Introduction

Company name: Virbac Limited

Address: Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk

IP30 9UP

Telephone: 01359 243243

Fax: 01359 243200

Website: www.virbac.co.uk

Presentation

A clear pour-on solution containing 0.5% w/v ivermectin PhEur.

Uses

For the treatment and control of the following species of gastro-intestinal roundworms, lungworms, eyeworms, warbles, mites and lice of cattle:

Gastro-intestinal roundworms

Ostertagia ostertagi (L4 larvae and adults including inhibited stages)

Haemonchus placei (L4 larvae and adults)

Trichostrongylus axei (L4 larvae and adults)

Trichostrongylus colubriformis (L4 larvae and adults)

Cooperia spp. (L4 larvae and adults)

Oesophagostomum radiatum (L4 larvae and adults)

Strongyloides papillosus (adults)

Trichuris spp. (adults)

Lungworms (adult and L4 larvae)

Dictyocaulus viviparus

Eyeworms (adult)

Thelazia spp.

Warbles

Hypoderma bovis

Hypoderma lineatum

Mange mites

Chorioptes bovis

Sarcoptes scabei var. bovis

Sucking lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Damalinia bovis

 

Virbamec Pour-On, at the recommended dose rate of 500 mcg ivermectin per kg bodyweight, controls re-infections:

Dictyocaulus viviparus:	for up to 28 days
Ostertagia spp:	for up to 21 days
Oesophagostomum radiatum:	for up to 21 days
Cooperia spp:	for up to 14 days
Trichostrongylus axei:	for up to 14 days

Virbamec Pour-On also controls horn fly (Haematobia irritans) for up to 35 days after treatment.

To obtain optimal benefit from the persistent activity of Virbamec Pour-On for grazing animals, it is recommended that calves which are set stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. Studies have shown that first-season grazing calves turned out to pasture in late April or May and treated with Virbamec Pour-on 3, 8 and 13 weeks after turn-out can be protected from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set stocked, all the calves are included in the programme and that no untreated cattle are added to the pasture.

Treated animals should always be monitored according to good husbandry practices.

Dosage and administration

Dosage

1ml per 10 kg bodyweight (based on a recommended dose rate of 500mcg per kg bodyweight).

Administration

The formulation should be applied along the mid-line of the back in a narrow strip between the withers and tailhead.

Contra-indications, warnings, etc

HIGHLY FLAMMABLE. KEEP AWAY FROM HEAT, SPARKS, NAKED FLAMES OR OTHER SOURCES OF IGNITION.

For animal treatment only.

Virbamec Pour-On has been specifically formulated for topical application in cattle and it should not be applied to other species, as severe adverse reactions, including fatalities in dogs, may occur.

Do not apply to areas of skin which have mange scabs or other lesions or to areas contaminated by mud or manure.

Cattle should not be treated when the hair or hide is wet. Rain falling on animals less than two hours fater dosing may result in reduced efficacy. However, the efficacy of Virbamec Pour-On against established infections of O. ostertagi or D. viviparus is not adversely affected if the hide is wet or rain falls shortly after treatment.

Operator warnings

Do not smoke or eat whilst handling the product. Wash hands after use. Virbamec Pour-On may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear nitrile rubber gloves, rubber boots and a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water and seek medical attention. Use only in well ventilated areas or outdoors.

Withdrawal period

Cattle must not be slaughtered for human consumption within 28 days after the last treatment. Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Disposal of containers

Unused product and containers should be disposed of in accordance with any guidance from an appropriate waste regulation authority.

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used product container.

Pharmaceutical precautions

Store away from heat (below 25°C) and protect from light. Store in tightly closed original container. If stored at below 0°C Virbamec Pour-On may appear cloudy. Allowing to warm to room temperature will restore the normal appearance without affecting efficacy.

Legal category

POM-VPS

Packaging Quantities

Virbamec Pour-On is available in 500 ml or 1 litre packs with a squeeze-measure-pour system or a 2.5 or 5.0 litre backpack with a draw-off cap.

Further information

At the recommended use level, Virbamec Pour-On had no adverse effect on breeding performance. Virbamec Pour-On can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. Virbamec Pour-On will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.

Market authorisation number

Vm 16971/4003