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SYNTHAMIN 9 5.5% AMINO ACID INTRAVENOUS INFUSION

Active substance(s): AMINOACETIC ACID / MAGNESIUM CHLORIDE / POTASSIUM PHOSPHATE DIBASIC / SODIUM ACETATE / SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SYNTHAMIN 9, 5.5% Amino Acid Intravenous
Infusion with electrolytes
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.

• your body has problems using certain amino acids
• your blood level of sodium, potassium, magnesium and/or
phosphorus is too high.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or nurse. You will not be given SYNTHAMIN if any of the above apply to
you.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet, Warnings and precautions
see section 4.
Talk to your doctor or nurse before SYNTHAMIN is given to
In this leaflet:
you.
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What SYNTHAMIN is and what it is used for
What you need to know before you are given SYNTHAMIN
How SYNTHAMIN is given
Possible side effects
How SYNTHAMIN is stored
Contents of the pack and other information

SYNTHAMIN will only be used if the solution is clear, free from
particles and the container is not damaged.
You will have regular blood and urine tests while being given
SYNTHAMIN. This will make sure that you are getting the right
amount of solution and if necessary you will be given other
treatments. More checks are made if SYNTHAMIN is being
given to a very young child.

Throughout this leaflet SYNTHAMIN 9, 5.5% Amino Acid
Intravenous Infusion with electrolytes will be called
SYNTHAMIN.

If any abnormal signs or symptoms of an allergic reaction
develop, such as fever, chills, skin rashes or difficulty in
breathing, excessive sweating, nausea or headache, tell the
doctor or the nurse: the infusion will be stopped immediately.

1 What SYNTHAMIN is and what it is used for

SYNTHAMIN can cause the formation of small particles in your
blood. If you start to have difficulty breathing or feel short
of breath, tell the doctor or the nurse: the infusion will be
stopped immediately and you may need other treatment.

SYNTHAMIN is a sterile solution which contains:
• amino acids – these are the building blocks which your
body uses to make proteins
• electrolytes – these chemicals are important for your body
to work properly.

Certain medications and illnesses can increase the risk
of developing infection or sepsis (bacteria in the blood).
There is a particular risk of infection or sepsis when a tube
SYNTHAMIN is used to give you food (nutrition) straight into
your blood, when you cannot take enough food by your mouth. (intravenous catheter) is placed in your vein. Your doctor will
carefully watch you for any signs of infection. Using aseptic
Your doctor will check your body has all the nutrition that
“germ free” techniques when placing and maintaining the
it needs for good health. If necessary, you may also have
catheter and when making the nutritional formula can reduce
vitamins (such as folic acid), minerals, fatty acids (the building
the risk of infection.
blocks of fats), electrolytes (salts) and sugar solutions (such
If you are severely malnourished such that you need to receive
as glucose) at the same time as SYNTHAMIN.
feeding through a vein, it is recommended that parenteral
nutrition is started slowly and carefully.
2 What you need to know before you are given
SYNTHAMIN may cause a stinging pain and redness at the
SYNTHAMIN
place where it goes into your vein if given into your arm.
SYNTHAMIN must not be given to you if:
Your doctor will monitor your condition at the onset of the
infusion, particularly if you currently have liver, kidney, heart
or circulation problems.

• you are allergic (hypersensitive) to any of the ingredients
of SYNTHAMIN (listed in section 6) or components of the
container

Amino acid solutions can increase the level of ammonia or
nitrogen-containing compounds in your blood. Your doctor will
check your blood tests for this.

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Giving a volume of SYNTHAMIN that is too large may cause
Your doctor should also be aware of severe conditions
affecting how your body handles fluid, sugars, fats, proteins or nausea, vomiting, chills and electrolyte disturbances, in such
salt (metabolic disorders). These conditions will be corrected situations the infusion should be stopped immediately.
before you are given SYNTHAMIN.
In some severe cases, your doctor may have to give you
temporary renal dialysis to help your kidneys eliminate the
Use with other medicines
excess product.
Tell your doctor or nurse if you are taking, have recently taken
To prevent these events occurring, your doctor will regularly
or might take any other medicines.
monitor your condition and test your blood parameters.
SYNTHAMIN with electrolytes contains potassium. Special
care should be taken in patients taking diuretics, ACE
inhibitors or angiotensin II receptor antagonists (drugs for high
4 Possible side effects
blood pressure) or immunosuppressants. These types of drugs
may increase potassium levels in your blood.
Like all medicines, SYNTHAMIN can cause side effects,
Pregnancy and breast-feeding
although not everybody gets them.
If you are pregnant, think you might be pregnant or are breast- If you notice any changes in the way you feel during or after
the treatment, tell your doctor or nurse right away.
feeding, tell your doctor. They will decide if you can be given
SYNTHAMIN.

The tests your doctor will perform while you are taking the
medicine are meant to minimise side effects.

Important information about some of the ingredients of
SYNTHAMIN

If any abnormal signs or symptoms of an allergic reaction
develop, such as abnormally low or high blood pressure,
appearance of a blue or purple coloration of the skin,
abnormally high heart rate, breathing difficulties, vomiting,
nausea, skin rashes, raised body temperature, excessive
sweating chills, and shivering, the infusion will be stopped
immediately.

This medicine contains potassium and sodium. Your doctor
will know how much you can be given.
3 How SYNTHAMIN is given
Your doctor will decide how much SYNTHAMIN you should be
given. It will depend on:

Other side effects have been noticed, occurring more or less
frequently:

– how much you weigh

• serious allergic reaction that is rapid in onset and may
cause death (anaphylaxis)

– what your body needs
– how much sugar solution (like glucose) you can be given

• formation of small particles blocking lung blood vessels
(pulmonary vascular precipitate).

– why you are being given it.

Reporting of side effects

• the usual daily dose for children is 2.2 grams of amino
acid (protein) per kilogram

If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see
details below). By reporting side effects you can help provide
more information on the safety of this medicine.

• the usual daily dose for adults weighing 70 kilograms is
56 grams of amino acid a day
• these are the recommended amounts to have each day,
but you may be given more or less

Yellow Card Scheme
• SYNTHAMIN is given as an infusion into a large vein in your www.mhra.gov.uk/yellowcard
chest (called the vena cava). The solution is slowly given to
you at a rate which will not be more than 70 millilitres per
hour.
5 How SYNTHAMIN is stored
• You will not be given more than 40 millilitres for every
Keep this medicine out of the sight and reach of children
kilogram of your bodyweight in a day.
SYNTHAMIN should be stored as follows: Do not store above
25ºC and protect it from light.

Children under two years old should not use SYNTHAMIN.
You will not be given SYNTHAMIN through the same tubes and
equipment used for any blood transfusion.

Do not use SYNTHAMIN after the expiry date which is stated
on the label after Exp. The expiry date means the last day of
that month.

If you are given too much
Your doctor will give you SYNTHAMIN so it is unlikely that you
will be given too much. If you are worried that you have had
too much, tell your doctor or nurse.
If the dose given is too high or the infusion too fast, the amino
acid content may make your blood too acid and you may have
too much fluid in the circulation.

SYNTHAMIN is for single use only. Partly used bags should not
be used again. Any left over solution should be thrown away
safely by a healthcare professional. All equipment will be
thrown away safely by a healthcare professional after use.
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For information about SYNTHAMIN or to
request this leaflet in formats such as audio
or large print please contact the Marketing
Authorisation Holder:
Tel: 01635 206345.

6 Contents of the pack and other information
What SYNTHAMIN contains
• The active substances are L-Leucine 0.402% w/v,
L-Isoleucine 0.330% w/v, L-Lysine (as hydrochloride
salt) 0.319% w/v, L-Valine 0.319% w/v, L-Phenylalanine
0.308% w/v, L-Histidine 0.264% w/v, L-Threonine 0.231%
w/v, L-Methionine 0.220% w/v, L-Tryptophan 0.099% w/v,
L-Alanine 1.138% w/v, L-Arginine 0.632% w/v, Amino
acetic acid (glycine) 0.566% w/v, L-Proline 0.374% w/v,
L-Serine 0.275% w/v, L-Tyrosine 0.022% w/v, Sodium
acetate 0.431% w/v, Dibasic potassium phosphate 0.522%
w/v, Sodium chloride 0.224% w/v, Magnesium chloride
0.102% w/v

Baxter and Synthamin are trademarks of Baxter International
Inc.

• The other ingredient is sterile water (called ‘water for
injections’). SYNTHAMIN can also sometimes contain a
very small amount of glacial acetic acid or sodium acetate
to adjust the pH of the solution.
What SYNTHAMIN looks like and the contents of the pack
SYNTHAMIN is a solution for infusion (a slow drip injection). It
is a clear sterile solution. It is available in sealed plastic bags
containing 250 ml, 500 ml, 1,000 ml, 2,000 ml* and 3,000 ml*.
* The 2,000 ml and 3,000 ml bags are bulk bags for a
compounding unit to use. They are not meant for use directly
in patients.
Marketing Authorisation Holder and Manufacturers
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Send all enquiries to this address.
SYNTHAMIN can be made at any of these places:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
NV Baxter SA
7860 – Lessines
Belgium
Baxter Healthcare SA
Castlebar
Co. Mayo
Ireland
This leaflet was last revised in 04/2014.

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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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