Synacthen Depot 1mg/1ml suspension for injection ampoules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Tetracosactide acetate

Beschikbaar vanaf:

Atnahs Pharma UK Ltd

ATC-code:

H01AA02

INN (Algemene Internationale Benaming):

Tetracosactide acetate

Dosering:

1mg/1ml

farmaceutische vorm:

Suspension for injection

Toedieningsweg:

Intramuscular

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06050100; GTIN: 5036631851945 5391525930077

Bijsluiter

Synacthen Depot PIL UK 016
PACKAGE LEAFLET : INFORMATION FOR THE PATIENT
SYNACTHEN
® DEPOT AMPOULES 1MG/ML
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 DEPOT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SYNACTHEN DEPOT
3.
HOW TO USE SYNACTHEN DEPOT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SYNACTHEN DEPOT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SYNACTHEN DEPOT IS AND WHAT IT IS USED FOR
Synacthen Depot 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 Depot is similar to the hormone that the pituitary gland
normally
produces (called ACTH) to make the adrenal glands produce certain
steroids.
Synacthen Depot PIL UK 016
When Synacthen Depot is injected it works on the adrenal glands by
‘telling’
them to produce more steroids.
Synacthen Depot is used in place of medicin

Productkenmerken

OBJECT 1
SYNACTHEN DEPOT AMPOULES 1MG/ML
Summary of Product Characteristics Updated 19-Oct-2017 | Mallinckrodt
Specialty Pharmaceuticals
Ireland Limited
1. Name of the medicinal product
Synacthen Depot Ampoules 1mg/ml
2. Qualitative and quantitative composition
Tetracosactide acetate 1mg/ml
Excipient(s) with known effect
Contains benzyl alcohol (10mg/ml).
Each ampoule contains a total of 3.32 mg of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
Tetracosactide acetate is absorbed on to zinc phosphate. A sterile,
milky white suspension, which settles
on standing, in a clear glass ampoule.
4. Clinical particulars
4.1 Therapeutic indications
_Therapeutic use_: Synacthen Depot should normally only be used for
short-term therapy in conditions for
which glucocorticoids are indicated in principle, for example, in
ulcerative colitis and Crohn's disease,
juvenile rheumatoid arthritis, or as adjunct therapy in patients with
rheumatoid arthritis and
osteoarthrosis. Synacthen Depot may be particularly useful in patients
unable to tolerate oral
glucocorticoid therapy or in patients where normal therapeutic doses
of glucocorticoids have been
ineffective.
_Diagnostic use_: As a diagnostic aid for the investigation of
adrenocortical insufficiency.
4.2 Posology and method of administration
Posology
THERAPEUTIC USE: Initially, daily doses of Synacthen Depot should be
given but after approximately 3
days, intermittent doses may be given.
_Adults_: Initially 1mg intramuscularly daily or 1mg every 12 hours in
acute cases. After the acute
symptoms of the disease have disappeared, treatment may be continued
at a dose of 1mg every 2 to 3
days; in patients who respond well, the dosage may be reduced to 0.5mg
every 2 to 3 days or 1mg per
week.
_Paediatric population:_
Due to the presence of benzyl alcohol, Synacthen Depot is
contraindicated in premature babies and in
neonates (less than one month). (See section 4.3 Contraindications).
_Children aged 3 to 5 years_: Initially 0.25 t