PHARMACILLIN 300 MG/ML SUSPENSION FOR INJECTION
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
20-05-2024
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Ingredient activ:
PROCAINE BENZYLPENICILLIN
Disponibil de la:
Chem-Pharm
Codul ATC:
QJ01CE09
INN (nume internaţional):
PROCAINE BENZYLPENICILLIN
Dozare:
300 Mg/Ml
Forma farmaceutică:
Suspension for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine, Equine - Food, Ovine, Porcine
Zonă Terapeutică:
Procaine penicillin
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
1997-10-01
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pharmacillin 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 v_itro 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)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2010_
_CRN 7005241_
_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 PHARMACILLIN INJECTION may cause a transient
pyrexia, vomiting, shivering, listlessness and inco-ordination.
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
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