Tribrissen 24% Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sulfadiazine, Trimethoprim

Available from:

Intervet UK Ltd

ATC code:

QJ01EW10

INN (International Name):

Sulfadiazine, Trimethoprim

Authorization status:

Expired

Summary of Product characteristics

Revised: June 2012
AN: 02106/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
Tribrissen 24% Suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG/ML
Trimethoprim
40
Sulfadiazine
200
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
Cats and dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is recommended for the treatment of bacterial infections
in cats
and dogs including:
Alimentary tract infections.
Respiratory tract infections.
Urogenital infections.
Skin infections and abscesses.
Antibacterial medication following surgery where asepsis cannot be
guaranteed.
4.3
CONTRAINDICATIONS
Do not administer intraperitoneally.
Do not use on animals with known sulphonamide sensitivity, causing,
for
example, immune-mediated sterile polyarthritis in dogs; with severe
liver
Page 1 of 6
Revised: June 2012
AN: 02106/2011
parenchymal damage; with blood dyscrasias; with or prone to dry eye;
or in
cases with severe renal impairment unless the dosage is reduced,
adequate
urinary output is maintained and close veterinary supervision is
available.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
If cats are treated for more than 5 days, the dose rate should not
exceed
30 mg/kg per day.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
A daily dose rate of 120 mg (0.5 ml) per kg bodyweight should not be
exceeded and care must be taken in measuring doses for very small
animals.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken to avoid accidental injection and contact with
the
skin.
Wash hands after use.
Su