Eprecis 20 mg/ml solution for injection for cattle

PRODUCT NAME
EPRECIS INJECTABLE 20MG/ML

Eprecis 20mg/ml injectable solution for cattle.

Active substance: eprinomectin…….20.0mg;
Excipient: Butylhydroxytoluene (E 321)…………0.8mg.

Pharmaceutical form:
-Injectable solution;
-Clear colorless to yellow solution.

Target species: cattle.

Lungworms:
Dictyocaulus vivparus;

Blood-sucking lice: Haematopinus eurysternus; Linognathus vituli; Solenopotes capillatus;

Horn flies: Haematobia irritans;

Insect larvae (parasitic stage): Hypoderma bovis; Hypoderma lineatum.

Mites: Sarcoptis scabiei var.bovis.

Dosage for each species, route of administration and method of administration:
Subcutaneous administration. A single administration of 0.2 mg. of eprinomectin per kilogram body weight, corresponding to 1 ml. of veterinary medicinal product per 100 kg. body weight.

Prevention of reinfestations:
The product protects treated animals against reinfestations with: Trichostrongylus spp. (including Trichostrongylus axei and Trichostrongylus colubriformis);
Haemonchus placei, Cooperia spp. (including Cooperia oncophora, Cooperia punctata, Cooperia surnabada);
Dictyocaulus viviparus;
Oesophagostomum radiatum;
Ostertagia spp. (including Ostertagia ostertagi and Ostertagia lyrata);
Nematodirus helvetianus for 14 days;
Haematobia irritans for at least 7 days.

Contraindications:
Do not use in other animal species;
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Use during pregnancy and lactation, or during laying:
Can be used during pregnancy and lactation.

Special warnings:
– Frequent and repeated use of antiparasitics of the same class over a long period of time should be avoided. Underdosing may result from underestimation of the body weight of the animals, incorrect administration of the product or lack of calibration of the dosing device (if applicable);
– Clinical cases suspected of anthelmintic resistance should be further investigated using appropriate laboratory tests. Resistance to eprinomectin has not been reported to date. The use of this product should be based on epidemiological information on the susceptibility of nematodes and recommendations on how to limit the development of anthelmintic resistance.

Special precautions for use:
Aseptic techniques must be followed for the administration of injectable preparations. Do not use in other species.
For veterinary use only:
To be supplied only on veterinary prescription

Adverse reactions:
Moderate to severe inflammation at the injection site is very common. This reaction resolves without treatment and does not affect the safety or efficacy of the product. Can be used during pregnancy or lactation.

Amounts and route of administration:
Subcutaneous administration:
A single administration of 0.2 mg. of eprinomectin per kg. body weight, corresponding to 1 ml. of veterinary medicinal product per 100 kg. body weight.
50 ml. or 100 ml. vials.
Do not exceed 30 punctures per vial. If more punctures are necessary, it is recommended to use a separate needle for the extraction of the product.
250 ml. vials. or 500 ml.
Do not exceed 20 punctures per vial. If more than 20 punctures per vial are required, it is recommended to use a separate needle to withdraw the product.

Overdose:
After subcutaneous administration of up to 5 times the recommended dose, no adverse reactions have been observed, except for a transient reaction at the injection site.

Withdrawal period:
Meat and offal: 63 days;
Milk: zero hours.

Pharmacological properties:
Pharmacotherapeutic group: endectocides; macrocyclic lactones of endectocides.

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