SOLOXINE 0.5 MG TABLET
Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Данни за продукта
(SPC)
16-02-2016
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Активна съставка:
LEVOTHYROXINE SODIUM
Предлага се от:
Virbac S.A.
АТС код:
QH03AA01
INN (Международно Name):
LEVOTHYROXINE SODIUM
дозиране:
0.5 mg/tablet
Лекарствена форма:
Tablets
Вид предписание :
POM
Терапевтична група:
Canine
Терапевтична област:
Levothyroxine sodium
Терапевтични показания:
Hormone
Статус Оторизация:
Authorised
Дата Оторизация:
2007-01-19
Данни за продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Soloxine 0.5 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Levothyroxine Sodium
0.50 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Small elliptical white 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/02/2016_
_CRN 7022962_
_page number: 1_
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 intervals whilst monitoring all clinical signs. Dogs with
concurrent hypoadrenocorticism should be stabilised witth apprpriate steroid therapy before commencing treatment
with levothyroxine sodium.
The effects of thyroxine therapy are slow in being manifested
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT T
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