Aminoplasmal b. braun 10%

Package leaflet: Information for the user

Aminoplasmal B. Braun 10%, solution for infusion
Amino acids
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Aminoplasmal B. Braun 10% is and what it is 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 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 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 recovery of the body.
The patient receives this solution when unable to take food normally. When receiving this solution, the patient will also receive other solutions, such as glucose solutions or fat emulsions. The solution may be administered to adults, adolescents, and children above 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has inherited 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 inadequate 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 kidney failure is not adequately treated using an artificial kidney.

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

• poorly controlled heart failure with significant circulatory disturbance,
• fluid accumulation in the lungs (pulmonary edema),
• excess water in the body, limb swelling (excessive hydration).

Special caution required when using Aminoplasmal B. Braun 10%

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

If the patient has a simultaneous deficiency of water and salts, appropriate amounts will be administered first to correct this deficiency. If the patient has a deficiency of potassium or sodium, appropriate doses of these electrolytes will be given.
Before and during administration of this solution, the physician will monitor fluid and electrolyte concentrations, blood glucose levels, serum protein levels, 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 trace elements.
The infusion site will be checked daily for signs of inflammation or infection.
Aminoplasmal B. Braun 10% and other medicines
You should tell your doctor or pharmacist about all medicines the patient is currently 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Typically, Aminoplasmal B. Braun 10% is administered to immobilized patients under controlled conditions (emergency treatment, acute care, or in an outpatient treatment unit). This excludes driving and operating machinery.

3. How to use Aminoplasmal B. Braun 10%

Dosage
Adults and adolescents aged 14 to 17 years
The doctor will decide the daily dose to be administered to the patient.
The usual dose is 10–20 ml per kg of body weight per day. The solution should be infused 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 adjust the dose according to the child's age, nutritional status, and current health condition.
The dose administered to children is approximately:
for children aged 2 to 4 years: 15 ml per kg of body weight per day
for children aged 5 to 13 years: 10 ml per kg of body weight per day
The solution should be infused at a rate not exceeding 1 ml per kg of body weight per hour.
Duration of treatment
Aminoplasmal B. Braun 10% may be used 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.
Use of a higher than recommended dose of Aminoplasmal B. Braun 10%
This is unlikely, as the doctor determines the daily doses. However, if the patient receives a higher than recommended dose or the solution is infused too rapidly, the patient may excrete some amino acids in the urine and may experience nausea, vomiting, or chills. In such a case, the infusion will be temporarily stopped and resumed later at a slower rate.
If you have any further doubts regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The adverse reactions mentioned are not specifically associated with Aminoplasmal B. Braun 10%,
but generally with parenteral nutrition, especially during its initial phase.
The following adverse effects may be serious. If any adverse reactions occur,
including any adverse reactions not listed in this leaflet, inform your doctor immediately,
who will discontinue administration of this medicine.
Not known (frequency cannot be estimated from available data)

• allergic reactions

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at 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 provide more information on the safety of this medicine.

5. How to store Aminoplasmal B. Braun 10%

Keep out of the sight and reach of 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 stated month.
Store the bottles in the outer packaging to protect from light.
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 the crystals have completely dissolved. Gently shake the container to ensure solution homogeneity.
Do not freeze.
After infusion, any unused portion of the solution should not be stored for later use.

6. Contents of the pack and other information

What Aminoplasmal B. Braun 10% contains

• The active substances in this medicine are amino acids.

This medicine contains:
per 1 ml per 250 ml per 500 ml per 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
(content equivalent to lysine) (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
(content equivalent to lysine) (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 components 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)
Osmolarity 864 mOsm/l
Titratable acidity (to pH 7.4), approximately 20 mmol/l
pH 5.7 - 6.3

What Aminoplasmal B. Braun 10% looks like and contents of the pack
Aminoplasmal B. Braun 10% is a colourless or slightly straw-coloured solution.
The product is supplied in colourless glass bottles with a capacity of 250 ml, 500 ml and 1,000 ml, sealed with a rubber stopper.
Bottles of 250 ml and 500 ml are available in cartons containing 10 bottles. Bottles of 1,000 ml are available in cartons containing 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
Tel.: +49-5661-71-0
Fax: +49-5661-71-45 67

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

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Information intended for healthcare professionals only:
Instructions for use
Use only a sterile infusion set for Aminoplasmal B. Braun 10% solution.
In total parenteral nutrition, it is necessary to add other nutrients to this medicinal product, such as carbohydrates, fats, vitamins and trace elements. All additives must be introduced under strictly aseptic conditions.
Mix thoroughly after addition of any additives. Particular attention must be paid to the compatibility of additives.

Special precautions for storage
Use only if the solution is clear and the container and closure are undamaged.
Storage below 15°C may result in crystallisation, but crystals can be easily redissolved by gently warming the solution to 25°C until completely dissolved. Gently shake the container to ensure solution homogeneity.

Stability after mixing with other components
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 storage duration and conditions thereafter.