Trimedoxine 4S Tablet

Summary of Product characteristics

                                Revised: September 2008
AN: 01185/2008
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimedoxine 4S Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bolus contains Trimethoprim 200mg and Sulfadiazine 1.0g.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Calves.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated primarily for the treatment of bacterial scours but may also
be used
for the treatment of acute salmonellosis and bacterial pneumonia.
4.3
CONTRA-INDICATIONS
Not to be administered to animals with functionally mature rumens.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special precautions.
Revised: September 2008
AN: 01185/2008
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For oral administration only.
(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.
Protective gloves should be worn to avoid skin sensitisation, which
may occur
when crushing the bolus of this product.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No known interactions.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
One bolus per 40kg bodyweight daily. This gives 30mg of combined
active
ingredients per kg bodyweight.
Treatment should be repeated daily until 2 days after the symptoms
have
resolved, but in cases of salmonellosis and bacterial pneumonia
treatment
should be continued for 5 consecutive days.
Treatment must not be
continued for more than 5 days.
The product may be administered whole, by hand or balling gun, or
dispersed
in water. Dosage by dispersion in water: Disperse each bolus by

                                
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