Neocell

Melovem 5 mg/ml solution for injection for cattle and pigs

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance: Meloxicam 5 mg

PHARMACEUTICAL FORM
Clear, greenish yellow solution for injection.

Target species
Cattle (calves and young 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.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post operative pain associated with minor soft tissue surgery such as castration.

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.
Do not use in pigs less than 2 days old.

Special warnings
Treatment of piglets with Melovem before castration reduces post operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30
minutes before surgical intervention.

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 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)
Transient swelling at the injection site was commonly reported in clinical studies following
subcutaneous administration in cattle. Injection site swelling may be painful.
Transient swelling at the injection site was observed in clinical studies following intramuscular
administration in pigs.
In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.

Use during pregnancy, lactation or lay
Cattle:
Can be used during pregnancy.

Pigs:
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. 10.0 ml/100 kg
body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg
body weight). If required, a second administration of meloxicam can be given after 24 hours.
It is recommended to administer the second injection at a different site since local tolerance has been
assessed after single injection only.
Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.
Particular care should be taken with regard to the accuracy of dosing including the use of an
appropriate dosing device and careful estimation of body weight.
Avoid introduction of contamination during use.

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

Withdrawal periods
Cattle:
Meat and offal: 15 days.
Not permitted for use in lactating animals producing milk for human consumption.
Pigs:
Meat and offal: 5 days.

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

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.
Special precautions for storage
Keep injection vial in the outer carton in order to protect from light.
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 100 ml, which is 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.