البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Nitenpyram
Elanco Europe Ltd
QP53BX02
Nitenpyram
Tablet
AVM-GSL - Authorised Veterinary Medicine – General Sales List
Dogs
Ectoparasiticide
Authorized
2001-08-03
Revised: August 2023 AN: 02041/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Capstar 57 mg tablets for large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE: Nitenpyram 57 mg EXCIPIENT(S): For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to light yellow, round, biconvex tablets, with bevelled edges, imprinted on one side with “HIH”, on the other side with “CG”. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea infestations (_C. felis_). 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE (i) Special precautions for use in animals Do not use on dogs weighing less than 11 kg. Revised: August 2023 AN: 02041/2022 Page 2 of 5 (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals None. Special precautions for the protection of the environment: Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Dogs: Very rare (<1 animal / 10,000 animals treated, including isolated reports): Excessive chewing, licking and/or grooming 1 , Hyperactivity, Vocalisation 1 Neurological signs (e.g., muscle tremor, ataxia, convulsion) 1 Panting 1 Increased scratching 2 1 Transient 2 For the first hour following administration; presumably caused by flea response to the veterinary medicinal product. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Pregnancy: Can be used during pregnancy. Lactation: Can be used during lactation. Laboratory studies in rats and rabbit اقرأ الوثيقة كاملة