EUTHYROX

Country: Indónesía

Tungumál: indónesíska

Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Virkt innihaldsefni:

LEVOTHYROXINE SODIUM

Fáanlegur frá:

MERCK TBK - Indonesia

INN (Alþjóðlegt nafn):

LEVOTHYROXINE SODIUM

Skammtar:

50 MCG

Lyfjaform:

TABLET

Einingar í pakka:

DUS, 4 BLISTER @ 25 TABLET

Framleitt af:

MERCK HEALTHCARE KGAA - Federal Republic of Germany

Leyfisdagur:

2021-02-16

Vara einkenni

_Page 1 of 5 _
EUTHYROX®
LEVOTHYROXINE SODIUM
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Euthyrox 50 mcg
: Each tablet contains 50 mcg Levothyroxine sodium
Euthyrox 100 mcg
: Each tablet contains 100 mcg Levothyroxine sodium
2.
PHARMACEUTICAL FORM
Tablet.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
Goitre (euthyroid goitre), prevention of goitre recurrence after
goitre surgery (relapse prophylaxis after
strumectomy), as concomitant therapy when taking medication for the
treatment of thyroid overactivity
(hyperthyroidism) after normal function has been achieved, thyroid
underactivity (hypothyroidism), after
total surgical removal of the thyroid gland (thyroidectomy) due to
thyroid carcinoma.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
The individual daily dose should be determined by laboratory tests and
clinical examinations. Particular
caution must be exercised when starting treatment with thyroid
hormones in elderly patients, patients with
coronary heart disease and patients with severe or long-standing
hypothyroidism, that is, a small dose
should be chosen to start with which can then be increased gradually
and at long intervals with frequent
thyroid hormone checks. Experience has shown that a small dose is also
sufficient for patients with a low
body weight and patients with a large nodular goitre.
INDICATIONS
(QUANTITY)
INTAKE
-
Goitre (euthyroid goitre)
In adults
In adolescents
(75 - 200 mcg)
(50 - 150 mcg)
once daily
once daily
-
Prevention of goitre once daily recurrence after goiter
surgery (strumectomy)
(75 - 200 mcg)
once daily
-
Hypothyroidism in adults at the start of therapy (Increase
by 25-50 mg at 2 to 4 weekly intervals)
As maintenance therapy
(25 - 50 mcg)
(125 - 250 mcg)
once daily
once daily
-
In children
At the start of therapy
As maintenance therapy
(12.5 - 50 mcg)
(100 - 150 mcg)
per m
2
body surface
once daily
once daily
-
Concomitant therapy with medication against
hyperthyroidism
(50 - 100 mcg)
once daily
-
After total surgical removal of the thyroid (thyroidectomy)
(150 - 300 mcg)
once dail