Norobrittin 15% w/v Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ampicillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CA01

INN (International Name):

Ampicillin

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

1994-08-24

Summary of Product characteristics

Revised 26 November 2008
AN: 00168/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norobrittin 15% w/v Suspension for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
15% w/v Ampicillin (as Ampicillin Trihydrate 17.32% w/v)
EXCIPIENTS:
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection
An off-white oily 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 ampicillin including:
_Bordetella bronchiseptica_
_Arcanobacterium (Actinomyces) pyogenes_
_Erysipelothrix rhusiopathiae_
_Mannheima haemolytica_
_Pasteurella multocida_
_Staphylococcus_ spp (non-penicillinase producing)
_Streptococcus_ spp
The product will therefore be effective in the treatment of infections
caused by
susceptible organisms including:
Erysipelas, navel/joint ill, respiratory tract infections including
pneumonia and
atrophic rhinitis, meningitis, septacaemia, urogenital tract
infections and the
control of secondary bacterial invaders in diseases of primary viral
origin
It will also have some effect in the treatment of enteritis caused by
_Salmonella_
spp. As Salmonella species show variable susceptibility to Ampicillin,
sensitivity testing is recommended prior to treatment.
Revised 26 November 2008
AN: 00168/2008
4.3
CONTRA-INDICATIONS
Do not administer to penicillin sensitive animals.
Do not administer to small herbivores such as gerbils, guinea pigs,
hamsters,
and rabbits.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to likely variability (time, geographical) in the occurrence of
resistant
bacteria for ampicillin, bacteriological sampling and susceptibility
testing are
recommended.
To ensure that the product is administered by deep intramuscular
injection, a
needle of the appropriat