Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: 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
AN: 00885/2018 Issued: May 2019 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 _EXCIPIENTS:_ For the full list of excipients, see section 6.1. 3. PHARMAPEUTICAL FORM Oral powder . White to off-white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig and chicken (broiler, pullet, breeder). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment of respiratory tract infections, gastro-intestinal tract infections, urogenital infections, ear necrosis, secondary infections following viral infections and septicemia 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Sick animals have an altered drinking behaviour and should be medicated parenterally where applicable. AN: 00885/2018 Issued: May 2019 Page 2 of 6 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 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 t Διαβάστε το πλήρες έγγραφο