FORTHYRON 400 MICROGRAM TABLET
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
28-04-2024
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Ingredient activ:
LEVOTHYROXINE SODIUM
Disponibil de la:
Eurovet Animal Health B.V.
Codul ATC:
QH03AA01
Dozare:
400 Microgram
Forma farmaceutică:
Tablets
Grupul Terapeutică:
Hormone
Zonă Terapeutică:
Canine
Data de autorizare:
2006-03-01
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Forthyron 400 microgram tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
400µg levothyroxine sodium per tablet equivalent to 388µg levothyroxine
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White to off white round tablets, scored on one side.
Tablets divisible into 4 parts.
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis hypothyroidism should be confirmed with appropriate tests.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN 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 stabilisation is achieved is recommended. Gradual introduction of therapy is
also recommended for dogs with other concurrent illnesses; particularly diabetes melli
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