BAYCUBIS 325 MG/G POUDRE POUR ADMINISTRATION DANS L'EAU DE BOISSON POUR POULETS
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-12-2012
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Active ingredient:
phenoxymethylpenicillin sodium salt 325 mg/g
Available from:
Bayer B.V. – Animal Health Division
ATC code:
QJ01CE02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
Phenoxymethylpenicillin
Therapeutic area:
Chicken
Authorization date:
2011-04-19
Summary of Product characteristics
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
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