Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A clear, yellow to amber spot-on solution.

Each ml contains 200 mg metaflumizone

Each unit dose (pipette) of ProMeris delivers:

	Volume (ml)	Metaflumizone (mg)
ProMeris for Small Cats (≤ 4kg)	0.8	160
ProMeris for Large Cats (> 4kg)	1.6	320

Uses

Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats above 8 weeks of age. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Dosage and administration

Dosage

The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight. The following table defines the size of pipette to be used according to the weight of the cat.

Weight of Cat (kg)	Pipette size to be used	Volume (ml)
≤4	ProMeris for Small Cats	0.8
>4	ProMeris for Large Cats	1.6

Method of administration

For external use only. Spot-on use.

Remove the pipette from the package. Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line. The top of the tip will fold back against the pipette.

Apply the content of the pipette to a single spot on the skin of the cat’s neck at the base of the skull.

Part the fur on the cat’s neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.

Do not apply the veterinary medicinal product to the surface of the cat’s hair coat.

Treatment schedule

For optimal control of flea infestation the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.

The veterinary medicinal product will prevent flea infestation for up to 6 weeks following a single administration depending on the level of environmental rechallenge.

Contra-indications, warnings, etc

Do not use in kittens under 8 weeks of age.

In sick or debilitated animals use only according to the benefit/risk assessment.

Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in queens. Laboratory studies with metaflumizone in rats and/or rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit/risk assessment by the responsible veterinarian.

This veterinary medicinal product is for spot-on application only. Do not administer orally or via any other route.

It is important to apply the dose to an area where the animal cannot lick it off. Do not allow animals to groom each other following treatment.

Care should be taken to ensure that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Hypersalivation may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.

The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site. A dry residue may also be observed. This is normal and will generally resolve within 1 – 4 days after administration. These changes do not affect the safety or efficacy of the veterinary medicinal product.

Withdrawal period

Not applicable

Operator warnings

Avoid direct contact with skin, eyes or mouth. Wash hands thoroughly after use. In case of accidental spillage onto skin, wash off immediately with soap and water. If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water.

Do not smoke, drink or eat while handling the product.

Avoid direct contact with treated animals until the application site is dry.

Children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended to treat the animals during the evening and that recently treated animals are not allowed to sleep with owners, especially children.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Carefully dispose of used pipettes immediately after use.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Do not store above 25 °C.

Do not use after the expiry date stated on the carton after “EXP”.

Legal category

POM-V

Prescription Only Medicine – Veterinarian

To be supplied only on veterinary prescription

Packaging Quantities

Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.

Not all pack sizes may be marketed.

Further information

For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide. In addition it is recommended to treat the environment with a suitable insecticide.

Marketing authorisation number

EU/2/06/064/001 - 004.

Significant Changes