Aminoplasmal Hepa 10%

Package Leaflet: Information for the User

Aminoplasmal Hepa – 10%, Solution for Injection

Amino Acids

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Aminoplasmal Hepa – 10% and what is it used for
• 2. Important information before using Aminoplasmal Hepa – 10%
• 3. How to use Aminoplasmal Hepa – 10%
• 4. Possible side effects
• 5. How to store Aminoplasmal Hepa – 10%
• 6. Contents of the pack and other information

1. What is Aminoplasmal Hepa – 10% and what is it used for

Aminoplasmal Hepa – 10% is a solution administered through a tube with a needle inserted into a vein (intravenous infusion).
The solution contains amino acids, which are essential for the body's growth or recovery.
The medicine is administered in cases of severe liver disorders. It may prevent the occurrence or lead to the disappearance of brain function disorders that occur in severe liver diseases.
In such cases, the patient may not be able to perform complex tasks. They may also be sleepy, almost or completely unconscious.
The medicine is administered to patients who are unable to take food normally or cannot be fed through a tube inserted into the stomach. This solution can be used in adults, adolescents, and children over 2 years old.

2. Important information before using Aminoplasmal Hepa – 10%

When not to use Aminoplasmal Hepa – 10%

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a congenital defect of protein and amino acid metabolism;
• if the patient has severe (life-threatening) circulatory disorders (shock);
• if the patient has insufficient oxygen supply (hypoxia);
• if the patient's blood has accumulated acidic substances (metabolic acidosis).
• if the patient has severe kidney disease (severe renal failure) that is not properly treated with dialysis or similar therapies;
• if the patient has uncontrolled heart failure with significant circulatory disorders (uncontrolled heart failure);
• if the patient has fluid accumulation in the lungs (acute pulmonary edema);
• if the patient has electrolyte or fluid balance disorders.

Newborns, infants, and young children under 2 years of age
The solution should not be administered to newborns, infants, and children under 2 years of age, as the composition of the solution is not suitable for the special needs of this age group.
Children and adolescents
The safety and efficacy of Aminoplasmal Hepa – 10% in children have not been established.

Warnings and precautions

Before starting treatment with Aminoplasmal Hepa – 10%, the patient should discuss it with their doctor or pharmacist,

• if the patient has kidney function disorders, the doctor will carefully consider the use of the medicine. Then, the daily dose will be carefully adjusted according to the severity of the kidney function disorders;
• if the patient has heart function disorders;
• if the patient has highly concentrated blood serum (high osmolality of serum).

In case of fluid or electrolyte balance disorders before administering this medicine, such disorders should be corrected. Examples of such disorders include concurrent fluid and electrolyte deficiency (hypotonic dehydration), sodium deficiency (hyponatremia), or potassium deficiency (hypokalemia).
Before and during the administration of this medicine, the doctor will monitor the levels of electrolytes, blood sugar, fluid balance, acid-base balance, protein levels in the blood, and kidney function. To this end, blood and urine samples will be taken and analyzed.
The current treatment of liver disease will be continued. It will not be replaced by amino acid infusions.
Patients usually receive Aminoplasmal Hepa – 10% as part of intravenous nutrition, which also includes non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, vitamins, fluids, and trace elements.

Aminoplasmal Hepa – 10% and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
If the patient is pregnant, they will receive this medicine only if the doctor considers it necessary for their recovery. There is no available data on the use of this medicine in pregnant women.
Breastfeeding
At therapeutic doses of Aminoplasmal Hepa – 10%, no effect on the breastfed newborn/child is expected. Nevertheless, breastfeeding is not recommended for women who require intravenous nutrition.

Driving and using machines

The medicine is usually administered to immobilized patients in a controlled environment (emergency treatment, acute episode treatment in a hospital or day ward). This excludes driving and operating machines.
Aminoplasmal Hepa – 10% contains sodium
The medicine contains from 0.3 to 2.3 mmol of sodium (the main component of common salt) per 1000 ml. The doctor will take this into account in patients who need to control their sodium intake.

3. How to use Aminoplasmal Hepa – 10%

This medicine is administered by medical professionals.
Dosage
Adults
The doctor will carefully adjust the dose based on the patient's age, development stage, and underlying disease.
Usually, it will be 8 to 15 ml per kg of body weight per day. The solution will be administered at a rate not exceeding 1 ml per kg of body weight per hour.
Duration of treatment
This medicine can be used for as long as the patient requires intravenous nutrition and for as long as there is a risk of brain function deterioration.
Method of administration
The medicine will be administered through a tube inserted into a vein (intravenous infusion).

Using a higher dose of Aminoplasmal Hepa – 10% than recommended

This is unlikely, as the doctor determines the daily doses for the patient.
However, if the patient receives a higher dose of the solution than recommended or the solution is administered too quickly, they may experience nausea, vomiting, chills, or headache.
It may also lead to an increase in the level of acidic substances (metabolic acidosis) or ammonia (hyperammonemia) in the blood and to the loss of amino acids in the urine.
There may also be an excess of fluid in the body (overhydration), electrolyte balance disorders, and fluid accumulation in the lungs (pulmonary edema).
In such a case, the infusion will be discontinued and resumed later at a slower rate.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Such side effects are not clearly related to Aminoplasmal Hepa – 10%, but rather to intravenous nutrition in general, especially in the initial treatment phase.

The following side effects may be serious. If you experience any of the following side effects, tell your doctor immediately, who will discontinue the administration of this medicine:

Unknown (frequency cannot be estimated from the available data)

• allergic reactions

Other side effects

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aminoplasmal Hepa – 10%

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton.
The expiry date refers to the last day of the stated month.
Store the bottle in the outer packaging to protect it from light.
Do not store above 25°C.
Do not freeze.
After infusion, never store the remaining solution for later use.

6. Contents of the pack and other information

What Aminoplasmal Hepa – 10% contains

The active substances of the medicine are amino acids.
The medicine contains:
per 1 ml
per 500 ml
per 1000 ml
Isoleucine
8.80 mg
4.40 g
8.80 g
Leucine
13.60 mg
6.80 g
13.60 g
Lysine acetate
10.60 mg
5.30 g
10.60 g
(which corresponds to the amount of lysine)
(7.51 mg)
(3.75 g)
(7.51 g)
Methionine
1.20 mg
0.60 g
1.20 g
Phenylalanine
1.60 mg
0.80 g
1.60 g
Threonine
4.60 mg
2.30 g
4.60 g
Tryptophan
1.50 mg
0.75 g
1.50 g
Valine
10.60 mg
5.30 g
10.60 g
Arginine
8.80 mg
4.40 g
8.80 g
Histidine
4.70 mg
2.35 g
4.70 g
Glycine
6.30 mg
3.15 g
6.30 g
Alanine
8.30 mg
4.15 g
8.30 g
Proline
7.10 mg
3.55 g
7.10 g
Aspartic acid
2.50 mg
1.25 g
2.50 g
Asparagine monohydrate
0.55 mg
0.27 g
0.55 g
(which corresponds to the amount of asparagine)
(0.48 mg)
(0.24 g)
(0.48 g)
Acetylcysteine
0.80 mg
0.40 g
0.80 g
(which corresponds to the amount of cysteine)
(0.59 mg)
(0.29 g)
(0.59 g)
Glutamic acid
5.70 mg
2.85 g
5.70 g
Ornithine hydrochloride
1.66 mg
0.83 g
1.66 g
(which corresponds to the amount of ornithine)
(1.30 mg)
(0.65 g)
(1.30 g)
Serine
3.70 mg
1.85 g
3.70 g
Acetyltyrosine
0.86 mg
0.43 g
0.86 g
(which corresponds to the amount of tyrosine)
(0.70 mg)
(0.35 g)
(0.70 g)
Other ingredients are sodium hydroxide or hydrochloric acid (to adjust pH), disodium edetate, and water for injections.

Electrolyte concentrations

Acetates
51
mmol/l
Chlorides
10
mmol/l
Amino acid content
100
g/l
Nitrogen content
15.3
g/l
Energy value
1675
kJ/l ≙ 400 kcal/l
Theoretical osmolality
875
mOsm/l
pH
5.5 – 6.5

What Aminoplasmal Hepa – 10% looks like and contents of the pack

Aminoplasmal Hepa – 10% is a clear and colorless or slightly yellowish aqueous solution.
The product is supplied in 500 ml glass bottles closed with elastomeric stoppers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany

Mailing address:
34209 Melsungen, Germany
Phone number:
+49-5661-71-0
Fax:
+49-5661-71-45 67

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only:

Instructions for handling the medicine

No special requirements for disposal.
Containers are intended for single use only. After use, the container and any remaining medicine should be disposed of.
Use only if the solution is clear and colorless or slightly yellowish and the bottle and its closure are not damaged.
Use only a sterile infusion set for the administration of Aminoplasmal Hepa – 10% solution.
If it is necessary to add other nutritional components to this medicinal product, such as carbohydrates, fats, vitamins, electrolytes, and trace elements, in the context of total parenteral nutrition, such additions should be made under strictly aseptic conditions.
Shake well after adding any additives. Aminoplasmal Hepa – 10% should only be mixed with other nutritional components for which compatibility has been documented. Information on compatibility for various additives and the shelf life of such additives can be obtained from the manufacturer upon request.

Special precautions for storage

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

Shelf life Unopened container

3 years
After first opening of the container
The medicinal product should be used immediately.
After addition of additives
From a microbiological point of view, the mixture should be infused immediately. If the mixture is not infused immediately, the responsibility for the storage conditions and storage time before administration lies with the user and normally should not exceed 24 hours at 2°C-8°C, unless mixing has been carried out under controlled and validated aseptic conditions.
For further information on this medicinal product, see the Summary of Product Characteristics.