Neocell

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

QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance: Meloxicam     20 mg

PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.

Target species
Cattle, pigs and horses.

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.

Contraindications
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.

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.
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 (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, intramuscular as well as intravenous 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 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.

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.

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 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).
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.

Horses:
Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.

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
Keep injection vial in the outer carton in order to protect from light.
Do not refrigerate or freeze. Protect from frost.

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.