Norbet 0.25 mg Tablets

Summary of Product characteristics

                                Revised: July 2010
ATCVet code amended
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbet 0.25 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains 0.25 mg Betamethasone.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A small white circular, tablet with convex faces and a break-line.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Norbet Tablets are specifically indicated for the treatment of canine
allergic
dermatoses.
4.3
CONTRAINDICATIONS
Systemic corticosteroid therapy is generally contra-indicated in
patients with
renal disease and diabetes mellitus.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
During a course of treatment the situation should be reviewed
frequently by close
veterinary supervision.
See all warnings 4.5 and 4.6.
1
Revised: July 2010
ATCVet code amended
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Anti-inflammatory corticosteroids such as betamethasone are known to
exert a wide range of side effects. Whilst single high doses are
generally
well tolerated, they may induce severe side effects in long term use
and
when esters possessing a long duration of action are administered.
Dosage in medium to long-term use should therefore generally be kept
to
the minimum necessary to control symptoms.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Avoid contact with eyes.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Steroids themselves, during treatment, may cause Cushingoid symptoms
involving significant alteration of fat, carbohydrate, protein and
mineral
metabolism e.g. redistribution of body fat, muscle weakness and
wastage and
osteoporosis may result. During therapy effective doses suppress the
Hypothalamo-Pituitreal-Adrenal axis. Following cessation of treatment,
symptoms of adrenal insufficiency extending to adren
                                
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