AMINOPLASMAL HEPA SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Aminoplasmal HEPA 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 Package Leaflet

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

1. What is Aminoplasmal HEPA and what is it used for

Aminoplasmal HEPA is a solution that is administered through a small tube with a cannula placed in a vein (intravenous infusion)

The solution contains essential amino acids for growth or recovery of the body.

You will receive this medicine when your liver function is severely damaged. It can help prevent or reverse deterioration of brain function associated with severe liver disease.

In these conditions, you may not be able to perform complex tasks. You may also feel drowsy, or become almost or completely unconscious.

You will receive this medicine if you cannot eat normally and 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 HEPA

Do not use Aminoplasmal HEPA

• 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 any congenital anomalies of protein and amino acid metabolism;
• if you have severe (potentially life-threatening) circulatory disorders (cardiovascular shock);
• if you have insufficient oxygen supply (hypoxia);
• if you have acidic substances accumulated in your blood (metabolic acidosis);
• if you have severe untreated kidney dysfunction (severe renal failure) not adequately treated with a hemodialysis apparatus or similar treatments;
• if you have poorly controlled heart failure with significant impairment of blood circulation (decompensated heart failure);
• if you have fluid accumulation in the lungs (acute pulmonary edema);
• if you have alterations in the balance of salt (electrolytes) and water in your body.

Newborns, Infants, and Children under 2 years

This solution must not be administered to newborns, infants, or children under 2 years, as the composition of the solution does not adequately meet the particular nutritional needs of this age group.

Children and Adolescents

The safety and efficacy of Aminoplasmal HEPA in children have not yet been established.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Aminoplasmal HEPA;

• if your kidneys do not work properly, your doctor will consider whether this solution is suitable for you. Your daily dose will be carefully adjusted according to the severity of renal failure;
• if you have any heart failure;
• if you have abnormally high blood serum concentration (high serum osmolality).

If you have alterations in the balance of salt and water, this condition should be corrected before you receive this medicine. Some examples of this condition are lack of water and salts at the same time (hypotonic dehydration) or lack of sodium (hyponatremia) or potassium (hypokalemia).

Before and while you receive this medicine, your blood salt levels, blood sugar levels, water balance, acid-base balance, blood proteins, and kidneys will be monitored. For this purpose, blood and urine samples will be taken and analyzed.

Established hepatic treatment will be continued. It will not be replaced with amino acid infusions.

Generally, you will be administered Aminoplasmal HEPA as part of an intravenous nutrition regimen that also includes non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, vitamins, fluids, and trace elements.

Use of Aminoplasmal HEPA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 receive this medicine only if your doctor considers it necessary for your recovery. There are no available data on the use of this medicine in pregnant women.

Breastfeeding

At therapeutic doses of Aminoplasmal HEPA, no effect on the newborn/infant is expected. However, breastfeeding is not recommended if women need intravenous nutrition 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 in a day-care unit). This will exclude driving and using machines.

Aminoplasmal HEPA contains Sodium

This medicine contains 6.9 to 52.9 mg of sodium (main component of kitchen/table salt) per 1000 ml. This is equivalent to 0.3% - 2.6% of the maximum recommended daily dose of sodium for an adult.

3. How to use Aminoplasmal HEPA

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

Adults

Your doctor will determine the amount you need daily.

As a general rule, it will be 8 to 15 ml/kg of body weight per day. The solution will flow at a speed not exceeding 1 ml per kg of body weight per hour.

Children and Adolescents

The doses for the age group indicated below are mean guideline values. The exact dose must be adjusted individually according to age, stage of development, and predominant disease and severity of the condition.

The initial dose will be 5 ml/kg of body weight/day up to a gradual increase of 15 ml/kg of body weight/day during treatment depending on the recovery of liver function.

The solution will flow at a speed not exceeding 1 ml per kg of body weight per hour.

Duration of treatment

This medicine can be used as long as you need intravenous nutrition and if there is a risk that brain function will worsen again.

If you receive more Aminoplasmal HEPA than you should

This is unlikely to happen since your doctor will determine your daily doses.

However, if you receive an overdose or the solution is administered too quickly, you may feel nausea, vomit, or suffer from chills or headache.

Additionally, your blood may contain too many acidic substances (metabolic acidosis) or too much ammonia (hyperammonemia), and you may lose amino acids in the urine.

You may also have too much fluid in your body (hyperhydration), your electrolyte balance may be altered (electrolyte imbalance), and you may have fluid in your lungs (pulmonary edema).

If this happens, the infusion can be interrupted and resumed at a lower speed after some time.

If you have used more Aminoplasmal HEPA than you should, consult your doctor, pharmacist, or call the Toxicology Information Service (telephone 91-562 04 20) indicating the medicine and the amount used.

If you have any further questions on the use of this product, 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 may not be related to Aminoplasmal HEPA but can occur with any type of intravenous nutrition, especially at the beginning.

The following side effects may be serious. If you experience any of the following side effects, tell your doctor immediately. He/she 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, nausea

Reporting of side effects:

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal HEPA

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 of the vial and the carton after EXP. The expiry date is the last day of the month stated.

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

Do not store above 25°C.

Do not freeze.

The remaining solution should never be stored for later use once the infusion is finished.

6. Contents of the pack and other information

Composition of Aminoplasmal HEPA

The active substances are amino acids.

This medicine contains:

The other components are: Disodium edetate and water for injections.

Appearance of the product and packaging

Aminoplasmal HEPA is a clear, colorless or slightly amber-colored aqueous solution.

The product is presented in transparent glass vials of 500 ml and 1000 ml, closed with elastomeric stoppers.

The 500 ml vials are available in packs of 10 units. The 1000 ml vials are available in packs of 6 units.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

• Braun Melsungen AG

Carl-Braun Strasse, 2

D-34212 Melsungen

Germany

Date of last revision of this leaflet:June 2019.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Handling instructions

No special requirements for disposal.

Single-use containers. Discard the container and unused contents after use.

It should only be used if the solution is clear, colorless, or slightly amber-colored and if the vial and its closure are not damaged.

Use a sterile administration set for the infusion of Aminoplasmal HEPA.

If it is necessary to add other nutrients, such as carbohydrates, lipids, vitamins, electrolytes, and trace elements, to this medicine during total parenteral nutrition, the mixture should be prepared under strict aseptic conditions. Mix well after adding any additive. Aminoplasmal HEPA can only be mixed with other nutrients whose compatibility has been documented. The compatibility data of the different additives and the corresponding shelf life of these mixtures can be provided by the manufacturer upon request.

Special precautions for storage

The product should not be used if the solution is not clear and colorless or slightly amber-colored or if the vial or its closure is damaged.

The containers are for single use. Discard the container and unused contents after use.

Shelf life

Unopened container

3 years

After first opening of the container

The medicine should be used immediately.

After mixing with additives

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

For complete information on this medicine, consult the Summary of Product Characteristics.