Tribrissen 48% Suspension for Injection

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Sulfadiazine, Trimethoprim

Commercializzato da:

MSD Animal Health UK Limited

Codice ATC:

QJ01EW10

INN (Nome Internazionale):

Sulfadiazine, Trimethoprim

Forma farmaceutica:

Suspension for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cattle, Horses, Pigs

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

1990-05-30

Scheda tecnica

Revised: June 2012
AN: 02107/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Tribrissen 48% Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG/ML
Trimethoprim
80
Sulfadiazine
400
OTHER CONSTITUENTS
Sodium metabisulphite (E223)
1
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
The undisturbed product is cream-coloured amorphous sediment in a
clear,
pale yellow to brown solution. On agitation, a cream- to brown-
coloured
aqueous suspension for injection is formed.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product may be used in the treatment of a wide range of diseases
and
conditions of bacterial origin in cattle, pigs and horses associated
with
sensitive species of organisms:
Respiratory infections of bacterial origin; urogenital tract
infections; alimentary
tract infections; other infections such as foul-in-the-foot, severe
mastitis,
bacterial agalactia of sows, infections of the eye, ear or mouth. It
may also
be used for antibacterial medication in surgical cases where infection
is likely
to be present, e.g. with compound fractures and where there is
established
peritonitis.
4.3
CONTRAINDICATIONS
None
Revised: June 2012
AN: 02107/2012
Page 2 of 5
4.4
SPECIAL WARNINGS FOR TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not administer by the intravenous or intra-peritoneal route, as on
rare occasions death has rapidly followed injection, especially by the
intravenous route.
ii.
Special precautions to be taken by the person administering the
product
Care should be taken to avoid accidental injection and contact with
the
skin.
Wash hands after use.
Sulphonamides may cause hypersensitivity (allergy) following
injection,
inhalation, ingestion or skin contact. Hypersensitivity to
sulphonamides may lead to cross reactions with other antbiotics.
Allergic reac