Aminosteril N-hepa 8%

Leaflet attached to the packaging: information for the user

AMINOSTERIL N-HEPA 8%, solution for infusion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is AMINOSTERIL N-HEPA 8% and what is it used for
• 2. Important information before using AMINOSTERIL N-HEPA 8%
• 3. How to use AMINOSTERIL N-HEPA 8%
• 4. Possible side effects
• 5. How to store AMINOSTERIL N-HEPA 8%
• 6. Contents of the packaging and other information

1. What is AMINOSTERIL N-HEPA 8% and what is it used for

AMINOSTERIL N-HEPA 8% is an amino acid solution intended for parenteral nutrition. It should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins and trace elements.
The medicine is administered by intravenous infusion.
Indications for use:

• Parenteral nutrition in severe cases of liver failure, with or without accompanying disorders of the nervous system (hepatic encephalopathy), when oral or enteral nutrition is impossible, insufficient or contraindicated.

2. Important information before using AMINOSTERIL N-HEPA 8%

When not to use AMINOSTERIL N-HEPA 8%

Do not use the medicine:

• if the patient has amino acid metabolism disorders (components of proteins);
• if the patient has metabolic acidosis (accumulation of excessive amounts of acidic substances or decreased concentration of basic substances in the blood);
• if the patient is overhydrated (excess water in the body);
• if the patient has decreased sodium levels in the blood (hyponatremia);
• if the patient has decreased potassium levels in the blood (hypokalemia);
• if the patient has kidney failure;
• if the patient has uncontrolled circulatory failure (decreased blood flow through tissues and organs, manifested by shortness of breath, fatigue, swelling of the lower limbs);
• if the patient is in shock and has symptoms of hypoxia (life-threatening condition caused by hypoxia of vital organs).

Warnings and precautions

Before starting treatment with AMINOSTERIL N-HEPA 8%, discuss it with your doctor or nurse.
During administration of AMINOSTERIL N-HEPA 8%, the doctor will order blood tests (determination of electrolyte levels, glucose, proteins, creatinine and liver function tests).
The doctor will also order monitoring of fluid balance (amount of fluids taken in and excreted by the body) and acid-base balance (proper ratio of acidic and basic compounds in the body).
During peripheral vein infusion (especially with a rate greater than recommended), thrombophlebitis (see section 4. Possible side effects) may occur.
Therefore, frequent checks of the infusion site are recommended.
The doctor will ensure the proper administration of this medicine.

AMINOSTERIL N-HEPA 8% and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interaction between AMINOSTERIL N-HEPA 8% and other medicines has been found.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before using this medicine.
The doctor will decide whether to use this medicine in pregnant or breastfeeding women.

Driving and using machines

AMINOSTERIL N-HEPA 8% has no effect on the ability to drive and use machines.

3. How to use AMINOSTERIL N-HEPA 8%

This medicine is administered only by medical personnel. Do not use the medicine yourself.
In case of doubts, consult a doctor.
The dosage is determined individually by the doctor for each patient, depending on their clinical condition, body weight and laboratory test results.

Using a higher dose of AMINOSTERIL N-HEPA 8% than recommended

In case of using a higher dose of the medicine, tell your doctor or nurse immediately.
The medicine should be used according to the instructions. Otherwise, amino acid imbalance and severe metabolic disorders may occur.
During peripheral vein infusion with a rate greater than recommended, thrombophlebitis (see section 4. Possible side effects) may occur.
Overdose of the medicine, especially in patients with liver function disorders caused by the disease, may cause nausea, vomiting, chills and increased excretion of amino acids by the kidneys.
If symptoms of overdose occur, the doctor will decide on further use of this medicine.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the injection site, thrombophlebitis (formation of inflammation and small blood clots, manifested by palpable hardening of the vein, redness around it, pain and tenderness) may occur.
During proper administration of the medicine, no other side effects are known.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AMINOSTERIL N-HEPA 8%

Store the medicine out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Store in the original packaging to protect from light.
After opening, the packaging cannot be stored. Unused medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice any solid particles in it or if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What AMINOSTERIL N-HEPA 8% contains

• The active substances of the medicine are:

1000 ml of solution contains:
L-isoleucine
10.40 g
L-leucine
13.09 g
L-lysine acetate
9.71 g
which corresponds to 6.88 g of L-lysine
L-methionine
1.10 g
N-acetyl-L-cysteine
0.70 g
(which corresponds to 0.52 g of L-cysteine)
L-phenylalanine
0.88 g
L-threonine
4.40 g
L-tryptophan
0.70 g
L-valine
10.08 g
L-arginine
10.72 g
L-histidine
2.80 g
glycine
5.82 g
L-alanine
4.64 g
L-proline
5.73 g
L-serine
2.24 g

• The other ingredients are water for injections, acetic acid.

Amino acids in total
80.00 g/l
Total nitrogen
12.90 g/l
Total energy value
1340 kJ/l = 320 kcal/l
Theoretical osmolality
770 mOsm/l
Acidity of the solution

• 12 - 25 mmol NaOH/l pH 5.7 - 6.3

What AMINOSTERIL N-HEPA 8% looks like and what the packaging contains

The medicine is a clear, colorless solution for infusion.
The packaging of the medicine is a glass bottle containing 500 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the leaflet:04.11.2024

Information intended exclusively for healthcare professionals:

Dosage and administration

Intravenous administration.
Unless otherwise prescribed by the doctor, the recommended dosage is:
1.0 to 1.25 ml/kg body weight/hour, which corresponds to 0.08 to 0.1 g of amino acids per kg body weight/hour.
Maximum infusion rate:
1.25 ml/kg body weight/hour, which corresponds to 0.1 g of amino acids per kg body weight/hour.
Maximum daily dose:
1.5 g of amino acids/kg body weight, which corresponds to 18.75 ml/kg body weight, which corresponds to 1300 ml for 70 kg body weight.
For administration into a central or peripheral vein.
AMINOSTERIL N-HEPA 8% should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins and trace elements.
Ideally, carbohydrate solutions and/or fat emulsions should be administered simultaneously.
The medicine can be used for as long as the patient's clinical condition requires or until amino acid metabolism returns to normal.
Children:
There are no data on the use of the medicine in children.

Overdose

AMINOSTERIL N-HEPA 8% is an amino acid solution for parenteral nutrition.
Acute poisoning does not occur if the medicine is administered according to the instructions.
Infusion into a peripheral vein at a rate greater than recommended may cause thrombophlebitis.
Exceeding the recommended doses, especially in patients with liver function disorders caused by the disease, may cause nausea, vomiting, chills and increased excretion of amino acids by the kidneys. If symptoms of overdose occur, continue the infusion at a lower rate or discontinue it.

Preparation of the medicine for use

After opening the bottle, the medicine should be used immediately.
AMINOSTERIL N-HEPA 8% should only be used with sterile equipment for administration.
For single use only.
Do not use the medicine AMINOSTERIL N-HEPA 8% after the expiry date.
Use only a clear solution free from solid particles, with undamaged packaging.
Unused contents of opened bottles should be discarded; they should not be stored for further use.

Incompatibilities

Do not mix amino acid solutions with other medicines, except for parenteral nutrition products, due to the risk of microbial contamination and incompatibilities.
When mixing the medicine AMINOSTERIL N-HEPA 8% with other components of parenteral nutrition, such as carbohydrates, fat emulsions, electrolytes, vitamins or trace elements, to ensure complete parenteral nutrition, pay particular attention to maintaining aseptic conditions during mixing and, in particular, to pharmaceutical compatibility.
Data on pharmaceutical compatibility are available on request from the representative of the marketing authorization holder.

Shelf life and storage conditions

Shelf life after first opening of the packaging
From a microbiological point of view, the medicine should be used immediately, unless the opening method precludes the risk of microbial contamination.
Shelf life after mixing with other components
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the person administering the medicine is responsible for the storage conditions and time after mixing. This time should not exceed 24 hours at a temperature of 2°C to 8°C, unless mixing took place in controlled and validated aseptic conditions.
Store in a temperature below 25°C.
Do not freeze.
Store in the original packaging to protect from light.

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.