SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

PYRIPROXYFEN 1% PREMIX FOR DOG VIRBAC.

2. Qualitative and quantitative composition

Pyriproxyfen……………………………0.01 g

Excipient Q.S. 1 g

For a full list of excipients see point 6.1

3. Pharmaceutical form

Premix for medicated feed

4. Clinical particulars

4.1. Target species

Dogs

4.2. Indications for use, specifying the target species

Prevention of flea multiplication by sterilising the eggs

4.3. Contraindications

None known

4.4. Special warnings for each target species

If there are several dogs in a same home, the treatment should be administered to all of them.

As this feed contains pyriproxyfen, a medicinal product, dogs should not be given more feed than is recommended : i.e., do not exceed the recommended daily amount of 100 grams of medicated feed per 10 kg bodyweight per day.

All animals in the home should be treated with a suitable flea control preparation, at the same time that the product is administered to the dogs.

4.5. Special precautions for use

i) Special precautions for use in animals

If there is an existing flea infestation when the animal is treated or if there are occasional flea infestations during treatment, adult fleas must be eliminated with appropriate insecticidal medicines.

This medicinal premix is intended for the manufacturing of solid medicinal foods and cannot be used as it is. The mixing rate of the medicinal premix with the solid food cannot be lower than 5 kg/tonne

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

When incorporating the product into feed, it is recommended that workers should wear appropriate dust masks

iii) Other precautions

4.6. Adverse reactions (frequency and seriousness)

None known

4.7. Use during pregnancy, lactation or lay

Studies in laboratory animals (rat, mouse, rabbit) did not reveal any teratogenic or embryotoxic effects attributable to pyriproxyfen. The safety of this medicinal food in nursing and pregnant bitches has been demonstrated. The use of the medicinal food in nursing and pregnant bitches is therefore possible

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

None known

4.9. Amount(s) to be administered and administration route

500 μg of pyriproxyfen per kg bodyweight per day, as a single administration. This is equivalent to 100 g of medicated feed per day for a dog weighing 10 kg.

In general, the first administration should take place just before the assumed first infestation period. The treatment should be carried on until the usual infestation period ends. Treatment may be extended beyond this period, to prevent any risk of reinfestations.

If the administration is temporarily stopped (for a maximum of 2 days, e.g. for the week-end, the holidays or temporary appetite reduction, etc.), the dog remains protected.

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

No undesirable effect has been shown when the medicinal food is administered at doses up to 10 times the recommended dose

4.11. Withdrawal period(s)

Not applicable

5. Pharmacological properties

Pharmacotherapeutic group: ectoparasiticide for systemic use

ATC Vet code: QP53RX

5.1. Pharmacodynamic properties

Pyriproxyfen is an insect growth inhibitor which imitates the juvenile hormone. It stops eggs and larvae developing and prevents the appearance of new adult fleas. It acts by absorption by adult fleas, sterilising the eggs during their maturation before being laid

5.2. Pharmacokinetic particulars

The product is for oral use only after mixing into feed.

Pyriproxyfen is absorbed via the intestinal tract in sufficient quantity to exert a systemic activity on mature adult female fleas. This activity takes place within an hour following the dog’s first meal.

After the first oral administration of 10 g/kg of the product (corresponding to a dose of 500 µg/kg of Pyriproxyfen), C_max of 21.5 ± 4.0 ng/ml was obtained at 4.0 ± 1.3 hours post-dose and the 24h-AUC (between two administrations) was 145.2 ± 34.0 ng.h/mL.

Mean elimination half-life of Pyriproxyfen was 10.0 ± 3.4 hours. Absolute bioavailability was 49 ± 10 %.

No significant difference was observed when comparing pharmacokinetic parameters obtained after the first and the sixth days of administration. Therefore, no accumulation of pyriproxyfen in plasma is expected after 6 days treatment of medicated feed.

Environmental properties

6. Pharmaceutical particulars

6.1. List of excipients

Propylene glycol dicaprylate/dicaprate

Wholemeal wheat (as support

)

6.2. Incompatibilities

None known.

6.3. Shelf-life

Premix for medicated feed : before opening the bags : 15 months.

Medicated feed : before opening the bags : 9 months

6.4. Special precautions for storage

Do not store the medicated feed above 30°C.

Keep the container in the outer carton.

6.5. Nature and composition of immediate packaging

Low density polyethylene bag

Box of 1.5 kg bag

Box of 22.5 kg bag

Barrel of 1.5 kg bag

Barrel of 22.5 kg bag

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

This product is dangerous to fish and aquatic life.

Any unused product or waste material should be disposed of in accordance with national requirements.

7. Marketing authorisation holder

VIRBAC

BP 27

06511 CARROS CEDEX

8. Marketing authorisation number(s)