AMINOSTERIL N-HEPA 8% SOLUTION FOR INTRAVENOUS INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminosteril N-Hepa 8%solution for infusion

Contents of the pack:

1. What is Aminosteril N-Hepa 8% and what is it used for
2. What you need to know before you 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 is Aminosteril N-Hepa 8% and what is it used for

Aminosteril N-Hepa 8% is a solution for intravenous infusion. It belongs to the group of medicines known as amino acid solutions for parenteral nutrition.

Aminosteril N-Hepa 8% is used to provide an intake of 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 you use Aminosteril N-Hepa 8%

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

• are allergic to any of the components present in the solution
• have any congenital anomaly in amino acid metabolism
• have a severe alteration of circulation with vital risk (shock)
• have insufficient oxygen supply (hypoxia)
• have acidic substances accumulated in your blood (metabolic acidosis)
• have kidney failure
• have low levels of sodium (hyponatremia) or potassium (hypokalemia)

You should not receive infusions if you have:

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

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

Warnings and precautions

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

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

You should be checked daily at the infusion site for possible signs of inflammation or infection.

Children

There is no experience in children.

Other medicines and Aminosteril N-Hepa 8%

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Using Aminosteril N-Hepa 8% with food and drinks

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

Pregnancy, breast-feeding:

No specific studies have been conducted to evaluate the safety of Aminosteril N-Hepa 8% in pregnancy or breast-feeding.

Your doctor will consider the benefit/risk ratio before administering Aminosteril N-Hepa 8% to pregnant or breast-feeding women.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

After receiving Aminosteril N-Hepa 8%, your ability to drive or use machines will not be affected.

3. How to use Aminosteril N-Hepa 8%

Aminosteril N-Hepa 8% will be administered into your blood through a drip.

Your doctor will decide your dose based on your body weight and clinical situation.

For doctors and healthcare professionals, please refer to “Posology and method of administration” at the end of this leaflet, where details regarding dosage and administration are indicated.

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 if the solution is used as recommended.

A too rapid infusion through peripheral veins can cause thrombophlebitis (due to the osmolarity of the solution).

Depending on the previous situation, some patients may experience an alteration of pathologically-induced regulation and a worsening of hepatic capacity, nausea, vomiting, chills, and renal loss of amino acids after an overdose.

If symptoms of overdose appear, the infusion should be slowed down or interrupted.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Between 1 and 10 in every 1000 patients treated may experience headache, chills, fever, nausea, or vomiting, although these effects are not related to this solution, they can occur in general in parenteral nutrition, especially at the start.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any other type of side effect, tell your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System http://www.notificaRAM.es. By reporting side 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 is the last day of the month indicated.

Use Aminosteril N-Hepa 8% only if the solution is transparent, colorless, free of particles, and the container is intact.

Discard any unused solution.

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 pack and other information

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

corresponding to L-Cysteine 0.52 g

L-phenylalanine 0.88g

The other components are: Water for injections

Appearance of the product and contents of the pack

Aminosteril N-Hepa 8% is a sterile, transparent, and colorless solution.

Pack sizes:

500 ml glass bottles

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005-Barcelona (Spain)

Manufacturer

Fresenius Kabi AustriaGmbH

Haffnerstrasse 36,

A-8055 Graz,

Austria

This leaflet was last revised inFebruary 2009

Other sources of information

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

<---------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Posology and method of administrationFor 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 and 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 peripheral or central venous administration.

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 should be administered simultaneously.

This preparation can be used for as long as the patient's clinical situation requires 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, liver function tests.

Electrolytes and carbohydrates should be administered in balanced doses, using a bypass or an "all-in-one" mixing bag, if necessary.

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

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

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

Incompatibilities

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

Mixing with other parenteral nutrition products can only be done when compatibility has been documented. See the "Instructions for use/handling" section below.

Instructions for use/handling

For intravenous use only.

Use immediately after opening the bottle.

Aminosteril N-Hepa 8% should 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 container.

Use only transparent, particle-free solutions with intact containers.

Discard any unused solution.

Amino acid solutions should not be mixed with other medicinal products, except for parenteral nutrition products, due to the high risk of microbiological contamination and incompatibilities. When mixing other nutrients, such as carbohydrates, lipid emulsions, electrolytes, vitamins, or trace elements, with Aminosteril N-Hepa 8% for complete parenteral nutrition, caution should be exercised regarding the use of aseptic techniques, mixing, and in particular, compatibility.

Compatibility data from the manufacturer are available upon request.

Shelf life

Shelf life of the medicinal product as packaged for sale

3 years

Shelf life after opening of the container

From a microbiological point of view, unless the method of opening precludes the risk of microbiological contamination, the product should be used immediately.

Shelf life after mixing with other components

From a microbiological point of view, 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 and validated aseptic conditions.