Norodine 80 Tablets

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine 80 Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Trimethoprim
80 mg
Sulfadiazine
400 mg.
EXCIPIENTS:
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
A circular, uncoated, white tablet scored on one face.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
When
susceptible
organisms
are
present
Norodine
80
Tablets
may
be
effective
in
treating
the
following
conditions:
alimentary
tract
infections,
respiratory and urogenital infections, skin and wound infections and
eye and
ear infections.
4.3
CONTRAINDICATIONS
Norodine 80 Tablets are not suitable for use in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria
isolated from the animal. If this is not possible, therapy should be
based on
local epidemiological information.
Not
recommended
in
dogs
with
known
hypersensitivity,
or
hepatic
dysfunction.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Take care to avoid skin contact. Wash hands 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 you develop symptoms following exposure such as a skin rash, you
should seek medical advice and show the doctor this warning.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A low incidence of polyarthropathy and Keratoconjunctivitis Sicca (Dry
Eye)
has
been
reported
in
dogs
following
oral
administration
of
potentiated
sulphonamides. If either of t
                                
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