Synacthen 250micrograms/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tetracosactide acetate

Available from:

Atnahs Pharma UK Ltd

ATC code:

H01AA02

INN (International Name):

Tetracosactide acetate

Dosage:

250microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100; GTIN: 5036631851938 5391525930060

Patient Information leaflet

Synacthen Ampoules PIL UK 015
PACKAGE LEAFLET : INFORMATION FOR THE PATIENT
SYNACTHEN
® AMPOULES 250 MICROGRAMS
TETRACOSACTIDE ACETATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse.

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 nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
WHAT SYNACTHEN AMPOULES IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SYNACTHEN AMPOULES
3.
HOW TO USE SYNACTHEN AMPOULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SYNACTHEN AMPOULES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SYNACTHEN AMPOULES IS AND WHAT IT IS USED FOR
Synacthen Ampoules belongs to a group of medicines called pituitary
hormones
and analogues.
The pituitary gland is a small gland inside the brain which controls
many other
glands in the body, including the thyroid and adrenal glands. The
pituitary gland
produces hormones which send chemical messages to various parts of the
body
and affect many bodily functions such as blood pressure, blood sugar
levels,
growth and menstrual cycle.
The adrenal glands are found on top of the kidneys and make the
body’s natural
steroids which can affect blood pressure and the way the body handles
the
sugars, protein and fats absorbed from food. They also make adrenaline
which
controls the body’s response to different types of stress.
Synacthen Ampoules PIL UK 015
Synacthen Ampoules is used as a test to find out if the pituitary and
adrenal
glands are working normally.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SYNACTHEN AMPOULES
YOU SHOULD NOT BE GIVEN SYNACTHEN AMPOULES IF:

you are allergic (hypersensitive) to adrenocorticotropic h

Summary of Product characteristics

OBJECT 1
SYNACTHEN AMPOULES 250 MICROGRAMS PER ML
Summary of Product Characteristics Updated 18-Oct-2017 | Mallinckrodt
Specialty Pharmaceuticals
Ireland Limited
1. Name of the medicinal product
Synacthen Ampoules 250 mcg
2. Qualitative and quantitative composition
Tetracosactide acetate 250micrograms per ampoule.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
A clear colourless aqueous solution for intramuscular injection or
intravenous infusion in a 1 mL clear
glass ampoule.
4. Clinical particulars
4.1 Therapeutic indications
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 250micrograms (1ml) Synacthen. Adrenocortical function can be
regarded as normal if the post-
injection rise in plasma cortisol concentration increases by 200
nmol/litre (70 micrograms/litre),i.e. if the
value 30 minutes after injection is >500 nmol/litre (180
micrograms/litre), adrenocortical function is
regarded as normal.
All the plasma samples should be stored in a refrigerator until plasma
cortisol level estimation.
Where the 30-minute test has yielded inconclusive results, or where it
is desired to determine the
functional reserve of the adrenal cortex, a 5-hour test can be
performed with Synacthen Depot (see
separate Summary of Product Characteristics). Furthermore, a 3-day
test with Synacthen Depot may be
used to differentiate between primary and secondary adrenocortical
insufficiency.
_Children_: An intravenous dose of 250micrograms/1.73m² body surface
area has been suggested. Thus for
children aged 5