AMINOPLASMAL B.BRAUN 5% SOLUTION FOR INFUSION

2. What you need to know before you use Aminoplasmal B. Braun 5%

Do not use Aminoplasmal B. Braun 5%

• 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 poorly 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 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 should 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 5%

• 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 5%")
• 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 you are given 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 5% as part of an intravenous feeding regimen that also includes non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, as well as vitamins, fluids, and trace elements.

If you are given this medicine in a small vein (peripheral vein), the infusion site will be checked daily for signs of irritation or inflammation of the vein (thrombophlebitis).

Using Aminoplasmal B. Braun 5% 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 data available on the use of this medicine in pregnant women.

Breastfeeding

At therapeutic doses of Aminoplasmal B. Braun 5%, no effects are expected in the newborn/child during breastfeeding. However, breastfeeding is not recommended if women need intravenous feeding 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 5%

A healthcare professional will administer Aminoplasmal B. Braun 5% 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 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 feeding.

If you have received more Aminoplasmal B. Braun 5% than you should

This is unlikely to happen, as your doctor will determine your daily doses. However, if you receive an overdose or if the solution flows too quickly, you may feel nauseous or 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 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 further questions on 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 5%, but can occur with any type of intravenous feeding, 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

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

Reactions at the infusion site, including local pain, irritation, or inflammation of the vein (thrombophlebitis)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal B. Braun 5%

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 and carton. The expiry date refers to the last day of the month shown.

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, may 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.

The solution should only be used if the container closure is not damaged and the solution is clear.

After infusion, any remaining solution should 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

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

Aminoplasmal B. Braun 5% is a clear, colorless to slightly straw-colored solution and does not contain particles.

The product is available 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 available in packs of 6.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder and manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Postal 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 authorization holder

• Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

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

France Aminoplasmal 8, solution for infusion

Germany Aminoplasmal B. Braun 5

Portugal Aminoplasmal B. Braun 5%

Spain Aminoplasmal B. Braun 5% 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.

Aminoplasmal B. Braun 5% can be administered through a central or peripheral vein.

Dosage

Adults and adolescents from 14 to 17years

Your doctor will determine the amount of solution you need each day.

The normal dose will be 20 – 40 ml per kg of your body weight per day. The solution will flow at a rate not exceeding 2 ml per kg of your body weight per hour.

Children from2 to13years

In the case of children, the doctor will carefully adjust the dose based on age, developmental status, and existing disease.

The amounts to be administered will be approximately:

From 2 to 4 years: 30 ml per kg of body weight per day

From 5 to 13 years: 20 ml per kg of body weight per day

For severely ill children, the amount to be administered may be higher (up to 60 ml per kg of body weight per day).

The solution will be administered at a rate not exceeding 2 ml per kg of body weight per hour.

In cases where the amino acid requirements are 1 g 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 to avoid fluid overload.

Renal Insufficiency

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

Hepatic Insufficiency

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

Handling Instructions

Use a sterile administration set for the infusion of Aminoplasmal B. Braun 5% solution for infusion.

If, as part of 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 5% 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 or if the container or its cap is 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 opening and mixing method 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.

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For complete information on this medication, consult the Summary of Product Characteristics or the technical data sheet.