Aminoplasmal B. Braun 10%

Leaflet attached to the packaging: information for the user

Aminoplasmal B. Braun 10%, solution for infusion

Amino acids

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aminoplasmal B. Braun 10% and what is it used for
• 2. Important information before using Aminoplasmal B. Braun 10%
• 3. How to use Aminoplasmal B. Braun 10%
• 4. Possible side effects
• 5. How to store Aminoplasmal B. Braun 10%
• 6. Contents of the packaging and other information

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

Aminoplasmal B. Braun 10% is a solution administered to the patient through a small tube with a cannula inserted into a vein (intravenous infusion).
The solution contains amino acids, which are essential for growth and the body's return to health.
The patient receives this solution when they are unable to normally take food. When taking this solution, the patient will also receive other solutions, such as glucose solutions or fat emulsions. The solution can be administered to adults, adolescents, and children over 2 years of age.

2. Important information before using Aminoplasmal B. Braun 10%

When not to use Aminoplasmal B. Braun 10%

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has congenital disorders of protein and amino acid metabolism;
• if the patient has severe circulatory disorders (e.g. life-threatening, such as shock);
• if the patient has insufficient oxygen supply;
• if acidic substances have accumulated in the patient's blood (acidosis);
• if the patient suffers from severe liver disease;
• if the patient with renal failure is not properly treated with dialysis.

This solution should not be administered to newborns and children under 2 years of age, as its composition does not meet the special nutritional requirements of this age group.
The patient should not receive any infusions in the following cases:

• insufficiently controlled heart failure with significant circulatory disorders,
• fluid accumulation in the lungs (pulmonary edema),
• excess water in the body, swelling of the limbs (excessive hydration).

The doctor will exercise special caution when using Aminoplasmal B. Braun 10%

• if the patient suffers from a disorder of protein and amino acid metabolism due to other reasons than those listed above (see section "When not to use Aminoplasmal B. Braun 10%");
• if the patient suffers from liver or kidney dysfunction;
• if the patient suffers from heart dysfunction;
• if the patient has highly concentrated blood serum (high osmolality of serum).

In the event that the patient has both water and salt deficiency, they will first receive an appropriate dose of these to correct the deficiency. If the patient has a potassium or sodium deficiency, they will receive appropriate doses of these electrolytes.
Before and during the administration of this solution to the patient, the doctor will monitor fluid concentrations, electrolytes, blood sugar levels, protein levels in serum, acid-base balance, and liver and kidney function.
Usually, Aminoplasmal B. Braun 10% is administered to the patient as part of parenteral nutrition, which also includes energy-providing compounds (carbohydrate solutions, fat emulsions), vitamins, electrolytes, and microelements.
The infusion site will be checked daily for signs of inflammation or infection.

Aminoplasmal B. Braun 10% and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Usually, Aminoplasmal B. Braun 10% is administered to immobilized patients in controlled conditions (emergency treatment, urgent care, or day care). This excludes driving and operating machines.

3. How to use Aminoplasmal B. Braun 10%

How to use Aminoplasmal B. Braun 10%%

Dosage

Adults and adolescents from 14 to 17 years old
The doctor will decide what dose of the medicine to administer to the patient per day.
Usually, doses of 10-20 ml per kg of body weight per day are used. The solution is administered at a rate not exceeding 1 ml per kg of body weight per hour.
Children from 2 to 13 years old
In the case of children, the doctor will carefully adjust the dose according to the child's age, nutritional status, and current health status.
The dose administered to children is approximately:
in the case of children from 2 to 4 years old:
15 ml per kg of body weight per day
in the case of children from 5 to 13 years old:
10 ml per kg of body weight per day
The solution is administered at a rate not exceeding 1 ml per kg of body weight per hour.

Duration of treatment

Aminoplasmal B. Braun 10% can be used for as long as the patient requires intravenous nutrition.

Method of administration

The solution is administered to the patient through a small, plastic tube inserted into one of the large veins.

Using a higher dose of Aminoplasmal B. Braun 10% than recommended

This is unlikely, as the doctor determines the daily doses. However, if the patient receives a higher dose of the solution than recommended or the solution is administered too quickly, the patient will excrete some of the amino acids with urine, may feel nausea or vomiting, or have chills. In this case, the infusion will be temporarily discontinued and resumed later at a lower rate.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects mentioned are not clearly related to Aminoplasmal B. Braun 10%, but rather to intravenous nutrition in general, especially in its initial stage.

The following side effects may be serious. If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, who will discontinue the administration of this medicine.

Unknown (frequency cannot be estimated from the available data)

• allergic reactions

Other side effects

Not very common (may occur in up to 1 in 100 patients)

• vomiting, nausea,
• headache,
• chills,
• fever.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aminoplasmal B. Braun 10%

Store in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the bottle or label.
The expiry date refers to the last day of the given month.
Bottles should be stored in the outer packaging to protect from light.
Do not store at a temperature above 25°C.
Storing the solution at a temperature below 15°C may lead to the formation of crystals, which can be easily dissolved by gently heating the solution to a temperature of 25°C until they are completely dissolved. Gently shake the container to ensure the homogeneity of the solution.
Do not freeze.
After infusion, do not store the remaining solution for later use.

6. Contents of the packaging and other information

What Aminoplasmal B. Braun 10% contains

• The active substances of the medicine are amino acids.

This medicine contains:
in 1 ml in 250 ml in 500 ml in 1,000 ml
Isoleucine
5.00 mg
1.25 g
2.50 g
5.00 g
Leucine
8.90 mg
2.23 g
4.45 g
8.90 g
Lysine acetate
5.74 mg
1.44 g
2.87 g
5.74 g
(lysine equivalent)
(4.07 mg)
(1.02 g)
(2.04 g)
(4.07 g)
Lysine monohydrate
3.12 mg
0.78 g
1.56 g
3.12 g
(lysine equivalent)
(2.78 mg)
(0.70 g)
(1.39 g)
(2.78 g)
Methionine
4.40 mg
1.10 g
2.20 g
4.40 g
Phenylalanine
4.70 mg
1.18 g
2.35 g
4.70 g
Threonine
4.20 mg
1.05 g
2.10 g
4.20 g
Tryptophan
1.60 mg
0.40 g
0.80 g
1.60 g
Valine
6.20 mg
1.55 g
3.10 g
6.20 g
Arginine
11.50 mg
2.88 g
5.75 g
11.50 g
Histidine
3.00 mg
0.75 g
1.50 g
3.00 g
Alanine
10.50 mg
2.63 g
5.25 g
10.50 g
Glycine
12.00 mg
3.00 g
6.00 g
12.00 g
Aspartic acid
5.60 mg
1.40 g
2.80 g
5.60 g
Glutamic acid
7.20 mg
1.80 g
3.60 g
7.20 g
Proline
5.50 mg
1.38 g
2.75 g
5.50 g
Serine
2.30 mg
0.58 g
1.15 g
2.30 g
Tyrosine
0.40 mg
0.10 g
0.20 g
0.40 g

• Other ingredients are: acetylcysteine, citric acid monohydrate (for pH adjustment), and water for injections.

Electrolyte concentrations

Acetate
28
mmol/l
Citrate
2.0
mmol/l
Amino acid content
100
g/l
Nitrogen content
15.8
g/l
Energy value
1,675
kJ/l (400 kcal/l)
Osmolality
864
mOsm/l
Buffering capacity (to pH 7.4), approximately 20
mmol/l
pH
5.7 - 6.3

What Aminoplasmal B. Braun 10% looks like and what the packaging contains

Aminoplasmal B. Braun 10% is a colorless or slightly straw-colored solution.
The product is supplied in colorless glass bottles with a capacity of 250 ml, 500 ml, and 1,000 ml, closed with a rubber stopper.
Bottles with a capacity of 250 ml and 500 ml are available in collective packaging of 10 bottles. Bottles with a capacity of 1,000 ml are available in collective packaging of 6 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany

Mailing address
34209 Melsungen, Germany
Phone:
+49-5661-71-0
Fax:
+49-5661-71-45 67

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

European Economic Area

Austria
Aminoplasmal B. Braun 10% Infusionslösung
Czech Republic
Aminoplasmal B. Braun 10%
Denmark
Aminoplasmal
Finland
Aminoplasmal 16 N/l
Spain
Aminoplasmal B. Braun 10% solución para perfusión
Netherlands
Aminoplasmal B. Braun 10% E-vrij, oplossing voor infusie
Lithuania
Aminoplasmal B. Braun 10% infuzinis tirpalas
Latvia
Aminoplasmal B. Braun 10% šķīdums infūzijām
Germany
Aminoplasmal B. Braun 10%
Poland
Aminoplasmal B. Braun 10%
Portugal
Aminoplasmal B. Braun 10%
Slovakia
Aminoplasmal B. Braun 10%
Slovenia
Amixal 100 mg/ml raztopina za infundiranje
United Kingdom

• B. Braun Aminoplasmal 10% solution for infusion Italy Amixal

Date of last revision of the leaflet: 17.02.2021

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Information intended exclusively for healthcare professionals:

Instructions for use

Use only a sterile infusion set for the administration of Aminoplasmal B. Braun 10% solution.
In the case of complete parenteral nutrition, it is necessary to add other nutritional components to this medicinal product, such as carbohydrates, fats, vitamins, and microelements, while adding admixtures should be carried out under strictly aseptic conditions.
Mix thoroughly after adding any admixtures. Pay particular attention to the compatibility of additives.

Special precautions for storage

Use only if the solution is clear and the container and its closure are not damaged.
Storing the solution at a temperature below 15°C may lead to the formation of crystals, which can be easily dissolved by gently heating the solution to a temperature of 25°C until they are completely dissolved. Gently shake the container to ensure the homogeneity of the solution.

Shelf life after mixing with other ingredients

Do not store in the refrigerator.
From a microbiological point of view, the product should be used immediately if the method of opening and mixing does not eliminate the risk of microbiological contamination. If the product is not used immediately, the user is responsible for the further storage period and conditions.