Norodine 24 Solution for Injection

Summary of Product characteristics

                                Revised: July 2023
AN: 00498/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine 24 Solution For Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Trimethoprim
4.00% w/v
Sulfadiazine
20.00% w/v
EXCIPIENTS:
Chlorocresol
0.1% w/w
Sodium Formaldehyde Sulphoxylate Dihydrate
0.1% w/w
N-methyl pyrrolidone
51.50 % w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution For Injection
A sterile clear yellow aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
Cattle
Pigs
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Norodine
24
Injectable
Solution
is
indicated
in
the
treatment
of
systemic
infections
caused
by
or
associated
with
organisms
sensitive
to
the
Trimethoprim:Sulfadiazine combination. The spectrum of activity
includes both
Gram-positive and Gram-negative organisms including:
_Actinobacilli_
_Actinomycae_
_Bordetella_ spp
_Brucella_
Corynebacteria
_Escherichia coli_
_Haemophilus_ spp
_Klebsiella_ spp
Revised: July 2023
AN: 00498/2023
Page 2 of 6
_Pasteurella_ spp
_Pneumococci_
_Proteus_
_Salmonella_ spp
Staphylococci
Streptococci
_Vibrio_
4.3
CONTRAINDICATIONS
Norodine 24 Injectable Solution should not be given by routes other
than those
recommended.
Not
to
be
administered
intraperitoneally,
intra-arterially
or
intrathecally.
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For
intravenous
administration
the
product
should
be
warmed
to
body
temperature and injected slowly over as long a period as is reasonably
practical.
At the first sign of intolerance the injection should be interrupted
and shock
treatment initiated.
Adequate drinking water should be available during the therapeutic
effect of the
product.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINA
                                
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