Aminoplasmal B. Braun 10% E

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Aminoplasmal B. Braun 10% E solution for infusion

Amino acids and electrolytes

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.
• Ask your doctor or pharmacist if you have any further questions.
• If you experience any side effects, including any 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% E and what is it used for
• 2. Important information before using Aminoplasmal B. Braun 10% E
• 3. How to use Aminoplasmal B. Braun 10% E
• 4. Possible side effects
• 5. How to store Aminoplasmal B. Braun 10% E
• 6. Contents of the pack and other information

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

Aminoplasmal B. Braun 10% E is a solution that is administered through a small tube directly into a vein (intravenous infusion). This solution contains amino acids and electrolytes that are essential for growth and recovery. This medicine will be given if normal feeding is not possible. During administration of this solution, the patient will also receive other solutions, such as glucose solutions or fat emulsions. This solution can be administered to adults, adolescents, and children over 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 any of the other ingredients of this medicine (listed in section 6);
• if the patient has congenital disorders of protein or amino acid metabolism;
• if the patient has severe (life-threatening) circulatory disorders (shock);
• if the patient has insufficient oxygen supply;
• if the patient has acidosis (accumulation of acids in the blood);
• if the patient has severe liver disease;
• if the patient has renal failure with insufficient 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 meet the special nutritional requirements of this age group. Infusions must not be administered in the following cases:

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

Warnings and precautions

Before starting treatment with Aminoplasmal B. Braun 10% E, consult your doctor or pharmacist.

• if the patient has disorders of protein and amino acid metabolism caused by other factors than those listed above (see "When not to use the medicine...");
• if the patient has liver or kidney function disorders;
• if the patient has heart function disorders;
• if the patient has excessively concentrated blood serum (high osmolality of serum).

In case of simultaneous occurrence of fluid and mineral deficiencies, they will be supplied to the patient first to balance the disorder. In case of sodium deficiency, the patient will receive a sufficient amount. Before and during administration of this solution, the doctor will monitor fluid, electrolyte, blood sugar, serum protein, acid-base balance, and liver and kidney function. Usually, Aminoplasmal B. Braun 10% E is 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

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

Driving and using machines

Aminoplasmal B. Braun 10% E is usually administered to patients who are immobilized, in a controlled environment (emergency department, hospital, or day care center), 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 recommendations. In case of doubts, consult your doctor or pharmacist.

Dosage Adults and adolescents from 14 to 17 years old

The 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 from 2 to 13 years oldIn the case of children, the doctor will carefully determine the dose suitable for the child's age, nutritional status, and disease. The dose administered to children will be approximately:

• 2-4 years: 15 ml per kg of body weight per day
• 5-13 years: 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 treatmentAminoplasmal B. Braun 10% E can be administered for as long as parenteral nutrition is necessary.

Method of administration

Aminoplasmal B. Braun 10% E is administered to the patient through 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 case of overdose or too rapid infusion, some amino acids will be excreted in the urine, and overdose may manifest as nausea, vomiting, or shivering. In such a case, the infusion should be temporarily discontinued and resumed later at a slower rate. In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may be serious. If you experience any side effects, including any not listed in this 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 affect up to 1 in 100 people)

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

Reporting side effects

If you experience any side effects, including any not listed in this 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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. By reporting side effects, you can help 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 month. Bottles should be stored in the outer packaging to protect from light. Do not freeze. After completion of the infusion, do not store any remaining solution for later use. Do not store above 25°C. Storage at temperatures below 15°C may lead to the formation of crystals, which can be easily dissolved by gently warming the solution to 25°C. Gently shake the container to ensure the homogeneity of the solution.

6. Contents of the pack and other information

What Aminoplasmal B. Braun 10% E contains

The active substances of the medicine are amino acids and electrolytes. This medicine 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 The medicine also contains acetylcysteine, citric acid monohydrate (for pH adjustment), and water for injections.

Electrolyte concentration

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 osmolality 1021 mOsm/l Measured 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 colorless or slightly yellowish solution. The product is supplied in glass bottles with a capacity of 250 ml, 500 ml, and 1000 ml, closed with a rubber stopper. Bottles of 250 ml and 500 ml are supplied in packaging containing 10 pieces. Bottles of 1000 ml are supplied in packaging containing 6 pieces. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Postal address34209 Melsungen, Germany Phone: +49-5661-71-0 Fax: +49-5661-71-45 67

This medicinal product has been authorized 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 Date of last revision of the leaflet:17.02.2021
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Information intended for healthcare professionals only:

Instructions for preparation of the medicinal product for use

For infusion of Aminoplasmal B. Braun 10% E, use sterile infusion equipment. If, as part of comprehensive parenteral nutrition, it is necessary to add other nutrients, such as carbohydrates, fats, vitamins, and trace elements, to this medicine, the process of adding these substances should be carried out under strict asepsis. After adding any additives, the entire contents should be thoroughly mixed. Particular attention should be paid to the compatibility of the mixed solutions.

Special precautions for storage

Use only if the solution is clear, and the container and packaging are not damaged. Storage at temperatures below 15°C may lead to the formation of crystals, which dissolve after gentle warming of the solution to 25°C. Gently shake the container to ensure the homogeneity of the solution.

Shelf life after addition of 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 microbial contamination. If the product is not used immediately, the user is responsible for the subsequent storage period and conditions.