国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Moxidectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AB02
Moxidectin
5 milligram(s)/millilitre
Pour-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
moxidectin
Authorised
2020-01-24
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Moxodex 5 mg/ml Pour on solution for cattle Ridamec 5 mg_ml solution pour-on pour bovins (FR) Moxodex vet 5 mg/ml Pour on solution for cattle (FI, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Moxidectin 5 mg Excipients: Butylhydroxyanisole E320 0.10 mg Tert butyl hydroquinone E319 0.03 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pour-on solution. A clear colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections of cattle with parasites sensitive to moxidectin. For the treatment of infections caused by: - ADULT AND LARVAL GASTRO-INTESTINAL NEMATODES: _Haemonchus placei _ _Ostertagia ostertagi _ (including inhibited larvae) _ _ _Trichostrongylus axei _ _Nematodirus helvetianus _ _Cooperia oncophora _ _Cooperia punctata _ (adults) _ _ _Oesophagostomum radiatum _ (adults) _ _ _Bunostomum phlebotomum _ (adults) _ _ - ADULT RESPIRATORY TRACT NEMATODE _Dictyocaulus viviparous _ _ _ - WARBLES (MIGRATING LARVAE) _Hypoderma bovis _ _Hypoderma lineatum _ - LICE _Linognathus vituli _ _Haematopinus eurysternus _ _Solenopotes capillatus _ _Bovicola bovis (Damalinia bovis) _ _ _ - MANGE MITES _Sarcoptes scabiei _ _Psoroptes ovis _ _Chorioptes bovis _ _ _ - HORN FLIES _Haematobia irritans _ _ _ The product has a persistent effect in preventing against reinfection by: _Ostertagia ostertagi _ for 5 weeks _Dictyocaulus viviparus _ for 6 weeks. _ _ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Not to be used in other species as severe adverse reactions, including fatalities in dogs, may occur. 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 fr 完全なドキュメントを読む