Norodine Granules

Summary of Product characteristics

                                Revised: 09 February 2009
AN: 01625/2007
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine Granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 37.5g sachet contains:
Trimethoprim
2.5g
Sulfadiazine
12.5g
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
White to off-white granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Recommended in the treatment of infections in horses caused by
organisms sensitive
to trimethoprim/ sulfadiazine combinations.
When susceptible organisms are present, may be effective in treating
the following
conditions:
Alimentary tract infections including diarrhoea.
Respiratory tract infections including pneumonia, pleurisy and
strangles.
Wounds, septicemia and general infections.
4.3
CONTRAINDICATIONS
Do not use in horses with known sulfonamide sensitivity, with hepatic
damage or with
blood dyscrasias.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: 09 February 2009
AN: 01625/2007
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and take
into account
official and local antimicrobial policies.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Avoid inhalation and
take care to avoid skin and eye contact. Gloves and suitable eye
protection should be worn whilst handling this product. Wash hands and
exposed skin
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 warni
                                
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