Procillin 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Procaine benzylpenicillin

Disponibil de la:

Bimeda Animal Health Limited

Codul ATC:

QJ01CE09

INN (nume internaţional):

Procaine benzylpenicillin

Dozare:

300 milligram(s)/millilitre

Forma farmaceutică:

Suspension for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

procaine benzylpenicillin

Statutul autorizaţiei:

Authorised

Data de autorizare:

1987-10-01

Caracteristicilor produsului

Health Products Regulatory Authority
19 June 2020
CRN000VYC
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procillin 300 mg/ml Suspension for Injection for Cattle, Sheep and
Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Procaine benzylpenicillin
300 mg
EXCIPIENTS
Methyl parahydroxybenzoate E218
2.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial infections sensitive to penicillin.
These include both gram positive and gram negative organisms
as follows:
_Streptococcus_ spp.
_Listeria_ spp.
_Leptospira_ spp.
_Actinomyces pyogenes_
_Bacillus anthracis_
_Erysipelothrix rhusiopathiae_
_Corynebacterium pseudotuberculosis_
_Corynebacterium renale_
4.3 CONTRAINDICATIONS
Do not inject intravenously.
Do not administer to animals known to be sensitive to penicillin.
Do not use in sheep producing milk for human consumption.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cattle and sheep: None.
Pigs: Occasionally in suckling and fattening pigs, administration of
procaine penicillin may cause a transient pyrexia, vomiting,
shivering, listlessness and incoordination.
Additionally in pregnant sows and gilts a vulval discharge which could
be associated with abortion has been reported. Care
should be taken not to overdose.
Health Products Regulatory Authority
19 June 2020
CRN000VYC
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO ANIMALS
Penicillins and cephalosporins may cause sensitization following
injection, inhalation, ingestion or skin contact. Sensitivity to
penicillins may lead to cross sensitivity to cephalosporins and vice
versa. Allergic reactions to these substances may
occasionally be serious.
Do not han