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INTERCEPTOR® (Milbemycin Oxime) FLAVOR TABS®

By: Novartis Animal Health

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INTERCEPTOR Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworms (Toxocara canis, Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety

INTERCEPTOR has been tested safely in over 75 different breeds of dogs, including collies, pregnant females, breeding males and females, and puppies over two weeks of age. In well-controlled clinical field studies, 786 dogs completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, shampoos and dips.

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin related effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

Some nursing puppies, at 2, 4, and 6 weeks of age, given greatly exaggerated oral INTERCEPTOR doses (9.6 mg/kg = 19X) exhibited signs typified by tremors, vocalization and ataxia. These effects were all transient and puppies returned to normal within 24 to 48 hours. No effects were observed in puppies given the recommended dose of INTERCEPTOR (0.5 mg/kg). This product has not been tested in dogs less than 1 kg weight.

A rising-dose safety study conducted in roughcoated collies manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency in one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How Supplied

INTERCEPTOR Flavor Tabs are available in four tablet sizes (see Dosage section), formulated according to the weight of the dog. Each tablet size is available in color-coded packages of 6 tablets each which are packaged 10 per display carton.

Storage Conditions

INTERCEPTOR Flavor Tabs should be stored at room temperature, between 59° and 86°F (15°-30°C).

U.S. Patent No. 4,547,520

Manufactured for:
Novartis Animal Health US, Inc.
Greensboro, NC 27404, USA

NADA #140-915, Approved by FDA.

®1999 NovartisNAH/INT-FT/VI/1
08/98

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