Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Closantel
Elanco GmbH
QP52AG09
Closantel
50 milligram(s)/millilitre
Solution for injection
LM: Licensed Merchant as defined in relevant national legislation
closantel
Authorised
2012-10-12
Health Products Regulatory Authority 03 May 2019 CRN0091QM Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Closantel 50 mg (equivalent to closantel sodium dihydrate 54.375 mg) EXCIPIENTS: Propylene glycol 414.4 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow to amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of liver fluke, gastro-intestinal nematodes and arthropods. TREMATODES - _Fasciola hepatica_ - _Fasciola gigantica_ NEMATODES - _Haemonchus placei_ - _Bunostomum phlebotomum_ - _Oesophagostomum radiatum_ ARTHROPODS - _Hypoderma bovis_ - _Hypoderma lineatum_ 4.3 CONTRAINDICATIONS See section 4.11. Do not administer to animals with known hypersensitivity to the active ingredient. Not for i.v. or i.m. use. Health Products Regulatory Authority 03 May 2019 CRN0091QM Page 2 of 5 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) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. The use of this product should be based on local (regional, farm) epidemiologic Lesen Sie das vollständige Dokument