国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Amoxicillin
Dopharma Research B.V.
QJ01CA04
Amoxicillin
Oral powder
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs
Antimicrobial
Authorized
2014-06-27
Revised: January 2024 AN: 01621/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amoxy Active, 697 mg/g, oral powder for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Amoxicillin 697 mg as amoxicilline trihydrate 800 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. White to off-white oral powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens (broilers, pullets, chickens for reproduction). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment of respiratory tract infections, gastro-intestinal tract infections, urogenital infections, secondary infections following viral infections and septicaemia caused by micro-organisms susceptible to amoxicillin. Chickens: Treatment of respiratory tract infections and gastro-intestinal tract infections caused by micro-organisms susceptible to amoxicillin. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to penicillin or other substances of the beta-lactam group or to any of the excipients. Do not use in the presence of ß-lactamase-producing bacteria. Do not use in lagomorphs and rodents such as guinea pigs, hamsters or gerbils. Do not use in animals with serious kidney malfunction including anuria and oliguria. Do not use in ruminants or horses. Revised: January 2024 AN: 01621/2023 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Sick animals have an altered drinking behaviour and should be medicated parenterally where applicable. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the ta 阅读完整的文件