Trinacol Solution for Injection

Summary of Product characteristics

                                Revised: 27
th
May 2009
AN: 01739/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trinacol Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substances :
Sulfadiazine 200mg
Trimethoprim 40mg
Chlorocresol 1mg as antimicrobial preservative
Sodium Formaldehyde Sulphoxylate dihydrate 1mg as antioxidant
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A clear yellow aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
For use in cattle, pigs and dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Trinacol is indicated in the treatment of acute, subacute and chronic
conditions of bacterial origin in cattle, pigs and dogs.
The therapeutic spectrum includes both Gram-negative and Gram-positive
bacteria including _Streptococci, Staphylococci, Actinobacilli,
Actinomycae, _
_Salmonella, Pasteurella, Pneumococci, Proteus, E. Coli,
Corynebacteria, _
_Vibrio, Bordetella, Brucella, Klebsiellae and Haemophilae._
4.3
CONTRAINDICATIONS
Injections should not be given by routes other than those recommended.
Not
to be administered intraperitoneally. Do not administer to animals
with known
sulphonamide sensitivity, severe liver parenchymal damage, or blood
dyscrasias.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS.
Adequate drinking water should be available during the therapeutic
effect of
the product.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care must be taken to avoid accidental self injection.
Revised: 27
th
May 2009
AN: 01739/2008
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Anaphylactic shock potentially fatal, has been observed on occasions
following administration of potentiated sulphonamide preparations
particularly
by intravenous route. Veterinary surgeons should be mindful of this
possibility
during the injection process. For intraven
                                
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