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AMINOPLASMAL 10% SOLUTION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / LYSINE MONOHYDRATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / THREONINE / TRYPTOPHAN / TYROSINE / VALINE

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451/12260941/1014

Package leaflet: Information for the user

Aminoplasmal 10% solution for infusion
Amino acids
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Other medicines and Aminoplasmal 10% solution for infusion

1. What Aminoplasmal 10% solution for infusion is and what it is used for
2. What you need to know before you use Aminoplasmal 10% solution for
infusion
3. How to use Aminoplasmal 10% solution for infusion
4. Possible side effects
5. How to store Aminoplasmal 10% solution for infusion
6. Contents of the pack and other information

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

1. What Aminoplasmal 10% solution for infusion is and
what it is used for

Aminoplasmal 10% solution for infusion 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.

Aminoplasmal 10% solution for infusion is a solution which is given to you
through a small tube with a cannula placed in a vein (intravenous infusion).
The solution 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. This solution can be given to adults, adolescents and
children over 2 years.

2. What you need to know before you use
Aminoplasmal 10% solution for infusion
Do not use Aminoplasmal 10% solution for infusion
• if you are allergic to any of the active substances or any of the other
ingredients of this medicine (listed in section 6)
• 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 because the composition of the solution does not properly
meet the special nutrition requirements of this age group..
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).

Warnings and precautions

Talk to your doctor or pharmacist before using Aminoplasmal 10%
solution for infusion
• if you suffer from an impairment of your metabolism of proteins and
amino acids caused by any condition other than mentioned above (see
section “Do not use …”).
• 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).
If you are lacking water and salts at the same time, you will first receive
sufficient amounts of these in order to correct that disorder. If you are
lacking potassium or sodium, you will receive sufficient amounts of these.
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.
Usually you will receive Aminoplasmal 10% solution for infusion 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.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.

Driving and using machines

Dokument = 210 x 297 mm (DIN A4)
2 Seiten
Lätus 1009

3. How to use Aminoplasmal 10% solution for infusion
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Dosage
Adults and adolescents from 14 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 13 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:
2 – 4 years: 15 ml per kg of your body weight per day
5 – 13 years: 10 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.
Duration of use
Aminoplasmal 10% solution for infusion 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 Aminoplasmal 10% solution for infusion
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 medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Such side effects are not specifically related to the solution Aminoplasmal
10% solution for infusion but may occur with any kind of intravenous
feeding, especially at the beginning.

The following side effects may be serious. If any of the
following side effects occur, tell your doctor immediately, he
will stop giving you this medicine:
Not known (frequency cannot be estimated from the available data)
• Allergic reactions

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Other side effects
Uncommon (may affect up to 1 in 100 people)
• Vomiting, feeling sick
• Headache
• Shivering
• Fever

Electrolyte concentrations
Acetate
Citrate
Amino acid content
Nitrogen content

28 mmol/l
2.0 mmol/l
100 g/l
15.8 g/l

Energy
1675 kJ/l  400 kcal/l
Osmolarity 
864 mOsm/l
20 mmol/l
If you get any side effects, talk to your doctor, pharmacist or nurse. Titration acidity (to pH 7.4), approximately
5.7 – 6.3
This includes any possible side effects not listed in this leaflet. You pH
can also report side effects directly via the Yellow Card Scheme at: What Aminoplasmal 10% solution for infusion looks like and
www.mhra.gov.uk/yellowcard
contents of the pack
By reporting side effects you can help provide more information on the Aminoplasmal 10% solution for infusion is a clear, colourless up to faintly
safety of this medicine.
straw-coloured solution.
The product comes in colourless glass bottles of 250 ml, 500 ml and 1000
5. How to store Aminoplasmal 10% solution for infusion ml, which are each closed by rubber stoppers.
The 250 ml and 500 ml bottles are available in packs of 10. The 1000 ml
Keep this medicine out of the sight and reach of children.
bottles are available in packs of 6.
Do not use this medicine after the expiry date which is stated on the bottle Not all pack sizes may be marketed.
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. Marketing Authorisation Holder and Manufacturer
After infusion, any remaining solution should never be stored for later use. B. Braun Melsungen AG
Carl-Braun-Straße 1, 34212 Melsungen, Germany
6. Contents of the pack and other information
Postal address
34209 Melsungen, Germany
What Aminoplasmal 10% solution for infusion contains
Phone: +49-5661-71-0
The active substances are amino acids.
Fax: +49-5661-71-45 67
This medicine contains:

per 1 ml per 250 ml per 500 ml per 1000 ml This medicinal product is authorised in the Member States of
Isoleucine
5.00 mg
1.25 g
2.50 g
5.00 g the EEA under the following names:
Aminoplasmal B. Braun 10 % Infusionslösung
Leucine
8.90 mg
2.23 g
4.45 g
8.90 g Austria
Aminoplasmal 16, oplossing voor infusie
Lysine acetate
5.74 mg
1.44 g
2.87 g
5.74 g Belgium
(equivalent to lysine) (4.07 mg)
(1.02 g)
(2.04 g)
(4.07 g) Czech Republic Aminoplasmal B. Braun 10 %
Aminoplasmal
Lysine monohydrate
3.12 mg
0.78 g
1.56 g
3.12 g Denmark
Aminoplasmal B. Braun 10 % Infusionslösung
(equivalent to lysine) (2.78 mg)
(0.70 g)
(1.39 g)
(2.78 g) Germany
Aminoplasmal B. Braun 10 %
Methionine
4.40 mg
1.10 g
2.20 g
4.40 g Estonia
Phenylalanine
4.70 mg
1.18 g
2.35 g
4.70 g Spain
Aminoplasmal B. Braun 10 % solución para perfusión
Threonine
4.20 mg
1.05 g
2.10 g
4.20 g Finland
Aminoplasmal 16 N/l infuusioneste, liuos
Tryptophan
1.60 mg
0.40 g
0.80 g
1.60 g Hungary
Aminoplasmal B. Braun 10 %, oldatos infúzió
Valine
6.20 mg
1.55 g
3.10 g
6.20 g Italy
Amixal 10 %, soluzione per infusione
Arginine
11.50 mg
2.88 g
5.75 g
11.50 g Lithuania
Aminoplasmal B. Braun 10 % infuzinis tirpalas
Histidine
3.00 mg
0.75 g
1.50 g
3.00 g Latvia
Aminoplasmal B. Braun 10 % šķīdums infūzijām
Alanine
10.50 mg
2.63 g
5.25 g
10.50 g Netherlands Aminoplasmal B. Braun 10 % E-vrij, oplossing voor infusie
Glycine
12.00 mg
3.00 g
6.00 g
12.00 g Poland
Aminoplasmal B. Braun 10 %
Aspartic acid
5.60 mg
1.40 g
2.80 g
5.60 g Portugal
Aminoplasmal B. Braun 10 %
Glutamic acid
7.20 mg
1.80 g
3.60 g
7.20 g Slovakia
Aminoplasmal B. Braun 10 %
Proline
5.50 mg
1.38 g
2.75 g
5.50 g Slovenia
Amixal 100 mg/ml raztopina za infundiranje
Serine
2.30 mg
0.58 g
1.15 g
2.30 g United Kingdom Aminoplasmal 10% solution for infusion
Tyrosine
0.40 mg
0.10 g
0.20 g
0.40 g
The other ingredients are acetylcysteine, citric acid monohydrate (for pH- This leaflet was last revised in September 2014.
adjustment) and water for injections.

Reporting of side effects

The following information is intended for healthcare professionals only:

Instructions for handling
Use a sterile giving set for infusion of Aminoplasmal 10% solution for infusion.
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.
Special precaution for storage
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.
Shelf life 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.

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34209 Melsungen, Germany

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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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