SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

PROGRAM 80 mg Suspension for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance: Lufenuron (INN), 80 mg per syringe (0.8 ml of a 10% suspension)

Excipient(s): Povidone 12 in an aqueous vehicle.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection

White to yellow suspension in a pre-filled single-dose syringe for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Cats equal to or greater than 4 kg bodyweight.

4.2 Indications for use, specifying the target species

The product is intended for the prevention of flea multiplication in cats by inhibiting the development of flea eggs to adults for 6 months. The product is effective against eggs and larval stages of fleas.

Effective blood levels of Lufenuron are attained within 21 days.

4.3 Contraindications

Do not use in dogs. The excipient Polyvinylpyrrolidone (Povidone) is a potent histamine releasing substance in dogs. A severe reaction may occur in dogs that is not observed in cats.

4.4 Special warnings

If cats have flea infestation at the start of treatment, the use of a flea adulticide is recommended. It is essential that all cats (except for unweaned kittens) living in a household are treated with the product to stop flea infestation. Dogs in the same household should be treated as recommended by the prescribing veterinary surgeon.

4.5 Special precautions for use

Special precautions for use in animals

The injection should be carried out under aseptic conditions.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In the case of self-inoculation a local reaction may occur. In such circumstances seek medical advice.

4.6 Adverse reactions (frequency and seriousness)

Adverse reactions are very rarely reported. On very rare occasions injection with the product may cause pain, oedema or alopecia at the injection site. In particular, a small painless swelling may occur and usually disappears within 6 weeks after administration. In very rare cases lethargy has been reported for a few hours after injection, however it disappears quickly.

4.7 Use during pregnancy, lactation or lay

Pregnancy:

Can be used during pregnancy.

Lactation:

Can be used during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

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

Weight of cats in kg	less than 4	Equal to or greater than 4
dose	1 PROGRAM 40 Syringe	1 PROGRAM 80 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.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In a study where the product was administered to cats at 5 times the recommended dose, 3 times at 2 monthly intervals, the only adverse effect observed was transient inflammatory reaction at the injection sites.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

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

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, ectoparasicitcides for systemic use, chitinsynthesisinhibitors

ATCvet code: QP53BC01 (Lufenuron)

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 substance 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 particulars

After subcutaneous administration of the product, the active substance is absorbed from a small depot at the site of injection 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 substance in the bloodstream (above 50 – 100 ppb) for at least 6 months.

6. PHARMACEUTICAL PARTICULARS

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: 5 years.

The syringe must only be used once.

6.4. Special precautions for storage

Do not freeze.

Keep the syringes in the outer carton.

6.5 Nature and composition of immediate packaging

The product is available as prefilled sterile, disposable 1 ml Dupharject glass syringes, containing a withdrawable volume of 0.8 ml of a sterile white to yellow aqueous injectable suspension.

The syringes are ready to use and fitted with a stainless steel needle (gauge 25; 0.5 x 16 mm).

10 individually blistered syringes are packed in a cardboard box.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

8. MARKETING AUTHORISATION NUMBER

Vm 00879/4035

9. DATE OF FIRST AUTHORISATION

05 December 1997

10. DATE OF REVISION OF THE TEXT

March 2016

16 March 2016