Norocillin 300 mg/ml Suspension for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Procaine benzylpenicillin

可用日期:

Norbrook Laboratories (Ireland) Limited

ATC代码:

QJ01CE01

INN（国际名称）:

Procaine benzylpenicillin

剂量:

300 milligram(s)/millilitre

药物剂型:

Suspension for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

benzylpenicillin

授权状态:

Authorised

授权日期:

1987-10-01

产品特点

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