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

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Phenoxymethylpenicillin

זמין מ:

Dopharma Research B.V.

קוד ATC:

QJ01CE02

INN (שם בינלאומי):

Phenoxymethylpenicillin

כמות:

325 milligram(s)/gram

טופס פרצבטיות:

Powder for oral solution

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Chickens

איזור תרפויטי:

phenoxymethylpenicillin

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

2006-10-25

מאפייני מוצר

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