Melovem 30 mg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active substance:

Meloxicam 30 mg

Excipients:

Clear yellow solution.

3

Pharmacological properties

4.1 ATCvet code:

QM01AC06

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

Absorption After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values 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 Cmax 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.

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 biological elimination half-life is approximately 2.5 hours.

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

3

Target species

Cattle and pigs.

3

Indications

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-metritisagalactia syndrome) with appropriate antibiotic therapy.

3

Dosage

Cattle:

Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 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/150 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Avoid introduction of contamination during use.

When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper. The maximum number of broachings should be limited to 20.

3

Contraindications

See also section 3.7.

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.

3

Adverse reactions

Cattle and pigs:

Common (1 to 10 animals / 100 animals treated): Injection site swelling1

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Anaphylactoid reaction2

1 Transient swelling following subcutaneous administration in cattle.

2 May be serious (including fatal) and should be treated symptomatically.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

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 (NSAID) 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. Laboratory studies with the excipient N- methyl pyrrolidone have shown evidence of foetal malformations in rabbits and rats. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy and lactation or in animals intended for breeding. Laboratory studies with the excipient N-methyl pyrrolidone have shown evidence of foetal malformations in rabbits and rats. Use only according to the benefit-risk assessment by the responsible veterinarian.

See also section 3.3.

3

Interactions

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

3

Overdose

In the case of overdosage symptomatic treatment should be initiated.

3

Special warnings

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

Melovem 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.

3

Withdrawal period

Cattle:

Meat and offal: 15 days.

Milk: 5 days.

Pigs:

Meat and offal: 5 days.

3

Incompatibilities

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

3

Immediate packaging

Cardboard box with 1 colourless, type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

3

Storage

Keep the injection vial in the outer carton in order to protect from light. This veterinary medicinal product does not require any special temperature storage conditions.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months.

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

3

Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 28365/5001

8 DATE OF FIRST AUTHORISATION

07 July 2009

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 04 November 2025

3

Registration holder

Dopharma Research B.V.

3