EUTHYROX 100 MCG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

LEVOTHYROXINE SODIUM

זמין מ:

MERCK SERONO LTD

קוד ATC:

H03AA01

טופס פרצבטיות:

TABLETS

הרכב:

LEVOTHYROXINE SODIUM 100 MCG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

MERCK HEALTHCARE KGAA, GERMANY

קבוצה תרפויטית:

LEVOTHYROXINE SODIUM

איזור תרפויטי:

LEVOTHYROXINE SODIUM

סממני תרפויטית:

Euthyrox 25 - 200 microgram :- Treatment of benign euthyroid goitre.- Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post - operative hormone status.- Substitution therapy in hypothyroidism.- Suppression therapy in thyroid cancer.Euthyrox 25 - 100 microgram :- Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism.Euthyrox 100/150/200 microgram :- Diagnostic use for thyroid suppression testing.

תאריך אישור:

2017-01-31

עלון מידע

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Euthyrox
®
25 microgram
Euthyrox
®
50 microgram
Euthyrox
®
100 microgram
Tablets
The active ingredient:
Each tablet contains levothyroxine sodium 25, 50 or 100 mcg.
Inactive ingredients and allergens in the medicine: see section 2
under “Important information
regarding some of the ingredients of the medicine” and section 6
“Further information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine.
If you have any further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their medical
condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR
Euthyrox, in various dosages, is used to treat the following
conditions:
•
benign enlargement of the thyroid gland (benign goitre - swelling of
the neck due to
enlargement of the thyroid gland) in patients with normal thyroid
function
•
prevention of recurrence of goitre after surgery
•
as a substitute for the natural hormone produced by the thyroid gland,
if your thyroid
gland does not produce enough thyroxine
•
suppression of tumor regrowth in patients with thyroid cancer
•
to
balance
the
levels
of
the
hormone
produced
by
the
thyroid
gland,
when
hyperthyroidism is treated with medicines that inhibit thyroid gland
activity
At a dosage of 100 mcg and above, Euthyrox is used to test thyroid
function.
Therapeutic group: Thyroid gland hormone.
Levothyroxine, the active substance in Euthyrox, is a synthetic
substitute for the natural
hormone produced by the thyroid gland and is used to treat diseases or
dysfunction of the
thyroid gland. Levothyroxine has the same activity as the natural
hormone produced by the
thyroid gland.
2.
BEFORE USING THE MEDICINE
In order to ensure the continuity o

מאפייני מוצר

Prescribing information
1.
NAME OF THE MEDICINAL PRODUCT
Euthyrox
®
25 microgram tablets
Euthyrox
®
50 microgram tablets
Euthyrox
®
100
microgram tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet Euthyrox 25 microgram contains 25 microgram levothyroxine
sodium.
1 tablet Euthyrox 50 microgram contains 50 microgram levothyroxine
sodium.
1 tablet Euthyrox 100 microgram contains 100 microgram levothyroxine
sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Off white, round, flat on both sides, with a bevelled edge, a dividing
score and an inscription on one side:
Euthyrox 25 microgram
EM 25
Euthyrox 50 microgram
EM 50
Euthyrox 100 microgram
EM 100
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Euthyrox 25 - 200 microgram:
-
Treatment of benign euthyroid goitre
-
Prophylaxis of relapse after surgery for euthyroid goitre, depending
on the post-operative hormone
status
-
Substitution therapy in hypothyroidism
-
Suppression therapy in thyroid cancer
Euthyrox 25 – 100 microgram:
-
Concomitant supplementation during anti-thyroid drug treatment of
hyperthyroidism
Euthyrox 100/150/200 microgram:
-
Diagnostic use for thyroid suppression testing
4.2
Posology and method of administration
Posology
2
The dosage recommendations given are only for guidance.
The individual daily dose should be determined on the basis of
laboratory tests and clinical examinations.
As a number of patients show elevated concentrations of T
4
and fT
4,
basal serum concentration of thyroid-
stimulating hormone provides a more reliable basis for following
treatment course.
Thyroid hormone therapy should be started at low dose and increased
gradually every 2 to 4 weeks until
the full replacement dose is reached.
_Paediatric population _
For neonates and infants with congenital hypothyroidism, where rapid
replacement is important, the initial
recommended dosage is 10 to 15 micrograms per kg BW per day for the
first 3 months. Thereafter, the
dose should be ad