Thyforon flavoured 600 microgram tablets for dogs

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Levothyroxine sodium

Mevcut itibaren:

Eurovet Animal Health B.V.

ATC kodu:

QH03AA01

INN (International Adı):

Levothyroxine sodium

Doz:

600 µg/tablet

Farmasötik formu:

Tablet

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Dogs

Terapötik alanı:

levothyroxine sodium

Terapötik endikasyonlar:

Hormone

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2011-11-11

Ürün özellikleri

Health Products Regulatory Authority
05 October 2020
CRN009SMT
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyforon flavoured 600 microgram tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE :
600 microgram levothyroxine sodium per tablet equivalent to 583
microgram levothyroxine
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Off white round tablet with brown spots, quadrisect with side scores.
The tablets may be divided into halves or quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of hypothyroidism in dogs.
4.3 CONTRAINDICATIONS
Do not use in dogs suffering from uncorrected adrenal insufficiency.
Do not use in cases of known hypersensitivity to levothyroxine sodium
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis of hypothyroidism should be confirmed with appropriate
tests.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The tablets are flavoured. In order to avoid any accidental ingestion,
store tablets out of reach of animals. A sudden increase in
demand for oxygen delivery to peripheral tissues, plus the
chronotropic effects of levothyroxine sodium, may place undue
stress on a poorly functioning heart, causing decompensation and signs
of congestive heart failure. Hypothyroid dogs suffering
from hypoadrenocorticism have a decreased ability to metabolise
levothyroxine sodium and therefore an increased risk of
thyrotoxicosis. Dogs with concurrent hypoadrenocorticism and
hypothyroidism should be stabilised with glucocorticoid and
mineralocorticoid treatment prior to treatment with levothyroxine
sodium to avoid precipitating a hypoadrenocortical crisis.
After this, thyroid tests should be repeated, then gradual
introduction of levothyroxine therapy, starting with 25% of the
normal dose, increasing by 25% increments every fortnight until
optimal sta