Recocam - summary of medicine characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Recocam 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 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.

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 excipient(s).

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

None.

• 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

Pregnancy and lactation:

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 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. 2.0 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 dose 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 musculoskeletal disorders, oral suspensions of meloxicam 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.

Do not broach the stopper more than 50 times.

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

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

• 4.11 Withdrawal periods

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: 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, 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 99.9%

Anhydrous citric acid

Poloxamer 188

Meglumine

Glycine

Macrogol 300

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

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 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal. Vials contain 10 ml, 50 ml or 100 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

Bimeda Animal Health Limited,

2, 3 & 4 Airton Close,

Tallaght, Dublin 24,

Ireland.

Tel:   +353 (0)1 4515011

Fax:   +353 (0)1 4621859

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/133/001–003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13/09/2011

Date of last renewal: 09/08/2016