Krajina: Grécko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
praziquantel 0
BAYER Pharma Division Sante Animale
Oral paste
2011-04-22
Final SPC DRONCIT RENEWAL February 2006 Dokument1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Droncit 9% Oral Gel for Horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Praziquantel …………………...........................90.0 mg Excipients Propyl P arahydroxybenzoate (E 216) …………0.2 mg Methyl Parahydroxybenzoate (E 218) …………1.4 mg Excipients ad………………………………………………1.0 g For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Gel for oral use in horse White soft gel 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Horse 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections with cestodes of the species _Anoplocephala perfoliata_, sensitive to praziquantel. 4.3. CONTRAINDICATIONS None known Milk: see section 4.11 (Do not use in mares from which milk is taken for human consumption) 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary. In order to limit excretion of the product and its metabolites on the pasture horses should remain stabled for 2 days after treatment. Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. MRLs for milk have not been established See section 4.11 Withdrawal periods Final SPC DRONCIT RENEWAL Prečítajte si celý dokument