Forthyron 200 microgram tablet
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
02-05-2024
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Virkt innihaldsefni:
levothyroxine sodium
Fáanlegur frá:
Eurovet Animal Health B.V.
ATC númer:
QH03AA01
Skammtar:
200 Microgram
Lyfjaform:
Tablets
Meðferðarhópur:
Canine
Lækningarsvæði:
Hormone
Leyfisstaða:
Authorised
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Forthyron 200 microgram tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
200µg levothyroxine sodium per tablet equivalent to 194µg 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/10/2010_
_CRN 7006850_
_page number: 1_
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
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