Interceptor Flavor Tabs

Interceptor Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5mg/kg).

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Milbemycin oxime 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 milbemycin oxime 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 milbemycin oxime (0.5 mg/kg). This product has not been tested in dogs less than 1 kg weight.

A rising-dose safety study conducted in rough coated 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.

Interceptor Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

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

Manufactured for:      

Novartis Animal Health US, Inc.,

Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

NAH/INT-FTC/VI/3

12/07

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.

©2007 Novartis

(milbemycin oxime) FLAVOR TABS®

The palatable once-a-month tablet that prevents heartworm disease and removes adult roundworms and hookworms in cats and kittens.

Package Label – 2.3 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies.

Net contents: 6 tablets. 2.3 mg each.

Product #20111 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use
by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH