Eprinomectin Injection 1% (For Veterinary Use Only)
COMPOSITION: Each ml contains: Eprinomectin10mg Excipient(ad.) Up to 1ml PHARMACODYNAMICS: The applicant has provided bibliographical data which show that eprinomectin acts by binding selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve or muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarisation of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels; the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels, and they do not readily cross the blood-brain barrier. INDICATIONS: Treatment of infestations by the following internal and external parasites sensitive to eprinomectin: Gastrointestinal roundworms: Ostertagia ostertagi ,Ostertagia lyrata ,Ostertagia spp. ,Cooperia oncophora ,Cooperia pectinata, Cooperia surnabada ,Cooperia punctata ,Cooperia spp., Haemonchus placei ,Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus spp. ,Bunostomun phlebotomum, Nematodirus helvetianus, Oesophagostomum radiatum ,Oesophagostomum spp. ,Trichuris spp. . Lungworms: Dictyocaulus viviparus. External parasites: Warbles (parasitic stages): Hypoderma bovis, Hypoderma lineatum; Mange mites: Sarcoptes scabiei var. bovis; Sucking lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus; Horn flies: Haematobia irritans. Prevention of reinfestations: The product protects the animals against reinfestations with: - Trichostrongylus spp. (including Trichostrongylus axei and Trichostrongylus colubriformis), Haemonchus placei, Cooperia spp. (includingCooperia oncophora, Cooperia punctata, Cooperia surnabada), Dictyocaulus viviparus, Oesophagostomum radiatum, Ostertagia spp.(including Ostertagia ostertagi and Ostertagia lyrata) and Nematodirus helvetianus for 14 days. - Haematobia irritans for at least 7 days. USAGE AND DOSAGE: Subcutaneous use. Single administration of 0.2 mg of eprinomectin per kg bodyweight; corresponding to 1ml of the veterinary medicinal product per 100 kg bodyweight. SIDE EFFECT: Following treatment, moderate to severe swelling at the site of injection is very common. Typically, the swelling resolves within 7 days, but induration (hardness) may persist for in excess of 21 days. Swelling may be associated with mild to moderate pain. This reaction disappears without any treatment and does not impair the safety or efficacy of the veterinary medicinal product.
PRECAUTION: Special precautions for use in animals Usual aseptic procedures for administration of a parenteral injection should be followed. Not to be used in other species; avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises. To avoid adverse reactions due to the death of warble larvae in the oesophagus or backbone, it is recommended to administer the product after the end of warble fly activity and before the larvae reach their resting sites in the body; consult a veterinary surgeon regarding the appropriate time for treatment. WITHDRAWAL TIME: 48 days Shelf life: 3 years STORAGE: Protect from light and store in a cool dry place and below 30ºC.
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