PROSPECTO: INFORMATION FOR THE USER

Aminosteril N-Hepa 8%solution for perfusion

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

Aminosteril N-Hepa 8% is used to provide aninput 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.

You should not be administered Aminosteril N-Hepa 8%, if you have:

• allergy to any of the components present in the solution
• any congenital anomaly in amino acid metabolism
• severe circulation alteration with vital risk (shock)
• insufficient oxygen supply (hypoxia)
• accumulated acidic substances in your blood (metabolic acidosis)
• kidney insufficiency
• too 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 suffer from any of the situations mentioned above, Aminosteril N-Hepa 8% should not be administered to you. Inform your healthcare professional, so they do not administer this treatment.

Warnings and precautions

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

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

Your condition should be monitored daily, at the infusion site, for possible signs of inflammation or infection.

Children

No experience in children.

Other medications and Aminosteril N-Hepa 8%

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

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

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

Pregnancy, lactation:

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

Your doctor should consider the benefit-risk ratio before administering Aminosteril N-Hepa 8% to pregnant women or those breastfeeding.

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Aminosteril N-Hepa 8% will be administered into your blood through an IV.

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

For doctors and healthcare professionals, please consult “Dosage and method of administration” at the end of this prospectus, 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 may cause thrombophlebitis (due to the osmolarity of the solution).

Depending on the patient's previous condition, some patients may experience a pathological regulation alteration and a worsening of liver function, nausea, vomiting, chills, and renal losses of amino acids after an overdose.

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

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

As with all hypertonic perfusion solutions, thrombophlebitis may appear if peripheral veins are used.

Between 1 and 10 out of every 1,000 treated patients may experience headaches, chills, fever, nausea, or vomiting, although these effects are not related to this solution and may occur in general in parenteral nutrition, especially at the beginning.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any other type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use http://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 25°C

Do not freeze

Store protected from light.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration 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 with the intact packaging.

Dispose of any unused solution remainder.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

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

corresponding to L-Cysteine 0.52 g

L-phenylalanine0.88g

The other components are: Water for injection preparations

Appearance of the product and contents of the container

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

Container sizes:

500 ml glass bottles

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005-Barcelona (Spain)

Responsible for manufacturing

Fresenius Kabi Austria GmbH

Haffnerstrasse 36,

A-8055 Graz,

Austria

This leaflet has been reviewed inFebruary 2009

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is directed solely to healthcare professionals:

Dosage and administrationOnly for intravenous infusion.

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 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 proper administration, carbohydrate solutions and/or lipid emulsions should be administered simultaneously.

This preparation can be used for as long as the clinical condition of the patient requires, or until the patient's amino acid metabolism has normalized.

Warnings and precautions for use

Electrolyte levels, 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 at balanced doses, using a bypass 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 severe metabolic disturbances.

The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for peripheral infusions is approximately 800 mosm/l, but this varies greatly with age, general condition of the patient, 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 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 below the section Instructions for use/manipulation.

Instructions for use/manipulation

For exclusive intravenous use.

Use immediately after opening the bottle.

Aminosteril N-Hepa 8% should be used exclusively with sterile administration equipment.

For single use only.

Do not use Aminosteril N-Hepa 8% after the expiration date indicated on the container.

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

Dispose of 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 aseptic techniques, mixing, 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 point of view, unless the opening method prevents 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 previous conditions 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.