Triiodothyronine 20 micrograms Powder for Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIOTHYRONINE SODIUM

Available from:

Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom

ATC code:

H03AA02

INN (International Name):

LIOTHYRONINE SODIUM 20 µg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

LIOTHYRONINE SODIUM 20 µg

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIIODOTHYRONINE 20 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION
Liothyronine 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, pharmacist or
nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS
IN THIS LEAFLET:
1. What Triiodothyronine injection is and what it is used for
2
What you need to know before you
use Triiodothyronine injection
3. How to use Triiodothyronine injection
4. Possible side effects
5. How to store Triiodothyronine injection
6.
Contents of the pack and other information
1. WHAT TRIIODOTHYRONINE INJECTION IS AND WHAT IT IS USED FOR
Triiodothyronine injection contains liothyronine sodium which is a
quick acting, naturally
occurring form of the hormone thyroxine.
Thyroxine is normally produced by the thyroid gland in the neck.
It controls many bodily functions, mainly to do with growth and
energy.
Triiodothyronine injection is used to treat severe under activity of
the thyroid gland (myxoedema)
when it is not possible to give thyroid treatment by mouth. It may be
used with other medicines
such as steroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRIIODOTHYRONINE INJECTION
DO NOT USE TRIIODOTHYRONINE INJECTION IF:
• you know that you are allergic to liothyronine sodium or any of
the other ingredients of
Triiodothyronine injection (see section 6 of this leaflet)
• you have a disease involving the heart or blood vessels.
• you have pain in the chest (angina pectoris)
• you have an overactive thyroid gland with raised levels of thyroid
hormones (thyrotoxicosis).
Please tell your doctor before you are given this injection if any of
the above applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Triiodothyronine
injection if y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Triiodothyronine 20 micrograms Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20mcg liothyronine sodium BP
Excipient(s) with known effect: Dextran 110
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sterile Intravenous injection, packed as a freeze-dried white plug, in
a neutral
glass ampoule for reconstitution with 1 or 2ml water for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
It is indicated for the treatment of myxoedema coma, usually in
conjunction
with other measures including the intravenous injection of a
corticosteroid.
For the treatment of less severe forms of myxoedema and for
maintenance
therapy, orally administered liothyronine should be used.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
5 to 20 micrograms given by slow intravenous injection and repeated at
intervals of
12 hours or less if required. The minimal interval between dosing is 4
hours.
An initial dose of 50 micrograms intravenously is used by some
physicians, followed
by further intravenous injections of 25 micrograms every 8 hours until
improvement
occurs. The dosage may then be reduced to 25 micrograms intravenously
twice daily.
Method of administration: Usually given by intravenous injection, as
the alkalinity of
the solution may cause irritation of the tissues if given by deep
intramuscular
injection. The solution is prepared by adding 1 or 2ml water for
injection to the
ampoule and shaking gently until the solution has dissolved.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
Liothyronine
sodium
is
contraindicated
in
patients
with
cardiovascular
disorders or angina of effort and thyrotoxicosis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Liothyronine
must
be
given
with
extreme
caution
in
myxoedema
coma
because too large a dose can precipitate heart failure, especially in
the elderly
patients and those w