PHARMACILLIN 300 MG/ML SUSPENSION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

PROCAINE BENZYLPENICILLIN

Available from:

Chem-Pharm

ATC code:

QJ01CE09

INN (International Name):

PROCAINE BENZYLPENICILLIN

Dosage:

300 Mg/Ml

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Equine - Food, Ovine, Porcine

Therapeutic area:

Procaine penicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1997-10-01

Summary of Product characteristics

                                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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