Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
moxidectin 20 mg/ml
Fort Dodge Santé Animale
QP54AB02
Solution for injection
moxidectin
Sheep
2012-02-17
Page 1 of 5 PACKAGE LEAFLET 2 PACKAGE LEAFLET CYDECTIN 2% w/v LA Solution for Injection for Sheep 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT MARKETING AUTHORISATION HOLDER: <_Pfizer/Fort Dodge subsidiaries in each Member State_> MANUFACTURER FOR THE BATCH RELEASE : Pfizer Olot, S.L.U. Carretera Camprodon s/n – La Riba 17813 – Vall de Bianya Gerona, Spain 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CYDECTIN 2% w/v LA Solution for Injection for Sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: ACTIVE SUBSTANCES Moxidectin 20 mg EXCIPIENTS Benzyl alcohol For a full list of excipients, see section 6.1 70 mg 4. INDICATION(S) Treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain anthropod parasites in sheep. Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of: - Gastro-intestinal nematodes: _ _ _Haemonchus contortus _(adults and L3)_ _ _Ostertagia (Teladorsagia) circumcincta _(adults and L3, including inhibited larvae)_ _ _Trichostrongylus axei _(adults)_ _ _Trichostrongylus colubriformis _(adults and L3)_ _ _ Nematodirus spathiger _(adults)_ _ _Cooperia curticei (macmasteri) _(adults)_ _ _ Cooperia punctata _(adults)_ _ _ Oesophagostomum columbianum _(L3)_ _ _Chabertia ovina _(adults)_ _ - Respiratory tract nematodes _Dictyocaulus filaria _(adults) - Larvae of Diptera _Oestrus ovis_: L1, L2, L3 3 - Mange mites_ _ _Psoroptes ovis _ Trials have shown that moxidectin is eff Read the complete document
Cydectin 2% LA for sheep PART IB Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYDECTIN 2% w/v LA Solution for Injection for Sheep Cydectin Larga Acción 20 mg/ml para ovino (Spain) Cydectin LA 20 mg/ml solution for injection for sheep (Italy) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES Moxidectin 20 mg EXCIPIENTS Benzyl alcohol For a full list of excipients, see section 6.1 70 mg 3. PHARMACEUTICAL FORM Solution for injection A clear yellow liquid solution for injection 4. CLINICAL PARTICULARS 5.1 TARGET SPECIES Sheep above 15kg bodyweight. 4.1 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain anthropod parasites in sheep. Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of: Cydectin 2% LA for sheep PART IB Summary of Product Characteristics - Gastro-intestinal nematodes: _ _ _. Haemonchus contortus _(adults and L3)_ _ _. Ostertagia (Teladorsagia) circumcincta _(adults and L3, including inhibited larvae) _ _ _. Trichostrongylus axei _(adults)_ _ _. Trichostrongylus colubriformis _(adults and L3)_ _ _. Nematodirus spathiger _(adults)_ _ _. Cooperia curticei (macmasteri) _(adults)_ _ _. Cooperia punctata _(adults)_ _ _. Oesophagostomum columbianum _(L3)_ _ _. Chabertia ovina _(adults)_ _ - Respiratory tract nematodes _Dictyocaulus filaria _(adults) - Larvae of Read the complete document