Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Febantel, Praziquantel, Pyrantel Embonate
Chanelle Pharmaceuticals Manufacturing Ltd
QP52AA51
Febantel, Praziquantel, Pyrantel Embonate
Tablet
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
Dogs
Anthelmintic
Authorized
2012-10-22
Revised: October 2019 AN: 00835/2019 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cazitel Plus XL Tablets For Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Praziquantel 175 mg Pyrantel Embonate 504 mg (equivalent to 175 mg pyrantel) Febantel 525 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet A yellow coloured oblong tablet with a breakline on both sides. The tablets can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In adult dogs: Treatment of mixed infections by nematodes and cestodes of the following species NEMATODES: ASCARIDS: _Toxocara canis_, _Toxascaris leonina_ (adult and late immature forms). HOOKWORMS: _Uncinaria stenocephala_, _Ancylostoma caninum_ (adults). WHIPWORMS: _Trichuris vulpis_ (adults). Revised: October 2019 AN: 00835/2019 Page 2 of 8 CESTODES: TAPEWORMS: _Echinococcus_ species, _(E. granulosus, E. multilocularis), Taenia_ species, _(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum_ (adult and immature forms). 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine compounds . Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. • Underdosing, which may be due to underestimation of body weight, misadministration of the product.” 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PREC Read the complete document