AMINOSTERIL N-HEPA 8% SOLUTION FOR INTRAVENOUS INFUSION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminosterid N-Hepa 8% solution for infusion

Package leaflet contents:

1. What Aminosteril N-Hepa 8% is and what it is used for
2. What you need to know before starting to use Aminosteril N-Hepa 8%
3. How to use Aminosteril N-Hepa 8%
4. Possible side effects
5. Storage of 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 a solution for intravenous infusion. It belongs to a group of medicines known as amino acid solutions for parenteral nutrition.

Aminosteril N-Hepa 8% is used to provide amino acids as part of a parenteral nutrition regimen in severe cases of hepatic insufficiency with or without encephalopathy, when oral or enteral nutrition is impossible, insufficient, or contraindicated.

2. What you need to know before using Aminosteril N-Hepa 8%

You will not be given Aminosteril N-Hepa 8% if you have:

• an allergy to any of the components present in the solution
• a congenital disorder in amino acid metabolism
• severe circulatory impairment with life-threatening risk (shock)
• inadequate supply of oxygen (hypoxia)
• accumulation of acidic substances in your blood (metabolic acidosis)
• kidney insufficiency
• excessively low levels of sodium (hyponatremia) or potassium (hypokalemia)

You should not receive infusions if you have:

• decompensated heart failure
• fluid accumulation in your lungs (pulmonary edema)
• excess water in your body (hyperhydration)

If you have any of the conditions mentioned above, you must not be given Aminosteril N-Hepa 8%. Inform your healthcare professional so that this treatment is not administered to you.

Warnings and precautions

If you experience an allergic reaction while receiving Aminosteril N-Hepa 8%, the infusion must be stopped immediately. Inform your doctor or nurse if you experience any of the following symptoms during the infusion:

• Fever (high temperature)
• Chills
• Skin rash
• Difficulty breathing

Possible signs of inflammation or infection at the infusion site should be checked daily.

Children

There is no experience with use in children.

Other medicines and Aminosteril N-Hepa 8%

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Use of Aminosteril N-Hepa 8% with food and beverages

Aminosteril N-Hepa 8% has no negative effect when administered together with food and beverages.

Pregnancy, lactation:

Specific studies to evaluate the safety of Aminosteril N-Hepa 8% during pregnancy or lactation have not been conducted.

The physician must consider the benefit-risk balance before administering Aminosteril N-Hepa 8% to pregnant or breastfeeding women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicinal product.

Driving and use of machines

After receiving Aminosteril N-Hepa 8%, your ability to drive or operate machinery is not expected to be affected.

3. How to use Aminosteril N-Hepa 8%

Aminosteril N-Hepa 8% will be administered into your bloodstream via an intravenous infusion.

Your doctor will determine your dose based on your body weight and clinical condition.

For physicians and healthcare professionals, please refer to “Posology and method of administration” at the end of this leaflet, which provides detailed information on dosage and administration.

If you receive more Aminosteril N-Hepa 8% than you should

Aminosteril N-Hepa 8% is an amino acid solution for parenteral nutrition. Acute intoxication is unlikely when the solution is used as recommended.

Too rapid infusion through peripheral veins may cause thrombophlebitis (due to the osmolarity of the solution).

Depending on the patient's prior condition, overdose may lead to disturbances in pathologically-induced regulation, worsening of liver function, nausea, vomiting, chills, and renal loss of amino acids.

If symptoms of overdose occur, the infusion should be slowed down or stopped.

In case of overdose or accidental ingestion, contact your doctor or the Toxicology Information Service immediately. Telephone (91) 562 04 20.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

As with all hypertonic infusion solutions, thrombophlebitis may occur if peripheral veins are used.

Between 1 and 10 out of every 1,000 patients treated may experience headache, chills, fever, nausea or vomiting. Although these effects are not related to this solution, they may generally occur with parenteral nutrition, especially at the beginning.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any other type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http:\www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of AMINOSTERIL N-HEPA 8%

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not freeze.

Store protected from light.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Use Aminosteril N-Hepa 8% only if the solution is clear, colourless, free from particles, and the container is intact.

Dispose of any unused solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Aminosteril N-Hepa 8% per 1000 ml:

corresponding to L-Cysteine 0.52 g

L-phenylalanine 0.88 g

The other components are: Water for injections

Appearance of the product and contents of the pack

Aminosteril N-Hepa 8% is a sterile, clear and colourless solution.

Pack sizes:

Glass bottles of 500 ml

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005-Barcelona (Spain)

Manufacturer

Fresenius Kabi Austria GmbH

Haffnerstrasse 36,

A-8055 Graz,

Austria

This leaflet has been reviewed in February 2009

Other sources of information

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

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This information is intended for healthcare professionals only:

Dosage and method of administration For intravenous infusion only.

Unless otherwise prescribed, the recommended dose is:

1.0 to 1.25 ml/kg body weight/hour = 0.08 – 0.1 g amino acids per kg body weight per hour.

Maximum infusion rate:

1.25 ml/kg body weight/hour corresponding to 0.1 g amino acids/kg body weight/hour

Maximum daily dose:

1.5 g of amino acids/kg body weight

corresponding to 18.75 ml/kg body weight

corresponding to 1,300 ml for a body weight of 70 kg

For administration via peripheral or central venous route.

Aminosteril N-Hepa 8% is used as part of a total parenteral nutrition regimen in combination with adequate amounts of energy supplements (carbohydrate solutions, lipid emulsions), electrolytes, vitamins and trace elements.

For adequate administration, carbohydrate solutions and/or lipid emulsions must be administered simultaneously.

This preparation may be used as long as clinically indicated or until the patient's amino acid metabolism has normalized.

Warnings and precautions for use

Serum electrolytes, fluid balance and acid-base balance should be monitored. Laboratory monitoring should also include blood glucose, serum proteins, creatinine, and liver function tests.

If necessary, electrolytes and carbohydrates should be administered in balanced doses, using a Y-site connection or a "all-in-one" mixing bag.

Due to the special composition of this product, its use in indications other than those recommended may lead to amino acid imbalances and serious metabolic disturbances.

The choice between peripheral or central vein administration depends on the final osmolarity of the mixture. The generally accepted limit for peripheral infusions is approximately 800 mosm/L, but this varies considerably depending on the patient's age, general condition, and characteristics of the peripheral veins.

To minimize the risk of thrombophlebitis during peripheral administration, frequent changes of the infusion site are recommended.

Incompatibilities

Amino acid solutions must not be mixed with other medicinal products except parenteral nutrition products, due to the risk of microbiological contamination and incompatibilities.

Mixing with other parenteral nutrition products should only be performed when compatibility has been documented. See section below, Instructions for use/handling.

Instructions for use/handling

For intravenous use only.

Use immediately after opening the bottle.

Aminosteril N-Hepa 8% must be used exclusively with a sterile administration set.

For single use only.

Do not use Aminosteril N-Hepa 8% after the expiry date stated on the packaging.

Use only clear, particle-free solutions in intact containers.

Discard any unused solution remaining after use.

Amino acid solutions must not be mixed with other medicinal products except parenteral nutrition products, due to the high risk of microbiological contamination and incompatibilities. When mixing with other nutrients such as carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to achieve complete parenteral nutrition, care must be taken regarding the use of aseptic techniques, mixing procedures, and particularly compatibility.

Compatibility data from the manufacturer are available upon request.

Shelf life

Shelf life of the packaged medicine for sale

3 years

Shelf life after opening the container

From a microbiological standpoint, unless the opening method avoids the risk of microbiological contamination, the product should be used immediately.

Shelf life after mixing with other components

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user. Normally, the mixture should not be stored for more than 24 hours at 2-8°C, unless the mixture has been prepared under controlled, validated aseptic conditions.