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

A pale yellow free-flowing aqueous solution containing 0.08% w/v ivermectin for oral administration. Contains benzyl alcohol as preservative.

Uses

For the treatment and control of gastro-intestinal nematodes, lungworms and nasal bots of sheep.

ORAMEC DRENCH at the recommended dose rate of 200 micrograms ivermectin per kg bodyweight provides effective control against the following parasites of sheep.

Gastro-intestinal roundworms (adult and immature): Haemonchus contortus, Ostertagia circumcincta, Trichostrongylus spp., Cooperia spp., Nematodirus spp., including N. battus, Strongyloides papillosus, Oesophagostomum spp., and adult Chabertia ovina.

Inhibited larval stages and benzimidazole resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.

Lungworms (adult and immature): Dictyocaulus filaria.

Nasal bot (all larval stages): Oestrus ovis.

Dosage and administration

Dosage

2.5 ml per 10 kg bodyweight (corresponding to the recommended dose rate of 200 micrograms ivermectin per kg bodyweight), administered orally with a dosing gun. The dosing gun should be calibrated sufficiently accurately to ensure precise dosing of young sheep.

Administration

Give as an oral drench.

Contra-indications, warnings, etc

For animal treatment only.

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

Wash hands after use.

Avoid contact with skin and eyes.

In case of accidental spillage onto the skin or eyes, wash the affected area with clean running water immediately. Seek medical attention if irritation persists.

ORAMEC DRENCH has been formulated specifically for use in sheep. It should not be used in other species, as severe adverse reactions, including fatalities in dogs, may occur.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment.

Sheep may be slaughtered for human consumption only from 6 days after the last treatment.

Do not use in lactating animals producing milk for human consumption.

If milk is to be used for human consumption animals should not be treated within 60 days prior to the commencement of lactation.

Container disposal

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

Do not store above 25°C. Protect from direct sunlight.

Keep out of the reach of children.

Legal category

POM-VPS

Packaging Quantities

1, 2.5 and 5 litre containers.

Further information

Some animals may cough slightly immediately after treatment. This passing response is of no consequence.

ORAMEC DRENCH can be administered to ewes at any stage of pregnancy. ORAMEC DRENCH will not affect the fertility of breeding ewes and rams and can be given to all ages of animals including young lambs.

ORAMEC DRENCH has demonstrated a wide safety margin at the recommended dose level. ORAMEC DRENCH may be used in sheep of all ages. During a study to assess toxicological effects only mild incoordination and depression were observed at 20 x the recommended dose level (4 mg ivermectin per kg bodweight administered by stomach tube). At 40 x the recommended dose level (8 mg ivermectin per kg bodyweight administered by stomach tube) acute symptoms (ataxia, staggering gait, incoordination and depression) were observed. Within 24 hours nearly all animals appeared normal and within 3 days all animals appeared clinically normal.

No antidote has been identified. However, symptomatic treatment may be beneficial.

Ivermectin belongs to the avermectin (3-AV) class of anthelmintic endectocides.

Marketing authorisation number

Vm 08327/4191.