LEVOTHYROXINE CLONMEL

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

LEVOTHYROXINE SODIUM

থেকে পাওয়া:

Clonmel Healthcare Ltd

এটিসি কোড:

H03AA01

INN (আন্তর্জাতিক নাম):

LEVOTHYROXINE SODIUM

ডোজ:

25 Microgram

ফার্মাসিউটিকাল ফর্ম:

Tablets

প্রশাসন রুট:

oral use

প্যাকেজ ইউনিট:

28, 30, 50, 90, 100 tablets

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক গ্রুপ:

Thyroid hormones

থেরাপিউটিক এলাকা:

levothyroxine sodium

থেরাপিউটিক ইঙ্গিত:

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

অনুমোদন অবস্থা:

Not Marketed

অনুমোদন তারিখ:

2015-09-11

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
25 microgram tablets
50 microgram tablets
75 microgram tablets
100 microgram tablets
125 microgram tablets
150 microgram tablets
175 microgram tablets
200 microgram tablets
LEVOTHYROXINE SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
Levothyroxine, the active substance in , is a synthetic
thyroid hormone for the
treatment of diseases and dysfunctions of the thyroid gland. It has
the same effect as the naturally
occurring thyroid hormones.
25 - 200 microgram is used
•
to treat benign goitre in patients with normal thyroid function,
•
to prevent recurrence of goitre after surgery,
•
to replace natural thyroid hormones, when your thyroid gland does not
produce enough,
•
to suppress tumour growth in patients with thyroid cancer.
25 - 100 microgram can also be used to balance thyroid
hormone levels, when
overproduction of hormones is treated with antithyroid medicines.
100/150/200 microgram may also be used in the testing
of your thyroid function.
2. WHAT YOU NEED TO KNOW BEFORE YOU

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine Clonmel 25 microgram tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 microgram tablet contains 25 microgram levothyroxine sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, round biconvex tablet with a score line on one
side,“25” engraved on the other side and with a
diameter of 7 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levothyroxine Clonmel 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.
Levothyroxine Clonmel 25 - 100 microgram:
•
Concomitant supplementation during anti-thyroid drug treatment of
hyperthyroidism.
Levothyroxine Clonmel 100/150/200 microgram:
•
Diagnostic use for thyroid suppression testing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In order to treat each patient according to his/her individual needs,
tablets are available with a levothyroxine sodium
content ranging from 25 to 200 microgram. Patients therefore usually
need to take only one tablet per day.
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 sho