SYNACTHEN DEPOT 1mg/ml amp.

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

NOVARTIS PHARMA EGYPT

Dosage:

1 mg/ml

Pharmaceutical form:

injection

Units in package:

1 ampoule

Manufactured by:

NOVARTIS PHARMA-SWITZERLAND

Authorization date:

1998-06-02

Patient Information leaflet

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 015
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 medicines like prednisolone or
cor

Safety Data Sheet

SAFETY DATA SEEET
SECTION 1: Identification of the substance/mixture and of the
company/undertaking
1.1. Product identifier
Identification number
Name of the substance
Synacthen Depot
-
-
Registration number
ACTH (1-24) * α1-24-Corticotropin * Tetracosactrin * Cosyntropin *
ACTH (adrenocorticotropic
hormone fragment) * Tetracosactide hexaacetate *
.alpha.1-24-Corticotropin, acetate (salt)
Synonyms
SYNAM
SDS number
SYNAM
Item Code
18-January-2018
Issue date
02
Version number
01-October-2019
Revision date
18-January-2018
Supersedes date
1.2. Relevant identified uses of the substance or mixture and uses
advised against
Drug product (pharmaceutical bulk, primary packed, finished product,
pharmaceutical
intermediate.
Identified uses
None known.
Uses advised against
1.3. Details of the supplier of the safety data sheet
Mallinckrodt Pharmaceuticals
Company name
College Business and Technology Park
Address
Cruiserath Road
Blanchardstown, Dublin 15, Ireland
Customer Service 353 1 696 0000 (Worldwide)
[e-mail]
e-mail
0 800 680 0425/ GB)[phone] (Access Code: 335277)
Emergency telephone
number
1.4. Emergency telephone number
112 (Available 24 hours a day. SDS/Product information may not be
available for
the Emergency Service.)
General in EU
SECTION 2: Eazards identification
2.1. Classification of the substance or mixture
The substance has been assessed and/or tested for its physical, health
and environmental hazards and the following
classification applies.
Classification according to Regulation (EC) No 1272/2008 as amended
H334 - May cause allergy or
asthma symptoms or breathing
difficulties if inhaled.
Category 1
Respiratory sensitisation
Eealth hazards
H317 - May cause an allergic skin
reaction.
Category 1
Skin sensitisation
Eazard summary
Harmful if inhaled. May cause allergy or asthma symptoms or breathing
difficulties if inhaled. May
cause an allergic skin reaction.
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains:
Sodium chloride, Ttetracosactide hexaacetate
E