NOROCILLIN 300 MG/ML SUSPENSION FOR INJECTION
Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Ürün özellikleri
(SPC)
14-03-2015
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Aktif bileşen:
procaine benzylpenicillin
Mevcut itibaren:
Norbrook Laboratories Limited
ATC kodu:
QJ01CE01
Doz:
300 Mg/Ml
Farmasötik formu:
Suspension for Injection
Reçete türü:
POM
Terapötik grubu:
Bovine, Equine - Food, Ovine, Porcine
Terapötik alanı:
Benzylpenicillin
Terapötik endikasyonlar:
Antibacterial
Yetkilendirme durumu:
Authorised
Yetkilendirme tarihi:
1987-10-01
Ürün özellikleri
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocillin 300 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
White/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.
Each ml contains:
ACTIVE SUBSTANCE:
Procaine Benzylpenicillin
300 mg
EXCIPIENTS:
*Hydroxybenzoate esters
1.5 mg
(*containing Ethyl Parahydroxybenzoate (E214), Propyl Parahydroxybenzoate (E216),
Methyl Parahydroxybenzoate (E218)
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/02/2015_
_CRN 7015542_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not inject intravenously.
Do not use in known cases of hypersensitivity to penicillins.
Do not use in sheep producing milk for human consumption.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in suckling and fattening pigs, administration of Norocillin may cause a transient pyrexia, vomiting,
shivering, listlessness and inco-ordination.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Administer by deep injection only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Penicillin and cephalosporins may cause hypersensitivity (allergy)
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