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Revised: 12 August 2009
AN: 00115/2009
SUMMARY OF PRODUCT CHARACTERISICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Tribrissen Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG / TABLET
Sulfadiazine
400
Trimethoprim
80
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Tablet
White, biconvex, branded scored tablets.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of alimentary tract infections, respiratory tract
infections; urogenital tract infections; skin infections, general
infections,
infections of the ear and eye, also wounds. 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
CONTRA-INDICATIONS
Do not administer to animals with known sulphonamide sensitivity,
severe liver parenchymal damage nor blood dyscrasias.
Do not administer in cases of severe renal impairment unless the
dosage is reduced, adequate renal output is maintained and close
veterinary supervision is available.
4.4
SPECIAL WARNINGS FOR TARGET SPECIES
None
Revised: 12 August 2009
AN: 00115/2009
4.5
SPECIAL PRECAUTIONS FOR USE
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
Take care to avoid skin contact. 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 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 you develop symptoms following exposure such as a skin
rash, you should seek medical advice and show the doctor this
warning.”
4.6
ADVE
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