País: Reino Unido
Língua: inglês
Origem: VMD (Veterinary Medicines Directorate)
Pyrantel Embonate
Cross Vetpharm Group Ltd
QP52AF02
Pyrantel Embonate
Oral paste
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Horses
Anthelmintic
Authorized
2015-03-27
AN: 00498/2014 Issued: March 2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF VETERINARY MEDICINAL PRODUCT Alonate-P 400 mg/g Oral Paste for Horses and Ponies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance mg/g Pyrantel embonate 400 mg/g Excipients Butylated Hydroxytoluene 0.2 mg/g For full list of excipients, please see section 6.1. 3. PHARMACEUTICAL FORM Oral Paste Pale yellow to buff coloured paste 4. CLINICAL PARTICULARS 4.2 TARGET SPECIES Horses and ponies. 4.3 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pyrantel embonate is a broad spectrum anthelmintic. Pyrantel embonate is indicated for use in the horse for the control and treatment of adult infections of large and small strongyles, Pinworms, Roundworms, Tapeworms. Pyrantel embonate has a broad spectrum of activity, including activity against: Large strongyles: _Stronglylus vulgaris, S. edentatus, S. equinus._ Small strongyles: _Trichonema spp. (Cyathostomes), Triodontophorus spp._ Pinworms: _Oxyuris equi, Probstmayria vivipara._ Large roundworms: _Parascaris equorum._ Tape worms: _Anoplocephala perfoliata._ 4.4 CONTRA-INDICATIONS Not for use in foals less than 4 weeks of age. Contraindicated in known sensitivity to pyrantel and in severely debilitated animals. Page 1 of 6 AN: 00498/2014 Issued: March 2015 4.5 SPECIAL WARNINGS FOR EACH TARGET SPECIES. 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 weight, misadministration of the product, or lack of calibration of the dosing device(if any). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to a Leia o documento completo