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SYNACTHEN AMPOULES 250 MCG

Active substance(s): TETRACOSACTIDE ACETATE / TETRACOSACTIDE ACETATE / TETRACOSACTIDE ACETATE

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The liquid will be drawn up into a syringe and injected into a muscle or vein by your doctor or nurse. You will be
given a single injection of Synacthen Ampoules. You will have two blood samples taken, one before the injection
of Synacthen Ampoules and the other 30 minutes after injection. These blood samples will show whether your
adrenal glands are functioning as well as they should.
Adults including elderly patients will be given 250 micrograms (one ampoule).
Children will be given a lower dose based on their age and weight.
What to do if you think you have received more Synacthen Ampoules 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 Ampoules
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.
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Anaphylactic shock or severe allergic reaction (symptoms may include redness or pain at the injection site,
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lips, tongue or other parts of the body, feeling very unwell). This tends to be more severe in people, who
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after the injection. If you have had an allergic reaction, you should never be treated with Synacthen Ampoules
or similar medicines again.

bleeding into the adrenal gland (small glands above the kidneys) which may result in sudden stomach or back
pain, 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.
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allergic reaction with skin irritation and swelling
menstrual (period) problems
swelling of the face (moon face)
increased thirst
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decreased or blurred vision
high blood pressure
heart problems which can cause shortness of
breath or ankle swelling
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with a rash, arthritis or kidney failure)
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severe stomach and back pain
feeling or actually being sick
general feeling of being unwell
acne, other skin problems or unusual bruising
muscle cramps or pain, muscle weakness
pain in back, hips, arms, shoulders or legs
itching
poor healing of wounds
increased chance of infection
abscess
increase in the number of white blood cells
which can cause bleeding, fever, infection or
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unusual increase in hair growth on body or face
thinning of the skin
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diabetes mellitus (increased sugar levels in your
blood and urine)
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sodium retention
low levels of potassium which can cause muscle
weakness, muscle twitching or abnormal heart
beat or low levels of calcium which can cause
muscle cramps, stomach cramps or spasms. Your
doctor may want to take a blood test to measure
your blood levels of potassium or calcium
increased appetite
headache
protrusion of the eye-balls in their sockets
glaucoma/blurred vision
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stomach pain or a bloated stomach
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small, round, dark red spots on the skin
bruising
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darkening or lightening of skin colour
increased sweating
bone thinning and fractures of the bones
ruptured tendon, the symptoms of which include
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and rapid bruising at the site
slowing of the rate of growth in children
weight increase.

Reporting of suspected adverse reactions
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safety of this medicine.
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Synacthen Ampoules will be stored in the hospital pharmacy.
Keep out of the sight and reach of children.
Do not use Synacthen Ampoules 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 Ampoules contains
Synacthen Ampoules contains the active ingredient tetracosactide acetate 250 micrograms per ampoule.
The other ingredients are acetic acid, sodium acetate, sodium chloride and water for injections.
What Synacthen Ampoules looks like and contents of the pack
Synacthen is a clear, colourless sterile liquid that comes in a 1ml (millilitre) clear glass ampoule.
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Mallinckrodt Specialty Pharmaceuticals Ireland Ltd, Sandyford Business Centre, Unit 7, Dublin 18, Ireland
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Mallinckrodt Specialty Pharmaceuticals Ireland Ltd, College Business & Technology Park,
Cruiserath, Blanchardstown, Dublin 15, Ireland

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about anything, 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
The following information is intended for medical or healthcare professionals only:
1. Dosage
Indication
Adults:

Method of administration
This preparation of Synacthen Ampoules is intended for administration for diagnostic purposes only as
a single intramuscular or intravenous dose; it is not to be used for repeated therapeutic administration.
The 30-minute Synacthen Ampoules diagnostic test: This test is based on measurement of the plasma cortisol
concentration immediately before and exactly 30 minutes after an intramuscular or intravenous injection of
250micrograms (1ml) Synacthen Ampoules. Adrenocortical function can be regarded as normal if the postinjection rise in plasma cortisol concentration increased by 200nmol/litre (70 micrograms/litre), i.e. if the value
30 minutes after injection is >500nmol/litre (180 micrograms/litre), adrenocortical function is regarded as
normal. All the plasma samples should be stored in a refrigerator until plasma cortisol level estimation.
Where the 30-minute test has yielded inconclusive results, or where it is desired to determine the
functional reserve of the adrenal cortex, a 5-hour test can be performed with Synacthen Depot (see
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Children:

An intravenous dose of 250micrograms/1.73m² body surface area has been suggested. Thus for children
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ages, standard body surface area tables should be consulted.

Elderly:

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2. Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
3. Overdose
Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes.
4. Storage
Synacthen should be protected from light and stored in a refrigerator (2 - 8°C).

Expand Transcript

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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