Synacthen 250 micrograms/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tetracosactide acetate

Available from:

Alfasigma S.p.A

ATC code:

H01AA; H01AA02

INN (International Name):

Tetracosactide acetate

Dosage:

250 mcg/ml microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

ACTH; tetracosactide

Authorization status:

Not marketed

Authorization date:

1978-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNACTHEN 250 MICROGRAMS/ML, SOLUTION FOR INJECTION
(TETRACOSACTIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Synacthen 250 micrograms/ml is and what it is used for
2.
What you need to know before you use Synacthen 250 micrograms/ml
3.
How to use Synacthen 250 micrograms/ml
4.
Possible side effects
5.
How to store Synacthen 250 micrograms/ml
6.
Contents of the pack and other information
1.
WHAT SYNACTHEN 250 MICROGRAMS/ML IS AND WHAT IT IS USED FOR
Synacthen ampoules contains tetracosactide. This is a substance which
stimulates the adrenal glands
to produce certain hormones.
Synacthen (tetracosactide) is used as a test to find out the cause of
certain hormonal problems e.g.,
low levels of the hormone cortisol as in Addison’s disease. Two
blood samples will be taken, one
before the injection of Synacthen and the other 30 minutes after
injection. These blood samples will
show whether your adrenal glands are functioning as well as they
should by measuring the hormone
levels.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE SYNACTHEN 250
MICROGRAMS/ML
DO NOT TAKE SYNACTHEN:

if you are allergic (hypersensitive) to tetracosactide and/or ACTH
(Adrenocorticotropic
hormone) or any of the other ingredients of this medicine (listed in
section 6).

If you have allergic disorders (e.g. asthma).
2
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Synacthen if you have
previously experienced adverse
reactions to ACTH, Synacthen or other drugs.
TA

Summary of Product characteristics

Health Products Regulatory Authority
09 March 2022
CRN009PDJ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Synacthen 250 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
One ampoule of 1 ml contains 250 micrograms of Tetracosactide (as
tetracosactide acetate).
EXCIPIENT WITH KNOWN EFFECT:
One ampoule of 1 ml contains 3.33 mg of sodium (as sodium acetate and
sodium chloride).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
As a diagnostic test for the investigation of adrenocortical
insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
This preparation of Synacthen is intended for administration for
diagnostic purposes only as a single intramuscular or
intravenous dose; it is not to be used for repeated therapeutic
administration.
_ _
_The 30-minute Synacthen diagnostic test_
This test is based on measurement of the plasma cortisol concentration
immediately before and exactly 30 minutes after an
intramuscular or intravenous injection of 250mcg (1ml) Synacthen.
Adrenocortical function can be regarded as normal if the
post-injection rise in plasma cortisol concentration amounts to at
least 200nmol/litre (70mcg/litre). All plasma samples should
be stored in a refrigerator until plasma cortisol level estimation.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
No studies have been performed in patients with renal impairment.
HEPATIC IMPAIRMENT
No studies have been performed in patients with hepatic impairment
ELDERLY POPULATION (AGED 65 YEARS AND ABOVE)
There is no evidence to suggest that dosage should be different in the
elderly.
USE IN CHILDREN
An intravenous dose of 250mcg/1.73 m
2
body surface area has been suggested. Thus for children aged 5-7
years,
approximately half the adult dose will be adequate. For more accurate
dosing of other ages, standard body