Inflacam - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam           1.5 mg

Excipient

Sodium benzoate       5 mg.

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Oral suspension.

A yellow coloured suspension.

4. CLINICAL PARTICULARS4.1 Target species

Dogs.

• 4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

• 4.4 Special warnings for each target species

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Inflacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have 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 adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam 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 veterinary products used previously.

• 4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after > 4 days), the dose of Inflacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.

Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using the Inflacam 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 (i.e. 0.1 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 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

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 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.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Saccharin sodium

Sodium carboxyl methyl cellulose

Colloidal silicon dioxide

Citric acid monohydrate

Sorbitol solution

Disodium hydrogen-phosphate dodecahydrate

Sodium benzoate

Honey flavour

Purified water.

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 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

15 ml HDPE bottle with a tamper resistant child proof closure or 42, 100 or 200 ml polyethylene terephthalate (PET) bottle with a tamper resistant child proof closure and two polypropylene measuring syringes: one for small dogs (up to 20 kg) and one for bigger dogs (up to 60 kg).

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/001 15 ml

EU/2/11/134/002 42 ml

EU/2/11/134/0­03 100 ml

EU/2/11/134/0­04 200 ml

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam 20 mg

Excipient

Ethanol (96%):   159.8 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection, Clear yellow solution.

4. CLINICAL PARTICULARS4.1 Target species

Cattle, pigs and horses

• 4.2 Indications for use, specifying the target species

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.

For the relief of post-operative pain following dehorning in calves.

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.

4.3 Contraindications

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.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

• 4.4 Special warnings for each target species

Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain. Inflacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

• 4.5 Special precautions for use

Special 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.

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.

• 4.6 Adverse reactions (frequency and seriousness)

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,_ which may be serious (including fatal), may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

Cattle and pigs

Can be used during pregnancy and lactation.

Horses

Do not use in pregnant or lactating mares.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticos­teroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

• 4.9 Amounts to be administered and administration route

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).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo -skeletal disorders, Inflacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose, symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Cattle

Meat and offal: 15 days.

Milk: 5 days.

Pigs

Meat and offal: 5 days.

Horses

Meat and offal: 5 days.

Not authorised for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.

• 5.2 Pharmacoki­netic particulars

Absorption

After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 ^g/ml and 2.7 ^g/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 ^g/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.

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. PHARMACEUTICAL PARTICULARS6.1 List of excipients

• - Ethanol (96%)

• - Poloxamer 188

• - Macrogol 400

• - Glycine

• - Sodium hydroxide

• - Hydrochloric acid, concentrated

• - Meglumine

• - Water for injections.

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

• 6.5 Nature and composition of immediate packaging

Cardboard box with 1 colourless glass injection vial containing 20 ml, 50 ml, 100 ml or 250 ml.

Each vial is closed with a rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/005 20 ml

EU/2/11/134/006 50 ml

EU/2/11/134/0­07 100 ml

EU/2/11/134/0­08 250 ml

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency ( /).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam 15 mg

Excipient

Sodium benzoate 5 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.

White to off-white viscous oral suspension.

4. CLINICAL PARTICULARS4.1 Target species

Horses

• 4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

4.3 Contraindications

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in horses less than 6 weeks of age.

• 4.4 Special warnings for each target species

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

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.

• 4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions which may be serious (including fatal), may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

• 4.9 Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.

The suspension should be given using the Inflacam measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

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. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

• 5.2 Pharmacoki­netic particulars

Absorption

When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution

Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism

The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy-and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Saccharin sodium

Carmellose sodium

Silica, colloidal anhydrous

Citric acid monohydrate

Sorbitol, liquid (non-crystallising)

Disodium phosphate dodecahydrate

Sodium benzoate

Honey aroma

Purified water

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening of the immediate packaging: 3 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

HDPE bottle containing 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/0­09 100 ml

EU/2/11/134/0­10 250 ml

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 2.5 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance

Meloxicam 1 mg

Meloxicam 2.5 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.

Pale-yellow, single-scored, chewable tablets.

The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS4.1 Target species

Dogs

• 4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

4.3 Contraindications

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

• 4.4 Special warnings

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species.

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 the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have 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 adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam 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 medicines 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.

• 4.9 Amounts to be administered and administration route

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.

Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the dog.

Inflacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:

The use of Inflacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Inflacam oral suspension for dogs is recommended.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QMO1AC06.

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-l (COX-I).

• 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. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Lactose monohydrate

Silicified microcrystalline cellulose

Sodium acid citrate

Crospovidone

Talc

Pork flavour

Magnesium stearate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.

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

PVC/PVDC blister packs with a 20 micron foil.

Pack sizes: 20 and 100 tablets.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

Ireland

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/011

EU/2/11/134/012

EU/2/11/134/013

EU/2/11/134/014

9. DATE OF FIRST AUTHORISATIONIRENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this product is available on the website of the European Medicines Agency.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam      5 mg

Excipient(s)

Ethanol (96%)    159.8 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear yellow solution.

4. CLINICAL PARTICULARS4.1 Target species

Dogs and cats.

• 4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

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.

Refer to section 4.7.

• 4.4 Special warnings for each target species

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

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.

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.

• 4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis, and gastrointestinal ulceration have 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.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Do not use in pregnant or lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

• 4.9 Amounts to be administered and administration route

Maximum number of piercings is 42 for all presentations.

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).

Inflacam 1.5 mg/ml oral suspension for dogs or Inflacam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

• 5.2 Pharmacoki­netic particulars

Absorption

Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 pg/ml in dogs and 1.1 pg/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.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

In dogs, 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.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79% in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Ethanol (96%)

Poloxamer 188

Macrogol 400

Glycine

Disodium edetate

Sodium hydroxide

Hydrochloric acid, concentrated

Meglumine

Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Keep the vial in the outer carton.

• 6.5 Nature and composition of immediate packaging

Carton box containing one colourless glass injection vial of 10 ml, 20 ml or 100ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/015 10 ml

EU/2/11/134/016 20 ml

EU/2/11/134/0­17 100ml

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam          5 mg

Excipient

Ethanol (96%)          159.8 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear yellow solution.

4. CLINICAL PARTICULARS4.1 Target species

Cattle (calves and young cattle) and pigs.

• 4.2 Indications for use, specifying the target species

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 the relief of post-operative pain following dehorning in calves.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For the relief of post-operative pain associated with minor soft tissue such as castration.

4.3 Contraindications

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Do not use in pigs less than 2 days old.

• 4.4 Special warnings for each target species

Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain. Inflacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Inflacam before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/se­dative is needed.

To obtain the best possible pain relieving post-surgery Inflacam should be administered 30 minutes before surgical intervention.

• 4.5 Special precautions for use

Special 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.

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.

• 4.6 Adverse reactions (frequency and seriousness)

A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy.

Pigs: Can be used during pregnancy and lactation

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticos­teroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

• 4.9 Amounts to be administered and administration route

Cattle

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.

10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Cattle

Meat and offal: 15 days.

Pigs

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. 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 and pigs.

• 5.2 Pharmacoki­netic particulars

Absorption

After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 gg/ml were reached after 7.7 hours in young cattle.

Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 gg/ml was reached within 1 hour in pigs.

Distribution

More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism

Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

• - Ethanol (96%)

• - Poloxamer 188

• - Macrogol 400

• - Glycine

• - Disodium edetate

• - Sodium hydroxide

• - Hydrochloric acid, concentrated

• - Meglumine

• - Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

• 6.5 Nature and composition of immediate packaging

Carton box containing 1 colourless glass injection vial of 20 ml, 50 ml or 100 ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/018 20 ml

EU/2/11/134/019 50 ml

EU/2/11/134/0­20 100 ml

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( /).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One sachet contains:

Active substance

Meloxicam 330 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Granules in sachet.

Pale yellow granules.

4. CLINICAL PARTICULARS4.1 Target species

Horses.

• 4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.

4.3 Contraindications

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in horses less than 6 weeks of age.

• 4.4 Special warnings for each target species.

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

In order to minimise risk of intolerance, the product should be mixed into muesli feed.

This product is only for use in horses weighing between 500 and 600 kg.

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.

• 4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in horses is not recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other NSAIDs or with anti-coagulant agents.

• 4.9 Amounts to be administered and administration route

In-feed use.

To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days.

The product should be added to 250 g of muesli feed, prior to feeding.

Each sachet contains one dose for a horse weighing between 500 and 600 kg and the dose must not be divided into smaller doses.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

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. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

• 5.2 Pharmacoki­netic particulars

Absorption

When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution

Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism

The metabolism is qualitatively similar in rats, humans, cattle and pigs (including mini-pigs), although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy-and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Glucose monohydrate

Povidone

Apple flavour (containing butylated hydroxyanisole (E320))

Crospovidone

6.2 Major 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: 3 years.

Shelf life after incorporation into muesli feed: use immediately.

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

Paper foil sachets (paper/PE/alu/PE) containing 1.5 g granules per sachet in a cardboard box.

Pack size: 20 and 100 sachets.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/021

EU/2/11/134/022

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of latest renewal: 09/11/2016

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance

Meloxicam 0.5 mg

Excipient

Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.

A smooth light yellow suspension.

4. CLINICAL PARTICULARS4.1 Target species

Cats.

• 4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

4.3 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.

• 4.4 Special warnings for each target species

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Post-operative pain and inflammation following surgical procedures:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-Inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.

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 adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Concurrent administration of potential nephrotoxic veterinary medicinal products 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.

• 4.9 Amounts to be administered and administration route

Oral use.

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Inflacam 5 mg/ml solution for injection for cats, continue treatment

24 hours later with Inflacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight (0.1 ml /kg). The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight (0.4 ml/kg) on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight (0.1 ml /kg) for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight (0.2 ml/kg) 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 (0.1 ml /kg). 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.

Route and method of administration

A one ml syringe is provided with the product. The precision of the syringe is not suitable for the treatment of cats below 1 kg.

Shake well before use. To be administered orally either mixed with food or directly into the mouth. Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

• 5.2 Pharmacoki­netic particulars

Absorption

If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Sodium benzoate

Glycerol

Citric acid monohydrate

Xanthan gum

Sodium dihydrogen phosphate monohydrate

Simethicone emulsion

Honey flavour

Silica, colloidal anhydrous

Water, purified

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.

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:

3 ml and 5 ml bottle:           14 days

10 ml and 15 ml bottle:        6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

• 6.5 Nature and composition of immediate packaging

White high density polyethylene bottle containing 10 ml or 15 ml with a tamper proof child resistant closure.

Polypropylene bottle containing 3 ml or 5 ml with a tamper proof child resistant closure.

Each bottle is packed in a cardboard box with a 1 ml measuring syringe (barrel in polypropylene and plunger/piston in high density polyethylene).

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

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland.

8. MARKETING AUTHORISATION NUMBERS

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/12/2011

Date of last renewal: 09/11/2016