Patient leaflet - Novaquin
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Novaquin 15 mg/ml oral suspension for horses
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Le Vet Beheer B.V.
Wilgenweg 7
3421 TV Oudewater
The Netherlands
Manufacturer responsible for batch release :
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Novaquin 15 mg/ml oral suspension for horses Meloxicam
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
Active substance
Meloxicam 15 mg.
Excipients
Sodium benzoate 1.75 mg
Yellowish-green viscous oral suspension.
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4. INDICATION(S)
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
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5. CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
6.
ADVERSE REACTIONS
Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). The clinical signs were reversible.
Loss of appetite, lethargy, abdominal pain and colitis have been reported in very rare cases. Anaphylactoid reactions, which may be serious (including fatal), may occur in very rare cases and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals, including isolated reports treated).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Horses.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage
Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Method and route of administration
Shake vigorously at least 20 times before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
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9. ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
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10. WITHDRAWAL PERIOD(S)
Meat and offal: 3 days.
Not authorised for use in mares producing milk for human consumption.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Shelf-life after first opening of the container: 5 months.
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12. SPECIAL WARNING(S)
Special precautions for use in animals :
Avoid use in any dehydrated, hypovolemic or hypotensive animal, as there is a potential risk of renal toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation :
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses Do not use in pregnant or lactating mares. See section “Contraindications”.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes) :
In case of overdose symptomatic treatment should be initiated.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED