AMINOPLASMAL B.BRAUN 15% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

AMINOPLASMAL B. BRAUN 15% Solution for Infusion

Amino Acids

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:

1. What AMINOPLASMAL B. BRAUN 15% is and what it is used for
2. What you need to know before you use AMINOPLASMAL B. BRAUN 15%
3. How to use AMINOPLASMAL B. BRAUN 15%
4. Possible side effects
5. Storage of AMINOPLASMAL B. BRAUN 15%
6. Contents of the pack and other information

1. What is Aminoplasmal B.Braun 15% and what is it used for

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 to recover.

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

2. What you need to know before you use Aminoplasmal B.Braun 15%

Do not use AMINOPLASMAL B. BRAUN 15%

• if you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6)

components of this medicine

• if you have an inborn error 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)
• if acidic substances accumulate in your blood (metabolic acidosis)
• if you have severe liver disease (severe liver failure)
• if you have severe untreated kidney failure with an artificial kidney or treatments
  • - if you have poorly controlled heart failure with significant impairment of blood circulation (decompensated heart failure)

• if you have water in your lungs (pulmonary edema)
• if you have excess water in your body (hyperhydration)
  • if your body fluid levels, salt concentration, and blood acidity are not normal (hydroelectrolytic imbalance disorders)

This solution must not be administered to newborns and children under 2 years of age because the composition of the solution does not adequately meet 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-inborn error of protein metabolism, your doctor will decide very carefully whether you can or should be given this medicine.

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

If the total concentration of dissolved substances in your blood is too high, your doctor will be particularly careful to avoid worsening of this disorder.

If your liver or kidneys are not functioning properly, your daily dose will be adjusted very carefully according to the impairment of your liver or kidney function and your type of treatment.

If you lack water and salts at the same time, you will first receive sufficient amounts of these to correct this disorder.

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

While you are receiving this medicine, the concentrations of salts and sugar in your blood, the water balance, the acid-base balance, the proteins in your blood, and the kidney and liver functions will be monitored. For this purpose, blood samples will be taken from you and your urine will be collected.

To make your intravenous nutrition complete, you will also receive carbohydrate solutions, and possibly also fat emulsions. Additionally, you will be administered essential fatty acids, vitamins, fluids, trace elements, and electrolytes as needed.

Children and adolescents

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

Using AMINOPLASMAL B. BRAUN 15% 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

There are no data on the use of AMINOPLASMAL B. BRAUN 15% in pregnant women. If you are pregnant, you will receive this medicine 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 on newborns/infants are expected. However, breastfeeding is not recommended if women need intravenous nutrition at that time.

Driving and using machines

This medicine has no influence on your ability to drive and use machines.

AMINOPLASMAL B. BRAUN 15% contains sodium

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

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

3. How to use Aminoplasmal B.Braun 15%

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

Your doctor will decide on the amount of this medicine you need and for how long you will be given this medicine.

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

Dosage

The amount of solution you will receive depends on your requirements for amino acids and fluids, and also on your existing disorder or disease.

Adults

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

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

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

Use in children

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

The dose for children is adjusted individually according to the child's age, developmental status, and clinical condition.

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

• For children from 2 to 4 years of age: 10 ml per kg of body weight per day, which corresponds to 1.5 g of amino acids per kg of body weight per day
• For children from 5 to 13 years of age: 6.7 ml per kg of body weight per day, which corresponds to 1.0 g of amino acids per kg of body weight per day
• Seriously ill children: if your child is seriously ill, the amount of amino acids needed may be higher (up to 3.0 g of amino acids per kg of body weight per day).

The infusion rate must not be more than 0.67 ml per kg of body weight per hour.

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 use

This medicine can be used as long as you need intravenous nutrition.

Method of administration

This medicine will be administered by infusion (drip) into a large central vein.

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

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

If this happens, your infusion will be stopped and started again some time later at a lower speed.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you get any of the following side effects, tell your doctor immediately, who will stop administering this medicine to you:

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

• Allergic reactions

Other side effects are:

Uncommon (affect 1 to 10 users in 1,000):

• Nausea, vomiting

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via 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 15%

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 on the outer packaging after «EXP:». The expiry date is the last day of the month stated.

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

Do not freeze.

Use only if the solution is clear and colorless or slightly straw-colored and the bottle and its closure do not show any signs of damage.

The bottles are for single use only. After use, any remaining solution after an infusion and the packaging must be discarded.

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 15%

The active substances are amino acids.

The solution contains:

The other ingredients are sodium hydroxide, citric acid monohydrate, and water for injections.

1,000 ml of solution contain:

Appearance of the product and pack contents

AMINOPLASMAL B. BRAUN 15% is a solution for infusion. The solution is clear, colorless, or slightly straw-colored.

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

• Content: 500 ml, 1,000 ml
• Pack sizes: 1 × 500 ml, 10 × 500 ml, 1 × 1,000 ml, 6 × 1,000 ml

Not all pack sizes may be marketed.

Marketing authorisation 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

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 medicine is authorised in the Member States of the European Economic Area under the following names:

France AMINOPLASMAL 25, solution pour perfusion

Germany AMINOPLASMAL – 15 % electrolyte- and carbohydrate-free

Poland AMINOPLASMAL 15 %

Spain AMINOPLASMAL B. BRAUN 15% solution for infusion

United Kingdom Aminoplasmal 15% solution for infusion

Date of last revision of this leaflet: June/2018

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”

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This information is intended only for healthcare professionals:

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

From a microbiological point of view, the mixtures should be administered immediately after preparation. If not administered immediately, the times and conditions of storage of the mixtures before administration are the responsibility of the user and would normally not exceed 24 hours at 2 °C to 8 °C, unless the mixture has been prepared in controlled and validated aseptic conditions.

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

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