Package Insert: Information for the User

Aminoplasmal B. Braun 10% Solution for Infusion

Amino Acids

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

- Keep this package insert. You may need to read 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 package insert. See section 4.

Aminoplasmal B. Braun 10% 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 ingest food normally and cannot be fed through a tube inserted into your stomach. This solution may be administered to adults, adolescents, and children over 2 years old.

Do not use Aminoplasmal B.Braun 10%:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6)
• if you have a congenital metabolic disorder of amino acids and proteins
• if you have a severe (life-threatening) circulation disorder (shock)
• if you receive insufficient oxygen supply (hypoxia)
• if you have accumulated acidic substances in your blood (metabolic acidosis)

• if you have inadequately controlled heart failure with significant alterations in your blood circulation (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 consider that solutions with amino acids are generally not to be used:

• if you have severe liver disease (severe hepatic insufficiency)
• if you have a severe kidney disorder (severe renal insufficiency) not adequately treated with 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 its composition does not adequately meet the special nutritional needs of this age group.

Warnings and precautions

Consult your doctor before receiving Aminoplasmal B. Braun 10%

• if you have a metabolic disorder of amino acids caused by a situation other than those listed in the previous section (see section "Do not use Aminoplasmal B. Braun 10%”)
• if you have any alteration of liver or kidney function
• if you have a heart function alteration
• if you have an abnormally high concentration of serum in your blood (increased serum osmolality).

Additional precautions adopted by your doctor

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

Before and while receiving this medication,your levels of salts and blood sugar, water balance, acid-base balance, blood proteins, and kidney and liver function will be monitored. Blood samples will be taken and your urine will be collected for analysis.

Generally, 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, electrolytesas well as vitamins, liquids, and oligoelements.

Use of Aminoplasmal B. Braun 10% with other medications

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

At therapeutic doses of AminoplasmalB.Braun10%, no 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 medication is generally 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.Braun10%.

The doctor will determine the necessary amount of medication 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 10% 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 the solution flows too quickly, you may feel nausea, have to vomit, or experience headaches.Additionally, your blood may containtoo 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 mineral salts in the body (electrolyte imbalance) and fluid in the lungs (pulmonary edema).If this happens, the infusion should be interrupted and resumed at a lower infusion 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 will experience them.

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

The following adverse effects can 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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 them from light.

Do not store at a temperature above 25 °C.

Store the solution in the cold, below 15 °C, it 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. Do not freeze.

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

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

Composition of Aminoplasmal B. Braun 10%

The active principles are amino acids.

This medicinal product contains:

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

Appearance of the product and contents of the packaging

Only use the solution if the cap of the packaging is not damaged and thesolution is transparent and colorless to a light beige 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 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.

Holder of the marketing authorization and responsible for manufacturing

Holder and responsible for manufacturing

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 medicinal product, please contact the local representative of the marketing authorization holder

B. Braun Medical SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

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

AustriaAminoplasmal B. Braun 10 % Infusionslösung

Czech RepublicAminoplasmal B. Braun 10 %

DenmarkAminoplasmal

GermanyAminoplasmal B. Braun 10 %

SpainAminoplasmal B. Braun 10% solución para perfusión

FinlandAminoplasmal 16 N/l

ItalyAmixal

LithuaniaAminoplasmal B. Braun 10 % infuzinis tirpalas

LatviaAminoplasmal B. Braun 10 % škidums infuzijam

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

PolandAminoplasmal B. Braun 10 %

PortugalAminoplasmal B. Braun 10 %

SlovakiaAminoplasmal B. Braun 10 %

SloveniaAmixal 100 mg/ml raztopina za infundiranje

United KingdomB. BraunAminoplasmal 10 % solution for infusion

Last review date of this leaflet:02/2021

For more detailed information about this medicinal product, 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 solely for healthcare professionals:

Administration route

Intravenous.

Only for central venous perfusion.

Dosage

The dose should be adjusted according 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 concomitant disease).

Adults and adolescents aged 14 to 17years

Daily dose:

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

?700–1.400ml for a 70kg

Maximum perfusion rate:

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

?1.17ml/min for a 70kg

Pediatric population

Newborns, infants and small children under two years

AminoplasmalB.Braun10% is contraindicated in newborns, infants and small children under2years (see section4.3).

Children and adolescents aged 2 to 13years

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

Daily dose for children aged 2 to 4years:

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

Daily dose for children aged 5 to 13years:

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

Severely ill children:For patients with severe illness, the recommended intake of amino acids may be higher (up to 3.0g amino acids/kg body weight per day).

Maximum perfusion rate:

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

In cases where the requirements for amino acids are1gper 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 content of amino acids may need to be used in order to avoid fluid overload.

Renal insufficiency

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

Instructions for handling

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

If, in parenteral nutrition, it is necessary to add other nutrients to this medicinal product, 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.Braun10% 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 transparente incolora until a light beige coloror if the packaging or its cap are damaged.Store the solution in cold, below 15°C, may cause the formation of crystals that can, however, dissolve easily by gentle heating to 25°C until complete dissolution. Gently shake the packaging to ensure homogeneity.

Single-use packaging. Dispose of the packaging 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 not used immediately, the storage conditions and times during use are the responsibility of the user.

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