AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Aminoplasmal B. Braun 10% E Solution for Infusion

Amino Acids and Electrolytes

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Aminoplasmal B. Braun 10% E is and what it is used for
2. What you need to know before you use Aminoplasmal B. Braun 10%
3. How to use Aminoplasmal B. Braun 10% E
4. Possible side effects
5. Storage of Aminoplasmal B. Braun 10% E
6. 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 that is administered through a small tube with a cannula that is inserted into a vein (intravenous infusion).

The solution contains amino acids and mineral salts (electrolytes), which are essential for the growth and recovery of the body.

You will receive this medicine if you are unable to eat normally and cannot be fed through a tube inserted into your stomach. This solution can be administered to adults, adolescents, and children over 2 years of age.

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

Do not use Aminoplasmal B. Braun 10% E:

• 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 a severe disturbance (life-threatening) of circulation (shock)
• if you are receiving insufficient oxygen (hypoxia)
• if you have acidic substances accumulated in your blood (metabolic acidosis)
• if you have too high levels of any of the mineral salts (electrolytes) contained in the solution

• 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 water in your body and your limbs are swollen (hyperhydration).

Your doctor will also take into account that solutions with amino acids should not normally be used:

? if you have severe liver disease (severe hepatic insufficiency)

? if you have severe kidney disease (severe renal insufficiency) that is 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 of age, 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% E

• 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% E")
• 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 salt balance is disturbed, this disturbance should be corrected before administering this medicine. Examples of this disturbance are simultaneous lack of water and mineral salts (hypotonic dehydration) or lack of sodium (hyponatremia) or potassium (hypokalemia)

Before and while you are receiving this medicine, your blood salt and sugar levels, 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% E as part of an intravenous nutrition regimen, which will also include energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, as well as vitamins, fluids, and trace elements.

Using Aminoplasmal B. Braun 10% E with other medicines

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 is no available data on the use of this medicine in pregnant women.

Breast-feeding

At therapeutic doses of Aminoplasmal B. Braun 10% E, no effects are expected in the newborn/child during breast-feeding. However, breast-feeding 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% E

A healthcare professional will administer Aminoplasmal B. Braun 10% E 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 that will be inserted into a vein.

Patients with renal or hepatic 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% E 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 nausea, need to 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 too much fluid in your body (hyperhydration), your body's mineral salt 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 the use of 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% E, 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 to you:

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, nausea

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% E

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.

Storing the solution in the cold, below 15°C, can cause the formation of crystals 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 other information

Composition of Aminoplasmal B. Braun 10% E

The active substances are amino acids and electrolytes.

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 a clear, colorless solution up to a light straw color and does not contain particles

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

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

Not all pack sizes may be marketed.

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 authorized in the Member States of the EEA with the following names:

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

Adults and adolescents from 14 to 17 years

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% E is contraindicated in newborns, infants, and young children under 2 years of age (see section 4.3).

Children and adolescents from 2 to 13 years

The doses for the age groups indicated below are mean values used as a guide. The exact dose must be adjusted individually according to age, developmental stage, 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 1.0g per kg of body weight per day or more, special attention should be paid to the limitations of fluid intake. In these situations, amino acid solutions with a higher amino acid content may need to be used in order to avoid fluid overload.

Renal insufficiency

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

Hepatic insufficiency

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

Handling instructions

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

If it is necessary to add other nutrients to this medication in total parenteral nutrition, 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% E 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 storage precautions

Do not use the product if the solution is not transparent and colorless to a slight straw color or if the vial or its cap are damaged.

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

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.

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 it is 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 Sheet or Summary of Product Characteristics.