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AMINOPLASMAL 15% SOLUTION FOR INFUSION

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

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Projekt19_Layout 1 17.10.14 10:35 Seite 1

Package leaflet: Information for the user

481/12615962/1014

B. Braun Melsungen AG · 34209 Melsungen, Germany

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Aminoplasmal® 15%
solution for infusion
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Aminoplasmal® 15% is and what it is used for
2. What you need to know before you use Aminoplasmal® 15%
3. How to use Aminoplasmal® 15%
4. Possible side effects
5. How to store Aminoplasmal® 15%
6. Contents of the pack and other information

While you are receiving this medicine, your blood salt levels, blood sugar
levels, the water balance, the acid-base balance, your blood proteins and
kidney and liver function will be monitored. For this purpose blood samples
will be taken and your urine will be collected and both will be analysed.
To make your intravenous feeding complete, you will also receive carbohydrate solutions and possibly also fat emulsions. Further you will be given
essential fatty acids, vitamins, fluids, trace elements and electrolytes as
necessary.

1. What Aminoplasmal® 15% is and what it is used for Other medicines and Aminoplasmal® 15%
Aminoplasmal® 15% is a solution for parenteral nutrition (intravenous
feeding). You will be given this medicine through a small tube placed in a
vein (intravenous drip or infusion).
It will supply you with amino acids when you are unable or not allowed to
eat normally and you cannot be fed through a tube placed into your stomach either.

2. What you need to know before you use Aminoplasmal® 15%
Do not use Aminoplasmal® 15%
• if you are allergic to any of the active substances or to any of the other
ingredients of this medicine (listed in section 6).
• if you have inborn disorders of your amino acid metabolism
• if you have severe life-threatening impairment of your circulation (state
of shock)
• if you have inadequate supply of oxygen to cells (hypoxia)
• if you have an abnormally high level of acids in the blood (metabolic acidosis)
• if you have severe liver disease (severe hepatic insufficiency)
• if you have severe kidney failure (severe renal insufficiency) not treated
with dialysis or haemofiltration
• if you have a severe heart weakness with impaired circulation (decompensated cardiac insufficiency)
• if you have water on the lungs (lung oedema)
• if you have excess body fluids (hyperhydration)
This solution is not suitable for children under 2 years because of its composition, so they should not receive it.

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.
Pregnancy
There are no data from the use of Aminoplasmal® 15% in pregnant women.
If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. Aminoplasmal® 15% should
only be given to pregnant women after careful consideration.

Breast-feeding
At therapeutic doses of Aminoplasmal® 15% no effects on the breastfed
newborns/infants are anticipated. Nevertheless, breast-feeding is not recommended if women need intravenous feeding in that time.

Driving and using machines
This medicine has no influence on your ability to drive and use machines.
Aminoplasmal® 15% contains sodium.
This medicine contains 5.3 mmol sodium per 1000 ml.
To be taken into consideration by patients on a controlled sodium diet.

3. How to use Aminoplasmal® 15%
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

The amount of solution you are going to receive depends on your requireTalk to your doctor, pharmacist or nurse before using Aminoplasmal® 15%. ment of amino acids and fluid and also on your actual condition or disease.
If you have a not inborn disorder of protein metabolism, your doctor will Adults
decide very carefully whether or not this medicine can or even must be The usual dose is 6.7 ml to 13.3 ml max. per kg body weight per day.
given to you.
This corresponds to 1.0 – 2.0 g of amino acids per kg body weight per day.
If your heart function is impaired, your daily fluid intake will be controlled This solution will be administered to you at a maximum rate of 0.67 ml per
very carefully in order to avoid any overload of your circulation.
kg body weight per hour.
If the overall concentration of dissolved substances in your blood is too
high, your doctor will exercise particular caution in order to avoid worsen- Use in children
Aminoplasmal® 15% must not be given to children under 2 years (see secing of this condition.
If your liver or your kidneys do not work well, your daily dose will be adjust- tion 2 ‘What you need to know before you use...’).
ed very carefully according to the impairment of your liver or kidney func- The dosage for children is adjusted individually according to age, status of
development and clinical condition of the child.
tion and your type of treatment.
If you are lacking water and salts at the same time, you will first receive The following may be taken as a guidance for the daily doses:
• For children 2 to 17 years old: 6.7 – 13.3 ml per kg body weight per day,
sufficient amounts of these in order to correct that disorder.
corresponding to 1.0 g - 2.0 g of amino acids per kg body weight per day
If you are lacking potassium or sodium, you will receive sufficient amounts
of these.

B|BRAUN
Schwarz
210x297 mm
481/12615962/1014
Lätus: 1856
Großbritannien
Font size 9,5

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Warnings and precautions

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481/12615962/1014

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• Critically ill children: If your child is critically ill, the amount of amino
acids required may be higher (up to 3.0 g amino acids/kg body weight per
day).
The rate of infusion should not be higher than 0.67 ml per kg body weight
per hour.
Patients with kidney or liver disease
The doses will be adjusted according to your individual requirements if you
have liver or kidney disease.
Duration of use
This medicine may be used as long as you need intravenous feeding.
Method of administration
This medicine will be administered to you by infusion (drip) in a large central vein.

If you use more Aminoplasmal® 15% than you should
Overdose or too rapid infusion may not be tolerated well and you may feel
sick, may have to vomit and may experience shivering or headache. Also,
your blood may contain too much acidic substances and you may lose
amino acids in the urine.
If this occurs, your infusion will be stopped and started again at a lower rate
some time later.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the medicine is used according to the directions given, no side effects are
to be expected.

Glycine
19.20 g
Alanine
22.35 g
Proline
7.35 g
Aspartic acid
7.95 g
Acetylcysteine
0.50 g
(equivalent to cysteine)
(0.37 g)
Glutamic acid
16.20 g
Serine
3.00 g
Tyrosine
0.50 g
The other ingredients are sodium hydroxide, citric acid monohydrate and
water for injections.
Amino acid content
150 g/l
Nitrogen content
24 g/l
Energy [kJ/l (kcal/l)]
2505 (600)
Theoretical osmolarity [mOsm/l]
1290
Titration acidity (to pH 7.4) [mmolNaOH/l]
approx. 31
pH
5.7 - 6.3

What Aminoplasmal® 15% looks like and contents of the pack
Aminoplasmal® 15% is a solution for infusion. The solution is clear, colourless or faintly straw-coloured.
Aminoplasmal® 15% is supplied in glass bottles, sealed with rubber stopper:
• Contents: 500 ml, 1000 ml
• Pack sizes: 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Reporting of side effects
Postal address:
If you get any side effects, talk to your doctor, pharmacist or nurse. This 34209 Melsungen
includes any possible side effects not listed in this leaflet. You can also Germany
report side effects directly via the Yellow Card Scheme at: Phone: +49-5661-71-0
www.mhra.gov.uk/yellowcard
Fax: +49-5661-71-4567
By reporting side effects you can help provide more information on the
This medicinal product is authorised in the Member States of the
safety of this medicine.

EEA under the following names:

France
AMINOPLASMAL 25, solution pour perfusion
Germany
AMINOPLASMAL – 15 % elektrolyt- und kohlenhydratfrei
Poland
AMINOPLASMAL 15 %
Keep this medicine out of the sight and reach of children.
AMINOPLASMAL B.BRAUN 15% solución para perfusion
Do not use this medicine after the expiry date which is stated on the label Spain
and the carton after “EXP:”. The expiry date refers to the last day of that United Kingdom Aminoplasmal® 15% solution for infusion
month.
This leaflet was last revised in September 2014
Keep the bottles in the outer carton in order to protect from light.
Do not freeze.
Only to be used if the solution is clear and colourless or faintly straw- The following information is intended for healthcare professioncoloured and the bottle and its closure are undamaged.
als only:
The bottles are for single use only. Any solution remaining after an infusion Aminoplasmal® 15% should only be mixed with other iv solutions, if comand the container must be disposed of after use.
patibility has been proven in advance. Compatibility data for different additives (e.g. glucose, lipids, electrolytes, trace elements, vitamins) and the corresponding shelf-life of such admixtures can be provided on demand by the
6. Contents of the pack and other information
manufacturer.
What Aminoplasmal® 15% contains
Chemical and physical in-use stability after mixture with other components
The active substances are amino acids.
of parenteral nutrition has been demonstrated for 7 days at 2-8°C plus
2 days at 25°C. Detailed information on tested components (e.g. glucose,
1000 ml of the solution contain:
Isoleucine
5.85 g lipids, electrolytes, trace elements, vitamins) and shelf life can be provided
Leucine
11.40 g on demand by the manufacturer.
Lysine monohydrate
8.93 g From a microbiological point of view, the product should be used immedi(equivalent to lysine)
(7.95 g) ately. If not used immediately, in-use storage times and conditions prior to
Methionine
5.70 g use are the responsibility of the user.
Phenylalanine
5.70 g It is essential that any admixture be prepared using strict aseptic techniques
Threonine
5.40 g as this nutrient mixture supports microbial growth.
Tryptophan
2.10 g Cool storage of the undiluted solution, below 15 °C, may lead to formation
Valine
7.20 g of crystals, that can, however, be easily dissolved by gentle warming at
Arginine
16.05 g 25 °C until dissolution is complete. Shake container gently to ensure homoHistidine
5.25 g geneity.

B|BRAUN B. Braun Melsungen AG
34209 Melsungen
Germany

Schwarz
210x297 mm
481/12615962/1014
Lätus: 1856
Großbritannien
Font size 9,5

0d0d1d0d1d1d1d1d1d0

5. How to store Aminoplasmal® 15%

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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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