Phenoxypen Water Soluble Powder, 325 mg/g powder for oral solution for chickens

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Phenoxymethylpenicillin

제공처:

Dopharma Research B.V.

ATC 코드:

QJ01CE02

INN (International Name):

Phenoxymethylpenicillin

복용량:

325 milligram(s)/gram

약제 형태:

Powder for oral solution

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Chickens

치료 영역:

phenoxymethylpenicillin

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2006-10-25

제품 특성 요약

Health Products Regulatory Authority
09 April 2020
CRN009L38
Page 1 of 4
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
Per gram:
ACTIVE SUBSTANCE
Phenoxymethylpenicillin
293 mg
equivalent to potassium phenoxymethylpenicillin
325 mg
EXCIPIENT
For the 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 cases 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
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 sometimes be
serious.
In case of accidental ingestion or serious symptoms of
hypersensitivity reactions such as skin rash following exposure,
swelling
of the face, lips or eyes or difficulty with breathing, seek medical
advice immediately and show the package leaflet to the
physician.
People with known hypersensitivity to p