Aminoplasmal B. Braun 5% solution for infusion: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aminoplasmal B. Braun 5% 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, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

What Aminoplasmal B. Braun 5% is and what it is used for
What you need to know before using Aminoplasmal B. Braun 5%
How to use Aminoplasmal B. Braun 5%
Possible side effects
How to store Aminoplasmal B. Braun 5%
Contents of the pack and other information

1. What Aminoplasmal B. Braun 5% is and what it is used for

Aminoplasmal B. Braun 5% 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 given to adults, adolescents, and children aged 2 years and older.

2. What you need to know before using Aminoplasmal B. Braun 5%

Do not use Aminoplasmal B. Braun 5%

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 and protein metabolism,
if you have a severe circulatory disorder (with life-threatening risk) (shock),
if you are receiving insufficient oxygen supply (hypoxia),
if you have an accumulation of acid substances in your blood (metabolic acidosis),
if you have a severe liver disease (severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy [grades III and IV]),
if you have a severe kidney disorder (severe renal insufficiency) not adequately treated by dialysis or similar treatments,
if you have inadequately controlled heart failure with significant impairment of blood circulation (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 young 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 5%

if you have any disorder of amino acid metabolism caused by a condition other than those listed above (see section "Do not use Aminoplasmal B. Braun 5%"),
if you have mild or moderate liver function impairment, decompensated liver cirrhosis with hepatic encephalopathy (grades I and II), or impaired kidney function,
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 both 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 collected for analysis.

Usually, you will receive Aminoplasmal B. Braun 5% 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.

If this medicine is administered into a small vein (peripheral vein), the infusion site will be checked daily for signs of irritation or inflammation of the vein (thrombophlebitis).

Use of Aminoplasmal B. Braun 5% 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 5%, effects on the newborn/infant who is breastfed are not expected. However, breastfeeding is not recommended if women simultaneously require 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). This excludes driving and operating machinery.

3. How to use Aminoplasmal B. Braun 5%

Follow exactly the instructions for administration of this medicine 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 usual dose is 20 – 40 ml per kg of body weight per day. The solution will flow at a rate not exceeding 2 ml per kg of body weight per hour.

Children aged 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: 20 – 50 ml per kg of body weight per day
From 3 to 18 years: 20 – 40 ml per kg of body weight per day

For seriously ill children, the amount administered may be higher (up to 60 ml per kg of body weight per day).

The solution will be administered at a rate not exceeding 2 ml per kg of body weight per hour.

Patients with renal or hepatic disease

Doses 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 kidney disease. When administered during dialysis, amino acid losses into the dialysate must be taken into account.

Duration of administration

This medicine may be used as long as intravenous feeding is required.

Method of administration

This medicine will be administered to you through a small tube inserted into a vein (intravenous infusion).

This medicine may be administered through one of your smaller (peripheral) or larger (central) veins.

If you have received more Aminoplasmal B. Braun 5% than you should

This is unlikely to occur, as your doctor will determine your daily doses. However, if you receive an overdose or if the solution flows too quickly, you may experience nausea and/or 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), an imbalance in your body's mineral salts (electrolyte imbalance), or 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 may cause adverse effects, although not everyone will experience them.

These adverse effects are not specifically related to Aminoplasmal B. Braun 5%, but may occur with any type of intravenous feeding, 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

Frequency not known (cannot be estimated from available data)

? Reactions at the infusion site, including local pain, irritation, or inflammation of the vein (thrombophlebitis)

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 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 5%

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the labels of the vial and 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 in cold conditions, below 15 °C, may cause crystal formation; however, these crystals can be easily dissolved by gentle warming to 25 °C until completely dissolved. Gently shake the container to ensure homogeneity.

Do not freeze.

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

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

6. Contents of the container and additional information

The active substances are amino acids.

This medicine contains:

*Amino acids:*	in 1 ml	in 250 ml	in 500 ml	in 1,000 ml
Isoleucine	2.50 mg	0.63 g	1.25 g	2.50 g
Leucine	4.45 mg	1.11 g	2.23 g	4.45 g
Lysine monohydrate	1.56 mg	0.39 g	0.78 g	1.56 g
(equivalent to lysine)	(1.39 mg)	(0.35 g)	(0.70 g)	(1.39 g)
Lysine acetate (equivalent to lysine) Methionine	2.87 mg (2.03 mg) 2.20 mg	0.72 g (0.51 g) 0.55 g	1.44 g (1.02 g) 1.10 g	2.87 g (2.03 g) 2.20 g
Phenylalanine	2.35 mg	0.59 g	1.18 g	2.35 g
Threonine	2.10 mg	0.53 g	1.05 g	2.10 g
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
Arginine	5.75 mg	1.44 g	2.88 g	5.75 g
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
Glycine	6.00 mg	1.50 g	3.00 g	6.00 g
Aspartic acid	2.80 mg	0.70 g	1.40 g	2.80 g
Glutamic acid	3.60 mg	0.90 g	1.80 g	3.60 g
Proline	2.75 mg	0.69 g	1.38 g	2.75 g
Serine	1.15 mg	0.29 g	0.58 g	1.15 g
Tyrosine	0.40 mg	0.10 g	0.20 g	0.40 g

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

Electrolyte concentrations:
Acetates			14 mmol/l
Citrates			1.00-2.0 mmol/l

Total amino acids	50 g/l
Total nitrogen	7.9 g/l
Caloric value [kJ/l (kcal/l)]	835 (200)
Theoretical osmolarity [mOsm/l]	435 mOsm/l
Acidity (titration to pH 7.4) [mmol NaOH/l]	approx. 9 mmol/l
pH:		5.7 – 6.3

Appearance of the product and contents of the container

Aminoplasmal B. Braun 5% 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. The 1,000 ml bottles are available in packs of 6.

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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization 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 under the following names:

France: Aminoplasmal 8, solution for infusion
Germany: Aminoplasmal B. Braun 5 Infusionslösung
Spain: Aminoplasmal B. Braun 5% solution for infusion

Date of the most recent review of this leaflet: 08/2025

Detailed 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:

Dosage

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

Patients with hepatic/renal insufficiency

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

Instructions for handling

Use a sterile administration set for the infusion of Aminoplasmal B. Braun 5% solution for infusion.

If, as part of complete parenteral nutrition, it is necessary to add other nutrients to this medicinal product, such as carbohydrates, lipids, vitamins, electrolytes and trace elements, such additions must be made under strict aseptic conditions. Mix thoroughly after adding any additive. Aminoplasmal B. Braun 5% 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 amount of up to 158 g/l glucose in the mixture.
Electrolytes: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total amount of up to 32 mmol/l sodium, 16 mmol/l potassium and 2 mmol/l magnesium in the mixture.
Lipids: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total amount of up to 50 g/l lipid emulsion in the mixture.
Trace elements and vitamins: Stability has been demonstrated for 24 hours at room temperature with commercially available trace elements and multivitamins (e.g., Tracutil, Cernevit) up to the standard recommended dose specified by the respective micronutrient manufacturer.

Special precautions for storage

The solution should only be used if the container closure is undamaged and the solution is clear, colourless to slightly straw-coloured, and practically free from 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, refer to the Summary of Product Characteristics.