Procillin 300 mg/ml Suspension for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Procaine benzylpenicillin

Fáanlegur frá:

Bimeda Chemicals

ATC númer:

QJ01CE09

INN (Alþjóðlegt nafn):

Procaine benzylpenicillin

Skammtar:

300 milligram(s)/millilitre

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle, Pigs, Sheep

Lækningarsvæði:

procaine benzylpenicillin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

1987-10-01

Vara einkenni

Health Products Regulatory Authority
12 November 2018
CRN000VY8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procillin 300 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Procaine benzylpenicillin
300 mg
EXCIPIENTS
Methyl parahydroxybenzoate E218
10 mg
(as preservative)
For a 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 _
Health Products Regulatory Authority
12 November 2018
CRN000VY8
Page 2 of 5
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.
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 handle