Land: Verenigd Koninkrijk
Taal: Engels
Bron: VMD (Veterinary Medicines Directorate)
Amoxicillin
Dopharma Research B.V.
QJ01CA04
Amoxicillin
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Duck, Turkeys
Antimicrobial
Authorized
2019-02-14
Unlimited renewal: July 2023 AN: 00743/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXY ACTIVE CTD 697 mg/g powder for use in drinking water for chickens, turkeys and ducks 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: _ACTIVE SUBSTANCE:_ Amoxicillin 697 mg as amoxicillin trihydrate 800 mg _EXCIPIENTS:_ For the full list of excipients, see section 6.1. 3. PHARMAPEUTICAL FORM Powder for use in drinking water. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broiler, pullet, breeder), turkeys, ducks (broiler, breeder). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Chickens, turkeys and ducks: treatment of infections caused by bacteria susceptible to amoxicillin. 4.3 CONTRAINDICATIONS Do not use in the presence of ß-lactamase-producing bacteria. Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores. Do not use in animals with known hypersensitivity to penicillins or other substances from the beta-lactam group or to any of the excipients. Do not use in ruminants or horses. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Unlimited renewal: July 2023 AN: 00743/2023 Page 2 of 6 Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the 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 target bacteria. Use of the product deviating from the instructions given in the product literature may increase the prevalence of bacteria resistant to the amoxicillin and may decrease the effectiveness of the treatment. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillins may cause hypersensitivity (allergy) following injection Lees het volledige document