Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
phenoxymethylpenicillin sodium salt 325 mg/g
Bayer B.V. – Animal Health Division
QJ01CE02
Powder for oral solution
Phenoxymethylpenicillin
Chicken
2011-04-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BayCubis, 325 mg/g powder for oral solution for chickens (NL) BayCubis, 325 mg/g Pulver zum Eingeben über das Trinkwasser (DE) BayCubis, 293 mg/g powder for oral solution for chickens (FR, IT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per gram: _ACTIVE SUBSTANCE: _ Phenoxymethylpenicillin 293 mg equivalent to potassium phenoxymethylpenicillin 325 mg _EXCIPIENT_: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Prevention of mortality at a group level from necrotic enteritis in chickens caused by _Clostridium _ _perfringens_ susceptible to phenoxymethylpenicillin. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The administration of the product may lead to an increase in medicated water consumption. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of the product should be based on susceptibility testing of the bacteria isolated from chickens that have already died on the farm. The product should not be used to compensate for poor hygiene and management of the chicken houses. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillin V may cause hypersensitivity reactions after injection, inhalation, oral ingestion, skin or eye contact. Hypersensitivity to penicillin V may l Read the complete document