AMINOPLASMAL B. BRAUN 10% SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aminoplasmal B. Braun 10% 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 reactions, consult your doctor or pharmacist, even if

they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Aminoplasmal B. Braun 10% is and what it is used for

Aminoplasmal B. Braun 10% is a solution administered through a small tube with a cannula inserted into a vein (intravenous infusion).

The solution contains amino acids, which are essential for growth and recovery of the body.

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

2. What you need to know before using Aminoplasmal B. Braun 10%

Do not use Aminoplasmal B. Braun 10%:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),

• if you have a congenital disorder of amino acid or protein metabolism,

• if you have severe circulatory impairment (with life-threatening risk) (shock),

• if you are receiving insufficient oxygen supply (hypoxia),

• if you have an accumulation of acidic substances in your blood (metabolic acidosis),

• if you have severe liver disease (severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy [grades III and IV]),

• if you have severe kidney impairment (severe renal insufficiency) not adequately treated by dialysis or similar treatments,

• if you have poorly controlled heart failure with significant circulatory impairment (decompensated heart failure),

• if you have fluid accumulation in your lungs (acute pulmonary edema),

• if the balance of salts (electrolytes) or water in your body is disturbed.

This solution must not be administered to newborns, infants, or children under two years of age, as its composition does not adequately meet the special nutritional requirements of this age group.

Warnings and precautions

Consult your doctor or pharmacist before using Aminoplasmal B. Braun 10%

• if you have any disorder of amino acid metabolism due to a condition different from those listed above (see section "Do not use Aminoplasmal B. Braun 10%"),
• if you have mild or moderate liver dysfunction, decompensated liver cirrhosis with hepatic encephalopathy (grades I and II), or kidney dysfunction,
• if you have impaired heart function,
• if your blood serum is abnormally concentrated (increased serum osmolarity).

If your body's water or mineral salt balance is disturbed, this imbalance must be corrected before administering this medicine. Examples include simultaneous deficiency of water and mineral salts (hypotonic dehydration), or deficiency of sodium (hyponatremia) or potassium (hypokalemia).

Before and during treatment with this medicine, your blood levels of electrolytes and glucose, fluid balance, acid-base balance, blood proteins, and kidney and liver function will be monitored. For this purpose, blood samples will be taken and your urine will be collected for analysis.

Usually, you will receive Aminoplasmal B. Braun 10% as part of an intravenous nutritional regimen, which will also include non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, as well as vitamins, fluids, and trace elements.

Use of Aminoplasmal B. Braun 10% 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant, you will only receive this medicine if your doctor considers it necessary for your recovery. There are no available data on the use of this medicine in pregnant women.

Breastfeeding

At therapeutic doses of Aminoplasmal B. Braun 10%, effects on the newborn/infant during breastfeeding are not expected. However, breastfeeding is not recommended if women require concomitant intravenous nutrition.

Driving and use of machines

This medicine is generally administered to immobile patients in a controlled setting (emergency treatment, acute treatment in a hospital or day-care center). Therefore, driving and operating machinery are excluded.

3. How to use Aminoplasmal B. Braun 10%

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults

Your doctor will determine the amount of solution you need each day.

The normal dose is 10–20 ml per kg of body weight per day. The solution will flow at a rate not exceeding 1 ml per kg of body weight per hour.

Children from 2 to 18 years

In children, the doctor will carefully adjust the dose according to age, stage of development, and existing illness.

The amounts to be administered are:

From 2 to less than 3 years: 10–25 ml per kg of body weight per day

From 3 to 18 years: 10–20 ml per kg of body weight per day

For seriously ill children, the amount administered may be higher (up to 30 ml per kg of body weight per day).

The solution will be administered at a rate not exceeding 1 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 disease (mild or moderate hepatic insufficiency or decompensated hepatic cirrhosis with hepatic encephalopathy [grades I and II]) or renal disease. When administered during dialysis, amino acid losses into the dialysate must be taken into account.

Duration of administration

This medicine may be used for as long as parenteral nutrition is required.

Method of administration

This medicine will be administered to you through a small tube inserted into one of your large veins (central venous infusion).

If you have received more Aminoplasmal B. Braun 10% than you should have

This is unlikely to happen, as your doctor will determine your daily doses.

However, if you receive an overdose or the solution flows too quickly, you may experience nausea, vomiting and/or headache. In addition, your blood may contain too much ammonia (hyperammonaemia), or you may lose amino acids in the urine. You may also develop fluid overload (hyperhydration), your body's mineral salt balance may be disturbed (electrolyte imbalance), and you may develop fluid in the lungs (pulmonary oedema). If this occurs, the infusion should be stopped and restarted after a certain time at a lower infusion rate.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects are not specifically related to Aminoplasmal B. Braun 10%, but may occur with any type of intravenous nutrition, especially at the beginning.

The following adverse effects can be serious. If any of the following occur, inform your doctor immediately, and he or she will stop administering this medicine:

Frequency not known (cannot be estimated from available data)

• Allergic reactions

Other adverse effects:

Uncommon (may affect up to 1 in 100 people)

• 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 via the Spanish Pharmacovigilance System for Human Medicines: 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 10%

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

Do not use this medicine after the expiry date stated on the label of the vial and the outer carton. The expiry date refers to the last day of the month indicated.

Store the vial in the outer packaging to protect it from light.

Do not store above 25 °C.

Storing the solution at cold temperatures, below 15 °C, may cause crystal formation; however, these crystals can be easily redissolved by gentle warming to 25 °C until complete dissolution. Gently shake the container to ensure homogeneity.

Do not freeze.

After infusion, any remaining solution must not be retained for future use.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Aminoplasmal B. Braun 10%

The active substances are amino acids.

This medicine contains:

The other components are acetylcysteine, citric acid monohydrate (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Aminoplasmal B. Braun 10% is a clear, colourless to slightly straw-coloured solution and practically free from visible particles.

The product is supplied in colourless glass bottles of 250 ml, 500 ml and 1,000 ml, closed with a rubber stopper.

The 250 ml and 500 ml bottles are available in packs of 10 units. The 1,000 ml bottles are supplied in packs of 6 units.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicinal product can be requested from the local representative of the Marketing Authorisation Holder

• Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

This medicinal product has been authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Germany Aminoplasmal B. Braun 10 % Infusionslösung

Czech Republic, Poland, Portugal, Slovakia Aminoplasmal B. Braun 10 %

Denmark Aminoplasmal

Spain Aminoplasmal B. Braun 10% solution for perfusion

Finland Aminoplasmal 16 N/l infuusioneste, liuos

Italy Amixal

Lithuania Aminoplasmal B. Braun 10 % infuzinis tirpalas

Latvia Aminoplasmal B. Braun 10 % škidums infuzijam

Netherlands Aminoplasmal B. Braun 10 % E-free, solution for infusion

Slovenia Maizal 100 mg/ml raztopina za infundiranje

United Kingdom (Northern Ireland) Aminoplasmal 10 % solution for infusion

Date of latest review of this summary: 08/2025

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

This information is intended for healthcare professionals only:

Dosage and administration

In cases where amino acid requirements are 1 g per kg of body weight per day or higher, special attention must be paid to limitations in fluid intake. In these situations, amino acid solutions with a higher amino acid concentration may need to be used to avoid fluid overload.

Patients with hepatic or renal insufficiency

Dosages should be individually adjusted in patients with mild or moderate hepatic insufficiency, decompensated liver cirrhosis with hepatic encephalopathy (grades I and II), or renal insufficiency. When administered during dialysis, amino acid losses into the dialysate must be taken into account.

Handling instructions

Use a sterile administration set for the infusion of Aminoplasmal B. Braun 10% solution for infusion.

If other nutrients such as carbohydrates, lipids, vitamins, electrolytes, and trace elements need to be added to this medicinal product for complete parenteral nutrition, such additions must be made under strict aseptic conditions. Mix thoroughly after adding any additive. Aminoplasmal B. Braun 10% may only be mixed with other nutrients whose compatibility has been documented. Upon request, the manufacturer will provide compatibility data for various additives and the corresponding shelf life of such mixtures.

Pay special attention to compatibility.

• Glucose: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total glucose concentration of up to 158 g/l in the mixture.
• Electrolytes: Physicochemical stability has been demonstrated for 24 hours at room temperature with total concentrations of up to 32 mmol/l of sodium, 16 mmol/l of potassium, and 2 mmol/l of magnesium in the mixture.
• Lipids: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total lipid emulsion concentration of up to 50 g/l in the mixture.
• Trace elements and vitamins: Stability has been demonstrated for 24 hours at room temperature when commercially available trace elements and multivitamins (e.g., Tracutil, Cernevit) are added up to the standard recommended dose provided by the respective micronutrient manufacturer.

Special storage precautions

The solution should only be used if the container’s closure is undamaged and if the solution is clear, colorless to slightly straw-colored, and practically free of visible particles.

Single-use containers. Discard the container and any remaining contents after use.

Shelf life after mixing with additives

Do not refrigerate.

Chemical and physical stability during use has been demonstrated for 24 hours at 25 °C. From a microbiological standpoint, unless the method of opening and mixing prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, the conditions and duration of storage during use are the responsibility of the user.

For complete information on this medicinal product, consult the Summary of Product Characteristics or the package leaflet.