EPRECIS INJ. 100ML / EPRINOMECTIN - for cows / per bovini

COMPOSITION

1 ml of product contains:

Active substance:

Eprinomectin 20 mg

Excipient(s):

Butylhydroxytoluene (E321) 0.8 mg

PHARMACEUTICAL FORM

Solution for injection. Clear colourless to pale yellow solution.

TARGET SPECIES

Cattle, goats, sheep

PHARMACODYNAMIC PROPERTIES 

Eprinomectin is a member of the macrocyclic lactone class of endectocides. The compounds of this class bind selectively with high affinity to chloride ion channels in muscle and nerve cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the muscle or nerve cells resulting in paralysis and death of the parasite. Compounds of this class may also interact with other chloride ion channels, such as those linked to the neurotransmitter gamma-aminobutyric acid (GABA). The safety margin of compounds of this class is due to the fact that mammals do not have glutamate chloride ion channels and macrocyclic lactones have a low affinity for other mammalian chloride ion channels, which is why they do not cross the blood-brain barrier. 

PHARMACOKINETICS

Absorption

Following subcutaneous administration, the bioavailability of eprinomectin is approximately 89%. Maximum plasma concentration of 58 μg/L was reached after 36-48 hours.

distribution

There is a linear relationship between the administered dose and the observed plasma concentration at therapeutic doses between 0.1 and 0.4 mg/kg. Eprinomectin has a high affinity (greater than 99%) for bovine plasma proteins.

Metabolism

Eprinomectin is not extensively metabolized in cattle. The metabolites of the molecule reach approximately 10% of the total residues in plasma, milk, edible tissues and feces.

Elimination

Eprinomectin has a half-life of 65-75 hours and the main route of elimination is through the feces.

Environmental properties

Like other macrocyclic lactones, eprinomectin may adversely affect other organisms that are not normally targeted by it. After treatment, excretion of potentially toxic levels of eprinomectin may take several weeks. Faeces containing eprinomectin excreted on pasture by treated animals may reduce the abundance of dung fauna which may affect its degradation. Eprinomectin is very toxic to aquatic organisms, persists in soil and may accumulate in sediments. 

HOW TO USE

Treatment of infestations with the following ectoparasites and endoparasites sensitive to eprinomectin:

Ostertagia ostertagi

Ostertagia lyrata

Ostertagia spp.

Cooperia oncophora

Cooperia pectinata

Surnabada Cooperative

Dotted cooperation

Cooperia spp.

Haemonchus placei

Trichostrongylus axis

Trichostrongylus colubriformis

Trichostrongylus spp.

Bunostomum phlebotomum

Nematodirus helvetianus

Oesophagostomum radiatum

Oesophagostomum spp.

Trichuris spp. 

Lungworms:

Dictyocaulus viviparous

Blood-sucking lice:

Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus

Horn flies:

Haematobia irritans

Insect larvae (parasitic stage):

Hypoderma bovis, Hypoderma lineatum

Mites:

Sarcoptes scabiei var. bovis

PREVENTING INFESTATIONS

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) and Nematodirus helvetianus for 14 days and Haematobia irritans for at least 7 days.

CAUTION

The following practices should be avoided as they increase the risk of developing resistance and ultimately lead to treatment ineffectiveness:

Frequent and repeated use of antiparasitics from the same class, over a long period of time.

Underdosing which may result from underestimation of the animals' body weight, 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 (such as the Faecal Egg Count Reduction Test). When test results show resistance to a particular anthelmintic, an anthelmintic belonging to a different 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 in parasitic species of cattle. The use of this product should be based on local epidemiological information (region, farms) on the susceptibility of nematodes and recommendations on how to limit the development of resistance to anthelmintics.

SPECIAL PRECAUTIONS

Special precautions for use in animals

The usual rules of asepsis for the administration of injectable preparations must be observed. Do not use in other species: avermectins can cause mortality in dogs, especially in Collies, Bobtails, related breeds and crossbreeds, and also in tortoises. To avoid adverse reactions caused by the death of Hypoderma spp. larvae in the oesophagus and spinal canal of cattle, it is recommended to administer the product immediately after the insect has finished its activity and before the larvae reach these areas. Seek the advice of a veterinarian to establish the correct period for administering the treatment.

This veterinary medicinal product causes severe eye irritation. Avoid contact with eyes! If splashed into eyes, rinse immediately with water.

This product may cause neurotoxicity. Care should 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 label to the physician. Avoid contact with skin. In case of accidental splashes, wash immediately with water. Avoid oral exposure. Do not eat, drink or smoke while handling this veterinary medicinal product. Wash hands after use. The excipient glycerol may cause foetal harm. In addition, the active substance eprinomectin may pass into breast milk. Pregnant or lactating women and women of childbearing potential should avoid contact with this product.

Do not use this product in case of known hypersensitivity to the active substance or to any of the excipients.

Eprinomectin is very toxic to aquatic organisms, persists in soil and may accumulate in sediments. The risk to aquatic ecosystems and dung 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 treated cattle away from watercourses for two to five weeks after treatment.

ADVERSE REACTIONS

Moderate to severe swelling at the injection site is very common. The swelling usually resolves within 7 days, but the areas may remain indurated for more than 21 days. The swelling may be accompanied by mild to moderate pain. This reaction resolves without treatment and does not affect the safety or efficacy of the product.

USE DURING PREGNANCY, LACTATION OR LAYING PERIOD

The product can be used during pregnancy or lactation.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER FORMS OF INTERACTION

Since eprinomectin binds tightly to plasma proteins, this should be taken into account when combining with other molecules with the same characteristics.

DOSAGE AND METHOD OF ADMINISTRATION

Subcutaneous administration.

A single administration of 0.2 mg 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 than 30 punctures are required, it is recommended to use a separate needle to withdraw the product.

250 ml or 500 ml bottles

Do not exceed 20 punctures per vial. If more than 20 punctures are required, it is recommended to use a separate needle to withdraw the product.

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

Overdose (symptoms, emergency procedures, antidotes), as appropriate

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

Waiting time

Cattle - Offal and offal: 63 days - Milk: zero hours

Sheep - Meat and offal: 42 days - Milk: zero hours

Goats - Meat and offal: 42 days - Milk: zero hours

incompatibility

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

VALIDITY PERIOD

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 6 months.

SPECIAL STORAGE PRECAUTIONS

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