Soloxine 0.1 mg Tablet

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

L Thyroxine Sodium

Commercializzato da:

Virbac

Codice ATC:

QH03AA01

INN (Nome Internazionale):

L Thyroxine Sodium

Forma farmaceutica:

Tablet

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Hormone

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

1997-01-08

Scheda tecnica

PART I.B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
I.B - 1
PRODUCT:
SOLOXINE 0.1 MG TABLET
COMPANY:
VIRBAC SA
DATE:
02/07/2010
DATE ISSUED: 02/07/2010
SUPERSEDES ISSUE: 24/01/2007
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Soloxine 0.1 mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
ACTIVE SUBSTANCE
Levothyroxine sodium
0.10 mg
EXCIPIENTS
Tartrazine E102
0.334 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Small elliptical yellow 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.
PART I.B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
I.B - 2
PRODUCT:
SOLOXINE 0.1 MG TABLET
COMPANY:
VIRBAC SA
DATE:
02/07/2010
DATE ISSUED: 02/07/2010
SUPERSEDES ISSUE: 24/01/2007
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.
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 accidenta