Frontline Spot On Cat 10% w/v Spot On Solution

Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Spot-on solution containing 10% w/v fipronil. Each pipette contains 0.5 ml (50 mg fipronil). Also contains butylhydroxyanisole (E320) and butylhydroxytoluene (E321).

Uses

The treatment and prevention of infestations by fleas (Ctenocephalides spp.), and ticks (Rhipicephalus spp., Dermacentor spp. and Ixodes spp.) in cats, and as part of a treatment strategy for Flea Allergy Dermatitis, where this has been previously diagnosed by a veterinary surgeon. The product controls infestations with Felicola subrostratus biting lice on cats. FRONTLINE Spot-On Cat can be used in kittens from 8 weeks of age and weighing at least 1kg.

Dosage and administration

Route of administration

By topical application to the skin.

Dosage

1 pipette of 0.5 ml per cat (approximately 7.5 - 15 mg/kg).

Method of administration

Hold upright. Tap the narrow part of the pipette to ensure that the contents are within the main body of the pipette. Break back the snap-off top of the spot-on pipette along the scored line. Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to empty its contents onto the skin, preferably at two spots, one at the base of the skull and a second 2-3 cms further back.

Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.

In the absence of safety studies, the minimum treatment interval is 4 weeks.

It is important to apply the dose to an area where the animal cannot lick off and to make sure that animals do not lick each other after treatment. If licking does occur, a brief period of hypersalivation may be observed, due mainly to the nature of the carrier.

Contra-indications, warnings, etc

For animal treatment only.

For external use only.

Animals should be weighed accurately prior to treatment.

Do not use in rabbits, as adverse reactions and even death could occur.

Animals or operators with a known hypersensitivity to insecticides or alcohol should avoid contact with FRONTLINE Spot-On Cat.

In the absence of available data, the product should not be used on kittens less than 8 weeks old and/or weighing less than 1kg.

Do not use on sick (systemic diseases, fever...) or convalescent animals.

Among the extremely rare suspected adverse reactions, transient cutaneous reactions at the application site (scaling, local alopecia, pruritis, erythema) and general pruritis or alopecia have been reported after use.

Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs) or vomiting have been observed after use.

Do not overdose.

Avoid contact with the animal's eyes.

Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Operator Warnings

The product can cause mucous membrane and eye irritation and so contact with the mouth and eyes should be avoided.

Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. After accidental ocular exposure the eye should be rinsed carefully with plain water.

As with all insecticides wash hands after use.

Do not smoke, eat or drink during application.

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

Pharmaceutical precautions

Store in the original package.

Store in a dry place.

Do not store above 30oC.

Keep out of the reach and sight of children.

Flammable.

Legal category

NFA-VPS

Packaging Quantities

Blister cards containing 3 or 6 pipettes of 0.5 ml.

Further information

Fipronil is a member of the phenylpyrazole family of non-systemic insecticides/acaricides, which acts by blocking the GABA receptor to kill the target parasite on contact.

FRONTLINE Spot-On Cat is effective against fleas for up to 5 weeks in cats and prevents re-infestation with all stages of Rhipicephalus spp., Dermacentor spp., and Ixodes spp. ticks for up to one month, depending on the level of environmental challenge. Newly arriving fleas are killed within 24 hours of landing on the animal. Re-treatment may safely be carried out at one month intervals.

FRONTLINE Spot-On Cat is licensed for use as part of a strategy for the treatment of Flea Allergy Dermatitis. For this condition, monthly application to the allergic patient and to other cats in the household is recommended.

FRONTLINE Spot-On Cat does not prevent ticks attaching to the animal, but ticks will be killed in the first 24-48 hours after attachment. Once dead, ticks will often drop off the animal, but any remaining ticks may easily be removed by a gentle pull, preferably using tweezers. There may be an attachment of single ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.

For optimum control of flea problems in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide. Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.

When treating infestations of lice, all in-contact cats should be treated with an appropriate product at the same time.

Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect.

The safety of the product was demonstrated in breeding, pregnant and lactating queens treated with multiple consecutive doses with up to 3 times the maximum recommended dose. FRONTLINE Spot-On Cat can be used in breeding, pregnant and lactating queens.

No adverse effects have been seen in cats and kittens aged 8 weeks or older and weighing about 1kg treated monthly with five times the recommended dose for six consecutive months. However, the risk of adverse effects may increase with overdosing. Itching may occur following treatment.

After the topical application of FRONTLINE Spot-On Cat, the products will spread from the site of treatment to cover the entire surface of the animal within 24 hours. After application, absorption of fipronil through the skin is negligible.

No known incompatibilities exist for the use of other insecticides or flea control products concurrently with FRONTLINE Spot-On Cat.

There are no data available on the effect of bathing and shampooing on the efficacy of FRONTLINE Spot-On Cat in cats. However, based on information available for dogs shampooed from 2 days after application of the product, it is not recommended to bath animals within 2 days after application of FRONTLINE Spot-On Cat.

The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.

Marketing authorisation number

Vm 08327/4133.

GTIN (Global Trade Item No)

Frontline Spot On Cat 3 pipette

03661103003298

Frontline Spot On Cat 6 pipette

03661103003724