Soloxine 0.2 mg Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

Virbac S.A.

ATC code:

QH03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

0.2 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

levothyroxine sodium

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2007-01-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Soloxine 0.2 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Levothyroxine Sodium
0.20 mg
EXCIPIENTS
Sunset Yellow FCF E110
0.1 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Small elliptical orange 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.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) 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 inte