ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
MELOXIDYL 1.5 mg/ml oral suspension for dogs.
2.
Composition for 1 ml
Active substance (s)
Meloxicam
1.5 mg
Excipients
Sodium benzoate
2 mg
For a full list of excipients, see section 6.1
3.
Pale yellow suspension.
4.
Dogs.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
4.3
Contra-indications
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, or where there is evidence of
individual hypersensitivity to the product.
Do not use in dogs less than 6 weeks of age.
None.
administering the medicinal product to the animals
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if there is a potential risk of increased
renal toxicity.
2
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to 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 drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood and apathy 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 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. The product 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 drugs should be observed for at least 24 hours before
commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
Oral use.
Shake well before use.
To be administered mixed with food.
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.
Particular care should be taken with regard to the accuracy of dosing.
The suspension can be given using the measuring syringes provided in the package. The syringe fits onto
the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg
meloxicam/kg body weight). Thus, for the first day, twice the maintenance volume will be required.
The suspension could be administered using the smallest syringe for dogs less than 7 kg body weight (one
graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 7 kg body
weight (one graduation corresponding to 2.5 kg of body weight).
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.
3
In the case of overdosage, symptomatic treatment should be initiated.
4.11
Withdrawal periods for the various foodstuffs, including those for which the withdrawal
period is zero
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non steroids.
ATCvet: 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 7.5 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.
4
6.1 List of excipients
Xanthan gum, silica colloidal anhydrous, sorbitol liquid non-crystallising, glycerol, xylitol, sodium
benzoate, citric acid anhydrous, purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
After first opening: 6 months.
6.4 Special precautions for storage
No special precautions for storage.
6.5 Nature and composition of immediate packaging
Material of the primary container
High density polyethylene bottle with high density polyethylene tamper evidence screw cap.
Low density polyethylene syringe insert for the polypropylene measuring syringes.
Pack sizes
Two measuring syringes are provided per each presentation.
10 ml bottle
32 ml bottle
100 ml bottle
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, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
CEVA SANTE ANIMALE
Z.I. la Ballastière
33500 Libourne
FRANCE
5
EU/2/06/070/001
EU/2/06/070/002
EU/2/06/070/003
9.
DATE OF THE FIRST AUTHORISATION OR DATE OF RENEWAL OF THE
AUTHORISATION
15.01.2007
26.01.2007
6
1.
MELOXIDYL 5 mg/ml solution for injection for dogs and cats
2.
One ml contains:
Active substance:
Meloxicam 5 mg.
Excipients:
Ethanol anhydrous 150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear, yellow solution.
4.1 Targetspecies
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.
7
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
increased 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 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects.
MELOXIDYL 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 drugs should be observed for at least 24 hours before
commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic 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).
MELOXIDYL 1.5 mg/ml oral suspension 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.
8
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 the 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 Pharmacodynamicproperties
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 Pharmacokineticparticulars
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 0.73 μg/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.
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.
9
6.1 List of excipients
Ethanol anhydrous
Poloxamer 188
Glycofurol
Meglumine
Glycine
Sodium Chloride
Sodium Hydroxide
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
Colourless type I glass injection vial of 10 ml, closed with a grey EPDM (Ethylene Propylene Diene
Monomer) rubber stopper and sealed with a flip off aluminium violet seal in a cardboard box.
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.
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
FRANCE
EU/2/06/070/004
10
15.01.2007
26/03/2010
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.
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs and horses
2.
One ml of MELOXIDYL 20 mg/ml solution for injection contains:
Active substance:
Meloxicam 20 mg
Excipient:
Ethanol anhydrous 150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection
Clear, colourless to yellowish solution.
4.1 Targetspecies
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.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
12
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.
Do not use in horses producing milk for human consumption.
See also section 4.3.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anti-coagulant 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.
13
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).
Avoid introduction of contamination during use.
In the case of overdose, symptomatic treatment should be initiated.
Cattle:
Meat and offal: 15 days
Milk: 5 days
Pigs:
Meat and offal: 5 days
Horses:
Meat and offal: 5 days.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATC vet code: QM01AC06
5.1 Pharmacodynamicproperties
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 B2 induced by E. coli endotoxin administration in
calves, lactating cows and pigs.
5.2 Pharmacokineticparticulars
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues 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 Cmax 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.
14
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, anhydrous
Poloxamer 188
Macrogol 300
Glycine
Sodium citrate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 30 months
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 1 colourless glass vial of 50 ml, 100 ml or 250 ml.
Each vial is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
15
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.
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
FRANCE
EU/2/06/070/005
EU/2/06/070/006
EU/2/06/070/007
15.01.2007
26.03.2010
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
1.
MELOXIDYL 0.5 mg/ml oral suspension for cats
2.
One ml of MELOXIDYL 0.5 mg/ml oral suspension for cats contains:
Active substance:
Meloxicam
0.5 mg
Excipient:
Sodium benzoate (E 211)
2.0 mg
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Pale yellow suspension.
4.1 Targetspecies
Cats.
Alleviation of inflammation and pain in chronic musculo-skeletal disorders in 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.
None.
17
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.
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
MELOXIDYL 0.5 mg/ml oral suspension for cats should not be used following parenteral injection of
meloxicam or any other non-steroidal anti-inflammatory drugs (NSAIDs) as appropriate dosage regimens
for such follow-up treatments have not been established in cats.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to 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 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. MELOXIDYL 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 drugs 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 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.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not
be exceeded.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
18
The suspension can be given using the measuring syringe provided in the package.
The syringe fits onto the bottle and has a kg-body weight scale (from 1 kg to 10 kg) which corresponds to
the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
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.
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 the 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 Pharmacodynamicproperties
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 Pharmacokineticparticulars
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.
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. Due to the loading dose, steady state is reached after 2
days (48h).
19
6.
6.1 List of excipients
- Xanthan gum
- Silica colloidal anhydrous
- Sorbitol liquid non-crystallising
- Glycerol
- Xylitol
- Sodium benzoate (E 211)
- Citric acid anhydrous
- Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 30 months
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
Material of the primary container
High density polyethylene bottle with high density polyethylene tamper evidence screw cap.
Low density polyethylene syringe insert for the polypropylene measuring syringe.
Pack size:
Cardboard box containing 15 ml bottle with one measuring syringe.
The measuring syringe has a kg-body weight scale for cats (1 to 10 kg).
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.
CEVA SANTE ANIMALE
10 Avenue de La Ballastière
33500 Libourne
FRANCE
EU/2/06/070/008
20
26/08/2010
26/08/2010
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
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S) 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
22
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Meloxidyl 1.5 mg/ml
CEVA SANTE ANIMALE - Z.I. Très le Bois - 22600 Loudeac - FRANCE
Vetem SpA - Lungomare Pirandello, 8 - 92014 Porto Empedocle (AG) - ITALY
Meloxidyl 5 mg/ml
CEVA SANTE ANIMALE – 10 avenue de la Ballastière – 33500 Libourne - FRANCE
ACCORD HEALTHCARE LIMITED - Sage House - 319 Pinner Road – Harrow – Middlesex
HA1 4HF - UNITED KINGDOM
The printed package leaflet of the medicinal product must state the name and address of the manufacturer
responsible for the release of the concerned batch.
Meloxidyl 20 mg/ml
CEVA SANTE ANIMALE – 10 avenue de la Ballastière – 33500 Libourne - FRANCE
Meloxidyl 0.5 mg/ml
CEVA SANTE ANIMALE - Z.I Très le Bois - 22600 Loudéac – FRANCE
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
Not applicable.
D. STATEMENT OF THE MRLs
Meloxidyl 1.5 mg/ml - Meloxidyl 5 mg/ml - Meloxidyl 0.5 mg/ml
Not applicable
23
Meloxidyl 20 mg/ml
The Committee for Veterinary Medicinal Products has recommended the inclusion of meloxicam in
Annex I of Council Regulation (EEC) No 2377/90 in accordance with the following table:
Pharmacologically
active substance(s)
Marker
residue
Animal
species
MRLs
Target
tissues
Other
provisions
Bovine 20 μg/kg
65 μg/kg
65 μg/kg
15 μg/kg
Muscle
Liver
Kidney
Milk
Meloxicam
Meloxicam
Porcine 20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
Equidae 20μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
The excipients listed in the table below are included in Annex II of Council Regulation (EC) No 2377/90
in accordance with the information shown:
Pharmacologically
active substance(s)
Animal
species
Other
provisions
Ethanol
All food producing species
Poloxamer 188
All food producing species
Macrogol 300
All food producing species
Sodium citrate
All food producing species
Water for injection
All food producing species
Glycine (E 640)
All food producing species
Sodium Hydroxide (E 524)
All food producing species
Hydrochloric acid (E 507)
All food producing species
Nitrogen (E 941)
All food producing species
Meglumine is considered as not falling within the scope of Regulation (EC) No 470/2009 at
concentrations up to 1.5 mg/kg bw (concentrations up to 34.75 mg/ml)
24
ANNEX III
LABELLING AND PACKAGE LEAFLET
25
A. LABELLING
26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 ml bottle
32 ml bottle
100 ml bottle
1.
MELOXIDYL 1.5 mg/ml oral suspension for dogs.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains 1.5 mg of meloxicam
2 mg of sodium benzoate
3.
Oral suspension.
4.
PACKAGE SIZE
10 ml
32 ml
100 ml
5.
Dogs.
6.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
To be administered mixed with food.
8.
Not applicable
27
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Shake well before use.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
10. EXPIRY DATE
EXP:
Once opened use within 6 months.
11. SPECIAL STORAGE CONDITIONS
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
Veterinary medicinal product subject to prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
CEVA SANTE ANIMALE
Z.I. la Ballastière
33500 Libourne
FRANCE
16. MARKETINGAUTHORISATIONNUMBER(S)
EU/2/06/070/001
EU/2/06/070/002
EU/2/06/070/003
28
17. MANUFACTURER’S BATCH NUMBER
Lot:
29
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10 ml bottle
32 ml bottle
100 ml bottle
1.
MELOXIDYL 1.5 mg/ml oral suspension for dogs.
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
10 ml
32 ml
100 ml.
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered mixed with food.
5.
Not applicable.
6.
BATCH NUMBER
Lot:
7.
EXPIRY DATE
EXP:
Once opened use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
30
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard box
1.
MELOXIDYL 5 mg/ml solution for injection for dogs, cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 ml contains: meloxicam 5 mg and excipient ethanol 150 mg
3.
Solution for injection.
4.
PACKAGE SIZE
10 ml
5.
Dogs and cats
6.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Dogs: intravenous or subcutaneous use
Cats: subcutaneous use
Read the package leaflet before use.
8.
31
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
Read the package leaflet before use.
10. EXPIRY DATE
EXP
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Do not store above 25 C
12. SPECIAL 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.
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
FRANCE
EU/2/06/070/004
17. MANUFACTURER’S BATCH NUMBER
Lot
32
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial label
1.
MELOXIDYL 5 mg/ml solution for injection for dogs, cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
1 ml contains: meloxicam 5 mg and excipient ethanol 150 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
4.
ROUTE(S) OF ADMINISTRATION
Dogs: IV or SC
Cats: SC
5.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
Shelf-life of broached vial: 28 days.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
33
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD BOX
1.
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs, horses
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Ethanol 150 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
50 ml
100 ml
250 ml
5.
Cattle, pigs, horses
6.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: Subcutaneous or Intravenous use
Pigs: Intramuscular use
Horses: Intravenous use
Read the package leaflet before use.
34
8.
Withdrawal period:
Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP
Shelf-life of broached vial: 28 days
11. SPECIAL STORAGE CONDITIONS
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Disposal: read package leaflet.
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.
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
FRANCE
35
EU/2/06/070/005
EU/2/06/070/006
EU/2/06/070/007
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
36
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
100 ml VIAL
250 ml
VIAL
1.
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs, horses
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Ethanol 150 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
100 ml
250 ml
5.
Cattle, pigs, horses
6.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: Subcutaneous or Intravenous use
Pigs: Intramuscular use
Horses: Intravenous use
Read the package leaflet before use.
37
8.
Withdrawal period:
Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP
Shelf-life of broached vial: 28 days
11. SPECIAL STORAGE CONDITIONS
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Disposal: read package leaflet.
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.
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
FRANCE
38
EU/2/06/070/006
EU/2/06/070/007
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
39
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
50 ml VIAL
1.
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs, horses
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 20 mg /ml
Ethanol 150 mg /ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
50 ml
4.
ROUTE(S) OF ADMINISTRATION
Cattle: SC or IV
Pigs: IM
Horses: IV
5.
Withdrawal period:
Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
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.
40
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard box
1.
MELOXIDYL 0.5 mg/ml oral suspension for cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 ml contains:
Meloxicam
0.5 mg
3.
Oral suspension.
4.
PACKAGE SIZE
15 ml
5.
Cats
6.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Read the package leaflet before use.
8.
Not applicable
41
Sodium benzoate
2 mg
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf life after first opening: 6 months.
11. SPECIAL STORAGE CONDITIONS
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Disposal: read package leaflet.
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.
CEVA SANTE ANIMALE
10 Avenue de La Ballastière
33500 Libourne
FRANCE
EU/2/06/070/008
17. MANUFACTURER’S BATCH NUMBER
Lot
42
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial label
1.
MELOXIDYL 0.5 mg/ml oral suspension for cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
15 ml
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
5.
Not applicable
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP
Shelf-life of opened bottle: 6 months
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET
MELOXIDYL 1.5 mg/ml oral suspension for dogs.
10, 32 & 100 ml
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CEVA SANTE ANIMALE
Z.I. la Ballastière
33500 Libourne
FRANCE
Manufacturers for the batch release:
CEVA SANTE ANIMALE
Z.I. Très le Bois
22600 Loudéac
FRANCE
Vetem SpA
Lungomare Pirandello, 8
92014 Porto Empedocle (AG)
ITALY
2.
MELOXIDYL 1.5 mg/ml oral suspension for dogs.
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains 1.5 mg of meloxicam
2 mg of sodium benzoate
4.
Meloxicam is a Non Steroidal Anti-Inflammatory Drug (NSAID) that alleviate inflammation and pain in
both acute and chronic musculo-skeletal disorders.
5.
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, or where there is evidence of
individual hypersensitivity to the product.
Do not use in dogs less than 6 weeks of age.
45
6.
ADVERSE REACTIONS
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood and apathy 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.
If you notice any serious effects or others effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
Shake well before use. To be administered mixed with food.
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.
The suspension can be given using the measuring syringes provided in the package. The syringe fits onto
the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1mg
Meloxicam/kg body weight). Thus, for the first day, twice the maintenance volume will be required.
Dosing procedure using the measuring syringe:
Shake bottle well.
Push down and
unscrew bottle top.
Attach the dosing
syringe to the bottle
by gently pushing
the end onto the top
of the bottle.
Turn the bottle and
syringe upside
down. Withdraw
the plunger until the
black line on the
plunger corresponds
to your dog’s
bodyweight in
kilograms.
Return the bottle
and syringe upright
and remove the
syringe.
Depress the plunger
to empty the
contents of the
syringe onto the
food.
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days after
the latest if no clinical improvement is apparent.
To avoid introduction of external contaminants during use, do not remove the bottle insert and keep the
provided syringes only for this product.
46
9. ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing.
The suspension could be administered using the smallest syringe for dogs less than 7 kg body weight (one
graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 7 kg body
weight (one graduation corresponding to 2.5 kg of body weight).
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Shelf life of opened bottle: 6 months.
Do not use after the expiry date stated on the carton and the bottle.
12. SPECIAL WARNING(S)
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if there is a potential risk of
increased renal toxicity.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high
protein binding may compete for binding and thus lead to toxic effects. MELOXIDYL
®
must not
be administered in conjunction with other NSAIDs or glucocortisosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse
effects andaccordingly a treatment-free period with such drugs should be observed for at least 24
hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacokinetic properties of the products used previously.
People with known hypersensitivity to 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.
In the case of overdosage, seek medical advice.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
26.01.2007
47
15. OTHERINFORMATION
10, 32 or 100 ml bottle with two syringes per presentation.
For any information about this veterinary medicinal product, please contact the marketing authorisation
holder:
CEVA SANTE ANIMALE
Z.I. La Ballastière
33500 Libourne
FRANCE
Tel: + 33 (0) 5 57 55 40 40
e-mail:
contact@ceva.com
48
PACKAGE LEAFLET FOR
MELOXIDYL 5 mg/ml solution for injection for dogs, cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CEVA SANTE ANIMALE –10 avenue de la Ballastière – 33500 Libourne - FRANCE
Manufacturer for the batch release:
ACCORD HEALTHCARE LIMITED - Sage House - 319 Pinner Road – Harrow – Middlesex
HA1 4HF – UK
2.
MELOXIDYL 5 mg/ml solution for injection for dogs, cats
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Meloxicam 5 mg/ml
Excipients: Ethanol 150 mg/ml
Clear, yellow solution.
4. INDICATION(S)
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.
5. CONTRAINDICATIONS
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.
49
6.
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. 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.If you notice
any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7.
Dogs and cats.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage for each species
Dogs
: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Cats
: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Method and route of administration
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
MELOXIDYL 1.5 mg/ml oral suspension 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.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection
before surgery, for example at the time of induction of anaesthesia.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single
subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use after the expiry date stated on the cardboard box and the vial after EXP.
Shelf-life after first opening the container: 28 days.
50
12. SPECIALWARNING(S)
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
anaesthesia.
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 any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased
renal toxicity.
Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as
appropriate dosage regimens for such follow-up treatments have not been established.
Precautions to be taken by the person administering the product
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 this package leaflet or the
label to the physician.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. MELOXIDYL 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 drugs should be observed for at least 24 hours before
commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
51
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
26.03.2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Pack size:
Cardboard box containing one 10 ml vial.
52
PACKAGE LEAFLET FOR
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs, horses
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
CEVA SANTE ANIMALE –10 avenue de la Ballastière – 33500 Libourne - FRANCE
2.
MELOXIDYL 20 mg/ml solution for injection for cattle, pigs, horses
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Meloxicam 20 mg/ml
Excipients: Ethanol anhydrous 150 mg/ml
Clear, colourless to yellowish solution.
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.
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.
5. CONTRAINDICATIONS
Do not use in horses less than 6 weeks of age.
Do not use in pregnant or lactating mares.
Do not use in horses producing milk for human consumption.
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.
53
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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle, pigs and horses
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. 2.5
ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.
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).
9.
ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
10. WITHDRAWAL PERIOD
Cattle: meat and offal: 15 days; milk: 5 days
Pigs: meat and offal: 5 days
Horses: 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.
Do not use after the expiry date which is stated on the cardboard box and vial after EXP.
Shelf-life after first opening the vial: 28 days.
54
12. SPECIALWARNING(S)
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.
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.
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 and pigs
:
Can be used during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory
drugs or with anti-coagulant agents.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
26.03.2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Cardboard box containing 1 colourless glass vial of 50 ml, 100 ml or 250 ml.
Not all pack sizes may be marketed.
55
PACKAGE LEAFLET FOR:
MELOXIDYL 0.5 mg/ml oral suspension for cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CEVA SANTE ANIMALE - 10 avenue de La Ballastière - 33500 Libourne - FRANCE
Manufacturer for the batch release:
CEVA SANTE ANIMALE – Z.I. Très le Bois - 22600 Loudéac - FRANCE
2.
MELOXIDYL 0.5 mg/ml oral suspension for cats
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
Meloxicam
0.5 mg
Sodium benzoate
2 mg
4.
Alleviation of inflammation and pain in chronic musculo-skeletal disorders in cats.
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
5. CONTRAINDICATIONS
- 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.
6.
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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
56
7.
Cats.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage
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.
Route and method of administration
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the measuring syringe provided in the package.
The syringe fits onto the bottle and has a kg-body weight scale (from 1 kg to 10 kg) which corresponds to
the maintenance dose (i.e. 0.05 mg meloxicam/kg body weight). Thus for initiation of the therapy on the
first day, twice the maintenance volume will be required.
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.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not
be exceeded
Please carefully follow the instructions of the veterinarian.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date stated on the label and the cardboard box after EXP.
Shelf-life after first opening: 6 months.
12. SPECIAL WARNING(S)
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 any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
57
MELOXIDYL 0.5 mg/ml oral suspension for cats should not be used following parenteral injection of
meloxicam or any other NSAID as appropriate dosage regimens for such follow-up treatments have not
been established in cats.
Precautions to be taken by the person administering the product
People with known hypersensitivity to 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.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. The product 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 drugs 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.
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 “Adverse reactions” are expected to be more
severe and more frequent. In the case of overdose symptomatic treatment should be initiated.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
26/08/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHERINFORMATION
Pack size:
Cardboard box containing 15 ml bottle with one measuring syringe.
The measuring syringe has a kg-body weight scale for cats (1 to 10 kg).
58
Source: European Medicines Agency
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