Soloxine 0.8 mg Tablet

Summary of Product characteristics

                                PART I.B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
I.B - 1
PRODUCT:
SOLOXINE 0.8 MG TABLET
COMPANY:
VIRBAC SA
DATE:
02/07/2010
 
DATE ISSUED: 02.07.2010 SUPERSEDES 09.01.2004
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Soloxine 0.8 mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
ACTIVE SUBSTANCE
Levothyroxine Sodium
0.80 mg
EXCIPIENTS
Indigo Carmine (E132)
0.075 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Small elliptical blue tablets.
Scored on the face of each tablet, strength in milligrams to the right
and the word SOLOXINE on the reverse.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the long term treatment of thyroid insufficiency in dogs.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in animals suffering from thyrotoxicosis or uncorrected
adrenal insufficiency.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Appropriate laboratory tests should be conducted to confirm the
diagnosis and ensure correct dosage.
Caution should be exercised in the treatment of dogs with clinically
significant cardiac disease, hypertension
or any disease rendering the animal susceptible to sharply increased
metabolic rate. In such cases,
consideration should be given to reducing the starting dose,
increasing the dose at intervals whilst monitoring
all clinical signs. Dogs with concurrent hypoadrenocorticism should be
stabilised with appropriate steroid
therapy before commencing treatment with levothyroxine sodium.
PART I.B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
I.B - 2
PRODUCT:
SOLOXINE 0.8 MG TABLET
COMPANY:
VIRBAC SA
DATE:
02/07/2010
 
DATE ISSUED: 02.07.2010 SUPERSEDES 09.01.2004
The effects of thyroxine therapy are slow in being manifested.
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
In case of accidental 
                                
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