Laboratory and clinical trials have shown that PROGRAM 6 Month Injectable for Cats is a safe, effective and convenient method to control flea populations. A single dose provides long-lasting control for a full six months.

In laboratory studies, PROGRAM 6 Month Injectable for Cats provided a cumulative percent control of egg development of 94.8% and 97.7% beginning 14 days post-treatment through six months post-treatment in the dose titration and dose confirmation studies, respectively. There was a 2-3 week "induction phase" in these studies before significant effects on flea reproduction were seen.

PROGRAM 6 Month Injectable for Cats was effective in controlling flea populations when administered to 183 pet cats in a clinical setting. At study initiation, treated cats averaged 43 fleas per cat. Six months post-injection these cats averaged 11 fleas per cat.

Dosage

PROGRAM 6 Month Injectable for Cats is injected subcutaneously once every six months at the recommended minimum dosage of 4.54 mg lufenuron per pound (10 mg/kg) of body weight.

Recommended Dosage Schedule

Body Weight                                Syringe Size                Lufenuron Dose
Up to 8.8 lbs.(4.0 kg).....................Small (0.4 ml).................40 mg
8.9 lbs. to 17.6 lbs.(4.1 to 8.0 kg)....Large (0.8 ml).................80 mg

Administration

Administer PROGRAM 6 Month Injectable for Cats subcutaneously using standard injection technique. Before administration, shake well to mix the sterile suspension thoroughly. Remove the needle guard and subcutaneously inject the entire contents of the syringe. Do not inject intramuscularly. The empty syringe should be disposed of in an approved manner.

To ensure the greatest benefits from the use of PROGRAM 6 Month Injectable for Cats, it is important to treat all cats within a household. All dogs within the household should be treated with lufenuron tablets. Untreated dogs and cats may develop infestations which could reduce the overall flea control within a household.

Do not administer this product to dogs.

Adverse Reactions

The following adverse reactions were observed in clinical field trials with PROGRAM 6 Month Injectable for Cats: pain on injection, injection site lumps/granulomas, vomiting, listlessness/lethargy, and anorexia.

Histologic examination of one cat's injection site lump showed evidence of inflammation surrounding an area of necrosis with marked proliferation of fibrous connective tissue. In another cat, granulomatous inflammation was noted which included non-pleomorphic fibrocytes and fibroplasia.

How Supplied

PROGRAM 6 Month Injectable for Cats is available in 0.4 ml and 0.8 ml unit dose syringes, formulated according to the weight of the cat. Unit dose packs are available in packages of 10 syringes per carton.

Storage Conditions

PROGRAM 6 Month Injectable for Cats should be stored at room temperature between 59° and 86°F (15-30°C).

Manufactured for:
Novartis Animal Health US, Inc.
Greensboro, NC 27404, USA
NADA # 141-105, Approved by FDA.

®1999 Novartis
NAH/PRO-FI/VI/1
2/98