Novartis
Program 40 mg solution for injection for cats < 4 kg

Treatment and prevention of flea infestations in cats

Some countries require a prescription to be issued for the sale of this drug.

PROGRAM 40 mg Suspension for Injection

2. Qualitative and Quantitative Composition of PROGRAM 40 mg

Active ingredient:  Lufenuron 40 mg per syringe (0.4ml of a 10% suspension)

For a full list of excipients see section 6.1

3. Pharmaceutical Form of PROGRAM 40 mg

Suspension for Injection
White, aqueous suspension

4. Clinical Particulars of PROGRAM 40 mg

4.1 Target species

Cats and weaned kittens less than 4 kg bodyweight.

4.2 Indications for use, specifying the target species

The product is intended for the 6-month long-term prevention and control of flea infestations and the treatment of FAD (flea allergic dermatitis) in cats. The product is effective against the pre-audit stages of the dominant flea species, Ctenocephalides felis and C. canis. It can be administered to all cats, including weaned kittens as well as pregnant and lactating queens.

4.3 Contra-indications

None known.

4.4 Special warnings for each target species

Not to be used in dogs.

In the cat, to achieve a six month flea control, a small subcutaneous depot is required. Injection site reaction may occur in some cats, in particular a small painless swelling at the injection site which disappears, in general, after a few weeks.

4.5 Special precautions for use

Special precautions for use in animals

For subcutaneous administration only.

The injection should be carried out under aseptic conditions.

4.5 ii) Special precautions to be taken by the person administering the medicinal product to the animals

Care should be taken to avoid accidental self-injection. In the event of accidental self-injection seek medical advice.
Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water. Seek medical attention if irritation persists.
Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Well tolerated by all cats but may cause a transient mild and painless reaction at the injection site. In rare cases, lethargy may occur for a few hours after injection, however, it quickly disappears.

4.7. Use during pregnancy, lactation or lay

No harmful effects are to be expected when this product is given during pregnancy and lactation.

4.8. Interaction with other medicinal products and other forms of interaction

No evidence of interactions with other medicaments has been observed.

4.9. Amounts to be administered and administration route

The minimum recommended dose is 10 mg Lufenuron per kg bodyweight when administered parenterally.

Weight of cats in kg

Less than 4

Dose: 1 PROGRAM 40mg  Suspension for Injection Syringe

Equal to or greater than 4

Dose: 1 PROGRAM 80mg Suspension for injection Syringe

For the product to be fully effective, the whole content of the syringe must be injected subcutaneously, e.g. dorsally anterior to the shoulder blades. It is recommended that cats be re-treated at 6-month intervals to ensure continuous effective control of flea development.

The syringe must be shaken vigorously to reconstitute the suspension and then injected immediately.

If cats have a high level of flea infestation at the start of treatment, it may be necessary to apply a flea adulticide during the first one or two months. In cases of severe hypersensitivity further use of an adulticide may be needed. It is essential that all cats (except for unweaned kittens) living in a household are treated to stop flea infestation. Dogs in the same household should be treated as recommended by the prescribing veterinary surgeon.

4.10. Overdose (symptoms, emergency procedure, antidotes) if necessary

No significant untoward effects due to overdosing have been observed in the target animal safety studies.

4.11. Withdrawal period

Not applicable

5. Pharmacological Properties of PROGRAM 40 mg

The active ingredient, Lufenuron, is an insect development inhibitor (IDI) belonging to the chemical class of benzoylureas.

ATCvet code QP53BC01

5.1 Pharmacodynamic Properties

Lufenuron (INN) is an inhibitor of chitin synthesis and deposition. When administered systemically to the animal, fleas infesting the cat ingest the active ingredient with their bloodmeal and transfer it to their eggs. As a consequence, the formation of larval chitin structures, a process essential to insects, and the development of viable offspring are blocked.

5.2 Pharmacokinetic Properties

After subcutaneous administration of the product, the active ingredient is absorbed from the injection site and preferentially sequestered in the adipose tissues, from where it is continuously released metabolically unchanged into the bloodstream. Effective blood levels of Lufenuron are attained within 21 days after the initial injection, and the low elimination rate assures an effective concentration of the active ingredient in the bloodstream (above 50-100 ppd) for at least 6 months.

6. Pharmaceutical Particulars of PROGRAM 40 mg

6.1 List of excipients

Polysorbate 21
Povidone 12
Sodium Chloride
Water for injections

6.2 Incompatibilities

None known.

6.3. Shelf Life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

6.4 Special Precautions for Storage

The syringe must only be used once.

Protect from freezing.

38.90
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