Lufenuron suspension for injection 10%.

FOR CATS ONLY
The six month injection that prevents and controls flea infestations on cats and in their habitat.

DESCRIPTION:
The active ingredient in PROGRAM is lufenuron (N-[2, 5-dichloro-4-(1,1,2,3,3,3,-hexafluoropropoxy)- phenylaminocarbonyl]-2,6-difluorobenzamide).

INDICATIONS:
PROGRAM Injection is indicated for use in the control of flea infestations on cats and in their habitat.

PROGRAM works by interrupting the flea life cycle, thereby preventing the build-up of flea infestations on cats and their surroundings. PROGRAM is indicated for use in cats, including pregnant and lactating queens, and weaned kittens.

Treatment should be initiated at least one month before the onset of the flea season and continued throughout the entire flea season to prevent the build up of a flea infestation. PROGRAM is also indicated for control of active mid season flea infestations. However, in this situation, flea adulticides should be used concurrently at labelled rates for the first 6 - 8 weeks. This provides time for PROGRAM to impact flea population dynamics by interrupting the life cycle.

DOSAGE:
PROGRAM Injection is injected subcutaneously once every six [6] months at the minimum dosage of 10 mg lufenuron per kg of body weight.

RECOMMENDED DOSAGE SCHEDULE:

ADMINISTRATION:
The syringe must be shaken vigorously to reconstitute the suspension prior to injection. Inject the entire contents of the syringe subcutaneously [e.g. dorsally anterior to the shoulder blades].

The first dose should be administered before the onset of the flea season. Treatment should continue year round in areas where fleas are present throughout the year. Discontinuation of the PROGRAM regimen may result in flea reinfestation from sources outside the pet's immediate environment. When using PROGRAM for control of active mid-season flea infestations, flea adulticidal products should be used concurrently for the first 6 - 8 weeks.

All dogs and cats inhabiting the same household must receive PROGRAM Tablets [dog] or PROGRAM Injection [cat]. Failure to treat all pets in the household may result in suboptimal flea control caused by reinfestation from untreated animals.

PROGRAM should be used as part of a comprehensive flea control plan under the direction of a veterinarian.

PHARMACOLOGY:
Lufenuron, the active ingredient of PROGRAM, belongs to the chemical group of benzoylphenylurea compounds. These compounds are classified as insect development inhibitors that interfere with the transport process involved in polymerization of chitin or in the deposition of chitin chains. Chitin is the principal component of the flea egg case and cuticle that forms the exoskeleton of larval stages and adult fleas. Most affected flea eggs fail to hatch and, of those that do hatch, surviving larval stages fail to develop.

The development-inhibiting effect of this drug occurs when the adult flea is exposed through the blood meal to lufenuron present in the animal's blood. Eggs and larvae from adult fleas exposed to lufenuron in this manner fail to develop properly and die. Because female fleas must feed on blood before they can lay eggs, entire populations of immature life stages are eliminated, resulting in flea control.

Lufenuron has no direct effect on mature fleas since they have fully developed exoskeletons. In order to control existing adult flea infestations, adulticidal products should be used concurrently for the first 6 - 8 weeks while PROGRAM is exerting its life cycle disrupting effect.

SAFETY:
PROGRAM has a wide margin of safety in cats.

PROGRAM has been tested safely in over 10 breeds of cats, including pregnant females, breeding males and females, and kittens. In well-controlled clinical studies, PROGRAM was safely used in cats, many of which received other commonly used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, insecticide shampoos and dips.
Breeding studies in purpose-bred cats demonstrated no adverse responses in either the parental generation or in the birth and survival rate of their progeny following exposure to high doses of lufenuron [in excess of 3 times the blood level achieved by a single dose]. Males and females were given multiple doses 60 days prior to mating through pairing, and females were continually dosed throughout gestation and weaning.

Lufenuron was evaluated in young adult cats approximately 9 months of age for 3 months at rates up to 17 times the monthly use rate, administered on 3 consecutive days each month, without observable adverse effects. In the same study, the drug was administered at exaggerated levels [17x] concomitantly with commonly used carbamate and pyrethroid insecticide products for fleas. No toxicity enhancing effects were observed when lufenuron was administered simultaneously with the topically applied commercial insecticides. Tolerability studies in juvenile cats [11 weeks of age] and young adult cats [7 months of age] at 10 times the monthly use rate indicated a high degree of tolerance to lufenuron.

For safety information in dogs, see PROGRAM Tablets package insert.

PHARMACOKINETICS:
Following administration, lufenuron is distributed from the vascular compartment to adipose tissue. It is released steadily back into the blood, thus maintaining levels above the minimum effective concentration between treatments.

Warning: Keep this and all drugs out of the reach of children. If accidentally self injected, call a physician.

Caution:
For use in cats only. Do NOT use in dogs.