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AMINOPLASMAL 5% SOLUTION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / DISODIUM PHOSPHATE DODECAHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE HYDROCHLORIDE / MAGNESIUM CHLORIDE HEXAHYDRATE / METHIONINE / PHENYLALANINE / POTASSIUM ACETATE / PROLINE / SERINE / SODIUM ACETATE

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438/12260939/1014

Package leaflet: Information for the user

Aminoplasmal 5% solution for infusion
Amino acids and Electrolytes
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:

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

1. What Aminoplasmal 5% solution for infusion is and
what it is used for

Other medicines and Aminoplasmal 5% solution for infusion

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

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

Aminoplasmal 5% solution for infusion is normally given to immobile
patients in a controlled setting (emergency treatment, acute treatment
Aminoplasmal 5% solution for infusion is a solution which is given to you in a hospital or a day therapy unit). This will exclude driving and using
through a small tube with a cannula placed in a vein (intravenous infusion). machines.
The solution contains amino acids and electrolytes that are essential for
the body to grow or to recover.
3. How to use Aminoplasmal 5% solution for infusion
You will receive this solution if you cannot eat food normally. When you
receive this solution you will also receive others like glucose solutions Always use this medicine exactly as your doctor or pharmacist has told
or fat emulsions. This solution can be given to adults, adolescents and you. Check with your doctor or pharmacist if you are not sure.
­chil-dren over 2 years.
Dosage
Adults and adolescents from 14 to 17 years
2. What you need to know before you use
Your doctor will determine the amount of solution you need each day.
Aminoplasmal 5% solution for infusion
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
Do not use Aminoplasmal 5% solution for infusion
• if you are allergic to any of the active substances or any of the other weight per hour.
ingredients of this medicine (listed in section 6)
Children from 2 to 13 years
• if you suffer from a genetic abnormality of your metabolism of proteins In children the doctor will adjust the dosage carefully according to the
and amino acids
individual child’s age, nutritional status and actual disease.
• if you have a severe (i.e. life-threatening) circulation disorder (shock)
The amounts to be given to children will be approximately:
• if you have insufficient oxygen supply
2 – 4 years: 30 ml per kg of your body weight per day
• if acidic substances accumulate in your blood (acidosis)
5 – 13 years: 20 ml per kg of your body weight per day
• if you have a severe liver disease
The solution will run in at a rate of not more than 2 ml per kg of your body
• if you have kidney failure not adequately treated by artificial kidney
weight per hour.
• if you have too high blood levels of any of the electrolytes included in
Duration of use
the solution.
This solution must not be administered to new-born babies and children Aminoplasmal 5% solution for infusion may be used as long as you need
under 2 years because the composition of the solution does not properly intravenous feeding.
meet the special nutrition requirements of this age group.
Method of administration
You should not receive any infusions if you have:
The solution will be administered to you through a small plastic tube
• poorly controlled heart failure with marked impairment of your blood inserted into one of your large veins.
circulation
If you receive more Aminoplasmal 5% solution for infusion
• accumulation of fluid in your lungs (lung oedema)
than you should
• excess water in your body, swelling of limbs (hyperhydration).
It is unlikely that this will occur because your doctor will determine your
Warnings and precautions
daily doses. However, if you receive an overdose or the solution is running
Talk to your doctor or pharmacist before using Aminoplasmal 5% solution in too fast, you will lose part of the amino acids in urine, you may feel sick
for infusion
or vomit or you may shiver. If this happens, the infusion will be stopped
• if you suffer from an impairment of your metabolism of proteins and temporarily and resumed later on at a lower infusion rate.
amino acids caused by any condition other than mentioned above (see
If you have any further questions on the use of this medicine, ask your
section “Do not use …”).
doctor or pharmacist.
• 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 4. Possible side effects
osmolarity).
If you are lacking water and salts at the same time, you will first receive Like all medicines, this medicine can cause side effects, although not
sufficient amounts of these in order to correct that disorder. If you are everybody gets them.
Such side effects are not specifically related to the solution Aminoplasmal
lacking sodium, you will receive sufficient amounts of it.
Before and while you are receiving this solution, the doctor will check 5% solution for infusion but may occur with any kind of intravenous
levels of fluids, electrolytes, blood sugar, serum proteins, acid base feeding, especially at the beginning.
balance and your liver and kidney function.
The following side effects may be serious. If any of the
Usually you will receive Aminoplasmal 5% solution for infusion as part of following side effects occur, tell your doctor immediately, he
intravenous feeding which also includes energy supplements (carbohydrate will stop giving you this medicine:
solutions, fat emulsions), vitamins, electrolytes and trace elements.
Not known (frequency cannot be estimated from the available data)
The site of infusion will be checked daily for signs of inflammation or • Allergic reactions
infection.

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schwarz
Dokument = 210 x 297 mm (DIN A4)
2 Seiten
Lätus 1004

GB___438
438/12260939/1014
GIF
(PIL)
Standort Melsungen
Font size: 9 pt.
G 131054

438/12260939/1014

Other side effects

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

The other ingredients are acetylcysteine, citric acid monohydrate (for pHadjustment) and water for injections.

Electrolyte concentrations
Sodium
50 mmol/l
Potassium
25 mmol/l
Magnesium
2.5 mmol/l
Acetate
35 mmol/l
Reporting of side effects
Chloride
45 mmol/l
If you get any side effects, talk to your doctor, pharmacist or nurse. Phosphate
10 mmol/l
This includes any possible side effects not listed in this leaflet. You Citrate
2.0 mmol/l
can also report side effects directly via the Yellow Card Scheme at:
Amino
acid
content
50 g/l
www.mhra.gov.uk/yellowcard
Nitrogen content
7.9 g/l
By reporting side effects you can help provide more information on the
Energy
835 kJ/l  200 kcal/l
safety of this medicine.
Osmolarity
592 mOsm/l
17 mmol/l
5. How to store Aminoplasmal 5% solution for infusion Titration acidity (to pH 7.4), approximately
pH
5.7 – 6.3
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and What Aminoplasmal 5% solution for infusion looks like and
carton labels. The expiry date refers to the last day of that month.
contents of the pack
Keep bottles in the outer carton in order to protect from light. Do not freeze. Aminoplasmal 5% solution for infusion is a clear, colourless up to faintly
After infusion, any remaining solution should never be stored for later use. straw-coloured solution.
The product comes in colourless glass bottles of 250 ml, 500 ml and 1000
6. Contents of the pack and other information
ml, which are each closed by rubber stoppers.
The 250 ml and 500 ml bottles are available in packs of 10. The 1000 ml
What Aminoplasmal 5% solution for infusion contains
bottles are available in packs of 6.
The active substances are amino acids and electrolytes.
Not all pack sizes may be marketed.
This medicine contains:

per 1 ml per 250 ml per 500 ml per 1000 ml
Isoleucine
2.50 mg
0.63 g
1.25 g 
2.50 g Marketing Authorisation Holder and Manufacturer
Leucine
4.45 mg
1.11 g
2.23 g 
4.45 g B. Braun Melsungen AG
Lysine hydrochloride
4.28 mg
1.07 g
2.14 g 
4.28 g Carl-Braun-Straße 1
(equivalent to lysine) (3.43 mg)
(0.86 g)
(1.72 g) 
(3.43 g) 34212 Melsungen
Methionine
2.20 mg
0.55 g
1.10 g 
2.20 g Germany
Phenylalanine
2.35 mg
0.59 g
1.18 g 
2.35 g Postal address
Threonine
2.10 mg
0.53 g
1.05 g 
2.10 g 34209 Melsungen, Germany
Tryptophan
0.80 mg
0.20 g
0.40 g 
0.80 g
Valine
3.10 mg
0.78 g
1.55 g 
3.10 g Phone: +49-5661-71-0
Arginine
5.75 mg
1.44 g
2.88 g 
5.75 g Fax: +49-5661-71-45 67
Histidine
1.50 mg
0.38 g
0.75 g 
1.50 g
Alanine
5.25 mg
1.31 g
2.63 g 
5.25 g This medicinal product is authorised in the Member States of
Glycine
6.00 mg
1.50 g
3.00 g 
6.00 g the EEA under the following names:
Aminoplasmal B. Braun 5% E
Aspartic acid
2.80 mg
0.70 g
1.40 g 
2.80 g Bulgaria
Glutamic acid
3.60 mg
0.90 g
1.80 g
3.60 g Czech Republic Aminoplasmal B. Braun 5% E
Aminoplasmal B. Braun 5% E Infusionslösung
Proline
2.75 mg
0.69 g
1.38 g
2.75 g Germany
Aminoplasmal B. Braun 5% E
Serine
1.15 mg
0.29 g
0.58 g
1.15 g Estonia
Aminoplasmal B. Braun 5% E διάλυμα για έγχυση
Tyrosine
0.40 mg
0.10 g
0.20 g
0.40 g Greece
Hungary
Aminoplasmal B. Braun 5% E, oldatos infúzió
Sodium acetate
Amielect 5%, soluzione per infusione
trihydrate
1.361 mg
0.340 g
0.681 g
1.361 g Italy
Aminoplasmal B. Braun 5% E, šķīdums infūzijām
Sodium chloride
0.964 mg
0.241 g
0.482 g
0.964 g Latvia
Aminoplasmal B. Braun 5% E, oplossing voor infusie
Sodium hydroxide
0.140 mg
0.035 g
0.070 g
0.140 g Netherlands
Aminoplasmal B. Braun 5% E
Potassium acetate
2.453 mg
0.613 g
1.227 g
2.453 g Portugal
Slovakia
Aminoplasmal B. Braun 5% E
Magnesium chloride
hexahydrate
0.508 mg
0.127 g
0.254 g
0.508 g United Kingdom Aminoplasmal 5% solution for infusion
Disodium phosphate
dodecahydrate
3.581 mg
0.895 g
1.791 g
3.581 g This leaflet was last revised in September 2014.

The following information is intended for healthcare professionals only:
Dosage

In the case of amino acid requirements of 1 g per kg body weight per day or more, particular attention should be paid to the limitations of fluid input.
To avoid fluid overload, amino acid solutions with higher amino acid content may have to be used in such situations.

Instructions for handling

Use a sterile giving set for infusion of Aminoplasmal 5% 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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B. Braun Melsungen AG
34209 Melsungen, Germany

17.10.14 08:54

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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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