Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NITROXINIL
Merial Animal Health Limited
QP52AG08
NITROXINIL
340 Mg/Ml
Solution for Injection
LM-Licensed Merchant
Bovine, Ovine
Nitroxinil
Endoparasiticide
Authorised
1999-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Trodax 340 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Nitroxynil 340 mg/ml as N-ethylglucamine salt. EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Bright orange-red solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Trodax 34% is indicated for the treatment of fascioliasis (infestation of mature and immature Fasciola hepatica) in cattle and sheep. It is also effective, at the recommended dose rate, against adult and larval infestations of Haemonchus contortus in cattle and sheep and Haemonchus placei, Oesophagostomum radiatum and Bunostomum phlebotomum in cattle. However, Trodax should not be regarded or used as a broad spectrum anthelmintic. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Do not exceed the stated dose. Do not use in dogs as fatalities have been reported. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/07/2013_ _CRN 7014909_ _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 bodyweight, misadministration of the product, or lack of calibration of the dosing device. Suspected clinical cases of resistance to anthelmintics should be further investigated Read the complete document