Emdocam - summary of medicine characteristics

NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:

Meloxicam        20 mg

Excipient:

Ethanol            150 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 Emdocam 20 minutes before dehorning reduces post-operative pain. Emdocam 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 AntiInflammatory 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 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, including isolated reports treated).

• 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 anticoagulant medicinal products.

• 4.9 Amounts to be administered and administration route

Cattle

Single subcutaneous or intravenous injection at a dose 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 dose of 0.4 mg meloxicam/kg body weight (i.e. 2 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 dose of 0.6 mg meloxicam/kg body weight (i.e. 3 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, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.

Avoid introduction of contamination during use.

Do not breach the vial more than 50 times.

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

In case of overdose, symptomatic treatment should be initiated.

• 4.11 Withdrawal periods

Not authorised to 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, Cmaxvalues 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 300

• - Glycine

• - Sodium hydroxide

• - Hydrochloric acid

• - Meglumine

• - Water for injections

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 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

Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml. Each vial is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

• 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

Emdoka bvba

• J. Lijsenstraat 16

B-2321 Hoogstraten

Belgium

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/128/001–003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18.08.2011

Date of last renewal: 21.06.2016

10. DATE OF REVISION OF THE TEXT

DD.MM.YYYY

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.

NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Meloxicam          15.0 mg

Excipients:

Sodium benzoate      1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

Yellow 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 animals 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.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

• 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.

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 in very rare cases.

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 anticoagulant 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 measuring syringe provided in the package. The syringe fits onto the bottle and has volume scale and a “kg-body weight” scale which corresponds to the maintenance dose (i.e. 0.6 mg meloxicam / kg body weight).

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 case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal period(s)

Meat and offal: 3 days.

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

5. PHARMACOLOGICAL PROPERTIES

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. 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

Sodium benzoate

Sorbitol, liquid

Glycerol

Saccharin sodium

Xylitol

Sodium dihydrogen phosphate dihydrate

Silica, colloidal anhydrous

Xanthan gum

Citric acid

Honey aroma

Purified water

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 first opening of 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

High density polyethylene bottle with a HDPE tamper-proof child-resistant screw cap and a 24 ml polypropylene measuring syringe with a volume scale and a “kg-body weight” scale which corresponds to the maintenance dose (i.e. 0.6 mg meloxicam / kg body weight).

Pack sizes :

Cardboard box with 1 bottle of 125 ml and a measuring syringe

Cardboard box with 1 bottle of 336 ml and a measuring syringe

Not all pack sizes may be marketed.

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

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

7. MARKETING AUTHORISATION HOLDER

Emdoka bvba

• J. Lijsenstraat 16

B-2321 Hoogstraten

Belgium

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/128/009 (125 ml)

EU/2/11/128/0­10(336 ml)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18.08.2011

Date of last renewal: 21.06.2016

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

Each ml contains:

Active substance:

Meloxicam 5 mg

Excipients:

Ethanol 150 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 surgery such as castration.

4.3 Contraindications

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

Cattle:

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

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

Pigs:

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

Do not use in pigs less than 2 days old.

Special warnings for each target species

Cattle:

Treatment of calves with Emdocam 20 minutes before dehorning reduces post-operative pain.

Emdocam alone will not provide adequate pain relief during the dehorning procedure.

To obtain pain relief during surgery co-medication with an appropriate anaesthetic/se­dative/analge­sic is needed.

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

Pigs:

Treatment of piglets with Emdocam before castration reduces post-operative pain.

To obtain pain relief during surgery co-medication with an appropriate anaesthetic/se­dative/analge­sic is needed.

To obtain the best possible pain-relieving effect post-surgery Emdocam 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 severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydratation, as there may be a potential risk of renal toxicity.

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

Special precautions to be taken by the person administering the veterinary medicinal product to animals Meloxicam may cause allergic reactions. People with known hypersensitivity to Non Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Accidental self-injection may give rise to pain. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

• 4.6 Adverse reactions (frequency and seriousness)

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.

Anaphylactic reactions, which may be serious (including fatal), may occur in very rare cases 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

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.

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 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.

As the vial should not be broached more than 50 times the user should select the most appropriate vial size according to the target species to be treated.

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

In case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal periods

Cattle (calves and young 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 properties. 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 cy clooxygenase-1 (COX-1). 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 ^g/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 ^g/ml was reached within 1 hour in pigs.

Distribution

More than 98 % of meloxicam is bound to plasma proteins in cattle and pigs.

In cattle and pigs, 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 metabolized to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

The main pathway of meloxicam biotransformation is oxidation.

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

Poloxamer 188

Sodium chloride

Glycine

Hydrochloric acid

Sodium hydroxide

Glycofurol

Meglumine

Water for injections

6.2 Major incompatibilities

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

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

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

6.4. Special precautions for storage

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

• 6.5 Nature and composition of immediate packaging

Colourless type I glass vials closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Pack sizes:

Cardboard box containing 1 vial of 50 ml

Cardboard box containing 1 vial of 100 ml

Cardboard box containing 1 vial of 250 ml

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

Emdoka bvba

John Lijsenstraat 16

2321 Hoogstraten

Belgium

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/128/004–006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18.08.2011

Date of last renewal: 21.06.2016

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

Each ml contains:

Active substance:

Meloxicam 5 mg

Excipients:

Ethanol 150 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, 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 cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in pregnant or lactating dogs and cats.

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

Do not use in dogs and cats less than 6 weeks of age nor in cats of less than 2 kg.

• 4.4 Special warnings for each target species

None.

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 severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydratation, as there may be a potential risk of renal toxicity.

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

Special precautions to be taken by the person administering the veterinary medicinal product to animals Meloxicam may cause allergic reactions. People with known hypersensitivity to Non Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Accidental self-injection may give rise to pain. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

• 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 rarely been reported.

Elevated liver enzymes have been reported in very rare cases.

Haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported in very rare cases. 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.

Anaphylactoid reactions may occur and should be treated symptomatically in very rare cases.

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 (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. Emdocam must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

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

Amounts to be administered and administration route

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.

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).

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.

As the vial should not be broached more than 50 times the user should select the most appropriate vial size according to the target species to be treated.

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

In case of overdose symptomatic treatment should be initiated.

• 4.11 Withdrawal periods

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, anti-exudative, analgesic and antipyretic properties. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

• 5.2 Pharmacoki­netic particulars

Absorption

Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 ^g/ml in dogs and 1.1 ^g/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 and cats. more than 97% of meloxicam is bound to plasma proteins in dogs and cats.

The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism

Meloxicam is predominantly found in plasma. It is also a major biliary excretion product in dogs and cats whereas urine contains only traces of the parent compound

In cats five major metabolites were detected all having been shown to be pharmacologically inactive.

The main pathway of meloxicam biotransformation is oxidation.

Elimination

In dogs and cats, 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 dogs.

In cats, 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

Poloxamer 188

Sodium chloride

Glycine

Hydrochloric acid

Sodium hydroxide

Glycofurol

Meglumine

Water for injections

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: 3years.

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 type I glass vials closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Pack sizes:

Cardboard box containing 1 vial of 20 ml

Cardboard box containing 1 vial of 50 ml

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

7. MARKETING AUTHORISATION HOLDER

Emdoka bvba

John Lijsenstraat 16

2321 Hoogstraten

Belgium

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/128/007–008

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18.08.2011

Date of last renewal: 21.06.2016