Ivomec Injection

Presentation

A sterile non-aqueous solution for injection containing 10 mg/ml 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:

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:

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.

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.

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

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.

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.

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:

- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

- Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device (if any).

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.

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.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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.

Marketing authorisation number

Vm 08327/4188.