Synacthen 0.25mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tetracosactide, Quantity: 0.25 mg/mL

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; acetic acid; sodium acetate

Administration route:

Intramuscular, Intravenous

Units in package:

1 X 1mL ampoule

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 12 AUGUST 1999: As a diagnostic aid in the assessment of suspected adrenocortical hypofunction.

Product summary:

Visual Identification: Clear liquid, colourless; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

SYNACTHEN
®
_tetracosactide (tetracosactrin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Synacthen.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Synacthen
against the benefits they expect it
will give you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNACTHEN IS
USED FOR
Synacthen is used as a diagnostic test
to find out if the adrenal glands,
small glands next to the kidneys, are
working as well as they should. The
Synacthen test is given as a single
injection into the muscle.
Synacthen is used as a test only. It is
not used to treat poorly functioning
adrenal glands.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SYNACTHEN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Synacthen is only available with a
doctor's prescription. It is not habit-
forming.
BEFORE YOU ARE GIVEN
SYNACTHEN
_WHEN YOU MUST NOT HAVE IT_
YOU SHOULD NOT BE GIVEN SYNACTHEN
IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
tetracosactide (tetracosactrin), the
active ingredient in Synacthen
•
any of the other ingredients of
Synacthen listed at the end of this
leaflet
•
a similar medicine called ACTH
or corticotrophin
Symptoms of an allergic reaction
may include redness or pain at the
injection site, rash, itching, hives or
flushing of the skin, dizziness,
nausea (feeling sick) or vomiting,
difficulty breathing, swelling

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - SYNACTHEN
®
(TETRACOSACTIDE (TETRACOSACTRIN))
1. NAME OF THE MEDICINE
tetracosactide (tetracosactrin)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Synacthen is the first corticotrophic preparation to be produced
entirely by synthesis and displays all of the
pharmacological properties of endogenous ACTH. It is a long-chain
polypeptide composed of the first 24 of
the 39 amino acids contained in the naturally occurring ACTH
(corticotrophin) molecule.
In contrast to ACTH preparations obtained by extraction, the
composition of Synacthen is not subject to
variation, so that dosage can be expressed in terms of weight. For the
purposes of clinical use, Synacthen
1mg corresponds approximately to 100 international units of ACTH (as
defined in the Third International
Working Standard). Studies have shown that a single test dose of
Synacthen 250 micrograms
(corresponding to 25 IU) administered by intramuscular injection is
sufficient to elicit a marked rise in plasma
cortisol within 30 minutes.
Synacthen ampoules contain 250 micrograms tetracosactide
(tetracosactrin) (as the hexa-acetate salt) per 1
mL of solution.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for injection
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a diagnostic aid in the assessment of suspected adrenocortical
hypofunction.
4.2 DOSE AND METHOD OF ADMINISTRATION
Refer to Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE -
Effects on laboratory tests and
Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTIONS for
information on drugs that may interfere with test results.
SYNACTHEN 30 MINUTE TEST
This test is based on the increase in plasma cortisol recorded 30
minutes after an intramuscular injection of
Synacthen 250 micrograms. Two blood specimens should be taken, the
first immediately before and the
second exactly 30 minutes after the injection of Synacthen. If the
plasma cortisol rises to at least 200
nanomoles/L (70 micrograms/L)