SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml solution for injection contains:

Active substance:

Meloxicam 20 mg

Excipients:

Ethanol, anhydrous 158.00 mg

For a 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, pig and horse

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 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

None.

4. 5 Special precautions for use

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.

Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

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

If accidental skin contact occurs, wash the affected area thoroughly.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

In cattle, a single subcutaneous injection can cause a non-painful swelling that lasts up to 23 days. Intravenous injection is generally well-tolerated.

In pigs, two consecutive intramuscular injections have a local irritant effect that can last up to 9 days.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In 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 displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, 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.

Do not use in horses producing milk for human consumption.

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 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).

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

In the case of overdosage symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle:

Meat and offal: 15 days

Milk: 5 days

Pigs:

Meat and offal: 8 days

Horses:

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, 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 B₂induced by E. coli endotoxin administration in calves, lactating cows and pigs.

5.2 Pharmacokinetic particulars

Absorption

In pigs, maximum plasma concentrations of meloxicam were reached at 1.0 h post administration of single intramuscular administration of Animeloxan 20 mg/mlat a dose of 0.4 mg meloxicam/kg body weight.

In cattle, maximum plasma concentrations of meloxicam were reached at 6.8 h post single subcutaneous administration of Animeloxan 20 mg/mlat a dose of 0.5 mg meloxicam/kg body weight.

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

In pigs, the mean terminal half-life was calculated to be approximately 3.2 h for meloxicam following intramuscular administration.

In cattle, the mean terminal half-life following subcutaneous administration was calculated to be approximately 14.0 h for meloxicam.

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

N-Methyl 2- Pyrrolidone

Ethanol, anhydrous

Sodium hydroxide

Hydrochloric acid, dilute

Water for injection

6.2 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: 28 days.

6.4. Special precautions for storage

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

6.5 Nature and composition of immediate packaging

Clear glass (type I) bottles of 50 ml and 100 ml, each closed with bromobutyl rubber stoppers and fixed with Aluminium/PP flip caps.

Available in cardboard boxes containing:

1 x 50 ml or 12 x 50 ml

1 x 100 ml or 12 x 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

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

aniMedica GmbH

Im Süedfeld 9

48308 Senden-Bösensell

Germany

8. MARKETING AUTHORISATION NUMBER

Vm24745/4015

9. DATE OF FIRST AUTHORISATION

Date:28 March 2012

10. DATE OF REVISION OF THE TEXT

Date:November2014

Approved: 04 December2014