Label: Information for the User

AMINOPLASMAL B. BRAUN 15% Solution for Perfusion

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 15% is a solution that will be administered to you through a small tube with a cannula placed in a vein (intravenous infusion).

The solution contains amino acids that are essential for the body to grow or recover.

This medication will be administered to you if you are unable to eat normally and cannot be fed through a tube placed in your stomach. This solution may be administered to adults, adolescents, and children over 2 years of age.

No use AMINOPLASMAL B. BRAUN 15%

- If you are allergic to any of the active ingredients or to any of the other components of this medication (listed in section 6)

- If you have an innate disorder of protein and amino acid metabolism

- If you have a severe (potentially life-threatening) disorder of your circulation (shock)

- If you have insufficient oxygen supply (hypoxia)

- Ifacidic substances accumulate in your blood (metabolic acidosis)

- If you have severe liver disease (severe liver insufficiency)

- If you have untreated severe kidney insufficiencyadequately treated with a dialysis machine or treatments

• - If you have uncontrolled heart failure with significant alteration of blood circulation (decompensated heart failure)

- If you have fluid in your lungs (pulmonary edema)

- If you have excess fluid in your body (hyperhydration)

• if your body fluid levels, salt concentration, and blood acidity are not normal (electrolyte imbalance disorders)

This solution should not be administered to newborns and children under 2 years of age due to the composition of the solution not adequately meeting the special nutritional needs of this age group.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using AMINOPLASMAL B. BRAUN 15%.

If you have a non-innate disorder of protein metabolism, your doctor will carefully decide whether you can, or even should, receive this medication.

If your heart function is altered, your daily fluid intake will be carefully controlled to avoid any overload of your circulation.

If the total concentration of dissolved substances in your blood is too high, your doctor will take special care to avoid worsening this condition.

If your liver or kidneys do not function well, your daily dose will be carefully adjusted according to the alteration of your liver or renal function and your type of treatment.

If you lack water and salt at the same time, you will first receive sufficient amounts of both to correct this condition.

If you lack potassium or sodium, you will receive sufficient amounts of these.

While receiving this medication, your blood sugar and salt levels, fluid balance, acid-base balance, blood proteins, and renal and hepatic functions will be monitored. This will be done by analyzing blood samples taken from you and urine collected from you.

To make your intravenous nutrition complete, you will also receive carbohydrate solutions, and possibly, also fat emulsions. Additionally, you will be given essential fatty acids, vitamins, liquids, oligoelements, and electrolytes as needed.

Children and adolescents

This solution is not suitable for children under 2years of age due to its composition, so they should not receive it.

Use of AMINOPLASMAL B. BRAUN 15% with other medications

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

Pregnancy and breastfeeding

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

Pregnancy

There are no data on the use of AMINOPLASMAL B. BRAUN 15% in pregnant women. If you are pregnant, you will receive this medication only if your doctor considers it absolutely necessary for your recovery. AMINOPLASMAL B. BRAUN 15% should only be administered to pregnant women after careful consideration.

Breastfeeding

At therapeutic doses of AMINOPLASMAL B. BRAUN 15%, no effects are expected on newborns/lactants. However, breastfeeding is not recommended if women need intravenous nutrition at that time.

Driving and operating machines

This medication has no influence on your ability to drive and operate machines.

AMINOPLASMAL B. BRAUN 15% contains sodium

This medication contains 121.9mg of sodium (main component of table salt/for cooking) in each 1,000ml.

This is equivalent to 6.095% of the maximum daily sodium intake recommended for an adult.

AMINOPLASMAL B.BRAUN 15% is administered by healthcare professionals.

The doctor will decide the necessary amount of this medication and for how long it will be administered to patients.

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

Dosage

The amount of solution to be received depends on the patient's requirements for amino acids and liquids, as well as their existing disorder or disease.

Adults

The usual dose is 6.7 ml to 13.3 ml per kg of body weight per day.

This corresponds to 1.0 to 2.0 g of amino acids per kg of body weight per day.

This solution will be administered at a maximum rate of 0.67 ml per kg of body weight per hour.

Use in children

AMINOPLASMAL B. BRAUN 15% should not be administered to children under 2 years of age (see section 2 "What you need to know before starting to use...").

The dose for children will be adjusted individually according to age, developmental status, and clinical condition of the child.

The following may be considered as a guide for daily doses:

• For children aged 2 to 4 years: 10 ml per kg of body weight per day, corresponding to 1.5 g of amino acids per kg of body weight per day
• For children aged 5 to 13 years: 6.7 ml per kg of body weight per day, corresponding to 1.0 g of amino acids per kg of body weight per day
• Severely ill children: if your child is severely ill, the amount of amino acids required may be higher (up to 3.0 g of amino acids per kg of body weight per day).

The infusion rate should not exceed 0.67 ml per kg of body weight per hour.

Patients with liver or kidney disease

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

Duration of use

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

Administration form

This medication will be administered to you through infusion (drip) in a large central vein.

If you use more AMINOPLASMAL B. BRAUN 15% than you should

Overdose or too rapid infusion may not be tolerated well and you may feel unwell, may have to vomit, and may experience chills or headache. Additionally, your blood may contain too many acidic substances and you may lose amino acids in the urine.

If this occurs, your infusion will be stopped and restarted at a lower rate some time later.

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

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

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

Unknown frequency (cannot be estimated from available data):

- Allergic reactions

Other adverse effects are:

Rare (affect between 1 and 10 users in every 1,000):

- Nausea, vomiting

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Annex 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 label and on the outer packaging after «CAD:». The expiration date is the last day of the month indicated.

Store the vials in the outer packaging to protect them from light.

Do not freeze.

Use only if the solution is transparent and colorless or slightly yellowish and the vial and its closure do not show any damage.

The vials are for single use. After use, any remaining solution after a perfusion and the container must be discarded.

Medications should not be thrown down the drain or in the trash. Dispose of the 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 the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of AMINOPLASMAL B. BRAUN 15%

The active principles are amino acids.

The solution contains:

The other components are sodium hydroxide, citric acid monohydrate, and water for injection preparations.

1.000 ml of solution contains:

Appearance of the product and contents of the packaging

AMINOPLASMAL B. BRAUN 15% is a perfusion solution. The solution is transparent, colorless, or slightly yellowish.

AMINOPLASMAL B. BRAUN 15% is supplied in glass bottles, sealed with rubber stoppers:

• Content: 500 ml, 1.000 ml
• Packaging sizes: 1 × 500 ml, 10 × 500 ml, 1 × 1.000 ml, 6 × 1.000 ml

Only some packaging sizes may be commercially available.

Holder of the marketing authorization 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

Local representative

B.Braun Medical S.A.

Ctra de Terrassa 121 -08191

(Rubí) Barcelona

Phone 93 582 95 80

Fax: 93 588 10 96

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

FranceAMINOPLASMAL 25, solution for perfusion

GermanyAMINOPLASMAL – 15 % electrolyte- and carbohydrate-free

PolandAMINOPLASMAL 15 %

SpainAMINOPLASMAL B. BRAUN 15% solution for perfusion

United KingdomAminoplasmal 15% solution for infusion

Last revision date of this leaflet: June/2018

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/ ”

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This information is intended solely for healthcare professionals:

AMINOPLASMAL B. BRAUN 15% should only be mixed with other i.v. solutions if compatibility has been previously demonstrated. The manufacturer may provide, upon request, data on the compatibility of different additives (e.g. glucose, lipids, electrolytes, oligoelements, vitamins) and the corresponding shelf life of these mixtures.

From a microbiological point of view, the mixtures should be administered immediately after preparation. If they are not administered immediately, the preparation and storage times of the mixtures before use are the responsibility of the user and are normally not greater than 24hours between 2°C and 8°C, unless the mixture was prepared in controlled and validated aseptic conditions.

It is essential that any mixture is prepared using strict aseptic techniques since this mixture of nutrients is compatible with microbial growth.

Storage of the undiluted solution at a temperature below 15 °C may lead to the formation of crystals, which can, however, be easily dissolved by gentle warming to 25 °C until complete dissolution. Gently shake the container to ensure homogeneity.