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SYNACTHEN DEPOT AMPOULES 1MG/ML

Active substance(s): TETRACOSACTIDE ACETATE / TETRACOSACTIDE ACETATE

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PACKAGE LEAFLET: Information for the patient

Synacthen® Depot Ampoules 1mg/ml
Tetracosactide acetate

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

FPO
Pharmacode

Read all of this leaflet carefully before you are given this medicine because it
contains important information for you
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1. What Synacthen Depot is and what it is used for
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2. What you need to know before you are given Synacthen Depot
Do not use Synacthen Depot if:
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Warnings and precautions
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Other medicines and Synacthen Depot
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Synacthen Depot with food and drink
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Synacthen Depot contains benzyl alcohol
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3. How to use Synacthen Depot
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1. Dosage
Indication
Therapeutic use!
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Diagnostic use:

Method of administration
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Adults
Adults including elderly patients will usually start treatment with 1mg once or twice daily for about three days. As your condition
improves, this dose will then be reduced over a period of several weeks, to 0.5mg every two to three days or 1mg once a week
Children
Children aged 3-12 years will be given a lower dose based on their age and weight. They will start with an injection every day. This
will then be reduced to once every 2 to 8 days.
Your doctor may monitor growth or organise heart scans in children who are given this medicine for a long period of time.
How should Synacthen Depot be given?
The ampoules should be shaken before use. The liquid in the ampoule will be drawn up into a syringe and injected into a muscle
by your doctor or nurse (never into a vein).
For how long should Synacthen Depot be given?
For therapeutic use: Synacthen will not cure your condition but it may relieve some of the symptoms. The injections can be
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For diagnostic tests use: You will be given a single injection of Synacthen Depot. You will have six blood samples taken, one
before the injection and the others 30 minutes, 1, 2, 3, 4 and 5 hours after the injection. These blood samples will show whether
your adrenal glands are functioning as well as they should.
What to do if you think you have received more Synacthen Depot than you should
As this medicine is given to you in hospital, it is very unlikely that an overdose will happen. If anyone receives this medicine by
accident, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty
packet to the doctor.
If you forget to take Synacthen Depot
As a doctor or nurse is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or nurse.
4. Possible side effects
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Serious side effects:
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should be monitored carefully for 30 minutes after each injection. If you get a reaction like this when you are not under medical
supervision, contact your doctor or nearest hospital accident and emergency department immediately. Once you have had an
allergic reaction like this, you should never be treated with Synacthen Depot or similar medicines again.
࠮ bleeding of the adrenal gland (small glands above the kidneys) which may result in sudden pain in the stomach and back,
weakness, fainting, loss of appetite and feeling or actually being sick
࠮ blood clot (symptoms may include pain, swelling, redness, warmth and tenderness in the area of the clot depending on
location in the body)
࠮ blood in your stools
࠮ blood in your urine
࠮ blood in your vomit.
If you experience any of these at any time, tell your doctor straight away or go immediately to the nearest hospital accident and
emergency department.
Side effects which may occur with Synacthen Depot include the following:
low levels of calcium which can cause muscle cramps,
࠮ menstrual (period) problems
stomach cramps or spasms. Your doctor may want
࠮ swelling of the face (moon face)
to take a blood test to measure your blood levels of
࠮ increased thirst
potassium or calcium
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࠮ decreased or blurred vision
࠮ headache
࠮ high blood pressure
࠮ protrusion of the eye-balls in their sockets
࠮ heart problems which can cause shortness of breath or
࠮ glaucoma/blurred vision
ankle swelling
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stomach and back pain
࠮ bruising
࠮ acne, other skin problems or unusual bruising
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࠮ muscle cramps or pain, muscle weakness
࠮ darkening or lightening of skin colour
࠮ pain in back, hips, arms, shoulders or legs
࠮ increased sweating
࠮ poor healing of wounds
࠮ bone thinning and fractures of the bones
࠮ increased chance of infection
࠮ hormonal imbalance
࠮ abscess
࠮ ruptured tendon, the symptoms of which include severe
࠮ increase in the number of white blood cells which can
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࠮ unusual increase in hair growth on body or face
࠮ slowing of the rate of growth in children
࠮ diabetes mellitus (increased sugar levels in your blood
࠮ weight increase
and urine)
࠮ long term use in children up to 5 years may cause
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changes to the heart
࠮ sodium retention
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࠮ low levels of potassium which can cause muscle
weakness, muscle twitching or abnormal heart beat or
Reporting of suspected adverse reactions
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5. How to store Synacthen Depot
Synacthen Depot will be stored in the hospital pharmacy.
Keep out of the sight and reach of children.
Do not use Synacthen Depot after the expiry date which is stated on the ampoule and the carton. The expiry date refers to the last
day of that month after EXP.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no
longer require. These measures will help protect the environment.
6. Contents of the pack and other information
What Synacthen Depot contains
The active substance of Synacthen Depot is tetracosactide acetate 1 mg per ampoule.
;OLV[OLYPUNYLKPLU[ZHYLaPUJJOSVYPKLHUO`KYV\ZW\YLKPZVKP\TWOVZWOH[LKVKLJHO`KYH[LILUa`SHSJVOVS mg/5 ml), sodium
chloride, sodium hydroxide and water for injections.
What Synacthen Depot looks like and contents of the pack
Synacthen Depot is a sterile, milky white suspension in a 1 mL (millilitre) clear glass ampoule. Synacthen Depot comes in packs of
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Marketing Authorisation Holder:
Mallinckrodt Specialty Pharmaceuticals Ireland Ltd, Sandyford Business Centre, Unit 7, Dublin 18, Ireland
Manufacturer:
Mallinckrodt Specialty Pharmaceuticals Ireland Ltd, College Business & Technology Park,
Cruiserath, Blanchardstown, Dublin 15, Ireland
;OLPUMVYTH[PVUPU[OPZSLHÅL[HWWSPLZVUS`[V:`UHJ[OLU(TWV\SLZ0M`V\OH]LHU`X\LZ[PVUZVY`V\HYLUV[Z\YLHIV\[HU`[OPUN
ask your doctor or a nurse.
;OPZSLHÅL[^HZSHZ[YL]PZLKPU!July 2017
SYNACTHEN is a registered trademark of Novartis AG and is used under licence
by Mallinckrodt Pharmaceuticals.
© Mallinckrodt Pharmaceuticals

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This test is based on measurement of the plasma cortisol concentration before and exactly
30 minutes, 1, 2, 3, 4 and 5 hours after an intramuscular injection of 1mg Synacthen Depot.
If adrenocortical function is normal, baseline plasma cortisol (normally >200 nmol/L) doubles
in [OLÄYZ[OV\YHUK[OLUJVU[PU\LZ[VYPZLZSV^S`HZMVSSV^Z!
Table Hourly cortisol levels:
Time
1st hour
2nd hour
3rd hour
4th hour
5th hour

nmol/L
600 – 1250 nmol/L
750 – 1500 nmol/L
800 – 1550 nmol/L
950 – 1650 nmol/L
1000 – 1800 nmol/L

If plasma cortisol rises more slowly than indicated above, this may be the result of Addison’s
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function, or overdose of corticosteroids.
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Premature babies and neonates
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All the plasma samples should be stored in a refrigerator until plasma cortisol level estimation.
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No paediatric dosage has been established.
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2. Storage
Synacthen Depot should be stored in a refrigerator (2-8°C), in the original package.
3. Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.

None

Pharmaceuticals

07/2017

GTIN:

GBU:

REV:

Package Type:

File Name:

Offset Lithography

Pharmacode

US Only

Print Process:

Barcode Format:

Check here if:

Country Specific

10025x-pl5816-gb0717.indd

Notes: Folds to 60.00 mm x 50.00 mm (2.362” x 1.969” approx) Pharmacode Reads “FPO”, Binary ”FPO”

Multiple Countries

148.00 mm W x 420.00 mm H

Metric
Dimensions:

LT10025 (FPO)

Artwork/Part #:

Consumer Medicine Information

5.827” W x 16.535” H (approx)

Dimensions:

170142

Job #:

ADDITIONAL JOB INFORMATION

Synacthen Depot

Product Brand and
Descriptor:

JOB INFORMATION

Global Labeling Operations

Fonts Used:

Linked Images:

Helvetica Neue Family

InDesign
148x420_Template_Front.ai
148x420_Template_Back.ai
Depot_Art_front.ai
Depot_Art_back.ai

TECHNICAL INFORMATION

Application:

Black

NUMBER OF COLORS

CMO
CMO
United Kingdom(GB)
rr2
July 11, 2017

OTHER INFORMATION
Additional Notes:

Date:

Graphic Designer

Country:

Print Vendor:

Manufacturing Site:

GBU-SPECIFIC INFORMATION

Regulatory Affairs
675 McDonnell Boulevard 30-2
Hazelwood, MO 63042

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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