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 and 10% w/v clorsulon.

Uses

For the treatment and control of gastro-intestinal roundworms, lungworms, adult liver fluke, eyeworms, warbles, mites and lice (as shown below) of beef and non-lactating dairy cattle.

IVOMEC Super Injection for Cattle at the recommended dosage level of 200 micrograms ivermectin and 2 mg clorsulon per kg bodyweight effectively controls the following parasites of cattle:

			Inhibited
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.	•
	Adult	Immature
Liver fluke:
Fasciola hepatica	•
Warbles (Parasitic stages):
Hypoderma bovis		•
H. lineatum		•
Mange Mites:
Psoroptes bovis	•	•
Sarcoptes scabiei var. bovis	•	•
Sucking Lice:
Linognathus vituli	•	•
Haematopinus eurysternus	•	•
Solenopotes capillatus	•	•

May also be used as an aid in the control of the biting louse (Damalinia bovis) and the mange mite (Chorioptes bovis), but complete elimination may not occur.

When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with IVOMEC Super Injection for Cattle given at the recommended dose rate of 0.2mg per kg 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 Super 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.

Dosage and administration

Dosage

1 ml per 50 kg bodyweight (based on a recommended dosage level of 200 micrograms ivermectin and 2 mg clorsulon per kg bodyweight).

Administration

IVOMEC Super should be administered only by subcutaneous injection at the recommended dosage level of 1 ml/50 kg bodyweight (based on a dosage level of 200 micrograms ivermectin plus 2 mg clorsulon per kg bodyweight) under the loose skin in front of, or behind the shoulder. A sterile 17 gauge ½ inch (15-20 mm) needle is recommended. Replace with a fresh sterile needle after every 10-12 animals or sooner if the needle becomes soiled. Divide doses greater than 10 ml between two injection sites. Different injection sites should be used for other parenteral products administered concurrently.

When the temperature of the product is below 5°C, difficulty in administration may be encountered due to increased viscosity. Warming the product and injection equipment to about 15°C will greatly increase the ease with which the product can be injected.

When using the 200 ml, 500 ml and 1000 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack size, use of a multidose syringe is recommended.

IVOMEC Super Injection for Cattle can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. IVOMEC Super Injection for Cattle will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.

Contra-indications, warnings, etc

For animal treatment only.

This product is not for intravenous or intramuscular use. Do not smoke, eat or drink 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.

IVOMEC Super Injection for Cattle is a low-volume product registered for use only in beef cattle and non-lactating dairy cattle. It should not be used in any other species as severe adverse reactions, including fatalities in dogs, may occur.

Transitory discomfort has been observed in some cattle following subcutaneous administration. An incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment.

Cattle (meat) - 66 days.

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.

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

Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Discard unused material. This product does not contain an antimicrobial preservative.

Swab the septum before removing each dose.

Keep out of the reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

50 ml, 200 ml, 500 ml and 1000 ml containers.

Further information

The administration of 25 ml IVOMEC Super per 50 kg bodyweight (ie. 25 times the usual level) resulted in an injection site lesion (including tissue necrosis, oedema, fibrosis and inflammation). No other drug related adverse reactions could be determined. No interactions have been identified between IVOMEC Super Injection for Cattle and other products.

Marketing authorisation number

Vm 08327/4167.

Significant Changes

Ivomec Super Injection for Cattle

Merial Animal Health Ltd

Change in cattle meat withdrawal period to 66 days (following EU referral).

19/01/2010