Ivomec Injection

Ivomec Classic Injection for Cattle and Sheep

Qualitative and quantitative composition

Active substance: Ivermectin 10 mg

For the full list of excipients, see below.

Pharmaceutical form

Solution for injection. A clear, pale, straw-coloured liquid.

Clinical particulars

Target species

Cattle and sheep.

Indications for use

Indicated for the effective treatment and control of the following parasites of cattle and sheep:

Cattle

Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)

Ostertagia ostertagi

Gastrointestinal Roundworms (Adult and L4)

Ostertagia lyrata

Cooperia oncophora

Cooperia pectinata

Cooperia punctata

Haemonchus placei

Trichostrongylus axei

Trichostrongylus colubriformis

Bunostomum phlebotomum

Oesophagostomum radiatum

Gastrointestinal Roundworms (Adult)

Strongyloides papillosus

Nematodirus helvetianus

Nematodirus spathiger

Trichuris spp.

Lungworms (Adult and L4)

Dictyocaulus viviparus

Eye Worms (Adult)

Thelazia spp.

Warbles

Hypoderma bovis

H. lineatum

Mange Mites

Psoroptes ovis

Sarcoptes scabei var. bovis

Sucking Lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

The product 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 Given at the recommended dosage of 1 ml per 50 kg bodyweight, the product controls re-infection with the following nematodes: Barbers pole worm (Haemonchus placei), Small intestinal worm (Cooperia spp.) and Hairworm (Trichostrongylus axei) for 14 days, Brown stomach worm (Ostertagia ostertagi) and Nodular worm (Oesophagostomum radiatum) for 21 days, and Lungworm (Dictyocaulus viviparus) for 28 days after treatment.

The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing program should be established by a qualified professional person.

Sheep

Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)

Ostertagia circumcincta

Haemonchus contortus

Gastrointestinal Roundworms (Adult and L4)

Ostertagia trifurcata

Trichostrongylus colubriformis

Cooperia curticei

Oesophagostomum columbianum

Nematodirus filicollis

Chabertia ovina

Gastrointestinal Roundworms (Adult)

Trichostrongylus axei

T. vitrinus

Oesophagostomum venulosum

Trichuris ovis

Lungworms (Adult and L4)

Dictyocaulus filaria

Lungworms (Adult)

Protostrongylus rufescens

Nasal Bots

Oestrus ovis

Mange Mites

Psoroptes ovis

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

Contra-indications

Do not inject intravenously or intramuscularly.

The product is specifically for use in the target species. Do not use in other species as severe adverse reactions, including fatalities in dogs, may occur.

Special warnings for each target species

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Resistance to macrocyclic lactones (which includes ivermectin) has been reported in Teladorsagia spp. in sheep and in Cooperia spp. in cattle within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Special precautions for use in animals

When treating groups of animals use only an automatic dosing device. 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.

Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. To ensure complete control 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 that all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment.

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

This product does not contain any antimicrobial preservative. Swab septum before removing each dose. Use a sterile needle and syringe.

Special precautions to be taken by the person administering the product to animals

Do not smoke, drink or eat 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 site of injection. In case of accidental self-injection, seek medical advice and show the label or package leaflet to the physician.

Adverse reactions

Cattle

Mild, transient discomfort has occasionally been observed in cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed.

Sheep

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

In both species these reactions disappear without treatment.

Use during pregnancy, lactation or lay

IVOMEC Classic Injection for Cattle and Sheep can be administered to 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, bulls and cows without affecting fertility. IVOMEC Classic Injection can be given to all ages of animals including young calves and lambs.

Interactions

IVOMEC Classic Injection for Cattle and Sheep has been used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites. Adequate vaccination of sheep against clostridial infections is strongly recommended.

Amounts to be administered and administration route

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.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Use this chart as a guide in working out the appropriate dose rate:

When treating sheep of less than 16 kg, 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 x 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.

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

Overdose

Cattle

Single doses of 4 mg 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.

Sheep

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

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.

Pharmaceutical particulars

Excipients

Glycerol Formal, Propylene Glycol.

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening the immediate packaging: 6 months.

Special precautions for storage

Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Discard unused material.

Immediate packaging

Polyethylene bottles of 200 ml and 500 ml.

Disposal

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used container. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing Authorisation Number

Vm 08327/4188

Legal category