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B. BRAUN AMINOPLASMAL 10 % SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Aminoplasmal 10%
solution for infusion
Amino acids

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 10% is and what it is used for
2. Before you use B. Braun Aminoplasmal 10%
3. How to use B. Braun Aminoplasmal 10%
4. Possible side effects
5. How to store B. Braun Aminoplasmal 10%
6. Further information

1. What B. Braun Aminoplasmal 10% is and
what it is used for
B. Braun Aminoplasmal 10% is a solution which is given to you through a
small tube with a cannula placed in a vein (intravenous infusion).
The solution is called a nutritional supplement. It contains amino acids
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 10%
You will not receive B. Braun Aminoplasmal 10%
• if you are allergic (hypersensitive) to any of the ingredients 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.
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 10%
• 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, your doctor will check
levels of your fluids, electrolytes, blood sugar, serum proteins, acid
base balance and your liver and kidney function.
• if you have too low levels of sodium or potassium in your blood.

• Usually you will receive B. Braun Aminoplasmal 10% 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.
Your doctor will decide very carefully whether or not you should receive
this solution in these situations.

Driving or using machines
B. Braun Aminoplasmal 10% 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 10%
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 10 – 20 ml per kg of your body weight per day. The
solution will run in at a rate of not more than 1 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:
15 ml per kg of your body weight per day
3rd – 5th year:
10 ml per kg of your body weight per day
6th – 14th year:
The solution will run in at a rate of not more than 1 ml per kg of your
body weight per hour.

Duration of use
B. Braun Aminoplasmal 10% 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 10% 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.



451/12260941/0311

4. Possible side effects

Electrolyte concentrations

Like all medicines, B. Braun Aminoplasmal 10% can have side effects
although not everybody gets them.
Such side effects are not specifically related to the solution B. Braun
Aminoplasmal 10% but may occur with any kind of intravenous feeding,
especially at the beginning.
Uncommon side effects (affects 1 to 10 treated patients of 1,000):
• Disorders of stomach and gut:
Vomiting, feeling sick
• General disorders:
Headache, shivering, fever
If any of the side effects become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Acetate
Citrate
Amino acid content
Nitrogen content
Energy
Osmolarity
Titration acidity (to pH 7.4), approximately
pH

28 mmol/l
2.0 mmol/l
100 g/l
15.8 g/l
1675 kJ/l  400 kcal/l
864 mOsm/l
20 mmol/l
5.7 – 6.3

What B. Braun Aminoplasmal 10% looks like and contents of
the pack

B. Braun Aminoplasmal 10% is a clear, colourless or faintly strawcoloured solution.
The product comes in colourless glass bottles of 250 ml, 500 ml and
Keep out of the reach and sight of children.
1000 ml, which are each closed by rubber stoppers.
Do not use B. Braun Aminoplasmal 10% after the expiry date stated on The 250 ml and 500 ml bottles are available in packs of 10. The 1000 ml
the bottle and carton labels.
bottles are available in packs of 6.
The expiry date refers to the last day of that month.
Not all pack sizes may be marketed.
Keep bottles in the outer carton in order to protect from light. Do not
Marketing Authorisation Holder and Manufacturer
freeze.
After infusion, any remaining solution should never be stored for later use. B. Braun Melsungen AG
Carl-Braun-Straße 1
Postal address
34212 Melsungen, Germany
34209 Melsungen, Germany
6. Further information
Phone: +49-5661-71-0
What B. Braun Aminoplasmal 10% contains
Fax: +49-5661-71-45 67
The active substances are amino acids.
This medicinal product is authorised in the Member States of
Per litre (1000 ml) this medicine contains:
the EEA under the following names:
Isoleucine
5.00 g
Leucine
8.90 g Please correct as follows:
Lysine acetate
5.74 g
Austria
Aminoplasmal B. Braun 10% Infusionslösung
(equivalent to lysine, 4.07 g)
Aminoplasmal 16, oplossing voor infusie
Lysine monohydrate
3.12 g Belgium
Czech Republic
Aminoplasmal B. Braun 10%
(equivalent to lysine, 2.78 g)
Aminoplasmal B. Braun 10% Infusionslösung
Methionine
4.40 g Germany
Estonia
Aminoplasmal B. Braun 10%
Phenylalanine
4.70 g
Spain
Aminoplasmal B. Braun 10% solución para perfusión
Threonine
4.20 g
Aminoplasmal 16 N/l infuusioneste, liuos
Tryptophan
1.60 g Finland
Greece
Aminoplasmal B. Braun 10% διάλυμα για έγχυση
Valine
6.20 g
Hungary
Aminoplasmal B. Braun 10%, oldatos infúzió
Arginine
11.50 g
Amixal 10%, soluzione per infusione
Histidine
3.00 g Italy
Lithuania
Aminoplasmal B. Braun 10% infuzinis tirpalas
Alanine
10.50 g
Aminoplasmal B. Braun 10% Infusionslösung
12.00 g Luxembourg
Glycine
Latvia
Aminoplasmal B. Braun 10% šķīdums infūzijām
Aspartic acid
5.60 g
Portugal
Aminoplasmal B. Braun 10%
Glutamic acid
7.20 g
Aminoplasmal B. Braun 10%
5.50 g Slovakia
Proline
United Kingdom
B. Braun Aminoplasmal 10% solution for infusion
Serine
2.30 g
This leaflet was last approved in August 2011.
Tyrosine
0.40 g
The other ingredients are acetylcysteine, citric acid monohydrate and
water for injections.

5. How to store B. Braun Aminoplasmal 10%

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL Storage after mixing with other components
OR HEALTHCARE PROFESSIONALS ONLY:
Special precaution for storage
Instructions for handling
Use a sterile giving set for infusion of B. Braun Aminoplasmal 10%.
If in the setting of complete parenteral nutrition it is necessary to add
other nutrients such as carbohydrates, lipids, vitamins and trace elements
to this medicinal product, admixing must be performed under strict
aseptic conditions. Mix well after admixture of any additive. Pay special
attention to compatibility.

The product must not be used if the solution is not clear or the container
or its closure are damaged.Cool storage of the solution, below 15 °C, may
lead to formation of crystals, that can, however, be easily dissolved by
gentle warming at 25 °C until dissolution is complete. Shake container
gently to ensure homogeneity.
Storage after mixing with other components
From the microbiological point of view, mixtures should be administered
immediately after preparation. If not administered immediately, storage
times and conditions of mixtures prior to use are the responsibility of the
user and would normally not be longer than 24 hours at 2 °C – 8 °C, unless
mixing has taken place under controlled and validated aseptic conditions.

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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