SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

PROGRAM 80mg Suspension for Injection

2. Qualitative and Quantitative Composition

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

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Suspension for injection

White, aqueous suspension

4. Clinical Particulars

Cats greater than or equal to 4 kg bodyweight.

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.

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

i. Special precautions for use in animals

For subcutaneous administration only.

The injection should be carried out under aseptic conditions.

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 case 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.

The product is 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

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

The minimum 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 40mg Suspension for Injection Syringe	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 procedures, 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

ATC vet code: QP53BX01

Pharmacotherapeutic group: Ectoparaciticides, insecticides and repellents, Ectoparasiticides for systemic use, Other ectoparasiticides for systemic use

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

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

6.1 List of excipients

Polysorbate 21

Povidone 12

Sodium Chloride

Water for injection

6.2 Incompatibilities

None known.

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

6.4 Special Precautions for Storage

Protect from freezing.

The syringe must only be used once.

6.5 Nature and Contents of Container

The product is available as prefilled sterile, disposable 1 ml Dupharject Type I glass syringes, containing a withdrawable volume of 0.8 ml. The syringes are ready to use and fitted with a stainless steel needle (gauge 25; 0.5 x 16 mm).

Pack Size

10 individually blistered syringes are packed in a cardboard box.

6.6 Special Precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.

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

7. Market Authorisation Holder

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

8. Marketing Authorisation number

Vm 00879/4038

9. Date of the first authorisation

24 December 1997

10. Date of revision of the text

March 2016

16 March 2016