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 pour-on solution containing 0.5% w/v eprinomectin for topical use in cattle.

Uses

For treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi and Cooperia spp.), lungworms, warbles, sucking and biting lice, chorioptic and sarcoptic mange mites in beef and dairy cattle.

EPRINEX Pour-On for Beef and Dairy Cattle, applied at the recommended dose volume of 1 ml/10 kg bodyweight, to achieve a dose level of 500 micrograms eprinomectin/kg, is indicated for treatment and control of the following parasites:

			Inhibited
PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia spp.	•	•
Ostertagia lyrata	•
Ostertagia ostertagi	•	•	•
Cooperia spp.	•	•	•
Cooperia oncophora	•	•
Cooperia pectinata	•	•
Cooperia punctata	•	•
Cooperia surnabada	•	•
Haemonchus placei	•	•
Trichostrongylus spp.	•	•
Trichostrongylus axei	•	•
Trichostrongylus colubriformis	•	•
Bunostomum phlebotomum	•	•
Nematodirus helvetianus	•	•
Oesophagostomum spp.	•
Oesophagostomum radiatum	•	•
Trichuris spp.	•
Lungworm:
Dictyocaulus viviparus	•	•
Warbles (parasitic stages):	Adult	Immature
Hypoderma bovis		•
H. lineatum		•
Mange Mites:
Chorioptes bovis	•	•
Sarcoptes scabiei var. bovis	•	•
Lice:
Linognathus vituli	•	•
Haematopinus eurysternus	•	•
Solenopotes capillatus	•	•
Damalinia bovis	•	•

Prolonged activity

EPRINEX Pour-On for Beef and Dairy Cattle, applied as recommended, controls re-infections with the following parasites:

	Prolonged activity
Dictyocaulus viviparus	up to 28 days
Ostertagia ostertagi	up to 28 days
Ostertagia lyrata	up to 28 days
Oesophagostomum radiatum	up to 28 days
Cooperia oncophora	up to 21 days
Cooperia punctata	up to 21 days
Cooperia surnabada	up to 21 days
Trichostrongylus axei	up to 21 days
Trichostrongylus colubriformis	up to 21 days
Haemonchus placei	up to 14 days
Nematodirus helvetianus	up to 14 days

For best results EPRINEX Pour-On for Beef and Dairy Cattle should be part of a programme to control both internal and external parasites of cattle based on the epidemiology of these parasites.

Dosage and administration

Administer only by topical application at the dose rate of 1 ml per 10 kg bodyweight, corresponding to the recommended dose rate of 0.5mg eprinomectin per kg bodyweight. The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.

Contra-indications, warnings, etc

For animal treatment only.

This product is formulated only for topical application to beef and dairy cattle, including lactating dairy cattle. Do not use in other animal species; avermectins can cause fatalities in dogs. Do not administer orally or by injection.

Do not apply to areas of the backline covered with mud or manure.

Use during pregnancy and lactation

Milk from cows may be used for human consumption at any time following treatment with EPRINEX Pour-On for Beef and Dairy Cattle. Studies have demonstrated a wide safety margin. Studies conducted at three times the recommended use level of 0.5 mg eprinomectin per kg bodyweight had no adverse effect on breeding performance of cows or bulls. EPRINEX Pour-On for Beef and Dairy Cattle may be used in dairy cattle during all stages of pregnancy and lactation.

Safety in target species

Studies have demonstrated a wide safety margin.

Withdrawal periods

Meat may only be taken for human consumption from 15 days after the last treatment.

There is no milk withdrawal period for lactating dairy cattle. Milk from treated cows may be used for human consumption at any time following treatment with EPRINEX Pour-On for Beef and Dairy Cattle.

Operator safety

Operators should wear rubber gloves when applying the product.

If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water.

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

Wash hands after use.

Should clothing become contaminated, remove as soon as possible and launder before re-use. In the event of ingestion, wash out mouth with water and seek medical advice.

Environmental safety

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

Keep container in the outer carton. Protect from light.

Keep out of the reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

EPRINEX Pour-On for Beef and Dairy Cattle is available in four pack sizes – 250 ml, 1 litre, 2.5 litres and 5 litres.

Further information

Rainfall at any time before or after treatment will not affect the efficacy of the product.

While mite and louse numbers decline rapidly following treatment, due to the feeding habits of the parasites, in some cases several weeks may be required for complete eradication.

No signs of toxicity appeared when 8-week old calves were treated at up to 5 times the therapeutic dose (i.e. 2.5 mg eprinomectin per kg bodyweight), 3 times at 7-day intervals. One calf treated once at 10 times the therapeutic dose (i.e. 5 mg per kg bodyweight) in the tolerance study showed transient mydriasis. There were no other adverse reactions to treatment. No antidote has been identified.

Marketing authorisation number

Vm 08327/4157.