DUPHAPEN 300 MG/ML SUSPENSION FOR INJECTION

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PROCAINE BENZYLPENICILLIN

Mevcut itibaren:

Zoetis Ireland Limited

ATC kodu:

QJ01CE09

INN (International Adı):

PROCAINE BENZYLPENICILLIN

Doz:

300 Per Cent

Farmasötik formu:

Suspension for Injection

Reçete türü:

POM

Terapötik grubu:

Bovine, Equine - Food, Ovine, Porcine

Terapötik alanı:

Procaine penicillin

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-08-29

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphapen 300 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Suspension for injection.
A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, Cows, Sheep, Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of systemic infections caused by or associated with organisms sensitive to penicillin. In vitro tests
have shown the following organisms to be sensitive:
Corynebacterium pyogenes
Erysipelothrix rhusiopathiae,
Listeria spp.
Pasteurella haemolytica
Pasteurella multocida,
Staphylococcus spp (non-penicillinase producing )
Streptococcus spp.
4.3 CONTRAINDICATIONS
Do not inject intravenously.
Do not use in known cases of hypersensitivity to penicillins.
Not for use in sheep producing milk for human consumption.
Each ml contains:
Active Substance:
Procaine Benzylpenicillin
300
mg
Excipients:
Hydroxybenzoate ester (as preservative)
1.5 mg
For a full list of excipients see section 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/08/2013_
_CRN 7015620_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in suckling and fattening pigs administration of Duphapen may cause a transient pyrexia, vomiting,
shivering, listlessness and in-coordination.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Administer by deep intramuscular injection only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin
contact. Hypersensitivity to penicillin may lead t