ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Loxicom 0.5 mg/ml oral suspension for dogs
Meloxicam
2.
Each ml contains:
Active substance:
Meloxicam
0.5 mg
Excipients:
Sodium benzoate
1.5 mg
For a full list of excipients, see section 6.1.
3.
Pale yellow oral suspension.
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 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 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.
2
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 adverse reactions 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. Loxicom 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 pharmacokinetic properties of the products used previously.
Oral use.
To be administered with food or directly into the mouth.
Shake well before use.
Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 4 ml/10 kg bodyweight) 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 bodyweight (i.e. 2 ml/10 kg bodyweight).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.
The suspension can be given using either of the two measuring syringes provided in the package. The
syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance
dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for the first day, twice the maintenance volume
will be required. Alternatively therapy may be initiated with Loxicom 5 mg/ml solution for injection.
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 overdose, symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic 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
Glycerol
Povidone K30
Xanthan Gum
Disodium Phosphate Dihydrate
4
Sodium Dihydrogen Phosphate Dihydrate
Citric Acid Anhydrous
Simethicone Emulsion
Purified water
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: 18 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
The veterinary medicinal product is presented in 15 ml and 30 ml polyethylene screw bottles with
HDPE/LDPE child resistant caps. Two polyethylene/polypropylene measuring syringes, a 1 ml and a
5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs. Each
syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.25 kg to 5.0 kg and the 5 ml
syringe for 1 kg to 25 kg.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
material 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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
8.
EU/2/08/090/001
EU/2/08/090/002
9.
10/02/2009
5
23/03/2010
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.
6
Loxicom 1.5 mg/ml oral suspension for dogs
2.
Each ml contains:
Active substance:
Meloxicam
1.5 mg
Excipients:
Sodium Benzoate
1.5 mg
For a full list of excipients, see section 6.1
3.
Pale yellow oral suspension.
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 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 no 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.
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 adverse reactions 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. Loxicom 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 pharmacokinetic properties of the products used previously.
Oral use.
To be administered with food or directly into the mouth.
Shake well before use.
Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 1.33 ml/10 kg bodyweight)
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 bodyweight (i.e. 0.667 ml/10 kg bodyweight).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.
The suspension can be given using either of the two measuring syringes provided in the package
(depending on weight of dog). The syringes fit onto the bottle and have a kg-bodyweight scale which
corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for the first day,
twice the maintenance volume will be required. Alternatively therapy may be initiated with Loxicom
5 mg/ml solution for injection.
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.
8
Avoid introduction of contamination during use.
In the case of overdose, symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic 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 in dogs. 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
Glycerol
Povidone K30
Xanthan Gum
9
Disodium Phosphate Dihydrate
Sodium Dihydrogen Phosphate Dihydrate
Citric Acid Anhydrous
Simethicone Emulsion
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 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
The veterinary medicinal product is presented in 10 ml, 32 ml and 100 ml polyethylene screw bottles
with HDPE/LDPE child resistant caps. Two polyethylene/polypropylene measuring syringes, a 1 ml
and 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs. Each
syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.5 kg to 15 kg and the 5 ml
syringe for 2.5 kg to 75 kg.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
material 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.
Norbrook Laboratories Limited
Station Works
Newry
Co Down, BT35 6JP
United Kingdom
8.
EU/2/08/090/003
EU/2/08/090/004
EU/2/08/090/005
9.
10/02/2009
10
23/03/2010
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
Loxicom 5 mg/ml solution for injection for dogs and cats
2.
Each ml contains:
Active substance:
Meloxicam
5 mg
Excipients:
Ethanol, anhydrous
150 mg
For a full list of excipients, see section 6.1.
3.
Pale yellow solution for injection.
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.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
12
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
Do not use an oral follow-up therapy containing meloxicam or other non-steroidal anti-inflammatory
drugs (NSAIDs) in cats, as no safe dosage for repeated oral administration has 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 adverse reactions 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. Loxicom 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
bodyweight (i.e. 0.4 ml/10 kg bodyweight). Loxicom 1.5 mg/ml oral suspension and Loxicom
0.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg
meloxicam/kg bodyweight, 24 hours after administration of the injection.
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 bodyweight (i.e. 0.4 ml/10 kg bodyweight) before
surgery, for example at the time of induction of anaesthesia.
13
Cats:
Reduction of post-operative pain: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg
bodyweight (i.e. 0.06 ml/kg bodyweight) 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: Anti-inflammatory and anti-rheumatic 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 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.
14
6.
6.1 List of excipients
Meglumine
Glycine
Ethanol (anhydrous)
Poloxamer 188
Sodium Chloride
Glycofurol
Sodium Hydroxide (for pH adjustment)
Hydrochloric Acid (for pH adjustment)
Water for Injection
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: 18 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
Colourless glass injection vial of 10, 20 or 100 ml, closed with a bromobutyl 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 product or waste
material derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
7.
Norbrook Laboratories Limited
Station Works
Newry
Co Down, BT35 6JP
United Kingdom
8.
EU/2/08/090/006
EU/2/08/090/007
EU/2/08/090/008
15
9.
10/02/2009
23/03/2010
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
Loxicom 0.5 mg/ml oral suspension for cats
2.
Each ml contains:
Active substance:
Meloxicam
0.5 mg
Excipient:
Sodium benzoate
1.5 mg
For a full list of excipients, see section 6.1.
3.
Pale yellow oral suspension.
4.
Cats.
Alleviation of inflammation and pain in chronic musculo-skeletal disorders in cats.
Do not use in pregnant or lactating cats.
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.
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Loxicom 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.
17
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 adverse reactions 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. Loxicom 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.
Oral use.
To be administered with food or directly into the mouth.
Shake well before use.
Initial treatment is a single dose of 0.1 mg meloxicam/kg bodyweight 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 bodyweight.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should
not be exceeded. The suspension should be given using the Loxicom measuring syringe provided in
the package.
Dosing Procedure:
The syringe fits onto 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 is 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.
18
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen
at relatively small overdose levels. In the 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.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory 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. Due to the loading dose, steady is reached after 2 days (48 h).
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.
6.1 List of excipients
Sodium Benzoate
Glycerol
Povidone K30
Xanthan Gum
19
Disodium Phosphate Dihydrate
Sodium Dihydrogen Phosphate Dihydrate
Citric Acid Anhydrous
Simethicone Emulsion
Purified water
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: 18 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
The veterinary medicinal product is presented in 15 ml polyethylene screw bottles with HDPE/LDPE
child resistant caps. The 1 ml measuring syringe has a kg-body weight scale for cats (0.5 to 10 kg).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
material 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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
Northern Ireland
8.
EU/2/08/090/009
9.
23/03/2010
20
23/03/2010
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.
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
Loxicom 0.5 mg/ml Oral Suspension
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
Name and address of the manufacturer responsible for batch release
:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
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.
23
Loxicom 1.5 mg/ml Oral Suspension
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
Name and address of the manufacturer responsible for batch release
:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
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.
24
Loxicom 5 mg/ml Solution for Injection
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
Name and address of the manufacturer responsible for batch release
:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
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.
25
Loxicom 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
:
Norbrook Laboratories Limited
Newry,
Co. Down
Northern Ireland
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
Not applicable.
D. STATEMENT OF MRLs
Not applicable.
26
ANNEX III
LABELLING AND PACKAGE LEAFLET
27
A. LABELLING
28
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box 15 and 30 ml bottle
1.
Loxicom 0.5 mg/ml oral suspension for dogs
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam
0.5 mg
Sodium benzoate
1.5 mg
3.
Oral suspension.
4.
PACKAGE SIZE
15 ml
30 ml
5.
Dogs.
6.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth.
Avoid introduction of contamination during use.
Read the package leaflet before use.
8.
Not applicable.
29
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP:
Once opened use within 6 months.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions
.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS,IF ANY
Dispose of waste material in accordance with local requirements.
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 OUR OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
EU/2/08/090/001 [15 ml]
EU/2/08/090/002 [30 ml]
17. MANUFACTURERS BATCH NUMBER
BN:
30
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 and 30 ml bottle
1.
Loxicom 0.5 mg/ml oral suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 0.5 mg/ml
3.
CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
15 ml
30 ml
4.
ROUTE OF ADMINISTRATION
Oral use.
Shake well before use.
5.
Not applicable.
6.
BATCH NUMBER
BN:
7.
EXPIRY DATE
EXP:
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
31
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box 10, 32 and 100 ml bottle
1.
Loxicom 1.5
mg/ml oral suspension for dogs
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
1.5
mg
Sodium benzoate
1.5 mg
3.
Oral suspension.
4.
PACKAGE SIZES
10 ml
32 ml
100 ml.
5.
Dogs.
6.
INDICATIONS
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth.
Avoid introduction of contamination during use.
Read the package leaflet before use.
8.
Not applicable.
32
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP:
Once opened use within 6 months.
11 SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
EU/2/08/090/003 [10 ml]
EU/2/08/090/004 [32 ml]
EU/2/08/090/005 [100 ml]
17. MANUFACTURER’S BATCH NUMBER
BN:
33
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
100
ml bottle
1.
Loxicom 1.5
mg/ml oral suspension for dogs
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
1.5
mg
Sodium benzoate
1.5 mg
3.
Oral suspension.
4.
PACKAGE SIZES
100 ml.
5.
Dogs.
6.
INDICATIONS
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth.
Avoid introduction of contamination during use.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
34
10. EXPIRY DATE
EXP:
Once opened use within 6 months.
11 SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
EU/2/08/090/005 [100 ml]
17. MANUFACTURER’S BATCH NUMBER
BN:
35
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10 and 32 ml bottle
1.
Loxicom 1.5
mg/ml oral suspension for dogs
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
Oral use.
Shake well before use.
Avoid introduction of contamination during use.
5.
Not applicable.
6.
BATCH NUMBER
BN:
7.
EXPIRY DATE
EXP:
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
36
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box 10
ml, 20
ml and 100
ml bottle
1.
Loxicom 5 mg/ml solution for injection for dogs and cats
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
150 mg
3.
Solution for injection.
4.
PACKAGE SIZES
10 ml
20 ml.
100 ml
5.
Dogs and cats.
6.
INDICATIONS
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.
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.
Avoid introduction of contamination during use.
37
Ethanol, anhydrous
5 mg
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP:
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
EU/2/08/090/006 [10 ml]
EU/2/08/090/007 [20 ml]
EU/2/08/090/008 [100 ml]
38
17. MANUFACTURER’S BATCH NUMBER
BN:
39
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
100
ml bottle
1.
Loxicom 5 mg/ml solution for injection for dogs and cats
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
5 mg
Ethanol, anhydrous
150 mg
3.
Solution for injection.
4.
PACKAGE SIZES
100 ml
5. TARGET SPECIES
Dogs and cats.
6.
INDICATIONS
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.
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.
Avoid introduction of contamination during use.
Read the package leaflet before use.
40
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP:
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
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.
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
EU/2/08/090/008 [100 ml]
17. MANUFACTURER’S BATCH NUMBER
BN:
41
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10
and 20
ml bottle
1.
Loxicom 5 mg/ml solution for injection for dogs and cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 5 mg/ml
3.
CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
20 ml
4.
ROUTE(S) OF ADMINISTRATION
Dogs: intravenous or subcutaneous use.
Cats: subcutaneous use.
5.
Not applicable.
6.
BATCH NUMBER
BN:
7.
EXPIRY DATE
EXP:
Shelf-life of opened bottle: 28 days
Once broached, use by……………………….
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
42
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Loxicom 0.5 mg/ml Oral Suspension for Cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam: 0.5 mg/ml.
Sodium Benzoate: 1.5 mg/ml.
3.
Oral suspension.
4.
PACKAGE SIZE
15 ml
5.
Cats.
6.
Alleviation of inflammation and pain in chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered orally either mixed with food or directly into the mouth using the Loxicom
measuring syringe provided.
Avoid introduction of contamination during use.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
43
9. SPECIAL WARNING(S), IF NECESSARY
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 cats less than 6 weeks old.
Loxicom 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.
10. EXPIRYDATE
EXP:
Shelf-life of opened bottle: 6 months.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Dispose of in accordance with local requirements.
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.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Norbrook Laboratories Limited
Newry
Co. Down
Northern Ireland
Telephone number: +44 (0) 2830260200
Fax number: +44 (0) 2830260201
44
MINIMUM PARTICULARS TO APPEAR ON SMALL IMEMEDIATE PACKAGING UNITS
1.
Loxicom 0.5
mg/ml Oral Suspension for Cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 0.5
mg/ml
3.
CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
15 ml
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth using the Loxicom measuring syringe
provided.
Avoid introduction of contamination during use.
Read the package leaflet before use.
5.
Not applicable.
6.
BATCH NUMBER
BN:
7.
EXPIRY DATE
EXP:
Shelf-life of opened bottle: 6 months.
Once broached, use by……..
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
To be supplied only on veterinary prescription.
46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET FOR:
Loxicom 0.5 mg/ml oral suspension for dogs
THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
Manufacturer for the batch release:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
Loxicom 0.5
mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
0.5
mg
Sodium benzoate
1.5 mg
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
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 dogs less than 6 weeks of age.
6.
ADVERSE REACTIONS
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 adverse reactions 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.
48
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage:
Initial treatment is a single dose of 0.2
mg meloxicam/kg bodyweight (i.e. 4 ml/10 kg bodyweight) 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 bodyweight (i.e. 2 ml/10 kg bodyweight).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.
Method and route of administration:
Oral use.
To be administered with food or directly into the mouth.
Shake well before use.
The suspension can be given using either of the two measuring syringes provided in the package. The
syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance
dose (i.e. 0.1
mg meloxicam/kg bodyweight). Thus for initiation of the therapy on the first day, twice
the maintenance volume will be required. Alternatively therapy may be initiated with Loxicom
5
mg/ml solution for injection.
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.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
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.
Shelf-life after first opening the container: 6 months.
49
Do not use after the expiry date stated on the carton and the bottle.
12.
SPECIAL WARNINGS
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.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Loxicom 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 pharmacokinetic properties of the products used previously.
In the case of overdose, symptomatic treatment should be initiated.
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 this package leaflet or the
label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via waste water or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
23/03/2010
15. OTHER INFORMATION
Polyethylene bottle containing 15 or 30 ml with two polyethylene/polypropylene measuring syringes.
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.
50
PACKAGE LEAFLET FOR:
Loxicom 1.5 mg/ml oral suspension for dogs
THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder:
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
Manufacturer for the batch release:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
Loxicom 1.5
mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
1.5
mg
Sodium benzoate
1.5
mg
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
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 dogs less than 6 weeks of age.
6.
ADVERSE REACTIONS
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 adverse reactions 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.
51
If you notice any serious effects or effects not mentioned in this leaflet, please inform your veterinary
surgeon.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage:
Initial treatment is a single dose of 0.2
mg meloxicam/kg bodyweight (i.e.
1.33
ml/10
kg bodyweight)
on the first day. Treatment is to be continued once daily by oral administration (at 24 hour interval) at
a maintenance dose of 0.1
mg meloxicam/kg bodyweight (i.e. 0.667
ml/10 kg bodyweight).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.
Method and route of administration:
Oral use. To be administered with food or directly into the mouth. Shake well before use.
The suspension can be given using either of the two measuring syringes provided in the package. The
syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance
dose (i.e. 0.1
mg meloxicam/kg bodyweight). Thus for initiation of the therapy on the first day, twice
the maintenance volume will be required.
Alternatively therapy may be initiated with Loxicom 5
mg/ml solution for injection.
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.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Shelf-life after first opening the container: 6 months.
Do not use after the expiry date stated on the carton and the bottle.
This veterinary medicinal product does not require any special storage conditions.
52
12. SPECIAL WARNINGS
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.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Loxicom 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 pharmacokinetic properties of the products used previously.
In the case of overdose symptomatic treatment should be initiated.
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 this package leaflet or the
label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, if any
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
23/03/2010
15. OTHER INFORMATION
Polyethylene bottle containing 10, 32 or 100
ml with two polyethylene/polypropylene measuring
syringes. 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.
53
PACKAGE LEAFLET FOR:
Loxicom 5
mg/ml solution for injection for dogs and cats
THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder:
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
United Kingdom
Manufacturer for the batch release:
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
Loxicom 5 mg/ml solution for injection for dogs and cats
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each ml contains:
Meloxicam
5 mg
Ethanol, anhydrous
150 mg
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.
54
6.
ADVERSE REACTIONS
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 adverse reactions 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.
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 bodyweight (i.e. 0.4 ml/10 kg).
Cats: single administration of 0.3 mg meloxicam/kg bodyweight (i.e. 0.06 ml/kg).
Method and route of administration:
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
Loxicom 1.5 mg/ml oral suspension or Loxicom 0.5 mg/ml oral suspension may be used for
continuation of treatment at a dosage of 0.1 mg meloxicam/kg bodyweight, 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.
Not applicable.
55
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 the bottle.
12.
SPECIAL WARNING(S)
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
anaesthesia.
Precautions for use in animals
If adverse effects 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.
Do not use an oral follow-up therapy containing meloxicam or other NSAIDs in cats, as no safe
dosage for repeated oral administration has been established.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Loxicom 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.
In the case of overdose symptomatic treatment should be initiated.
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.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, if any
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
56
14.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
23/03/2010
15.
OTHER INFORMATION
10 ml, 20 ml or 100 ml injection vial.
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.
57
PACKAGE LEAFLET:
Loxicom 0.5 mg/ml Oral Suspension for Cats
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Manufactured by:
Norbrook Laboratories Limited
Newry, Co. Down
Northern Ireland
Loxicom 0.5 mg/ml Oral Suspension for Cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each ml contains 0.5 mg of Meloxicam and 1.5 mg of Sodium Benzoate.
4.
INDICATION(S)
Alleviates inflammation and pain in chronic musculo-skeletal disorders in cats.
Should not be used in pregnant or lactating animals.
Should not be used in animals suffering from gastrointestinal disorders such as irritation and
haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Should not be used in case of hypersensitivity to the active substance or to any of the excipients.
Should not be used in cats less than 6 weeks old.
Typical adverse drug 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.
Cats.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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. The recommended dose should not be exceeded. Loxicom
58
0.5 mg/ml Oral Suspension for Cats is to be administered orally either mixed with food or directly into
the mouth. The suspension is given using the Loxicom measuring syringe provided in the package.
The syringe fits onto 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.
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.
9.
ADVICE ON CORRECT ADMINISTRATION
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen
at relatively small overdose levels. To ensure administration of a correct dose, body weight should be
determined as accurately as possible; accuracy of the dosing device should be checked.
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
This veterinary medicinal product does not require any special storage conditions.
12.
SPECIAL WARNINGS
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.
Loxicom 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.
Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
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 label
to the physician.
Interaction with other medicinal products:
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Loxicom 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 with Loxicom. The treatment free period, however, should take
into account the pharmacological properties of the products used previously.
59
For Animal Treatment Only.
Keep out of reach of children.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
23/03/2010
15.
OTHER INFORMATION
To be supplied only on veterinary prescription.
Mode of Action
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).
Package Information
Loxicom 0.5 mg/ml Oral Suspension for Cats is available in 15 ml volumes.
60
Source: European Medicines Agency
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