Package leaflet: Information for the user

Aminoplasmal B. Braun 10% E infusion solution
Amino acids and electrolytes
Please read all of this leaflet carefully before being given the medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you have any further questions.
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Aminoplasmal B. Braun 10% E is and what it is used for
Important information before being given Aminoplasmal B. Braun 10% E
How to use Aminoplasmal B. Braun 10% E
Possible side effects
How to store Aminoplasmal B. Braun 10% E
Contents of the pack and other information

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

Aminoplasmal B. Braun 10% E is a solution given through a small tube directly into a vein (intravenous infusion).
This solution contains amino acids and electrolytes, which are essential for growth and recovery.
This medicine will be given when normal feeding is not possible. While receiving this solution, you will also be given other solutions, such as glucose solutions or fat emulsions.
This solution can be given to adults, adolescents and children above 2 years of age.

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

When not to use Aminoplasmal B. Braun 10% E

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has inherited disorders of protein or amino acid metabolism;
if the patient has severe (i.e. life-threatening) circulatory disorders (shock);
if the patient has insufficient oxygen supply;
if the patient has accumulation of acids in the blood (acidosis);
if the patient has severe liver disease;
if the patient has kidney failure, accompanied by inadequate artificial blood purification (dialysis);
if the patient has too high a concentration of any of the electrolytes contained in the medicine in the blood.

This solution must not be administered to newborns and children under 2 years of age, as its composition does not adequately meet the specific nutritional requirements for this age group.
No infusions should be administered in the following cases:

untreated heart failure with significant circulatory disorders;
fluid accumulation in the lungs (pulmonary edema);
excess body water, limb swelling (overhydration).

Warnings and precautions
Before starting treatment with Aminoplasmal B. Braun 10% E, consult a doctor or pharmacist.

if the patient has protein and amino acid metabolism disorders caused by reasons other than those listed above (see section "When not to use Aminoplasmal B. Braun 10% E");
if the patient has impaired liver or kidney function;
if the patient has impaired heart function;
if the patient has abnormally concentrated blood serum (high serum osmolality).

If fluid and mineral deficiencies occur simultaneously, they will be corrected first by providing the necessary supplements. In case of sodium deficiency, an adequate amount will be provided.
Before and during administration of this solution, the doctor will monitor fluid and electrolyte levels, blood glucose, serum protein levels, acid-base balance, and liver and kidney function.
Aminoplasmal B. Braun 10% E is usually administered to the patient as part of parenteral nutrition, which also includes energy-providing compounds (carbohydrate solutions, fat emulsions), vitamins, electrolytes, and trace elements.
The infusion site will be checked daily for signs of inflammation or infection.

Aminoplasmal B. Braun 10% E and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning to become pregnant, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Aminoplasmal B. Braun 10% E is usually administered to immobilized patients in a controlled setting (emergency department, hospital, or day-care unit), which excludes the possibility of driving or operating machinery.

3. How to use Aminoplasmal B. Braun 10% E

This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt, consult your doctor or pharmacist.

Dosage
Adults and adolescents aged 14 to 17 years
Your doctor will determine the required daily dose of the medicine.
The usual daily dose is from 10 ml to 20 ml per kg of body weight per day. The solution should be administered at a rate not exceeding 1 ml per kg of body weight per hour.

Children aged 2 to 13 years
In children, the doctor will carefully determine the dose according to the child's age, nutritional status, and underlying disease.
The dose administered to children will be approximately:

2nd – 4th year of life: 15 ml per kg of body weight per day
5th – 13th year of life: 10 ml per kg of body weight per day
The solution should be administered at a rate not exceeding 1 ml per kg of body weight per hour.

Duration of treatment
Aminoplasmal B. Braun 10% E may be administered for as long as parenteral nutrition is required.

Method of administration
Aminoplasmal B. Braun 10% E is administered to the patient by infusion into a large central vein.

Use of a higher than recommended dose of Aminoplasmal B. Braun 10% E
Since the daily dose is determined by the doctor, overdose is unlikely.
However, in the event of an overdose or infusion administered too rapidly, some amino acids will be excreted in the urine, and overdose symptoms may include nausea, vomiting, or chills. In such a case, the infusion should be temporarily stopped and resumed later at a slower rate.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may be serious. If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, who will discontinue administration of this medicine:
Unknown (frequency cannot be estimated from the available data)

allergic reactions

Other adverse reactions
Not common (may affect up to 1 in 100 patients)

vomiting, nausea
headache
chills
fever

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Aminoplasmal B. Braun 10% E

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Store bottles in the outer packaging to protect from light. Do not freeze.
After completion of infusion, do not store any unused portion of the solution for later use.
Do not store above 25°C.
Storing the solution below 15°C may lead to crystal formation, which can however be easily dissolved by gently warming the solution to 25°C until complete dissolution. Gently shake the container to ensure solution homogeneity.

6. Contents of the pack and other information

What Aminoplasmal B. Braun 10% E contains
The active substances in this medicinal product are amino acids and electrolytes.
This medicinal product contains:
per 1 ml per 250 ml per 500 ml per 1000 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 hydrochloride 8.56 mg 2.14 g 4.28 g 8.56 g
(equivalent to lysine) (6.85 mg) (1.71 g) (3.43 g) (6.85 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
Sodium acetate trihydrate 2.858 mg 0.715 g 1.429 g 2.858 g
Sodium hydroxide 0.360 mg 0.090 g 0.180 g 0.360 g
Potassium acetate 2.453 mg 0.613 g 1.227 g 2.453 g
Magnesium chloride hexahydrate 0.508 mg 0.127 g 0.254 g 0.508 g
Disodium phosphate dodecahydrate 3.581 mg 0.895 g 1.791 g 3.581 g

Additionally, the medicinal product contains acetylcysteine, citric acid monohydrate (for pH adjustment), and water for injections.

Electrolyte concentrations
Sodium 50 mmol/l
Potassium 25 mmol/l
Magnesium 2.5 mmol/l
Acetate 46 mmol/l
Chloride 52 mmol/l
Phosphate 10 mmol/l
Citrate 2.0 mmol/l
Total amino acid content 100 g/l
Total nitrogen content 15.8 g/l
Energy 1675 kJ/l ≙ 400 kcal/l
Theoretical osmolarity 1021 mOsm/l
Titratable acidity (to pH 7.4), approximately 26 mmol/l
pH 5.7 – 6.3

What Aminoplasmal B. Braun 10% E looks like and contents of the pack
Aminoplasmal B. Braun 10% E is a colourless or slightly yellowish solution.
The product is supplied in 250 ml, 500 ml and 1000 ml colourless glass bottles closed with a rubber stopper.
Bottles of 250 ml and 500 ml are supplied in multipacks of 10 bottles. Bottles of 1000 ml are supplied in multipacks of 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address
34209 Melsungen, Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-45 67

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Bulgaria Aminoplasmal B. Braun 10 % E Solution for Infusion
Cyprus Aminoplasmal B. Braun 10 % E Solution for Infusion
Denmark Aminoplasmal Elektrolyt
Germany Aminoplasmal B. Braun 10 % E
Greece Aminoplasmal/ B. Braun E, Διάλυμα για έγχυση 10 %
Netherlands Aminoplasmal B. Braun 10 % E
Poland Aminoplasmal B. Braun 10 % E
Portugal Aminoplasmal B. Braun 10 % E
Romania Aminoplasmal 100 g/l cu electroliti solutie perfuzabilă
Spain Aminoplasmal B. Braun 10% E solución para perfusión

<----------------------------------------------------------------------------------------------------------------------------->
Information intended exclusively for healthcare professionals:
Instructions for preparing the medicinal product for administration
Sterile infusion equipment must be used for administering Aminoplasmal B. Braun 10% E.
If, as part of comprehensive parenteral nutrition therapy, it is necessary to add other nutritional substances such as carbohydrates, fats, vitamins and trace elements to this medicinal product, such additions must be carried out under strict aseptic conditions. After adding any substances, the solution must be thoroughly mixed. Particular attention must be paid to the compatibility of the solutions being mixed.

Special precautions for storage
Use only if the solution is clear and the container and packaging are undamaged.
Storage at temperatures below 15°C may lead to crystallisation. Crystals will dissolve upon gentle warming of the solution to 25°C. Gently shake the container to ensure solution homogeneity.

Shelf-life after addition of other components
Do not store in the refrigerator.
From a microbiological standpoint, 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 subsequent storage duration and conditions.

Aminoplasmal b. braun 10% e