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B. BRAUN AMINOPLASMAL 5 % E SOLUTION FOR INFUSION

Active substance: VALINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Aminoplasmal 5% E
solution for infusion

Amino acids and Electrolytes
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What B. Braun Aminoplasmal 5% E is and what it is used for
2. Before you use B. Braun Aminoplasmal 5% E
3. How to use B. Braun Aminoplasmal 5% E
4. Possible side effects
5. How to store B. Braun Aminoplasmal 5% E
6. Further information

1. What B. Braun Aminoplasmal 5% E is and
what it is used for

• Usually you will receive B. Braun Aminoplasmal 5% E as part of intravenous feeding which also includes energy supplements (carbohydrate
solutions, fat emulsions), vitamins, electrolytes and trace elements.
• The site of infusion will be checked daily for signs of inflammation or
infection.

Taking or using other medicines
You should inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, even those not prescribed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
B. Braun Aminoplasmal 5% E is a solution which is given to you through a Your doctor will decide very carefully whether or not you should receive
this solution in these situations.
small tube with a cannula placed in a vein (intravenous infusion).
The solution is called a nutritional supplement. It contains amino acids
and electrolytes that are essential for the body to grow or to recover.
You will receive this solution if you cannot eat food normally. When you
receive this solution you will also receive others like glucose solutions or
fat emulsions.

2. Before you use B. Braun Aminoplasmal 5% E
You will not receive B. Braun Aminoplasmal 5% E
• if you are allergic (hypersensitive) to any of the ingredients included in
the solution (see section 6 for a full list of ingredients)
• if you suffer from a genetic abnormality of your metabolism of proteins
and amino acids
• if you have a severe (i.e. life-threatening) circulation disorder (shock)
• if you have insufficient oxygen supply
• if acidic substances accumulate in your blood (acidosis)
• if you have a severe liver disease
• if you have kidney failure not adequately treated by artificial kidney
• if you have too high blood levels of any of the electrolytes included in
the solution.
This solution must not be administered to new-born babies and children
under 2 years.
You should not receive any infusions if you have:
• poorly controlled heart failure with marked impairment of your blood
circulation
• accumulation of fluid in your lungs (lung oedema)
• excess water in your body, swelling of limbs (hyperhydration).

Special care will be taken with B. Braun Aminoplasmal 5% E
• if you suffer from an impairment of your metabolism of proteins and
amino acids caused by any condition other than mentioned above (see
section “You will not receive …”).
• if you have an impairment of your liver or kidney function.
• if you have an impairment of your heart function.
• if you have abnormally high concentrated blood serum (high serum
osmolarity).
• Before and while you are receiving this solution, the doctor will check
levels of fluids, electrolytes, blood sugar, serum proteins, acid base
balance and your liver and kidney function.

Driving or using machines

B. Braun Aminoplasmal 5% E is normally given to immobile patients in a
controlled setting (emergency treatment, acute treatment in a hospital or
a day therapy unit). This will exclude driving and using machines.

3. How to use B. Braun Aminoplasmal 5% E
Dosage
Adults and adolescents from 15 to 17 years
Your doctor will determine the amount of solution you need each day.
In general, this will be 20 – 40 ml per kg of your body weight per day. The
solution will run in at a rate of not more than 2 ml per kg of your body
weight per hour.
Children from 2 to 14 years
In children the doctor will adjust the dosage carefully according to the
individual child’s age, nutritional status and actual disease.
The amounts to be given to children will be approximately:
3rd – 5th year: 30 ml per kg of your body weight per day
6th – 14th year: 20 ml per kg of your body weight per day
The solution will run in at a rate of not more than 2 ml per kg of your body
weight per hour.

Duration of use
B. Braun Aminoplasmal 5% E may be used as long as you need intravenous
feeding.

Method of administration
The solution will be administered to you through a small plastic tube
inserted into one of your large veins.

If you receive more B. Braun Aminoplasmal 5% E than you
should
It is unlikely that this will occur because your doctor will determine your
daily doses. However, if you receive an overdose or the solution is running
in too fast, you will lose part of the amino acids in urine, you may feel sick
or vomit or you may shiver. If this happens, the infusion will be stopped
temporarily and resumed later on at a lower infusion rate.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.



438/12260939/0311

4. Possible side effects

0.508 g
Magnesium chloride hexahydrate
3.581 g
Disodium phosphate dodecahydrate
Like all medicines, B. Braun Aminoplasmal 5% E can have side effects
The other ingredients are acetylcysteine, citric acid monohydrate and
although not everybody gets them.
water for injections.
Such side effects are not specifically related to the solution B. Braun
Aminoplasmal 5% E but may occur with any kind of intravenous feeding, Electrolyte concentrations
Sodium
50 mmol/l
especially at the beginning.
Potassium
25 mmol/l
Uncommon side effects (affects 1 to 10 treated patients of 1,000):
Magnesium
2.5 mmol/l
• Disorders of stomach and gut:
Vomiting, feeling sick
Acetate
35 mmol/l
• General disorders:
Headache, shivering, fever
Chloride
45 mmol/l
If any of the side effects become serious, or if you notice any side effects Phosphate
10 mmol/l
not listed in this leaflet, please tell your doctor or pharmacist.
Citrate
2.0 mmol/l
Amino acid content
50 g/l
5. How to store B. Braun Aminoplasmal 5% E
Nitrogen content
7.9 g/l
Keep out of the reach and sight of children.
Do not use B. Braun Aminoplasmal 5% E after the expiry date stated on
the bottle and carton labels. The expiry date refers to the last day of that
month.
Keep bottles in the outer carton in order to protect from light. Do not
freeze.
After infusion, any remaining solution should never be stored for later use.

6. Further information
What B. Braun Aminoplasmal 5% E contains
The active substances are amino acids and electrolytes.
Per litre (1000 ml) this medicine contains:
Isoleucine
Leucine
Lysine hydrochloride
(equivalent to lysine, 3.43 g)
Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Glycine
Aspartic acid
Glutamic acid
Proline
Serine
Tyrosine
Sodium acetate trihydrate
Sodium chloride
Sodium hydroxide
Potassium acetate

Energy
Osmolarity
Titration acidity (to pH 7.4), approximately
pH

835 kJ/l  200 kcal/l
588 mOsm/l
17 mmol/l
5.7 – 6.3

What B. Braun Aminoplasmal 5% E looks like and contents of
the pack
B. Braun Aminoplasmal 5% E is a clear, colourless or faintly strawcoloured solution.
The product comes in colourless glass bottles of 250 ml, 500 ml and
1000 ml, which are each closed by rubber stoppers.
The 250 ml and 500 ml bottles are available in packs of 10. The 1000 ml
bottles are available in packs of 6.
Not all pack sizes may be marketed.

2.50 g
4.45 g Marketing Authorisation Holder and Manufacturer
4.28 g B. Braun Melsungen AG
Carl-Braun-Straße 1
Postal address
34209 Melsungen, Germany
2.20 g 34212 Melsungen, Germany
2.35 g Phone: +49-5661-71-0
2.10 g Fax: +49-5661-71-45 67
0.80 g
This medicinal product is authorised in the Member States of
3.10 g
the EEA under the following names:
5.75 g
Aminoplasmal B. Braun 5% E Infusionslösung
1.50 g Austria
Aminoplasmal B. Braun 5% E
5.25 g Czech Republic
Germany
Aminoplasmal B. Braun 5% E Infusionslösung
6.00 g
Estonia
Aminoplasmal B. Braun 5% E
2.80 g
Aminoplasmal B. Braun 5% E διάλυμα για έγχυση
3.60 g Greece
Hungary
Aminoplasmal B. Braun 5% E, oldatos infúzió
2.75 g
Italy
Amielect 5%, soluzione per infusione
1.15 g
Aminoplasmal B. Braun 5% E Infusionslösung
0.40 g Luxembourg
Latvia
Aminoplasmal B. Braun 5% E, šķīdums infūzijām
1.361 g
Aminoplasmal B. Braun 5% E
0.964 g Portugal
Slovakia
Aminoplasmal B. Braun 5% E
0.140 g
United Kingdom B. Braun Aminoplasmal 5% E solution for infusion
2.453 g
This leaflet was last approved in August 2011.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL Storage after mixing with other components
OR HEALTHCARE PROFESSIONALS ONLY:
Special precaution for storage
The product must not be used if the solution is not clear or the container
Dosage
or its closure are damaged.
In the case of amino acid requirements of 1 g per kg body weight per day
Cool storage of the solution, below 15 °C, may lead to formation of crysor more, particular attention should be paid to the limitations of fluid
tals, that can, however, be easily dissolved by gentle warming at 25 °C uninput. To avoid fluid overload, amino acid solutions with higher amino acid
til dissolution is complete. Shake container gently to ensure homogeneity.
content may have to be used in such situations.
Storage after mixing with other components
Instructions for handling
From the microbiological point of view, mixtures should be administered
Use a sterile giving set for infusion of B. Braun Aminoplasmal 5% E.
immediately after preparation. If not administered immediately, storage
If in the setting of complete parenteral nutrition it is necessary to add times and conditions of mixtures prior to use are the responsibility of the
other nutrients such as carbohydrates, lipids, vitamins and trace elements user and would normally not be longer than 24 hours at 2 °C – 8 °C, unless
to this medicinal product, admixing must be performed under strict asep- mixing has taken place under controlled and validated aseptic conditions.
tic conditions. Mix well after admixture of any additive. Pay special attention to compatibility.

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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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