Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AMINOPLASMAL B. BRAUN 15% solution for infusion

Amino acids

Read the entire 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 questions, ask your doctor or pharmacist.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What AMINOPLASMAL B. BRAUN 15% is and what it is used for
What you need to know before using AMINOPLASMAL B. BRAUN 15%
How to use AMINOPLASMAL B. BRAUN 15%
Possible adverse effects
How to store AMINOPLASMAL B. BRAUN 15%
Contents of the pack and other information

1. What Aminoplasmal B. Braun 15% is and what it is used for

AMINOPLASMAL B. BRAUN 15% is a solution that will be administered to you through a small tube with a cannula placed into a vein (intravenous infusion).

The solution contains amino acids that are essential for the body to grow or recover.

This medicine will be given to you if you are unable to eat food normally and cannot be fed through a tube inserted into your stomach. This solution may be administered to adults, adolescents, and children over 2 years of age.

2. What you need to know before using Aminoplasmal B.Braun 15%

Do not use AMINOPLASMAL B. BRAUN 15%

if you are allergic to any of the active substances or to any of the other
components of this medicine (listed in section 6),
if you have a congenital disorder of protein and amino acid metabolism,
if you have a severe (i.e., potentially life-threatening) circulatory disorder (shock),
if you have insufficient oxygen supply (hypoxia),
if acidic substances accumulate in your blood (metabolic acidosis),
if you have severe liver disease (severe hepatic insufficiency),
if you have severe renal insufficiency not adequately treated with an artificial kidney or other treatments,
if you have poorly controlled heart failure with significant impairment of blood circulation (decompensated heart failure),
if you have fluid in the lungs (pulmonary edema),
if you have excess body water (hyperhydration),
if your body fluid levels, blood salt concentration, or blood acidity are not normal (hydroelectrolytic imbalance).

This solution must not be administered to newborns and children under 2 years of age, as the composition of the solution does not adequately meet the specific nutritional requirements of this age group.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using AMINOPLASMAL B. BRAUN 15%.

If you have an acquired (non-congenital) disorder of protein metabolism, your doctor will carefully decide whether this medicine can or should be administered to you.

If your heart function is impaired, your daily fluid intake will be closely monitored to prevent circulatory overload.

If the total concentration of dissolved substances in your blood is too high, your doctor will take special care to avoid worsening this condition.

If your liver or kidneys are not functioning properly, your daily dose will be carefully adjusted according to the degree of hepatic or renal impairment and your treatment regimen.

If you are deficient in both water and electrolytes, you will first receive adequate amounts of both to correct this imbalance.

If you are deficient in potassium or sodium, you will receive sufficient amounts of these electrolytes.

While receiving this medicine, blood concentrations of electrolytes and glucose, fluid balance, acid-base balance, blood proteins, and kidney and liver function will be monitored. This will involve analysis of blood samples taken from you and collected urine.

To ensure complete intravenous nutrition, you will also receive carbohydrate solutions and, possibly, fat emulsions. Additionally, essential fatty acids, vitamins, fluids, trace elements, and electrolytes will be administered as needed.

Children and adolescents

This solution is not suitable for children under 2 years of age due to its composition and must not be administered to them.

Use of AMINOPLASMAL B. BRAUN 15% with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no data available on the use of AMINOPLASMAL B. BRAUN 15% in pregnant women. If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery. AMINOPLASMAL B. BRAUN 15% should be administered to pregnant women only after careful consideration.

Breastfeeding

At therapeutic doses of AMINOPLASMAL B. BRAUN 15%, effects on newborns/infants are not expected. However, breastfeeding is not recommended if women require intravenous nutrition at that time.

Driving and use of machines

This medicine has no influence on your ability to drive or operate machinery.

AMINOPLASMAL B. BRAUN 15% contains sodium

This medicine contains 121.9 mg of sodium (a main component of table/cooking salt) in each 1,000 ml.

This corresponds to 6.095% of the maximum daily recommended sodium intake for an adult.

3. How to use Aminoplasmal B.Braun 15%

AMINOPLASMAL B. BRAUN 15% is administered by healthcare professionals.

The doctor will decide the required amount of this medicine and how long it will be given to the patient.

The solution will be administered through a small plastic tube inserted into a vein.

Dosage

The amount of solution you will receive depends on your requirements for amino acids and fluids, as well as your underlying disorder or illness.

Adults

The usual dose is 6.7 ml to 13.3 ml per kg of body weight per day.

This corresponds to between 1.0 and 2.0 g of amino acids per kg of body weight per day.

The solution will be administered at a maximum rate of 0.67 ml per kg of body weight per hour.

Use in children

AMINOPLASMAL B. BRAUN 15% should not be administered to children under 2 years of age (see section 2 "What you need to know before starting to use...").

The dose for children is individually adjusted according to age, stage of development, and clinical condition.

The following may be considered as a guide for daily doses:

For children aged 2 to 4 years: 10 ml per kg of body weight per day, corresponding to 1.5 g of amino acids per kg of body weight per day
For children aged 5 to 13 years: 6.7 ml per kg of body weight per day, corresponding to 1.0 g of amino acids per kg of body weight per day
Seriously ill children: if your child is seriously ill, the required amount of amino acids may be higher (up to 3.0 g of amino acids per kg of body weight per day).

The infusion rate must not exceed 0.67 ml per kg of body weight per hour.

Patients with renal or hepatic disease

Dosages will be adjusted according to individual needs if you have liver or kidney disease.

Duration of use

This medicine may be used for as long as you require intravenous nutrition.

Method of administration

This medicine will be administered by infusion (drip) into a large central vein.

If you use more AMINOPLASMAL B. BRAUN 15% than you should

Overdose or infusion that is too rapid may not be well tolerated and you may feel unwell, may experience vomiting, chills, or headache. In addition, your blood may contain excessive acidic substances and you may lose amino acids in the urine.

If this occurs, the infusion will be stopped and restarted some time later at a slower rate.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

The following adverse effects may be serious. If you experience any of the following adverse effects, inform your doctor immediately, who will stop administering this medicine to you:

Frequency not known (cannot be estimated from available data):

Allergic reactions

Other adverse effects are:

Uncommon (affects between 1 and 10 users in every 1,000):

Nausea, vomiting

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal B.Braun 15%

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and outer packaging following "EXP:". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Do not freeze.

Use only if the solution is clear and colourless or slightly yellowish and if the vial and its closure show no signs of damage.

The vials are for single use only. After use, any remaining solution following an infusion, as well as the container, must be discarded.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a pharmacy’s SIGRE Point (or any other medicine waste collection system). If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of AMINOPLASMAL B. BRAUN 15%

The active substances are amino acids.

The solution contains:

	per 1 ml	per 500 ml	per 1,000 ml
Isoleucine	5.850 mg	2.925 g	5.850 g
Leucine	11.400 mg	5.700 g	11.400 g
Lysine monohydrate	8.930 mg	4.465 g	8.930 g
(equivalent to lysine)	(7.950 mg)	(3.975 g)	(7.950 g)
Methionine	5.700 mg	2.850 g	5.700 g
Phenylalanine	5.700 mg	2.850 g	5.700 g
Threonine	5.400 mg	2.700 g	5.400 g
Tryptophan	2.100 mg	1.050 g	2.100 g
Valine	7.200 mg	3.600 g	7.200 g
Arginine	16.050 mg	8.025 g	16.050 g
Histidine	5.250 mg	2.625 g	5.250 g
Alanine	22.350 mg	11.175 g	22.350 g
Glycine	19.200 mg	9.600 g	19.200 g
Aspartic acid	7.950 mg	3.975 g	7.950 g
Glutamic acid	16.200 mg	8.100 g	16.200 g
Proline	7.350 mg	3.675 g	7.350 g
Serine	3.000 mg	1.500 g	3.000 g
Tyrosine	0.500 mg	0.250 g	0.500 g
Acetylcysteine	0.500 mg	0.250 g	0.500 g
(equivalent to cysteine)	(0.370 mg)	(0.185 g)	(0.370 g)

The other components are sodium hydroxide, citric acid monohydrate, and water for injections.

1.000 ml of solution contain:

Amino acid content	150	g/l
Nitrogen content	24	g/l
Sodium	5.3	mmol/l

Total energy [kJ/l (kcal/l)]	2,505	(600)
Theoretical osmolarity [mOsm/l]	1,290
Acidity (titration to pH 7.4) [mmol NaOH/l]	approx. 31
pH	5.7 - 6.3

Appearance of the medicinal product and content of the container

AMINOPLASMAL B. BRAUN 15% is an infusion solution. The solution is clear, colourless or slightly yellowish.

AMINOPLASMAL B. BRAUN 15% is supplied in glass bottles sealed with a rubber stopper:

Contents: 500 ml, 1,000 ml
Packaging sizes: 1 × 500 ml, 10 × 500 ml, 1 × 1,000 ml, 6 × 1,000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany

Postal Address:
34209 Melsungen
Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-4567

Local Representative

Braun Medical S.A.
Ctra de Terrassa 121
08191 Rubí (Barcelona)
Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

France: AMINOPLASMAL 25, solution for infusion
Germany: AMINOPLASMAL – 15 % elektrolyt- und kohlenhydratfrei
Poland: AMINOPLASMAL 15 %
Spain: AMINOPLASMAL B. BRAUN 15% solution for infusion
United Kingdom: Aminoplasmal 15% solution for infusion

Date of the most recent revision of this summary of product characteristics: 11/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

AMINOPLASMAL B. BRAUN 15% should only be mixed with other intravenous solutions if compatibility has previously been demonstrated. The manufacturer can provide, upon request, compatibility data for various additives (e.g., glucose, lipids, electrolytes, trace elements, vitamins) and the corresponding shelf life of such mixtures.

From a microbiological standpoint, mixtures should be administered immediately after preparation. If not administered immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 °C to 8 °C, unless the mixture has been prepared under controlled and validated aseptic conditions.

It is essential that any mixture be prepared using strict aseptic techniques, as this nutrient mixture supports microbial growth.

Storage of the undiluted solution at temperatures below 15 °C may lead to crystal formation, which however can be easily dissolved by gentle warming to 25 °C until complete dissolution. Gently shake the container to ensure homogeneity.

Aminoplasmal B. Braun 15% solution for infusion