Duphatrim IS Injectable Solution Trimethoprim 40 mg and Sulfadiazine 200 mg Solution for Injection

Summary of Product characteristics

                                Revised: August 2020
AN: 00663/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphatrim IS Injectable Solution
Trimethoprim 40 mg and Sulfadiazine 200 mg Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each ml contains Trimethoprim 40 mg and Sulfadiazine 200 mg.
EXCIPIENT(S):
The
product
also
contains
Chlorocresol
1.0
mg/ml
as
antimicrobial
preservative
and
Sodium
Formaldehyde
Sulphoxylate
1.0
mg/ml
as
antioxidant.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A sterile, clear yellow, aqueous solution for parenteral
administration.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
Cattle
Pigs
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Duphatrim IS is indicated in the treatment of systemic infections
caused by or associated with organisms sensitive to the Trimethoprim :
Sulfadiazine combination. The in vitro spectrum of activity includes
both Gram positive and Gram negative organisms including:
_Actinobacilli_
_Actinomycae_
_Bordetella_ spp.
_Brucella_
_Corynebacteria_
_Escherichia coli_
_Haemophilus_ spp.
_Klebsiella_ spp.
_Pasteurella_ spp.
Revised: August 2020
AN: 00663/2020
Page 2 of 6
_Pneumococci_
_Proteus_
_Salmonella_ spp.
_Staphylococci_
_Streptococci_
Duphatrim IS is indicated for use in horses, cattle, pigs, dogs and
cats for the
treatment of acute, subacute and chronic bacterial infections
sensitive to
trimethoprim/sulfadiazine
therapy
such
as:
Bacterial
infections
of
the
respiratory tract, including rhinitis, pneumonia, bronchitis and in
bacterial
infections secondary to viral disease such as viral pneumonia or
mycoplasma
infections. Urogenital tract infections, including cystitis,
vaginitis, urethritis,
nephritis and metritis.
Alimentary tract infections, including neonatal diarrhoea and
salmonellosis.
Other infections, such as foul-in-the-foot, severe mastitis, bacterial
agalactia of
sows, infections of the eye, ear or mouth.
4.3
CONTRAINDICAT
                                
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