Triiodothyronine 20 Micrograms Powder for Solution for Injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

LIOTHYRONINE SODIUM

Dostopno od:

Mercury Pharma Group Ltd

Koda artikla:

H03AA; H03AA02

INN (mednarodno ime):

LIOTHYRONINE SODIUM

Odmerek:

20 microgram(s)

Farmacevtska oblika:

Powder for solution for injection

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Thyroid hormones; liothyronine sodium

Status dovoljenje:

Not marketed

Datum dovoljenje:

1993-10-19

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIIODOTHYRONINE 20 MICROGRAMS POWDER FOR
SOLUTION FOR INJECTION
Liothyronine sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
HAVE THIS MEDICINE.
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 are given Triiodothyronine
injection
3. How Triiodothyronine injection is given
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 underactivity of
the thyroid gland (myxoedema
coma) 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 ARE GIVEN TRIIODOTHYRONINE
INJECTION
DO NOT TAKE 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 taking Triiodothyronine
injection if you:
• suffer from diabetes. The dosa

Lastnosti izdelka

Health Products Regulatory Authority
22 March 2019
CRN008MKD
Page 1 of 4
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 20 micrograms liothyronine sodium
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White, freeze-dried powder.
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
Dosage: 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.
Geriatric patients –In elderly patients with severe long-standing
hypothyroidism, treatment with liothyronine sodium should be
introduced with doses at the low end of the range, with smaller
increments and longer intervals between increases as
necessary.
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 o