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 sterile non-aqueous solution for injection containing 1%w/v ivermectin.

Uses

IVOMEC Classic Injection for Cattle and Sheep is indicated for the effective treatment and control of the following parasites of sheep and cattle:

			Inhibited
CATTLE PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia lyrata	•	•
Ostertagia ostertagi	•	•	•
Cooperia oncophora	•	•
Cooperia pectinata	•	•
Cooperia punctata	•	•
Haemonchus placei	•	•
Trichostrongylus axei	•	•
Trichostrongylus colubriformis	•	•
Bunostomum phlebotomum	•	•
Oesophagostomum radiatum	•	•
Strongyloides papillosus	•
Nematodirus helvetianus	•
Nematodirus spathiger	•
Trichuris spp.	•
Lungworms:
Dictyocaulus viviparus	•	•
Eye Worms:
Thelazia spp.	•

		Immature
	Adult	Stages
Warbles:
Hypoderma bovis		•
H. lineatum		•
Mange Mites:
Psoroptes bovis	•	•
Sarcoptes scabiei var. bovis	•	•
Sucking Lice:
Linognathus vituli	•	•
Haematopinus eurysternus	•	•
Solenopotes capillatus	•	•

IVOMEC Classic Injection for Cattle and Sheep may also be used as an aid in the control of biting lice (Damalinia bovis) and the mange mite (Chorioptes bovis), but complete elimination may not occur.

Persistent Activity in Cattle:

When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with IVOMEC Classic Injection for Cattle and Sheep at the recommended dose rate of 1ml per 50kg bodyweight controls re-infection with the following parasites of cattle:

	Prolonged Activity
Dictyocaulus viviparus	up to 28 days
Ostertagia ostertagi	up to 21 days
Oesophagostomum radiatum	up to 21 days
Cooperia spp.	up to 14 days
Trichostrongylus axei	up to 14 days
Haemonchus placei	up to 14 days

To obtain optimal benefit from the persistent activity of IVOMEC Classic Injection for Cattle and Sheep for grazing animals, it is recommended that calves which are set-stocked in the first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals 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.

			Inhibited
SHEEP PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia circumcincta	•	•	•
O. trifurcata	•	•
Haemonchus contortus	•	•	•
Trichostrongylus axei	•
T. colubriformis	•	•
T. vitrinus	•
Cooperia curticei	•	•
Oesophagostomum columbianum	•	•
O. venulosum	•
Nematodirus filicollis	•	•
Chabertia ovina	•	•
Trichuris ovis	•
Lungworms:
Dictyocaulus filaria	•	•
Protostrongylus rufescens	•
		Immature
	Adult	Stages
Nasal Bots:
Oestrus ovis		•
Mange Mites:
Psoroptes ovis	•	•

For the treatment and control of sheep scab Psoroptes ovis, two injections with a seven-day interval are required to treat clinical signs of scab and to eliminate mites.

Benzimidazole-resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.

Dosage and administration

IVOMEC Classic Injection for Cattle and Sheep should be given only by subcutaneous injection, using aseptic precautions, at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle and in the neck in sheep.

When treating sheep of less than 16kg, seek veterinary advice regarding the use of 1 ml disposable syringes graduated in increments of 0.1 ml. For the treatment of individual sheep, a syringe not exceeding 2.0 ml and calibrated in increments of 0.1 ml should be used.

Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep. The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of a sterile 17 gauge × ½ inch needle is suggested. Replace with a fresh sterile needle after every 10 to 12 animals. Injection of wet or dirty animals is not recommended.

Use this chart as a guide in working out the appropriate dose rate for Ivomec Classic Injection for Cattle and Sheep:
CATTLE (1ml/50kg)		SHEEP (0.5ml/25kg)
Bodyweight (kg)	Dose Volume (ml)	Bodyweight (kg)	Dose Volume (ml)
Up to 50	1.0	Up to 5	0.1
51-100	2.0	5.1-10	0.2
101-150	3.0	10.1-15	0.3
151-200	4.0	15.1-25	0.5
201-250	5.0	25.1-50	1.0
251-300	6.0	50.1-75	1.5
301-350	7.0	75.1-100	2.0
351-400	8.0
For cattle weighing over 400kg calculate the dose at the rate of 1ml per 50kg bodyweight.		For sheep weighing over 100kg calculate the dose at the rate of 0.5ml per 25kg bodyweight.

Contra-indications, warnings, etc

For animal treatment only.

This product is not to be used intramuscularly or intravenously.

The product has been formulated specifically for use in these target species. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

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

Wash hands after use.

Take care to avoid self-injection: the product may cause local irritation and/or pain at the injection site.

In sheep treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although a clinical improvement may be seen, elimination of all mites may not occur.

Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. Following treatment of infected sheep, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the sheep. It is important to ensure all sheep which have been in contact with infected sheep are treated. Contact between treated infected and non-treated, non-infected flocks must be avoided until at least 7 days after the last treatment.

Swab septum before removing each dose.

Use sterile needle and syringe.

When treating groups of animals use only an automatic dosing device (with vented draw-off apparatus when using the 50ml vial). Syringes must be filled from the vial through a dry sterile draw-off needle that has been placed in the vial stopper. Vial stoppers must not be broached more than 20 times.

Adequate vaccination of sheep against clostridial infections is strongly recommended.

IVOMEC Classic Injection for Cattle and Sheep can be administered to beef cows and ewes at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. It can be used in breeding ewes, rams, cows and bulls without affecting fertility. IVOMEC Classic Injection for Cattle and Sheep can be given to all ages of animals including young calves and lambs.

Withdrawal periods

Cattle (meat & offal): 49 days.

Cattle (milk): 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.

Sheep (meat & offal): 37 days.

Sheep (milk): Do not use in sheep producing milk for human consumption.

Container disposal

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with 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 out of the reach and sight of children.

Protect from direct sunlight.

This product does not contain any antimicrobial preservative.

Following withdrawal of the first dose, use the product within 6 months.

Discard unused material.

Legal category

POM-VPS

Packaging Quantities

Polyethylene bottles of 200 ml and 500 ml.

Further information

Sheep - discomfort, sometimes intense but usually transient, has been observed in some sheep following subcutaneous administration.

Cattle - mild and transient discomfort has occasionally been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed.

In both species these reactions disappeared without treatment.

Overdose

Sheep - dose levels up to 4mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

Cattle - single doses of 4mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression. No antidote has been identified, however, symptomatic therapy may be beneficial.

IVOMEC Classic Injection for Cattle and Sheep has been used concurrently without adverse effects with clostridial vaccine, given at separate injection sites.

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

Marketing authorisation number

Vm 08327/4188.

Significant Changes

Ivomec Classic Injection for Cattle and Sheep	Merial Animal Health Ltd	Sheep meat withdrawal period decreased from 42 to 37 days.	27/05/2009
Ivomec Classic Injection for Cattle and Sheep	Merial Animal Health Ltd	Change in cattle meat withdrawal period to 49 days (following EU referral).	21/01/2010