Synacthen Depot

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tetracosactide 1 mg/mL equivalent to Tetracosactide hexaacetate 1.12 mg/mL

Available from:

Clinect NZ Pty Limited

INN (International Name):

Tetracosactide 1 mg/mL (equivalent to Tetracosactide hexaacetate 1.12 mg/mL)

Dosage:

1 mg/mL

Pharmaceutical form:

Injection (depot)

Composition:

Active: Tetracosactide 1 mg/mL equivalent to Tetracosactide hexaacetate 1.12 mg/mL Excipient: Benzyl alcohol Dibasic sodium phosphate dodecahydrate Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection Zinc chloride

Units in package:

Ampoule, glass, type I, clear, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bachem AG

Therapeutic indications:

Diagnostic use for the investigation of adrenocortical insufficiency: A 5-hour test canbe peerformed using Synacthen Depot when the 30-minute test with Synacthen i.m./i.v. gives inconclusive results, or if the aim is to determine the functional reserve of the adrenal cortex.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, type I, clear - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1969-12-31

Patient Information leaflet

1
New Zealand Consumer Medicine Information
SYNACTHEN DEPOT I.M.

TETRACOSACTIDE HEXAACETATE
1 MG/ML SUSPENSION FOR INJECTION
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before you are given Synacthen
Depot i.m.

This leaflet answers some common questions about Synacthen Depot.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you or your child
having Synacthen Depot against the benefits they expect it will
provide.
If you have any concerns about this medicine, ask your doctor or
pharmacist.
This medicine has been prescribed only for you. Do not give it to
anybody else or use it for
any other illnesses.
If any of the side effects affects you severely, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNACTHEN DEPOT IS AND WHAT IT IS USED FOR
_WHAT SYNACTHEN DEPOT IS _
_ _
Synacthen Depot belongs to a group of medicines called pituitary
hormones and analogues.
Synacthen Depot is supplied as a liquid suspension in a 1 mL
colourless glass ampoule.
Synacthen Depot is given as an injection into a muscle.
_WHAT SYNACTHEN DEPOT IS USED FOR _
_ _
Synacthen Depot is used instead of steroids (medicines such as
cortisone) to treat a number
of different conditions:
•
acute exacerbations of multiple sclerosis
•
some types of seizures in children.
•
rheumatic diseases: as a short-term therapy in conditions for which
corticoids are
normally used.
2
•
skin diseases responsive to corticoids.
•
ulcerative colitis and Crohn’s disease.
•
additional therapy in cancer patients to improve the tolerability of
chemotherapy.
Synacthen Depot may also be 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.
_HOW SYNACTHEN DEPOT WORKS _
_ _
Synacthen Depot works by stimulating the adr

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
SYNACTHEN DEPOT I.M
®
(1MG/ML) SUSPENSION FOR INJECTION
The name of the medicine is Synacthen Depot i.m ® (1mg/mL) suspension
for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetracosactide 1mg/mL (as acetate)
For full list of excipients, SEE SECTION 6.1
3.
PHARMACEUTICALS FORM
Synacthen Depot injection is a milky-white, suspension for
intramuscular injection in a 1 mL ampoule.
_ACTIVE SUBSTANCE _
1 mg tetracosactide (beta
1-24
-corticotrophin) adsorbed to zinc phosphate per ampoule (as
hexaacetate).
_ACTIVE MOIETY _
Tetracosactide (beta
1-24
-corticotrophin).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_THERAPEUTIC USE _
_Neurological diseases: _
•
Acute exacerbations in patients suffering from multiple sclerosis.
•
West syndrome (Infantile myoclonic encephalopathy with
hypsarrhythmia).
_Rheumatic diseases: _
Short-term therapy in conditions for which
•
glucocorticoids are normally indicated;
•
in patients showing poor gastrointestinal tolerance of oral
glucocorticoids;
•
where glucocorticoids in normal doses have not elicited an adequate
response.
_Skin diseases: _
Long-term treatment of skin disorders responsive to glucocorticoids -
e.g. pemphigus, severe chronic
eczema, erythrodermal or pustular forms of psoriasis.
_Diseases of the gastrointestinal tract _
•
Ulcerative colitis;
•
regional enteritis.
_Oncology _
As adjuvant therapy to improve the tolerability of chemotherapy.
2
_DIAGNOSTIC USE FOR THE INVESTIGATION OF ADRENOCORTICAL INSUFFICIENCY:
_
A 5-hour test can be performed using Synacthen Depot when the
30-minute test with Synacthen i.m./i.v.
gives inconclusive results, or if the aim is to determine the
functional reserve of the adrenal cortex (see
Synacthen i.m./i.v. data sheet).
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
_Therapeutic use: _
Treatment is initiated with daily doses of Synacthen Depot and
continued with intermittent doses after about
3 days.
Adults:
The initial dose is 1 mg daily administered intramuscularly; in acute
cas