Navilox 3% W/W Powder For In-Feed Use
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Navilox 3% w/w powder for in-feed use
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoxsuprine Hydrochloride 3% w/w.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder for in-feed use.
Fine white powder.
4. CLINICAL PARTICULARS
4.2 Indications for use, specifying the target species
Cases of Navicular disease in the horse.
Do not administer to pregnant mares or following arterial haemorrhage. Do not administer within 14 days post-partum.
Isoxsuprine may be detected in urine at low levels for long variable periods after administration. No recommendation can therefore be given on withdrawal before competing, and consequently NAVILOX is not recommended for use in competition horses.
4.4 Special warnings for each target species
4.5 Special precautions for use
(i) Special precautions for use in animals
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid breathing the powder while mixing with feed.
It is recommended that a dust mask be worn when using this product. Use in a well ventilated area.
Do not eat, drink or smoke while using the product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
At the clinically recommended dose, no side effects have been reported.
Use during pregnancy, lactation or lay
No studies have been reported on use during pregnancy and lactation. Therefore, use is not recommended.
Interaction with other medicinal products and other forms of interaction
Amounts to be administered and administration route
Administer on an empty stomach, approximately 30 minutes before feeding, by adding to a small quantity of feed.
The optimum dosage regimen is 20mg of Navilox per kilogram of bodyweight (equivalent to 0.6mg Isoxsuprine hydrochloride/kg bodyweight).
Treatment should be continued over a full 12 week period according to the following schedule, for a 500kg horse.
Frequency of Dosage
Twice daily for 6 weeks
Once daily for 3 weeks
Alternate days for 3 weeks
3 level measures = 10g
Add to feed immediately before administration. Discard any remaining medicated feed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose may cause the animal to sweat but no other effects have been reported with oral administration. Animals should be treated symptomatically.
Not to be used in animals intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
5. PHARMACOLOGICAL PROPERTIES
Isoxsuprine is a phenylethylamine derivative of epinephrine. It is a vasodilator which also stimulates beta-adrenergic receptors. These effects cause direct relaxation of vascular and uterine smooth muscle. Its dilating action is greater on the arteries supplying skeletal muscles than on those supplying the skin. Isoxsuprine also produces positive ionotrophic effects, lowers blood viscosity and inhibits platelet aggregation.
In horses, orally administered Isoxsuprine has been used mainly for its effects on the peripheral circulation, in the treatment of Navicular disease, Podotrochlosis, Sesamoiditis and Arthrosis.
Isoxsuprine hydrochloride acts by improving the blood supply to the Navicular bone and thus treats the underlying blood flow problems associated with Navicular disease.
After intravenous administration of 0.6mg/kg isoxsuprine to horses, peak plasma concentrations were attained soon after it was given. These decreased over a 12 hour period in a bi-exponential way, with distribution and elimination half-lives of 14 minutes and 2.67 hours respectively.
Isoxsuprine is well absorbed from the gastro-intestinal tract and is excreted in the urine mainly as conjugates.
List of excipients
Shelf life of the veterinary product as packaged for sale; 2 years.
Special precautions for storage
Do not store above 25C. Store in a dry place away from animal feeding stuffs.
Reseal container after use.
Nature and composition of immediate packaging
The product is packed into 300g white high density polyethylene pots with white high density polypropylene screw tops. A clear polythene bag inner liner is sealed with a tie. Each pot is supplied with a 5ml scoop.
6.6 Special precautions for the disposal of unused veterinary medicinal product 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.
MARKETING AUTHORISATION HOLDER
Vétoquinol UK Limited
Buckingham Industrial Park
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 January 1991/10 January 2006
10. DATE OF REVISION OF THE TEXT