Nchi: Uingereza
Lugha: Kiingereza
Chanzo: VMD (Veterinary Medicines Directorate)
Febantel, Praziquantel, Pyrantel
Lavet Pharmaceuticals Ltd
QP52AA51
Febantel, Praziquantel, Pyrantel
Chewable tablet
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
Dogs
Anthelmintic
Authorized
2013-01-16
Revised: June 2020 AN: 00084/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VELOXA FORTE CHEWABLE TABLETS FOR DOGS (in Greece and Hungary) VELOXA 175/504/525 MG CHEWABLE TABLETS FOR DOGS (in, Finland, Norway and Sweden) VELOXA XL CHEWABLE TABLETS FOR DOGS (in France, Ireland and United Kingdom) ANTHELMEX FORTE CHEWABLE TABLETS FOR DOGS (in Austria, Belgium, Germany, Luxembourg and the Netherlands) HELM-EX CHEWABLE TABLETS FOR LARGE DOGS (in Spain) XINDEX FORTE CHEWABLE TABLETS FOR DOGS (in Italy) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCES: mg Febantel 525.0 Pyrantel 175.0 (corresponding to Pyrantel embonate) 504.0 Praziquantel 175.0 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Brownish, oval, divisible tablet. It can be divided into equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. Revised: June 2020 AN: 00084/2020 Page 2 of 6 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Anthelmintic for treatment of mixed infections by the following roundworms and tapeworms in dogs over 17.5 kg: Ascarids : Toxocara canis, Toxascaris leonina (adult and late immature forms) Hookworms : Uncinaria stenocephala, Ancylostoma caninum (adults) Whipworms : Trichuris vulpis (adults) Tapeworms : Echinococcus spp. Taenia spp. and Dipylidium caninum (adult and immature forms). 4.3 CONTRAINDICATIONS Do not use in animals with a known hypersensitivity to any of the active substances or the excipients. Please see also sections 4.7 and 4.8. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Fleas serve as intermediate hosts for one common type of tapeworm – _Dipylidium _ _caninum_. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken. 4.5 SPECIAL PRECAUTIONS FOR USE Special precaution Soma hati kamili