Norocillin 30% w/v Suspension for Injection

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Procaine Benzylpenicillin

Prieinama:

Norbrook Laboratories Limited

ATC kodas:

QJ01CE09

INN (Tarptautinis Pavadinimas):

Procaine Benzylpenicillin

Vaisto forma:

Suspension for injection

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Cattle, Pigs, Sheep

Gydymo sritis:

Antimicrobial

Autorizacija statusas:

Authorized

Leidimo data:

1998-04-20

Prekės savybės

Revised: August 2022
AN: 00248/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocillin 30% w/v Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Procaine Penicillin 300 mg/ml (30.0% w/v)
EXCIPIENTS:
Methyl Parahydroxybenzoate
0.112% w/v
Ethyl Parahydroxybenzoate
0.023% w/v
Propyl Parahydroxybenzoate
0.016% w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for Injection
A white to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
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:
_Arcanobacterium _
_(Actinomyces) _
_pyogenes, _
_Erysipelothrix _
_rhusiopathiae, _
_Listeria, Mannheima haemolytica, Pasteurella multocida,
Staphylococcus_ spp
(non-penicillinase producing) and _Streptococcus_ spp.
Norocillin is recommended, therefore, in the treatment of diseases
caused by
susceptible organisms including:
erysipelas; navel/joint-ill; respiratory tract infections including
pneumonia and
atrophic rhinitis; listeriosis; septicaemia; urogenital tract
infections and the
control of secondary bacterial invaders in diseases of primary viral
origin.
4.3
CONTRAINDICATIONS
Do not inject intravenously or intrathecally.
Do not use in known cases of hypersensitivity to penicillin.
Revised: August 2022
AN: 00248/2022
Page 2 of 5
Not to be used on very small herbivores such as guinea pigs, gerbils
and
hamsters.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Shake the container before use.
Care should be taken not to overdose.
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible, therapy
should
be based on local epidemiological information.
(ii)
Special
p