Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: VMD (Veterinary Medicines Directorate)
Praziquantel
Bayer plc
QP52AA01
Praziquantel
Oral gel
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Horses
Anthelmintic
Expired
2002-01-31
Revised: May 2014 AN: 01882/2013 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Droncit 9% Oral Gel for Horses [AT, DE, PT] Droncit vet oral gel (for horses) [DK, FI, IS, NO, SE] Equitape 90 mg/g Oral Gel for Horses [IE, UK] Droncit 9% Gel Oral Cheval [FR] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Praziquantel 90.0 mg Excipients Propyl Parahydroxybenzoate (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 Oral Gel 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 Revised: May 2014 AN: 01882/2013 Page 2 of 4 4.5. SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals None. ii) Special precautions to be taken by the person administering the medicinal products to animals Wash hands thoroughly after treating animals. Any spillage of the product onto human skin should be removed by washing with soap and water. Do not eat, drink or smoke during application 4.6. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In case of very high infestation levels, destruction of the tapeworms may cause a mild transient colic and loose faeces Prečítajte si celý dokument