PHENOXYPEN WATER SOLUBLE POWDER, 325 MG/G POWDER FOR ORAL SOLUTION FOR CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENOXYMETHYLPENICILLIN POTASSIUM

Available from:

Dopharma Research B.V.

ATC code:

QJ01CE02

INN (International Name):

PHENOXYMETHYLPENICILLIN POTASSIUM

Dosage:

325 mg/g

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Phenoxymethylpenicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2006-10-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenoxypen Water Soluble Powder, 325 mg/g powder for oral solution for chickens.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Per gram:
ACTIVE SUBSTANCE
Phenoxymethylpenicillin
293 mg
equivalent to potassium phenoxymethylpenicillin 325 mg
EXCIPIENT
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
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_Date Printed 07/02/2014_
_CRN 7016634_
_page number: 1_
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
Phenoxymethylpenicillin may cause hypersensitivity reactions after injection, inhalation, oral ingestion, skin or eye
contact. Hypersensitivity to phenoxymethylpenicillin may lead to cross-sensitivity to other penicillins and
cephalosporins, and vice versa. Allergic reactions caused by these substances can