Label: Information for the User

Aminoplasmal B. Braun 5% Solution for Infusion

Amino Acids

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Aminoplasmal B. Braun 5% is a solution administered through a small tube with a cannula inserted into a vein (intravenous perfusion).

The solution contains amino acids, which are essential for the growth and recovery of the body.

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

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 metabolic disorder of amino acids and proteins
• if you have a severe (life-threatening) circulatory disorder (shock)
• if you are receiving insufficient oxygen supply (hypoxia)
• if you have accumulated acidic substances in your blood (metabolic acidosis)

• if you have inadequately controlled heart failure with significant circulatory disorder (decompensated heart failure)
• if you have acute pulmonary edema
• if you have excessive body water and your extremities are swollen (hyperhydration)

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

• if you have severe liver disease (severe hepatic insufficiency)
• if you have severe kidney disorder (severe renal insufficiency) not adequately treated by dialysis or similar treatments

Newborns, infants, and children under two years old

This solution should not be administered to newborns, infants, or children under two years old, 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 Aminoplasmal B. Braun 5% is administered to you

• if you have a metabolic disorder of amino acids caused by a condition other than those listed in the previous section (see section "Do not use Aminoplasmal B. Braun 5%")
• if you have a disorder of liver or kidney function
• if you have a disorder of heart function
• if you have abnormally high serum osmolarity

Additional precautions adopted by your doctor

If your body's water and electrolyte balance is altered, this alteration should be corrected before administering this medicine. Examples of this alteration are simultaneous lack ofif you need water and electrolytes(hypotonic dehydration)or a lack of sodium (hyponatremia) or potassium (hypokalemia).

Your doctor will monitor your levels of salts and sugar in blood, water balance, acid-base balance, blood proteins, and kidney and liver function. This will be done by taking blood samples and collecting your urine for analysis.

Normally, you will receive Aminoplasmal B. Braun 5% as part of a regimen of intravenous nutrition, which will also include non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytesas well as vitamins, liquids, and oligoelements)

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

Use of Aminoplasmal B. Braun 5% with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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.No data are available on the use of this medicine in pregnant women.

Breastfeeding

At therapeutic doses of AminoplasmalB.Braun5% no adverse effects are expected in the newborn/infant during breastfeeding.However, breastfeeding is not recommended if women need intravenous nutrition at the same time.

Driving and operating machinery

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

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

The doctor will determine the amount of medication needed and the duration of treatment for the patients.

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

Patients with liver or kidney disease

Doses will be adjusted according to individual needs if you have liver or kidney disease.

Duration of administration

This medication can be used as long as intravenous nutrition is needed.

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

It is unlikely that this will 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 nausea or a desire to vomit or experience headaches. Additionally, your blood may contain too much ammonia (hyperammonemia) or you may lose amino acids in your urine. You may also experience excessive fluid in the body (hyperhydration), an imbalance of electrolytes, and fluid in the lungs (pulmonary edema). If this happens, the infusion should be interrupted and resumed at a slower rate after a certain period of time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

These adverse effects are not specifically related to Aminoplasmal B. Braun 5%, but may occur with any type of intravenous nutrition, especially at the beginning.

The following adverse effects may be serious. If any of the following adverse effects occur, inform your doctor immediately and they will stop administering this medication:

Unknown frequency (cannot be estimated from available data)

• Allergic reactions

Other adverse effects:

Rare (may affect up to 1 in 100 people)

• Vomiting

Unknown frequency(cannot be estimated from available data)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it isan adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the labels of the vial and the box. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 25°C.

Store the solution in the cold, below 15°C, may cause the formation of crystals that can, however, easily dissolve by gentle heating to 25°C until complete dissolution. Gently shake the container to ensure homogeneity.

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Do not freeze.

Only use the solution if the cap of the container is not damaged and the solution is clear.

After perfusion, no remaining solution should be stored for future use.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

The active principles are amino acids.

This medication contains:

The other components are acetylcysteine, citric acid monohydrate (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Aminoplasmal B. Braun 5% is a transparent, colorless solution that 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 boxes of 10 units. The 1,000 ml bottles are presented in boxes of 6 units.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder and responsible manufacturer

B. 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

For more information about this medication, please contact the local representative of the marketing authorization holder

B. Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

This medication has been authorized in the member states of the EEA with the following names:

FranceAminoplasmal 8, solution for perfusion

GermanyAminoplasmal B. Braun 5

PortugalAminoplasmal B. Braun 5%

SpainAminoplasmal B. Braun 5% solution for perfusion

Last review date of this leaflet:02/2021

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Administration route

Intravenous.

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

Dosage

Adults and adolescents aged 14 to 17years

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

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

Children aged 2 to 13years

In the case of children, the doctor will carefully adjust the dose according to age, developmental stage, and underlying disease.

The amounts to be administered will be approximately:

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

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

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

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

In cases where 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, solutions of amino acids 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 according to individual needs, the severity of the insufficiency, and the type of renal replacement therapy established (hemodialysis, hemofiltration, etc.).

Liver insufficiency

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

Handling instructions

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

If, as part of total parenteral nutrition, it is necessary to add other nutrients to this medication, such as carbohydrates, lipids, vitamins, electrolytes, and oligoelements, the addition should be made under strict aseptic conditions. Mix well after the inclusion of any additive. AminoplasmalB.Braun5% can only be mixed with other nutrients whose compatibility has been documented. On request, the manufacturer will provide compatibility data for different additives and the corresponding validity period of these mixtures.

Special precautions for storage

Do not use the product if the solution is not transparent or if the container or stopper is damaged.

Store the solution in the cold, below 15°C, may cause the formation of crystals that can, however, easily dissolve by gentle heating to 25°C until complete dissolution. Gently shake the container to ensure homogeneity.Single-use containers. Dispose of 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 usedimmediately. If not used immediately, the storage conditions and times during use are the responsibility of the user.

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For complete information about this medication, please consult the Technical Dossier or Summary of Product Characteristics.