EMA Version

October 2021 – AN: 01355/2021

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

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1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

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 PARTICULARS

4.1 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 cases 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 Metacam 20 minutes before dehorning reduces post-operative pain. Metacam 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.

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)

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

In horses, a transient swelling at the injection site was observed in isolated cases in clinical studies, but resolved without intervention.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience 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 treated in 100 animals)

- 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.

See also section 4.3.

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.

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, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In 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 to 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, 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, C_maxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

After two intramuscular doses of 0.4 mg meloxicam/kg, a C_max value of 1.9 µg/ml was reached after 1 hour in pigs.

Distribution

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

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 PARTICULARS

6.1 List of excipients

Ethanol

Poloxamer 188

Macrogol 300

Glycine

Disodium edetate

Sodium hydroxide

Hydrochloric acid

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 (20 ml, 50 ml, 100 ml or 250 ml vials):

3 years.

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

6.4 Special precautions for storage

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

6.5 Nature and composition of immediate packaging

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or 100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.

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

Not all pack sizes may be marketed.

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBERS

Vm 04491/5021

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998

Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

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