A clear, colourless to slight yellow-coloured solution with no visible particulates containing 1% w/v Ivermectin (10 mg/ml).

Animec Injection is indicated for the treatment of infections with the following parasites in beef and non-lactating dairy cattle or pigs:

For the effective treatment and control of gastro-intestinal roundworms, lungworms, warbles, mange mites and lice as shown below:

Gastro-intestinal roundworms (adult and fourth stage larvae): Ostertagia spp (including inhibited O. ostertagi), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Oesophagostomum radiatum, Nematodirus helvetianus (adult), N. spathiger (adult)

Lungworms (adult and fourth stage larvae): Dictyocaulus viviparus.

Warbles (parasitic stages): Hypoderma bovis and H. lineatum.

Mange mites: Psoroptes bovis, Sarcoptes scabiei var. bovis.

Sucking lice: Linognathus vituli, Haematopinus eurysternus.

The use of the product in cattle should take into account geographical differences in the occurrence patterns of parasites.

For the effective treatment and control of gastro-intestinal roundworms, lungworms, mange mites and lice as shown below:

Gastro-intestinal worms (adult and fourth stage larvae): Ascaris suum, Hyostrongylus rubidus, Oesophagostomum spp, Strongyloides ransomi (adult only)

Lungworms: Metastrongylus spp. (adult)

Lice: Haematopinus suis

Mange mites: Sarcoptes scabiei var. suis

For single administration only by subcutaneous injection. Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle, and 33 kg of bodyweight of pigs. Replace with a fresh sterile needle after every 10 to 12 animals. Massage the injection site after administration of the product. Injection of wet or dirty animals is not recommended.

To ensure administration of a correct dose, body weight should be determined as accurately as possible. Accuracy of the dosing device should be checked.

If animals are to be treated collectively rather than individually they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over- dosing..

The product should be given only by subcutaneous injection at the recommended dosage level of 200 microgram ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle. This is equivalent to 1 ml per 50 kg bodyweight. The volume administered per injection site should not exceed 10 ml.

In pigs, the recommended dosage level is 300 microgram ivermectin per kg bodyweight. This is equivalent to 1 ml per 33 kg bodyweight. The recommended route of administration is by subcutaneous injection into the neck.

In young pigs, especially those below 16 kg for which less than 0.5 ml of the product is indicated, dosing accurately is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

In the case of overdose a symptomatic treatment should be given.

Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

Do not administer by the intravenous or intramuscular route.

Do not use in animals with known hypersensitivity to the active ingredient.

Do not use in dogs or cats as severe adverse reactions 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 body weight, misadministration of the product, or lack of calibration of the dosing device.

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 ivermectin has been reported in Cooperia spp. and in Ostertagia ostertagi in cattle. Resistance has also been reported in Haemonchus contortus in cattle outside the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of this helminth species and recommendations on how to limit further selection for resistance to anthelmintics.

In cattle, to avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites. Consult your veterinarian on the correct timing of treatment.

Avermectins may not be well tolerated in non-target species. Cases of intolerance with fatal results are reported in dogs – especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.

Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels.

The product may cause local irritation and/or pain at the site of injection. Direct contact of the product with the skin should be avoided. Take care to avoid self administration.

Do not smoke or eat while handling the product.

Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The product is very toxic to aquatic organisms and dung insects.

Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.

Long term effects on dung insects caused by continuous or repeated use cannot be excluded therefore repeat treatments on a pasture within a season should only be given on the advice of a veterinarian.

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

Mild and transient pain reactions may be seen in some pigs following subcutaneous injection.

All these reactions disappeared without treatment.

The product can be administered during pregnancy and lactation in cows and sows. It can be used in breeding sows and boars and will not affect fertility.

Do not combine with vaccination against lungworm. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.

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

In the case of overdose a symptomatic treatment should be given.

Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

Meat and offal: 49 days.

Do not use in lactating cows producing milk for human consumption. Do not use in cattle producing milk for human consumption or in dairy cows within 60 days prior to calving.

Meat and offal: 28 days.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the immediate packaging: 28 days.

Do not use after the expiry date stated on the label and carton.

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

The product should not enter water courses as this may be dangerous to fish and other aquatic organisms.

50 ml, 250 ml and 500 ml containers.

Nil.