Aminosteril n-hepa 8%

Patient Information Leaflet

AMINOSTERIL N-HEPA 8%, solution for infusion
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What AMINOSTERIL N-HEPA 8% is and what it is used for
2. What you need to know 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 pack and other information

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

AMINOSTERIL N-HEPA 8% is an amino acid solution for parenteral nutrition. It should be used as part 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:

• Parenteral nutrition in severe cases of liver failure, with or without associated neurological dysfunction (hepatic encephalopathy), when oral or enteral nutrition is impossible, inadequate, or contraindicated.

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

When not to use AMINOSTERIL N-HEPA 8%
Do not use this medicinal product:

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

Warnings and precautions
Before starting treatment with AMINOSTERIL N-HEPA 8%, discuss this with your doctor or nurse.
During administration of AMINOSTERIL N-HEPA 8%, your doctor will order blood tests (to determine electrolyte, glucose, protein, creatinine levels, and liver function tests).
Your doctor will monitor fluid balance (the amount of fluids taken in and excreted from the body) and acid-base balance (appropriate ratio of acidic and alkaline compounds in the body).
When administered intravenously, especially via peripheral vein and at infusion rates higher than recommended, thrombophlebitis may occur (see section 4. Possible side effects).
Therefore, frequent monitoring of the infusion site is recommended.
The doctor will ensure the appropriate method of administration of this medicinal product.

AMINOSTERIL N-HEPA 8% and other medicinal products
Inform your doctor or pharmacist about all medicinal products the patient is currently using or has recently used, as well as any medicinal products the patient intends to use.
No interaction of AMINOSTERIL N-HEPA 8% with other medicinal products has been reported.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicinal product.
The doctor will decide whether to use this medicinal product during pregnancy or breastfeeding.

Driving and operating machinery
AMINOSTERIL N-HEPA 8% has no influence on the ability to drive or operate machinery.

3. How to use AMINOSTERIL N-HEPA 8%

This medicine is administered exclusively by medical personnel.
You must not use this medicine on your own.
If you have any doubts, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on the clinical condition, body weight, and laboratory test results.
Use of a higher than recommended dose of AMINOSTERIL N-HEPA 8%
If a higher than recommended dose is administered, inform the doctor or nurse immediately.
The medicine should be used strictly according to indications. Otherwise, disturbances in amino acid balance and severe metabolic disorders may occur.
In case of peripheral intravenous infusion at a rate higher than recommended, thrombophlebitis may occur (see section 4. Possible adverse reactions).
Overdose of the medicine, especially in patients with liver dysfunction due to 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.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
At the site of administration, thrombophlebitis (inflammation and small blood clots) may occur, characterized by a palpable vein hardening, redness around the vein, pain, and tenderness.
When the medicine is administered correctly, no other adverse reactions are known.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store AMINOSTERIL N-HEPA 8%

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Store in the original packaging to protect from light.
Once opened, the container must not be stored. Any unused portion of the 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 stated month.
Do not use this medicine if visible particles are present or if the container is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What AMINOSTERIL N-HEPA 8% contains

• The active substances are:

1000 ml of solution contains:
L-isoleucine 10.40 g
L-leucine 13.09 g
L-lysine acetate 9.71 g
corresponding to 6.88 g of L-lysine
L-methionine 1.10 g
N-acetyl-L-cysteine 0.70 g
(corresponding 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

• Other components: water for injections, glacial acetic acid.

Total amino acids 80.00 g/l
Total nitrogen 12.90 g/l
Total energy value 1340 kJ/l = 320 kcal/l
Theoretical osmolarity 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 contents of the pack
The medicine is a clear, colourless solution for infusion.
The pack is a glass bottle containing 500 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria

For further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Information intended exclusively for healthcare professionals:

Dosage and administration
Intravenous use.
Unless otherwise directed by a physician, the recommended dosage is:
1.0 to 1.25 ml/kg body weight/hour, corresponding 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, corresponding to 0.1 g of amino acids per kg body weight/hour.
Maximum daily dose:
1.5 g of amino acids/kg body weight, corresponding to 18.75 ml/kg body weight, equivalent to 1300 ml for a 70 kg body weight.
For administration via 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 product may be used as long as clinically indicated or until amino acid metabolism returns to normal.

Children
There are no data available on use in children.

Overdose
AMINOSTERIL N-HEPA 8% is an amino acid solution for parenteral nutrition. Acute toxicity does not occur when the product is administered according to indications.
Infusion into a peripheral vein at a rate exceeding the recommended rate may cause thrombophlebitis.
Exceeding the recommended doses, especially in patients with liver dysfunction due to disease, may lead to nausea, vomiting, chills, and increased renal excretion of amino acids. If symptoms of overdose occur, continue infusion at a reduced rate or discontinue infusion.

Preparation of the medicinal product for administration
After opening the bottle, the solution should be used immediately.
AMINOSTERIL N-HEPA 8% must be administered only using sterile equipment for intravenous infusion.
For single use only.
Do not use AMINOSTERIL N-HEPA 8% after the expiry date.
Use only clear solution, free from particulate matter, from an undamaged container.
Any unused portion from opened bottles must be discarded; do not store for later use.

Pharmaceutical incompatibilities
Do not mix amino acid solutions with other medicinal products, except for parenteral nutrition components, due to the risk of microbiological contamination and pharmaceutical incompatibilities.
When mixing AMINOSTERIL N-HEPA 8% with other parenteral nutrition components such as carbohydrates, fat emulsions, electrolytes, vitamins, or trace elements to provide complete parenteral nutrition, strict aseptic conditions must be maintained during mixing, and particular attention must be paid to pharmaceutical compatibility.
Information on pharmaceutical compatibility is available upon request from the responsible marketing authorization holder's representative.

Shelf life and storage conditions
Shelf life after first opening of the container
From a microbiological standpoint, the product should be used immediately, unless the method of opening excludes the risk of microbiological contamination.
Shelf life after mixing with other components
From a microbiological standpoint, the product should be used immediately. If not used immediately, the person administering the product is responsible for the storage conditions and duration. This period should not exceed 24 hours at a temperature of 2°C to 8°C, unless mixing was performed under controlled and validated aseptic conditions.
Store below 25°C.
Do not freeze.
Store in the original packaging to protect from light.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.