EPRIMEC inj

COMPOSITION

Each mL of product contains Eprinomectin 20 mg.

TARGET SPECIES

Cattle

INDICATIONS

Treatment of infestations with the following eprinomectin-susceptible ecto- and endoparasites:

Gastrointestinal nematodes produced by: Ostertagia ostertagi (adults, L4, including inhibited larvae); Ostertagia lyrata (adults and inhibited L4); Ostertagia spp. (adults, L4); Cooperia punctata (adults and L4); Cooperia oncophora (adults and L4); Cooperia pectinata (adults and L4); Cooperia surnabada (adulți și L4); Cooperia spp (adults, inhibited L4 and L4); Haemonchus placei (adults and L4); Mecistocirrus digitatus (adults); Trichostrongylus axei (adults and L4); Trichostrongylus colubriformis (adults and L4); Trichostrongylus spp (adults and L4); Bunostomum phlebotomum (adults); Nematodirus helvetianus (adults); Oesophagostomum radiatum (adults and L4); Oesophagostomum spp (adults); Trichuris Spp. (adults); Lung nematodoses produced by: Dictyocaulus viviparus (adults and L4); Hypodermosis caused by: Hypoderma bovis; Hypoderma lineatum (insect larvae); Infestations with chewing louse (biting): Linognathus vituli; Haematopinus. Horn fly: Haematobia irritans; Scabies caused by: Sarcoptes scabiei var. bovis. Preventing reinfection: The product protects animals treated against reinfections 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) and Nematodirus helvetianus for 14 days and Haematobia irritans for at least 7 days.

CONTRAINDICATIONS

Do not use in other animal species. Do not use in animals with known hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

Moderate to severe infections at the injection site are very common. Typically, inflammation is resolved after less than 7 days, but the areas may remain indurated for more than 21 days. Inflammation may be accompanied by mild to moderate pain. This reaction disappears without treatment and does not affect the safety or efficacy of the product.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous administration. A single administration of 0.2 mg Eprinomectin per kg body weight corresponds to 1 mL of veterinary medicinal product per 100 kg body weight. 50mL or 100mL vials: Do not exceed the number of 30 perforations per vial. If more than 30 perforations are required, it is recommended to use a separate needle to remove the product. 250mL or 500mL vials: Do not exceed the number of 20 perforations per vial. If more than 20 perforations are required, it is recommended to use a separate needle to remove the product.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

In order to administer a correct dose, body weight should be determined as accurately as possible. The precision of the dosing equipment will also be checked.

WITHDRAWAL PERIOD(S)

Meat and offal: 63 days

Milk: 0 days

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

The following practices that increase the risk of developing resistance and ultimately lead to treatment inefficiency should be avoided: Frequent and repeated use of antiparasitic drugs in the same class over a long period of time. Underdosage that may result from underestimation of animal body weight, wrong product administration or lack of calibration of the dosing device (if applicable). Suspected clinical cases of anthelmintic resistance should be further investigated using adequate laboratory tests (such as the faecal egg count reduction test). When test results show resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. To date, resistance to Eprinomectin (a macrocyclic lactone) has not been reported in the EU. However, resistance to other macrocyclic lactones has been reported in the EU for cattle parasite species. The use of this product should be based on local epidemiological information (region, farm) on nematode susceptibility and recommendations on how to limit the development of resistance to antihelmintics.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The usual aseptic rules for the administration of injections should be observed. Not to be used in other species: avermectins can be fatal in dogs, especially in Collie, Bobtail, related breeds and mutts, and in turtles. In order to avoid adverse reactions caused by the death of Hypoderma spp. larvae in the cattle oesophagus and spinal canal, it is recommended to administer the product immediately after the insect has ceased its activity and before the larvae reach these areas. Ask your vet for the correct treatment administration period.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

This veterinary medicinal product causes severe eye irritations. Avoid contact with eyes! If splashed in your eyes, rinse immediately with water. This product may cause neurotoxicity. Care must be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet and the product label to the physician. Avoid skin contact. Immediately flush with water in case of accidental splashing. Avoid oral exposure. Do not eat, drink or smoke while handling this veterinary medicine. Wash your hands after use. Excipient glycerol may cause foetal disorders. In addition, the active substance Eprinomectin may pass into breast milk. Pregnant or breastfeeding women as well as women of childbearing potential should avoid contact with this product. Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.

USE DURING PREGNANCY AND LACTATION 

The product can be used during gestation and lactation.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Because eprinomectin binds closely to plasma proteins, this should be taken into account when associating with other molecules with the same characteristics.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

After subcutaneous dosing of up to 5 times the recommended dose, no adverse reactions except a transient reaction (inflammation followed by induration) at the site of administration were observed.

INCOMPATIBILITIES

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

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with national requirements. Extremely dangerous for fish and aquatic organisms. Eprinomectin is highly toxic to aquatic organisms, persists in soil and can accumulate in sediments. The risk to aquatic ecosystems and manure fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle. The risk to aquatic ecosystems will be reduced by keeping the treated cattle away from the water courses for two to five weeks after treatment. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

50 mL, 100 mL, 250 mL and 500 mL brown polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.