Forthyron 200 Microgram Flavoured Tablet
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
18-05-2013
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Active ingredient:
levothyroxine sodium 200 µg
Available from:
Eurovet Animal Health
ATC code:
QH03AA01
Pharmaceutical form:
Tablet
Therapeutic group:
levothyroxine sodium
Therapeutic area:
Dogs
Authorization date:
2011-10-26
Summary of Product characteristics
Revised: December 2011
AN: 01146/2010
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forthyron flavoured 200 microgram tablets for dogs
UK: Thyforon flavoured 200 microgram tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONE TABLET CONTAINS:
200 microgram levothyroxine sodium per tablet equivalent to 194 microgram
levothyroxine
For a 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.
CONTRA-INDICATIONS
Do not use in dogs suffering from uncorrected adrenal insufficiency.
Do not use in cases of known hypersensitivity to levothyroxine sodium.
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.
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