Tribrissen Oral Paste

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sulfadiazine, Trimethoprim

Available from:

Schering-Plough Ltd

ATC code:

QJ01EW10

INN (International Name):

Sulfadiazine, Trimethoprim

Authorization status:

Expired

Summary of Product characteristics

Revised: 12 August 2009
AN: 00116/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Tribrissen Oral Paste
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
%W/W
Sulfadiazine
33.3
Trimethoprim
6.7
Each 37.5g of paste contains 2.5 g of trimethoprim and 12.5 g of
sulfadiazine.
EXCIPIENTS
Chlorocresol (preservative)
0.2%
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral paste.
Soft white paste.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is recommended for the treatment of bacterial diseases in
horses
including:
Alimentary tract infections.
Upper and lower respiratory tract infections, including strangles.
Infected wounds and cellulitis.
Antibacterial medication in surgical cases where asepsis cannot be
guaranteed.
4.3
CONTRA-INDICATIONS
Do not use in horses with known sulphonamide sensitivity, with severe
liver
parenchymal damage, nor with blood dyscrasias.
Revised: 12 August 2009
AN: 00116/2009
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
The same syringe should not be used to treat more than one animal
unless the animals
are either running together, or are on the same premises and in direct
contact with
each
other.
i.
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take
into account official and local antimicrobial policies.
ii.
Special precautions to be taken by the Person administering the
product to animals
Take care to avoid skin and eye contact. Gloves should be worn whilst
handling this
product. Wash hands and exposed skin after use.
Sulphonamides may cause hypersensitivity (allergy) following
injection, inhalation,
ingestion or skin contact. Hypersensitivity to sulphonamides may lead
to cross
reactions with other antibiotics. Allergic reactions to these
substances may
occasionally be serious.
1.
Do not handle this product if you know you are sensitive to
sulphonamides.
2.
If yo