Trimediazine Plain Oral Powder

Summary of Product characteristics

                                Revised: May 2018
AN: 00005/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimediazine Plain Oral Powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances
Trimethoprim.
5% w/w
Sulfadiazine.
25.0% w/w
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Trimediazine Plain is indicated for use in the treatment of bacterial
diseases in
horses, including upper and lower respiratory tract infections,
alimentary tract
infections and infected wounds.
4.3
CONTRA-INDICATIONS
Do not use in horses with severe liver parenchymal damage or kidney
damage
or known sulphonamide sensitivity, or horses with blood dyscrasias or
cardiac
arrhythmias. Do not exceed 7 days continuous treatment
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of Trimediazine Plain in horses under 1 year old should be
avoided.
4.5
SPECIAL PRECAUTIONS FOR USE
(I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
To avoid possible crystalluria, adequate water intake is essential.
Revised: May 2018
AN: 00005/2018
Page 2 of 4
(II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Persons handling this product should avoid inhalation of any dust and
contact with skin. Wear either a disposable half-mask respirator
conforming to European Standard to EN149 or a non-disposable
respirator to European Standard to EN140 with filter EN143 when
mixing or handling this product. Rubber gloves should be worn when
mixing or handling this product. Hands should be washed thoroughly
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 
                                
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