Norocillin 300 mg/ml Suspension for Injection

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Procaine benzylpenicillin

Dostępny od:

Norbrook Laboratories (Ireland) Limited

Kod ATC:

QJ01CE01

INN (International Nazwa):

Procaine benzylpenicillin

Dawkowanie:

300 milligram(s)/millilitre

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

benzylpenicillin

Status autoryzacji:

Authorised

Data autoryzacji:

1987-10-01

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocillin 300 mg/ml Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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)
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.
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)
following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin
may lead to cross
sensitivity to cephalosporins and vice versa. Allergic reaction to
these substances may
occasionally be serious.
1.
Do not handle this product if you know you are sensitised, or if you
have been
advised not to work with such preparations.
2.
Handle this p