Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
CLOSANTEL (AS SODIUM DIHYDRATE)
Norbrook Laboratories Limited
QP52AG09
CLOSANTEL (AS SODIUM DIHYDRATE)
50 Mg/Ml
Oral Suspension
LM-Licensed Merchant
Ovine
Closantel
Endoparasiticide
Authorised
2016-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Solantel 50 mg/ml Oral Suspension for Sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Closantel 50.0 mg (as Closantel Sodium Dihydrate 54.375 mg) EXCIPIENT(S): Propylene glycol (E1520) 217.6 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension Off-white to yellow suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of chronic and subacute fasciolosis (due to _Fasciola hepatica_). The product is effective against mature and late immature flukes (from 5 weeks immature). For the treatment of _Oestrus ovis _(Sheep Nasal Bot Fly)_._ For the treatment of inhibited, L4 and adult stages of _Haemonchus contortus_. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance or to any of the excipients. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 26/08/2016_ _CRN 7021464_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) stron Lugege kogu dokumenti