AMINOPLASMAL B.BRAUN 10% SOLUTION FOR INFUSION

2. What you need to know before using Aminoplasmal B. Braun 10%

Do not use Aminoplasmal B. Braun 10%:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
• if you have a congenital error of amino acid and protein metabolism
• if you have severe (life-threatening) circulatory disorders (shock)
• if you have insufficient oxygen supply (hypoxia)
• if you have acidic substances accumulated in your blood (metabolic acidosis)

• if you have inadequately controlled heart failure with significant impairment of your blood circulation (decompensated heart failure)
• if you have fluid accumulation in your lungs (acute pulmonary edema)
• if you have excess body water and your limbs are swollen (hyperhydration)

Your doctor will also consider that amino acid solutions are not normally used:

• if you have severe liver disease (severe liver failure)
• if you have severe kidney disease (severe renal failure) not adequately treated with dialysis or similar treatments

Newborns, infants, and young children under 2 years

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

Warnings and precautions

Consult your doctor before you are given Aminoplasmal B. Braun 10%

• if you have any amino acid metabolism problems caused by a situation other than those indicated in the previous section (see section "Do not use Aminoplasmal B. Braun 10%")
• if you have any liver or kidney function disorders
• if you have any heart function disorders
• if you have abnormally high serum osmolality.

Additional precautions taken by your doctor

If your body's water or mineral balance is disturbed, this disturbance should be corrected before administering this medicine. Examples of this disturbance are simultaneous lack of water and minerals (hypotonic dehydration) or lack of sodium (hyponatremia) or potassium (hypokalemia).

Before and while you are receiving this medicine, your blood levels of minerals and sugar, water balance, acid-base balance, blood proteins, and kidney and liver function will be monitored. For this purpose, blood samples will be taken and your urine will be collected for analysis.

Usually, you will receive Aminoplasmal B. Braun 10% as part of an intravenous nutrition regimen, which will also include non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, as well as vitamins, fluids, and trace elements.

Using Aminoplasmal B. Braun 10% with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

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

Pregnancy

If you are pregnant, you will only receive this medicine if your doctor considers it necessary for your recovery. There are no available data on the use of this medicine in pregnant women.

Breastfeeding

At therapeutic doses of Aminoplasmal B. Braun 10%, no effects are expected in the newborn/child during breastfeeding. However, breastfeeding is not recommended if women need intravenous nutrition at the same time.

Driving and using machines

This medicine is usually administered to immobile patients in a controlled environment (emergency treatment, acute treatment in a hospital or day care center). This excludes driving and using machines.

3. How to use Aminoplasmal B. Braun 10%

A healthcare professional will administer Aminoplasmal B. Braun 10% to you.

Your doctor will determine the amount of medicine you need and the duration of treatment.

The solution will be administered through a small plastic tube inserted into a vein.

Patients with kidney or liver disease

The doses will be adjusted according to your individual needs if you have liver or kidney disease.

Duration of administration

This medicine can be used as long as you need to receive intravenous nutrition.

If you have received more Aminoplasmal B. Braun 10% than you should

This is unlikely to happen, as your doctor will determine your daily doses.

However, if you receive an overdose or the solution flows too quickly, you may feel nauseous, vomit, or have headaches. Additionally, your blood may contain too much ammonia (hyperammonemia) or you may lose amino acids in your urine. You may also have excess fluid in your body (hyperhydration), your mineral balance may be disturbed (electrolyte imbalance), and you may have fluid in your lungs (pulmonary edema). If this happens, the infusion should be interrupted and resumed after some time at a lower infusion rate.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects are not specifically related to Aminoplasmal B. Braun 10%, but can occur with any type of intravenous nutrition, especially at the start.

The following side effects may be serious. If you experience any of the following side effects, tell your doctor immediately and he will stop administering this medicine:

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

• Allergic reactions

Other side effects:

Uncommon (may affect up to 1 in 100 people)

• Vomiting

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal B. Braun 10%

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the vial and the carton. The expiry date is the last day of the month stated.

Store the vial in the outer packaging to protect it from light.

Do not store above 25°C.

Store the solution in a cool place (below 15°C), which may cause crystallization that can, however, be easily dissolved by gentle warming to 25°C until complete dissolution. Shake the container gently to ensure homogeneity. Do not freeze.

After infusion, any remaining solution must not be stored for later use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Aminoplasmal B. Braun 10%

The active substances are amino acids.

This medicine contains:

The other ingredients are acetylcysteine, citric acid monohydrate (for pH adjustment), and water for injections.

Appearance of the product and pack contents

The solution should only be used if the vial stopper is not damaged and the solution is clear and colorless to a light straw color and does not contain particles.

The product is presented in colorless glass bottles of 250 ml, 500 ml, and 1,000 ml, closed with a rubber stopper.

The 250 ml and 500 ml bottles are available in packs of 10. The 1,000 ml bottles are presented in packs of 6.

Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder and manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Mailing address:

34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

You can request more information about this medicine from the local representative of the marketing authorisation holder

• Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

This medicine has been authorised in the Member States of the EEA under the following names:

Austria Aminoplasmal B. Braun 10 % Infusionslösung

Czech Republic Aminoplasmal B. Braun 10 %

Denmark Aminoplasmal

Germany Aminoplasmal B. Braun 10 %

Spain Aminoplasmal B. Braun 10% solution for infusion

Finland Aminoplasmal 16 N/l

Italy Amixal

Lithuania Aminoplasmal B. Braun 10 % infuzinis tirpalas

Latvia Aminoplasmal B. Braun 10 % šķīdums infuzijām

Netherlands Aminoplasmal B. Braun 10 % E-vrij, oplossing voor infusie

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

Date of last revision of this leaflet:02/2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Method of administration

Intravenous route.

Only for central venous infusion.

Posology

The dose must be adjusted to the individual needs of amino acids and fluids depending on the patient's clinical conditions (nutritional status and/or degree of nitrogen catabolism due to a concomitant disease).

Adults and adolescents from 14 to 17years

Daily dose:

1.0 – 2.0 g amino acids/kg body weight ? 10 – 20 ml/kg body weight

? 700 – 1,400 ml for a 70 kg patient

Maximum infusion rate:

0.1 g amino acids/kg body weight/h ? 1.0 ml/kg body weight/h

? 1.17 ml/min for a 70 kg patient

Pediatric population

Newborns, infants, and young children under 2 years

Aminoplasmal B. Braun 10% is contraindicated in newborns, infants, and young children under 2 years (see section 4.3).

Children and adolescents from 2 to 13years

The doses for the age groups indicated below are mean values used for guidance. The exact dose must be adjusted individually according to age, developmental status, and existing diseases.

Daily dose for children from 2 to 4 years:

1.5 g amino acids/kg body weight ? 15 ml/kg body weight

Daily dose for children from 5 to 13 years:

1.0 g amino acids/kg body weight ? 10 ml/kg body weight

Critically ill children: For critically ill patients, the recommended amino acid intake may be higher (up to 3.0 g amino acids/kg body weight per day).

Maximum infusion rate:

0.1 g amino acids/kg body weight/h ? 1.0 ml/kg body weight/h

In the event that amino acid requirements are 1g per kg of body weight per day or more, an assessment must be made

Renal Insufficiency

In patients with renal insufficiency, the dose should be adjusted carefully according to individual needs, the severity of organic insufficiency, and the type of established renal replacement therapy (hemodialysis, hemofiltration, etc.).

Hepatic Insufficiency

In patients with hepatic insufficiency, the dose should be adjusted carefully based on individual needs and the severity of organic insufficiency.

Handling Instructions

Use a sterile administration set for the perfusion of Aminoplasmal B. Braun 10% solution for perfusion.

If, in total parenteral nutrition, it is necessary to add other nutrients to this medication, such as carbohydrates, lipids, vitamins, electrolytes, and trace elements, the addition should be performed under strict aseptic conditions. Mix well after the inclusion of any additive. Aminoplasmal B. Braun 10% can only be mixed with other nutrients whose compatibility has been documented. Upon request, the manufacturer will provide compatibility data for different additives and the corresponding validity period of such mixtures.

Special Precautions for Storage

Do not use the product if the solution is not transparent and colorless to a slight straw color or if the container or its cap are damaged. Storing the solution in the cold, below 15°C, may cause the formation of crystals that can, however, be easily dissolved by gentle heating to 25°C until complete dissolution. Gently shake the container to ensure homogeneity.

Single-use containers. Discard the container and any contents after use.

Validity Period after Mixing with Additives

Do not refrigerate.

From a microbiological point of view, unless the method of opening and mixing prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, the conditions and storage times during use are the responsibility of the user.

For complete information on this medication, consult the Technical Data Sheet or Summary of Product Characteristics.