Animec 10mg/ml Solution for Injection 500ml

Animec 10mg/ml Solution for Injection 500ml.

Uses
Animec Injection is indicated for the effective treatment and control of the following harmful parasites of cattle and pigs:
Cattle
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.
Pigs
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 and somatic larval stage)
Lungworms: Metastrongylus spp. (adult)
Lice: Haematopinus suis
Mange mites: Sarcoptes scabiei var. suis

Dosage and administration
Each ml contains 10 mg of ivermectin sufficient to treat 50 kg bodyweight of cattle and 33 kg 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.
Cattle
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.
Pigs
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.
Young Pigs
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.
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.

Contra-indications, warnings, etc
For animal treatment only. Do not administer by the intravenous or intramuscular route. Do not use in animals with known hypersensitivity to the active ingredient.
The product has been formulated specifically for use in cattle and pigs only. Do not use in dogs or cats (see also ‘special warnings').

Special warnings
This product must not be mixed with other veterinary medicinal products.
Take care to avoid self administration; the product may cause local irritation and/or pain at the site of injection. Do not smoke or eat while handling the product. Wash hands after use.
This product does not contain an antimicrobial preservative. Swab septum before removing each dose.
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 Ostertagia ostertagi in cattle. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of these helminth species and recommendations on how to limit further selection for resistance to anthelmintics.

The product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. It can be used in breeding sows and boars and will not affect fertility. The product can be given to all ages of animals including young calves and piglets.
Administer the product only subcutaneously because intramuscular administration causes persistent drug residues at the site of injection.
In the case of overdose a symptomatic treatment should be given.
Cattle Single doses of 4.0mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.
Pigs A dose of 30mg ivermectin per kg (100 x the recommended dose of 0.3mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

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.

This product has been formulated specifically for use in cattle and pigs. It should not be used in other species as severe adverse reactions may occur, including fatalities in dogs. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.

Adverse reactions
The product is well tolerated and has a wide safety margin. 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.

Withdrawal periods
Cattle: 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.
Pigs: Meat and offal: 28 days.

Environmental warnings
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.

Pharmaceutical precautions
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 28 days.
Do not use after the expiry date stated on the label and carton.

Legal category
Legal category: POM-VPS

Packaging quantities
50 ml, 250 ml and 500 ml containers.