dose: 4 drops /kg body weight
Maintenance dose: 2 drops /kg body weight
Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which
corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the
maintenance volume will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.
8
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
In case of overdose symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 4.5 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.
6.
6.1 List of excipients
-
Sodium benzoate
9
-
Sorbitol, liquid
-
Glycerol
-
Saccharin sodium
-
Sodium dihydrogen phosphate dihydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid
-
Honey aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a
tamper proof child resistant closure. Each bottle is packed in a cardboard box and is equipped with a
polypropylene measuring syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml
9.
Date of first authorisation:
24.03.2000
10
-
Xylitol
Date of last renewal:
06.12.2007
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11
1.
Metacam 5 mg/ml solution for injection for dogs and cats
2.
One ml contains:
Active substance:
Meloxicam
5 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear yellow solution.
4.
Dogs and cats
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction
of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
anaesthesia.
12
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
Any oral follow-up therapy using meloxicam or other Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) should not be administered in cats, as appropriate dosage regimens for such follow-up
treatments have not been established.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. In dogs, these side effects occur generally
within the first treatment week and are in most cases transient and disappear following termination of
the treatment but in very rare cases may be serious or fatal.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia
and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg
body weight).
Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for dogs
may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours
after administration of the injection.
13
Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean
plasma concentrations of 0.73 g/ml in dogs and 1.1 µg/ml in cats were reached approximately
2.5 hours and 1.5 hours post administration, respectively.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs. More than 97 % of meloxicam is bound to plasma proteins. The
volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol,
an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
14
Elimination
Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats. Approximately
75 % of the administered dose is eliminated via faeces and the remainder via urine.
6.
6.1 List of excipients
-
Ethanol
-
Poloxamer 188
-
Sodium chloride
-
Sodium hydroxide
-
Glycofurol
-
Meglumine
-
Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/006 10ml
EU/2/97/004/011 20ml
15
-
Glycine
9.
Date of first authorisation:
24.03.2000
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
16
Date of last renewal:
06.12.2007
1.
Metacam 20 mg/ml solution for injection for cattle, pigs and horses
2.
One ml contains:
Active substance:
Meloxicam
20 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear yellow solution.
4.
Cattle, pigs and horses
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in
cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-
agalactia syndrome) with appropriate antibiotic therapy.
Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.
See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
17
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of
the diagnosis should be made as this could indicate the need for surgical intervention.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was
observed in less than 10 % of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Cattle and pigs:
Can be used during pregnancy and lactation.
Horses:
Do not use in pregnant or lactating mares.
See also section 4.3.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant agents.
Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy,
as appropriate.
18
Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg
body weight) in combination with antibiotic therapy, as appropriate. If required, a second
administration of meloxicam can be given after 24 hours.
Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg
body weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo –
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a
dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Avoid introduction of contamination during use.
In case of overdose, symptomatic treatment should be initiated.
4.11 Withdrawal periods
Cattle:
Meat and offal:
15 days
Milk: 5 days
Pigs:
Meat and offal: 5 days
Horses:
Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B
2
induced by
E. coli
endotoxin
administration in calves, lactating cows and pigs.
5.2 Pharmacokinetic particulars
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, C
max
values of 2.1 µg/ml and 2.7 µg/ml
were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a C
max
value of 1.9 µg/ml was reached after
1 hour in pigs.
Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are
to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle
and fat.
19
Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product
in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine
contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.
Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in
young cattle and lactating cows, respectively.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.
6.1
List of excipients
-
Ethanol
-
Poloxamer 188
-
Macrogol 300
-
Disodium edetate
-
Sodium hydroxide
-
Hydrochloric acid
-
Meglumine
-
Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml or 100 ml vials):
3 years
Shelf-life of the veterinary medicinal product as packaged for sale (250 ml vials): 2 years
Shelf-life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or
100 ml. Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
20
-
Glycine
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/027 1 x 20 ml
EU/2/97/004/007 1 x 50 ml
EU/2/97/004/008 1 x 100 ml
EU/2/97/004/031 1 x 250 ml
EU/2/97/004/028 12 x 20 ml
EU/2/97/004/014 12 x 50 ml
EU/2/97/004/015 12 x 100 ml
EU/2/97/004/032 6 x 250 ml
9.
Date of first authorisation:
23.04.2001
12.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
21
Date of last renewal:
06.12.2007
1.
Metacam 15 mg/ml oral suspension for horses
2.
One ml contains:
Active substance:
Meloxicam
15 mg
Excipient:
Sodium benzoate
1.5 mg
For a full list of excipients, see section 6.1.
3.
Oral suspension
Yellowish viscous oral suspension with a green tinge.
4.
Horses
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal
toxicity.
22
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or
maternotoxic effects. However, no data have been generated in horses. Therefore the use in this
species is not recommended during pregnancy and lactation.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.
To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small
quantity of food, prior to feeding.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.
Shake well before use.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
Avoid introduction of contamination during use.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Meat and offal: 3 days.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
23
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B
2
induced by intravenous
E. coli
endotoxin administration in calves and pigs.
5.2 Pharmacokinetic particulars
Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is
approximately 98%. Maximal plasma concentrations are obtained after approximately 2-3 hours. The
accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Distribution
Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is
0.12 l/kg.
Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although
quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy-
and 5-carboxy-metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated.
All major metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.
6.
6.1 List of excipients
-
Sodium benzoate
-
Glycerol
-
Saccharin sodium
-
Xylitol
-
Sodium dihydrogen phosphate dihydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid
-
Honey aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening of the immediate packaging: 6 months
24
-
Sorbitol, liquid
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter
and a tamper proof child resistant closure and a polypropylene measuring syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml
9.
Date of first authorisation:
08.10.2003
Date of last renewal:
06.12.2007
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
25
1.
Metacam 0.5 mg/ml oral suspension for dogs
2.
One ml contains:
Active substance:
Meloxicam
0.5 mg (equivalent to 0.02 mg per drop)
Excipients:
Sodium benzoate
1.5 mg (equivalent to 0.06 mg per drop)
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Yellowish viscous oral suspension with a green tinge.
4.
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
0.5 mg/ml oral suspension for cats should be used.
26
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non Steroidal Anti-inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These side effects occur generally within the
first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of
Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and
inflammation associated with chronic musculo-skeletal disorders may vary over time.
Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.
Dosing procedure using the drop dispenser of the bottle:
Initial dose: 10 drops /kg body weight
Maintenance dose: 5 drops /kg body weight
Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which
corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the
maintenance volume will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.
27
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
In case of overdose symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 4.5 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.
6.
6.1 List of excipients
-
Sodium benzoate
28
-
Sorbitol, liquid
-
Glycerol
-
Saccharin sodium
-
Sodium dihydrogen phosphate dihydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid
-
Honey aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polyethylene bottle containing 15 ml or 30 ml with a polyethylene dropper and a tamper proof child
resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene
measuring syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/012 15 ml
EU/2/97/004/013 30 ml
9.
Date of first authorisation:
01.08.2005
Date of last renewal:
06.12.2007
29
-
Xylitol
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
30
1.
Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs
2.
One chewable tablet contains:
Active substance:
Meloxicam
1 mg
Meloxicam
2.5 mg
Excipients:
For a full list of excipients, see section 6.1.
3.
Chewable tablets
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or
"M25" on one side.
The tablet can be divided into equal halves
4.
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
31
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These side effects occur generally within the
first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation (see section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be
given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.
Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken
by most dogs voluntarily.
Dose scheme for the maintenance dose:
Body weight (kg)
Number of chewable tablets
mg/kg
1 mg
2.5 mg
4.0–7.0
½
0.13–0.1
7.1–10.0
1
0.14–0.1
32
10.1– 15.0
1½
0.15–0.1
15.1–20.0
2
0.13–0.1
20.1–25.0
1
0.12–0.1
25.1–35.0
1½
0.15–0.1
35.1–50.0
2
0.14–0.1
The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days
if no clinical improvement is apparent.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATC vet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 4.5 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
33
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated in faeces and the remainder in urine.
6.
6.1 List of excipients
-
Sodium citrate dihydrate
-
Iron oxide brown
-
Iron oxide yellow
-
Cellulose, microcrystalline
-
Meat Dry Flavour
-
Silica, colloidal anhydrous
-
Magnesium stearate
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
34
-
Maize starch
8.
Metacam 1 mg chewable tablets for dogs:
Blisters :
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets
Metacam 2.5 mg chewable tablets for dogs:
Blisters :
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets
9.
Date of first authorisation:
23.03.2006
Date of last renewal:
06.12.2007
12.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
35
1.
Metacam 0.5 mg/ml oral suspension for cats
2.
One ml contains:
Active substance:
Meloxicam
0.5 mg (equivalent to 0.017 mg per drop)
Excipient:
Sodium benzoate
1.5 mg (equivalent to 0.05 mg per drop)
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Yellowish viscous oral suspension with a green tinge.
4.
Cats
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
36
Post-operative pain and inflammation following surgical procedures:
In case additional pain relief is required, multimodal pain therapy should be considered.
Chronic musculoskeletal disorders:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of
appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been
reported. These side effects are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment
24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg
body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to
four days.
Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment
is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of
0.05 mg meloxicam/kg body weight.
A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at
the latest if no clinical improvement is apparent.
37
Route and method of administration
Dosing procedure using the drop dispenser of the bottle
:
Dose of 0.1 mg meloxicam/kg body weight: 6 drops /kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops /kg body weight
Dosing procedure using the measuring syringe
:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which
corresponds to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of
chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should
not be exceeded.
Avoid introduction of contamination during use.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen
at relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and
more frequent. In case of overdose symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after
approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly
delayed.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.
38
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Five major metabolites have been identified.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for
other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation and
there are no pharmacologically active metabolites.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the
recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in
the faeces (49% as unchanged meloxicam, 30% as metabolites).
6.
6.1 List of excipients
-
Sodium benzoate
-
Sorbitol, liquid
-
Saccharin sodium
-
Xylitol
-
Sodium dihydrogen phosphate dihydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid
-
Honey aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
3 ml bottle:
18 months
10 ml and 15 ml bottle:
3 years
Shelf-life after first opening the immediate packaging:
3 ml bottle:
14 days
10 ml and 15 ml bottle:
6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper proof child resistant
closure.
Polyethylene bottle containing 10 ml or 15 ml with a polyethylene dropper and a tamper proof child
resistant closure.
39
-
Glycerol
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe
which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
9.
Date of first authorisation:
20.04.2007
Date of last renewal:
06.12.2007
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
40
1.
Metacam 2 mg/ml solution for injection for cats
2.
One ml contains:
Active substance:
Meloxicam
2 mg
Excipients:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear yellow solution.
4.
Cats
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal
toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.
41
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported.
These adverse reactions are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged
animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into
consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function
cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacological properties of the products used previously.
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by
administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg
body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour
intervals.
Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has
also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.
This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is
possible e.g. feral cats. In this case do not use oral follow up treatment.
Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.
In the case of overdose symptomatic treatment should be initiated.
42
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean
plasma concentrations of 1.1 µg/ml were reached approximately 1.5 hours post administration.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.09 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Five major metabolites were detected all having
been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. As for other species investigated, the main pathway of
meloxicam biotransformation in cat is oxidation.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the
recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in
the faeces (49% as unchanged meloxicam, 30% as metabolites).
6.
6.1 List of excipients
-
Ethanol
-
Poloxamer 188
-
Glycine
-
Disodium edetate
-
Sodium hydroxide (for pH adjustment)
-
Hydrochloride acid (for pH adjustment)
-
Meglumine
-
Water for injections
43
-
Macrogol 300
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/039 10ml
EU/2/97/004/040 20ml
9.
Date of first authorisation:
02.07.2010
12.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
44
1.
Metacam 15 mg/ml oral suspension for pigs
2.
One ml contains:
Active substance(s):
Meloxicam
15 mg
Excipient(s):
Sodium benzoate
1.5 mg
For a full list of excipients, see section 6.1.
3.
Oral suspension
Yellowish viscous oral suspension with a green tinge.
4.
Pigs
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-
Agalactia syndrome MMA) with appropriate antibiotic therapy.
Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions..
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
45
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
None.
Can be used during pregnancy and lactation.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.
Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in
combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam
can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended.
To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to
feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.
Shake well before use.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Meat and offal: 5 days.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
46
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B
2
induced by intravenous
E. coli
endotoxin administration in pigs.
5.2 Pharmacokinetic particulars
Absorption
After a single oral dose of 0.4 mg meloxicam/kg a C
max
value of 0.81 µg/ml was reached after 2 hours.
Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are
to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle
and fat.
Metabolism
Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent
compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar
metabolites. All major metabolites have been shown to be pharmacologically inactive.
Elimination
After oral administration the mean plasma elimination half-life is approximately 2.3 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.
6.1 List of excipients
-
Sodium benzoate
-
Sorbitol, liquid
-
Glycerol
-
Saccharin sodium
-
Xylitol
-
Sodium dihydrogen phosphate dihydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid
-
Honey aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening of the immediate packaging: 6 months
47
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip
adapter, a tamper proof child resistant closure and a measuring syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml
9.
Date of first authorisation:
05.07.2010
07.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
48
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
49
Metacam 5 mg/ml solution for injection for cattle and pigs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable
D. STATEMENT OF THE MRLs
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic
classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
No entry
Anti-inflammatory
agents/Non-steroidal
anti-inflammatory
agents
Bovine,
caprine
15 μg/kg
Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
50
Metacam 1.5 mg/ml oral suspension for dogs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
51
Metacam 5 mg/ml solution for injection for dogs and cats
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
52
Metacam 20 mg/ml solution for injection for cattle, pigs and horses
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRL Target tissues
Other
provisions
Therapeutic
classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
No entry
Anti-inflammatory
agents/Non-steroidal
anti-inflammatory
agents
Bovine,
caprine
15 μg/kg Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
53
Metacam 15 mg/ml oral suspension for horses
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmaco-
logically active
substance
Marker residue Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
No entry
Anti-inflammatory
agents/Non-steroidal anti-
inflammatory agents
Bovine,
caprine
15 μg/kg Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
54
Metacam 0.5 mg/ml oral suspension for dogs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
55
Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
56
Metacam 0.5 mg/ml oral suspension for cats
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
57
Metacam 2 mg/ml solution for injection for cats
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/ Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
58
Metacam 15 mg/ml oral suspension for pigs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
No entry
Anti-inflammatory
agents/Non-steroidal anti-
inflammatory agents
Bovine,
caprine
15 μg/kg Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
59
ANNEX III
LABELLING AND PACKAGE LEAFLET
60
A. LABELLING
61
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Metacam 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
5 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
20 ml
50 ml
100 ml
12 x 20 ml
12 x 50 ml
12 x 100 ml
5.
Cattle (calves and young cattle) and pigs
6.
INDICATION(S)
Cattle:
Acute respiratory infection.
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Pigs:
Non-infectious locomotor disorders.
Post operative pain associated with minor soft tissue surgery such as castration.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection.
62
Pigs:
Single intramuscular injection. If required, a second administration can be given after 24 hours.
Single intramuscular injection before surgery.
Take care of accurate dosing, use of appropriate dosing device and estimation of body weight.
Read the package leaflet before use.
8.
Withdrawal period:
Cattle:
meat and offal: 15 days
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
63
Pigs:
meat and offal: 5 days
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/035 20 ml
EU/2/97/004/037 50 ml
EU/2/97/004/001 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
64
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Metacam 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
5 mg/ml
3.
solution for injection
4.
PACKAGE SIZE
100 ml
5.
Cattle (calves and young cattle) and pigs
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle
:
SC or IV injection.
Pigs:
IM injection.
Read the package leaflet before use.
8.
Withdrawal period:
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
65
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by...
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Read the package leaflet before use.
Read the package leaflet before use.
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/035 20 ml
EU/2/97/004/037 50 ml
EU/2/97/004/001 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
66
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Metacam 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2.
QUANITITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
50 ml
4.
ROUTE(S) OF ADMINISTRATION
Cattle:
SC or IV
Pigs:
IM
5.
Withdrawal period:
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by….
8.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
67
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Metacam 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
1.5 mg/ml
3.
Oral suspension
4.
PACKAGE SIZES
10 ml
32 ml
100 ml
180 ml
5.
Dogs
6.
INDICATION(S)
Acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
68
10. EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
69
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Metacam 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
1.5 mg/ml
3.
CONTENT BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
10 ml
32 ml
4.
ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
Once broached, use by…
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
70
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Metacam 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
1.5 mg/ml
3.
Oral suspension
4.
PACKAGE SIZES
100 ml
180 ml
5.
Dogs
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
71
10. EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
Once broached, use by….
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Read the package leaflet before use.
Boehringer Ingelheim Vetmedica GmbH
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
72
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Metacam 5 mg/ml solution for injection for dogs and cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
5 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
10 ml
20 ml
5.
Dogs and cats
6.
INDICATIONS
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
Post-operative pain: single intravenous or subcutaneous injection.
Cats:
Post-operative pain: single subcutaneous injection.
Read the package leaflet before use.
8
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
73
10. EXPIRY DATE
EXP. {month/year}
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/006 10 ml
EU/2/97/004/011 20 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
74
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Metacam 5 mg/ml solution for injection for dogs and cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
20 ml
4.
ROUTE(S) OF ADMINISTRATION
Dogs:
IV or SC
Cats:
SC
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
75
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Metacam 0.5 mg/ml oral suspension for dogs
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
0.5 mg/ml
3.
CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
15 ml
30 ml
4.
ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
Once broached, use by…
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
89
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box of blister
1.
Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
1 mg / chewable tablet
Meloxicam
2.5 mg / chewable tablet
3.
Chewable tablets
4.
PACKAGE SIZE(S)
7 tablets
84 tablets
252 tablets
5.
Dogs
6.
INDICATION(S)
Read the package leaflet before use
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Metacam 1 mg chewable tablets for dogs:
Oral use.
Single dose on the first day: 0.2 mg meloxicam/kg body weight. Maintenance dose:
0.1 mg meloxicam/kg body weight once daily (1 chewable tablet per 10 kg body weight).
Metacam 2.5 mg chewable tablets for dogs:
Oral use.
Single dose on the first day: 0.2 mg meloxicam/kg body weight. Maintenance dose:
0.1 mg meloxicam/kg body weight once daily (1 chewable tablet per 25 kg body weight).
Read the package leaflet before use.
90
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
Metacam 1 mg chewable tablets for dogs:
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets
91
Metacam 2,5 mg chewable tablets for dogs:
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
92
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Blisters
1.
Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs
Meloxicam
2.
Boehringer Ingelheim Vetmedica GmbH
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
93
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Metacam 0.5 mg/ml oral suspension for cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
0.5 mg/ml
3.
Oral suspension
4.
PACKAGE SIZES
3 ml
10 ml
15 ml
5.
Cats
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
94
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
10. EXPIRY DATE
EXP {month/year}
3 ml:
14 days
10 ml: Shelf-life of opened bottle:
6 months.
15 ml: Shelf-life of opened bottle:
6 months.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
95
Shelf-life of opened bottle:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Metacam 0.5 mg/ml oral suspension for cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
0.5 mg/ml
3.
CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
3 ml
4.
ROUTE OF ADMINISTRATION
Oral use.
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 14 days
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
96
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Metacam 0.5 mg/ml oral suspension for cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
0.5 mg/ml
3.
CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
10 ml
15 ml
4.
ROUTE OF ADMINISTRATION
Oral use.
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
Once broached, use by…
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
97
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Metacam 2 mg/ml solution for injection for cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 2 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
10 ml
20 ml
5.
Cats
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
S
ingle subcutaneous injection.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
Read the package leaflet before use.
98
10. EXPIRY DATE
EXP. {month/year}
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Not applicable.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/039 10 ml
EU/2/97/004/040 20 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
99
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Metacam 2 mg/ml solution for injection for cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 2 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
20 ml
4.
ROUTE OF ADMINISTRATION
SC
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
100
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Metacam 15 mg/ml oral suspension for pigs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
15 mg/ml
3.
Oral suspension
4.
PACKAGE SIZE
100 ml
250 ml
5.
Pigs
6.
INDICATION(S)
Read the package leaflet before use.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
After use, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it
dry.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Withdrawal period:
Meat and offal: 5 days.
103
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
Once broached, use by..............
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Read the package leaflet before use.
Read the package leaflet before use.
16. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
104
B. PACKAGE LEAFLET
105
PACKAGE LEAFLET FOR:
Metacam 5 mg/ml solution for injection for cattle and pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
Manufacturer
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
2.
Metacam 5 mg/ml solution for injection for cattle and pigs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam
150 mg
4.
INDICATION(S)
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in
cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post operative pain associated with minor soft tissue surgery such as castration.
5.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.
106
Ethanol
5 mg
6.
Subcutaneous, intramuscular as well as intravenous injection is well tolerated; only a slight transient
swelling at the injection site following subcutaneous administration was observed in less than 10 % of
the cattle treated in clinical studies.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle (calves and young cattle) and pigs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy,
as appropriate.
Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg
body weight). If required, a second administration of meloxicam can be given after 24 hours.
Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.
Particular care should be taken with regard to the accuracy of dosing including the use of an
appropriate dosing device and careful estimation of body weight.
9.
ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
10. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 28 days.
Do not use after the expiry date stated on the carton and bottle after EXP.
107
12. SPECIAL WARNING(S)
Treatment of piglets with Metacam before castration reduces post operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible pain relieving effect post surgery Metacam should be administered
30 minutes before surgical intervention.
Precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
Precautions to be taken by the person administering the product
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or
the label to the physician.
Use during pregnancy and lactation
Cattle:
Can be used during pregnancy.
Pigs:
Can be used during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant agents.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused medicines or waste materials should not be disposed of via wastewater or household
waste but in accordance with local requirements. These measures should help to protect the
environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
06.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
108
Source: European Medicines Agency
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