Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Moxidectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AB02
Moxidectin
1 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
moxidectin
Endectoparasiticides
Authorised
2017-08-25
Health Products Regulatory Authority 14 February 2022 CRN00CQ6J Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Moxodex 1 mg/ml oral solution for sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Moxidectin 1.00 mg EXCIPIENT: Benzyl Alcohol (E1519) 40.0 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution Clear colourless to yellowish solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of mixed infections of sheep with parasites sensitive to moxidectin Adult and/or immature gastro-intestinal nematodes: - _Haemonchus contortus _(including inhibited larvae) - _Teladorsagiacircumcincta _(including inhibited larvae) - _Teladorsagiatrifurcata_ - _Trichostrongylus axei _(including inhibited larvae) - _Trichostrongylus colubriformis_ - _Trichostrongylus vitrinus_ - _Nematodirus battus_ - _Nematodirus spathiger_ - _Nematodirus filicolis _(adults only) - _Strongyloides papillosus _(larval stages only) - _Cooperia curticei _(adults only) - _Cooperia oncophora_ - _Oesophagostomum columbianum_ - _Oesophagostomum venulosum _(adults only) - _Chabertia ovina_ - _Trichuris ovis _(adults only) Adult respiratory tract nematode: - _Dictyocaulus filaria_ The product has a persistent effect in preventing reinfection: for 5 weeks by _Teladorsagiacircumcincta _and _Haemonchus contortus_ for 4 weeks by _Oesophagostomum columbianum_ _ _ Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of: _Haemonchus contortus_ Health Products Regulatory Authority 14 February 2022 CRN00CQ6J Page 2 of 5 _Teladorsagiacircumcincta_ _Trichostrongylus colubriformis_ _Cooperia curticei_ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should Belgenin tamamını okuyun