Phenocillin 800 mg/g powder for use in drinking water for chickens

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
12-12-2020
Download 공공 평가 보고서 (PAR)
12-06-2017

유효 성분:

Phenoxymethylpenicillin potassium

제공처:

Eurovet Animal Health B.V.

ATC 코드:

QJ01CE02

INN (국제 이름):

Phenoxymethylpenicillin potassium

복용량:

800 milligram(s)/gram

약제 형태:

Powder for use in drinking water

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:

2016-01-22

제품 특성 요약

                                Health Products Regulatory Authority
11 December 2020
CRN009RTR
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenocillin 800 mg/g powder for use in drinking water for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g powder contains:
ACTIVE SUBSTANCE:
Phenoxymethylpenicillin 800 mg
(corresponding to phenoxymethylpenicillin potassium 887 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water. White or almost white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and metaphylaxis of necrotic enteritis caused by
_Clostridium perfringens_. The disease must have been
currently diagnosed in the flock before metaphylactic use.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
other substances of the beta-lactam group or to any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of
bacteria isolated from the animals on the farm. If this is not
possible, therapy should be based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria. The product should not be used to compensate for poor
hygiene and management of the farm houses.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to
phenoxymethylpenicillin and may decrease the effectiveness of
treatment with other penicillins, due to the potential for
cross-resistance. Official, national and regional antimicrobial
policies should be taken into account when the product is used.
Health Products Regulatory Authority
11 December 2020
CRN009RTR
Page 2 of 4
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Penicillins, such as
                                
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