Aminoplasmal 15%

Package Leaflet: Information for the User

Aminoplasmal 15% solution for infusion
Amino Acids

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Aminoplasmal 15% and what is it used for
• 2. Important information before using Aminoplasmal 15%
• 3. How to use Aminoplasmal 15%
• 4. Possible side effects
• 5. How to store Aminoplasmal 15%
• 6. Contents of the pack and other information

1. What is Aminoplasmal 15% and what is it used for

Aminoplasmal 15% is a solution administered to the patient through a small tube with a needle inserted into a vein (intravenous infusion).
The solution contains amino acids essential for the body's growth or recovery.
The patient will receive this medicine if they are unable to eat normally or cannot receive food through a tube inserted into the stomach. This solution can be administered to adults, adolescents, and children over 2 years of age.

2. Important information before using Aminoplasmal 15%

When not to use Aminoplasmal 15%:

• 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 defects of protein and amino acid metabolism;
• if the patient has severe (life-threatening) circulatory disorders (shock);
• if the patient has insufficient oxygen supply (hypoxia);
• if the patient's blood accumulates acidic substances (metabolic acidosis);
• if the patient has severe liver disease (severe liver failure);
• if the patient has severe kidney dysfunction (severe renal failure) not adequately treated with renal replacement therapy or similar therapies;
• if the patient has untreated congestive heart failure with significant circulatory impairment (decompensated heart failure);
• if the patient has fluid in the lungs (pulmonary edema);
• if the patient has an excess of fluid in the body and swelling of the limbs (overhydration);
• if the patient's blood has abnormal fluid, electrolyte, and acid-base balance.

This solution must not be administered to newborns, infants, and young children under 2 years of age, as the composition of the solution does not meet the special nutritional needs of children in this age group.

Warnings and precautions

Before starting treatment with Aminoplasmal 15%, discuss it with your doctor, pharmacist, or nurse.
If the patient has acquired protein metabolism disorders, the doctor will decide, after careful consideration, whether the patient cannot, may, or must receive this medicine.
If the patient has impaired heart function, the daily fluid intake will be carefully controlled to avoid overloading the circulatory system.
If the patient's blood has too high a concentration of dissolved substances, the doctor will exercise particular caution to avoid worsening this condition.
If the patient's liver or kidneys are not working properly, the daily dose of the medicine will be carefully adjusted according to the degree of liver or kidney dysfunction and the type of treatment.
If the patient has a water and salt deficiency, they will first receive an appropriate dose to correct this deficiency.
If the patient has a potassium or sodium deficiency, they will receive appropriate doses of these electrolytes.
During treatment with this medicine, the patient's blood electrolyte levels, blood sugar levels, fluid balance, acid-base balance, blood protein levels, and liver and kidney function will be closely monitored. For this purpose, blood and urine samples will be taken from the patient for analysis.
The patient will also receive carbohydrate solutions and possibly lipid emulsions to ensure complete parenteral nutrition. Additionally, if necessary, the patient will receive essential fatty acids, vitamins, fluids, trace elements, and electrolytes.

Children and adolescents

This solution is not suitable for children under 2 years of age due to its composition, and therefore should not be administered to them.

Other medicines and Aminoplasmal 15%

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 their doctor or pharmacist before using this medicine.
Pregnancy
There are no data on the use of Aminoplasmal 15% in pregnant women. If the patient is pregnant, this medicine will only be used if the doctor considers it essential. Aminoplasmal 15% should be administered to pregnant women only after careful consideration of the benefit-risk ratio.
Breastfeeding
When using Aminoplasmal 15% at therapeutic doses, no effect on the breastfed newborn/infant is expected. However, breastfeeding is not recommended during the period when the patient requires parenteral nutrition.

Driving and using machines

This medicine has no influence on the ability to drive and use machines.

Aminoplasmal 15% contains sodium

This medicine contains 121.9 mg of sodium (a major component of common salt) in 1000 ml of solution.
This corresponds to 6.095% of the recommended maximum daily intake of sodium for an adult.

3. How to use Aminoplasmal 15%

Aminoplasmal 15% is administered by healthcare professionals.
The doctor will decide how much of this medicine is needed and how long it will be administered to the patient.
The solution is administered through a small plastic tube inserted directly into a vein.

Dosage

The amount of solution the patient will receive depends on their individual needs for amino acids, as well as their current condition and disease.
Adults
The usual dose is 6.7 ml to a maximum of 13.3 ml per kg of body weight per day.
This corresponds to a dose of 1.0 - 2.0 g of amino acids per kg of body weight per day.
The solution should be administered at a maximum rate of 0.67 ml per kg of body weight per hour.
Use in children
Aminoplasmal 15% must not be administered to children under 2 years of age (see section 2 "Important information before using Aminoplasmal 15%").
The dosage in children is determined individually based on age, stage of development, and clinical condition of the child.
The following information can be used as a guideline for the daily dose:

• For children from 2 to 4 years: 10 ml per kg of body weight per day, which corresponds to a dose of 1.5 g of amino acids per kg of body weight per day.
• For children from 5 to 13 years: 6.7 ml per kg of body weight per day, which corresponds to a dose of 1.0 g of amino acids per kg of body weight per day.
• Critically ill children: in the case of critically ill children, the required dose of amino acids may be higher (up to 3.0 g of amino acids/kg of body weight per day).

The infusion rate should not exceed 0.67 ml per kg of body weight per hour.
Patients with kidney or liver disease
If the patient has kidney or liver disease, the dose will be adjusted according to individual needs.
Duration of treatment
This medicine may be used for as long as the patient requires parenteral nutrition.
Method of administration
This medicine is administered to the patient by intravenous infusion (drip) into a large central vein.

Use of a higher dose of Aminoplasmal 15% than recommended

Overdose or too rapid infusion may be poorly tolerated, and the patient may experience nausea, vomiting, chills, and headache. Additionally, the patient's blood may accumulate too many acidic substances, and the patient may lose amino acids in the urine.
In such a situation, the infusion will be stopped and resumed after some time at a lower rate.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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 of the following side effects, tell your doctor immediately, who will stop the administration of this medicine:

Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions

Other side effects include:
Not very common (affects 1 to 10 users in 1,000):

• nausea, vomiting

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 15%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after "EXP". The expiry date refers to the last day of the month.
Store the bottles in the outer packaging to protect from light.
Do not freeze.
Use the product only if the solution is clear and colorless or pale yellow, and the bottle and its closure are undamaged.
The bottles are for single use only. After use, discard any remaining solution and the container.

6. Contents of the pack and other information

What Aminoplasmal 15% contains

The active substances of the medicine are amino acids.
The solution contains:
per 1 ml
per 500 ml
per 1000 ml
Isoleucine
5.850 mg
2.925 g
5.850 g
Leucine
11.400 mg
5.700 g
11.400 g
Lysine monohydrate
(equivalent to lysine)
8.930 g
(7.950 mg)
Methionine
5.700 mg
2.850 g
5.700 g
Phenylalanine
5.700 mg
2.850 g
5.700 g
Threonine
5.400 mg
2.700 g
5.400 g
Tryptophan
2.100 mg
1.050 g
2.100 g
Valine
7.200 mg
3.600 g
7.200 g
Arginine
16.050 mg
8.025 g
16.050 g
Histidine
5.250 mg
2.625 g
5.250 g
Alanine
22.350 mg
11.175 g
22.350 g
Glycine
19.200 mg
9.600 g
19.200 g
Aspartic acid
7.950 mg
3.975 g
7.950 g
Glutamic acid
16.200 mg
8.100 g
16.200 g
Proline
7.350 mg
3.675 g
7.350 g
Serine
3.000 mg
1.500 g
3.000 g
Tyrosine
0.500 mg
0.250 g
0.500 g
Acetylcysteine
0.500 mg
0.250 g
0.500 g
(equivalent to cysteine)
(0.370 mg)
(0.185 g)
(0.370 g)
Other ingredients are sodium hydroxide, citric acid monohydrate, and water for injections.
1000 ml of solution contains:
8.930 mg
(7.950 mg)
4.465 g
(3.975 g)
Amino acid content
150 g/l
Nitrogen content
24 g/l
Sodium
5.3 mmol/l
Energy value [kJ/l (kcal/l)]
2505 (600)
Theoretical osmolality [mOsm/l]
1290
Acidity (titration to pH 7.4)
[mmol NaOH/l]
about 31
pH
5.7-6.3

What Aminoplasmal 15% looks like and contents of the pack

Aminoplasmal 15% is a solution for infusion. The solution is clear, colorless to pale yellow.
Aminoplasmal 15% is supplied in glass bottles closed with a rubber stopper:

• Capacity: 500 ml, 1000 ml
• Pack sizes: 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Postal address:
34209 Melsungen
Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567

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

France
AMINOPLASMAL 25, solution for perfusion
Germany
AMINOPLASMAL – 15 % electrolyte- and carbohydrate-free
Poland
Aminoplasmal 15 %
Spain
AMINOPLASMAL B.BRAUN 15% solution for perfusion
United Kingdom
Aminoplasmal 15% solution for infusion
Date of last revision of the package leaflet:26.04.2023
<------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:
AMINOPLASMAL 15% should only be mixed with other solutions for intravenous administration after prior confirmation of compatibility. Data on compatibility with various added substances (e.g., glucose, lipids, electrolytes, trace elements, vitamins) and the corresponding shelf-life of such mixtures can be provided upon request by the manufacturer.
From a microbiological point of view, mixtures should be administered immediately after preparation. If not administered immediately, the responsibility for the storage conditions and storage time of the mixtures before administration lies with the user, and the storage time should normally not exceed 24 hours at 2°C – 8°C, unless mixing has taken place in controlled and validated aseptic conditions.
It is essential to prepare such mixtures with strict adherence to aseptic principles, as this nutrient mixture promotes the growth of microorganisms.
Storage of the undiluted solution at temperatures below 15°C may lead to crystallization, which can be easily dissolved by carefully heating the solution to 25°C until complete dissolution. Shake the container gently to ensure homogeneity of the solution.