Neocell

Melovem 30 mg/ml solution for injection for cattle and pigs

QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance: Meloxicam         30 mg

PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.

Target species
Cattle and pigs.

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.

Contraindications
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.

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 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.

Adverse reactions (frequency and seriousness)
In cattle and pigs, subcutaneous as well as intramuscular 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.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.

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.

Amounts to be administered and administration route
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.

Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose symptomatic treatment should be initiated.

Withdrawal period(s)
Cattle:
Meat and offal: 15 days.
Milk:        5 days.

Pigs:
Meat and offal: 5 days.

Incompatibilities
None known.

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.

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

Nature and composition of immediate packaging
Cardboard box with 1 colourless, type I glass injection vial of 50 ml, 100 ml and 250 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

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.