Duphatrim Granules for Horses Trimethoprim 2.5 g and Sulfadiazine 12.5 g

Summary of Product characteristics

                                Revised: March 2010
AN: 01849/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphatrim Granules for Horses
Trimethoprim 2.5 g and sulfadiazine 12.5 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
The product contains trimethoprim and sulfadiazine as the active
ingredients
at concentrations of 6.67% w/w and 33.33% w/w, respectively, i.e.
6.67g of
trimethoprim per 100g of product and 33.33g of sulfadiazine per 100g
of
product.
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is recommended in the treatment of infections in horses
caused
by organisms sensitive to trimethoprim/sulfadiazine combinations.
When susceptible organisms are present, the product may be effective
in
treating the following conditions:
Alimentary tract infections, including diarrhoea.
Respiratory tract infections, including pneumonia, pleurisy and
strangles.
Wounds, septicaemia and general infections
4.3 CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS 
None known.
Revised: March 2010
AN: 01849/2009
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Do not use in horses with known sulphonamide sensitivity, with hepatic
damage or with blood dyscrasias.
ii. Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Avoid direct contact with skin and eyes. If contact occurs, wash
affected area
with copious amounts of water. Seek medical advice if irritation
persists.
Gloves should be worn whilst handling this product.
Wash hands and exposed skin after use.
Avoid inhaling dust from the product. The use of a mask is recommended
if
the product is handled regularly. Handle only in a well ventilated
area.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The use of trimethoprim-sulfadiazine combinati
                                
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