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Revised: October 2010
AN: 01015/2009
Page 1 of 5
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.
CONTRA-INDICATIONS
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 th
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