Label: Information for the User

Aminoplasmal HEPA Solution for Infusion

Amino Acids

Read this label carefully before starting to use the 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 HEPA is asolution that is administered through a small catheter placed in a vein (intravenous perfusion)

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

You will receive this medication when your liver function is severely impaired. It may help prevent or reverse a decline in brain function associated with severe liver diseases.

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

You will receive this medication 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 2years old.

Do not use Aminoplasmal HEPA

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6);
• if you have any congenital anomalies of protein and amino acid metabolism;
• if you have severe (potentially life-threatening) circulation disorders (cardiovascular shock);
• if you have insufficient oxygen supply (hypoxia);
• if you have accumulated acidic substances in your blood (metabolic acidosis);
• if you have severe kidney dysfunction (severe renal insufficiency) not adequately treated with a hemodialysis device or similar treatments;
• if you have uncontrolled heart failure with significant deterioration of blood circulation (decompensated heart failure);
• if you have acute pulmonary edema;
• if you have alterations in the balance of salt (electrolytes) and water in your body.

Newborns, infants, and children under two years

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

Children and adolescents

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

Warnings and precautions

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

• if your kidneys do not function properly, your doctor will consider whether this solution is suitable for you. Your daily dose will be carefully adjusted based on the severity of renal insufficiency;
• if you have any heart function insufficiency;
• if you have an 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 receiving this medication. Examples of this condition include dehydration with low sodium and potassium levels (hypotonic dehydration) or low sodium (hyponatremia) or potassium (hypokalemia) levels.

Before and while receiving this medication, your levels of salt in the blood, blood sugar, fluid balance, acid-base balance, blood proteins, and kidneys will be monitored. Blood and urine samples will be taken and analyzed for this purpose.

Continue with established liver treatment. Do not substitute with amino acid infusions.

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

Use of Aminoplasmal HEPA with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

At therapeutic doses of Aminoplasmal HEPA, no effect is expected on the newborn/infant. However, breastfeeding is not recommended if women need intravenous nutrition at the same time.

Driving and operating machinery

This medication is usually administered to immobile patients in a controlled environment (emergency treatment, acute treatment in a hospital or day care unit). This will exclude driving and operating machinery.

Aminoplasmal HEPA contains Sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult again with your doctor or pharmacist.

Dosage

Adults

Your doctor will determine the amount you need daily

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

Children and adolescents

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

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

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

Treatment duration

This medication can be used as long as you need intravenous nutrition and there is a risk that brain function may 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, vomiting, or experience 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 your urine

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

If this happens, the infusion may be interrupted and resumed at a lower speed after a certain time

If you have used more Aminoplasmal HEPA than you should, consult your doctor, pharmacist immediately or call the Toxicological Information Service (phone 91-562 04 20) indicating the medication and the amount used

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

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

These adverse effects are not necessarily related to Aminoplasmal HEPA, but can 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. Your doctor 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, Nausea

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. 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 bottle and the box after CAD. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 25°C.

Do not freeze.

The remaining solution should never be stored for future use once the infusion is completed.

Composition of Aminoplasmal HEPA

The active principles are amino acids.

This medication contains:

The other components are: Edetate disodium and water for injection preparations.

Appearance of the product and contents of the package

Aminoplasmal HEPA is a transparent, colorless or slightly yellowish aqueous solution.

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. Braun Melsungen AG

Carl-Braun Strasse, 2

D-34212 Melsungen

Germany

Last review date of this leaflet:June 2019.

Other sources of information

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (http//www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Handling instructions

No special disposal conditions are required.

Single-use containers. Dispose of thecontainer and contentsnot usedafter use.

Only useif the solution istransparent, colorless or slightly yellowish and the bottle and its closureare not damaged.

Use a sterile administration equipment for theperfusion of Aminoplasmal HEPA..

If during total parenteral nutrition it is necessary to add other nutrients such as, for example, carbohydrates, lipids, vitamins, electrolytes and oligoelements to this medication, the mixture should be prepared in 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 on request.

Special precautions for storage

The product should not be used if the solution is not transparent and colorless or slightly yellowish or if the bottle or its closure is damaged.

The containers are for single use. Dispose of the container and contents not used after use.

Shelf life

Unopened container

3years

After the first opening of the container

The medication should be used immediately.

After mixing with additives

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

For complete information on this medication, consult the Medicinal Product Technical File.