Authorisation For The Medicinal Product For Usoveterinario «Neoprinil Pour-On 5 Mg/ml ' Pour-On Solution For Bovinida Meat And Milk.

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Neoprinil Pour-On 5 mg/ml» pour-on soluzione per bovinida carne e da latte.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-09&atto.codiceRedazionale=15A00771&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Extract Decree 4 of January 12, 2015 decentralised procedure # FR/V/0255/001/DC.
Veterinary medicinal product NEOPRINIL POUR-ON 5 mg/ml pour-on solution for dairy and beef cattle.
A.I.C. holder: society Virbac 1ere avenue-2065 m-L.I.D. 06516 Carros, France.
Manufacturer responsible for batch release: the establishment of the company owner of the A.I.C. Virbac 1ere avenue-2065 m-L.I.D. 06516 Carros, France.
Authorised pack sizes and numbers of 1 liter bottle-A.I.C. A.I.C.: # 104,593,013;
2.5 liter bottle-A.I.C. # 104,593,025;
5 liter bottle-A.I.C. # 104,593,037;
flexible bag from 2.5 liters-A.I.C. # 104,593,049;
flexible bag 4.5 liters-A.I.C. # 104,593,052;
flexible bag from 8 liters-A.I.C. # 104,593,064.
Composition: 1 ml of solution contains: active ingredient: Eprinomectin 5.00 mg.
Other ingredients: pharmaceutical technology gained so as indicated in the record.
Target species: dairy and beef cattle.
Medical indications: for the treatment of parasitic infestations of the following sensitive to eprinomectin: gastrointestinal nematodes (adults and larvae L4): Ostertagia ostertagi (including L4 inhibited) Haemonchus placei, Ostertagia, Trichostrongylus lyrata (adults), Trichostrongylus axei, colubriformis, Cooperia SP. Cooperia oncophora (including L4 inhibited), Cooperia punctata, Bunostomum phlebotomum Cooperia, Nematodirus Spathiger, surnabada, Cooperia pectinata helvetianus, Oesophagostomum radiatum, Oesophagostomum sp. (adults), Trichuris discolor (adults);
Pulmonary nematodes: Dictyocaulus viviparus (adults and L4);
External parasites (larval): Hypoderma lineatum, warble fly;
Mange mites: Sarcoptes scabiei var. bovis, Chorioptes Bovis;
Haematopinus eurysternus Linognathus vituli, sucking lice Solenopotes capillatus:,;
Chewing lice: Damalinia bovis;
Haematobia irritans flies: pricking machines.
The product protects animals against King for 14 days: helvetianus Nematodirus Spathiger infestations;
Trichostrongylus axei and Haemonchus placei for 21 days;
Dictyocaulus viviparus, Cooperia oncophora, Cooperia punctata, Oesophagostomum radiatum Ostertagia ostertagi and Cooperia surnabada, for 28 days.
Validity: the veterinary medicinal product as packaged for sale: 2 years;
After first opening the immediate packaging: 12 months.
Waiting time: meat and offal: 15 days;
Milk: zero hours.
Dispensing scheme: to be supplied only upon presentation of medical veterinary prescription in triplicate not repeatable.
Date of Decree: immediate effect.