PATIENT INFORMATION LEAFLET

AMINOVEN 10% Solution for Infusion

Amino Acids

Aminoven 10% is a solution for intravenous perfusion. It is presented in 500 ml and 1000 ml glass bottles and in 500 ml and 1000 ml polipropylene bags with an outer bag.

Aminoven 10% provides nutrition through your circulatory system when you cannot eat normally. It supplies amino acids that your body will use to make proteins (to create and repair muscles, organs, and other bodily structures).

Aminoven 10% is normally mixed with lipids, carbohydrates, salts, and vitamins, which together serve to meet your total nutritional needs.

Do not use Aminoven 10%

-If you are allergic (hypersensitive) to any of the components of Aminoven 10%.

• If you have protein or amino acid metabolism disorders
• If you have metabolic acidosis (your body fluids and tissues have too high levels of acids)
• If you have untreated renal insufficiency or other forms of blood filtration
• If you have advanced liver insufficiency
• If you have fluid retention
• If you have shock
• If you have hypoxia (low oxygen levels)
• If you have decompensated heart failure

Aminoven 10% should not be administered to children under 2 years of age. For children under 2 years of age, pediatric amino acid preparations should be used, which are formulated to meet different metabolic requirements.

Warnings and precautions

Inform your doctor if:

• You have low potassium levels in your blood (hypokalemia)
• You have low sodium levels in your blood (hyponatremia)
• You have a folate deficiency
• You have heart problems (heart failure)

Your doctor or healthcare personnel will check before use that the solution is free of particles.

Use of Aminoven 10% with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant, think you may be pregnant, or are breastfeeding, as your doctor will decide whether you should receive Aminoven 10%.

Driving and operating machinery

Aminoven 10% does not affect your ability to drive or operate machinery.

Follow exactly the administration instructions for Aminoven 10% as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

This medication will be administered by infusion (intravenous drip).

The amount and speed at which the infusion is administered will depend on your needs.

Your doctor will decide what the correct dose is that should be administered to you.

You may be monitored during your treatment.

If you use more Aminoven 10% than you should:

It is very unlikely that you will be administered more infusion than you should be given, as your doctor or healthcare staff will monitor you during treatment.

The effects of an overdose may include nausea, vomiting, and chills. If you experience these symptoms or believe you have been given too much Aminoven 10%, inform your doctor or nurse immediately.

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

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

The following adverse effects have been observed when the infusion was administered too quickly:

• Loss of potassium or sodium from the blood
• Folate deficiency

The following adverse effects may appear at the injection site:

• Irritation in the vein
• Thrombophlebitis (formation of a clot) at the venous administration site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an 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:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Your doctor and hospital pharmacist are responsible for the correct conservation, use, and disposal of Aminoven 10%.

Do not freeze and store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of any unused solution.

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

Composition of Aminoven 10%

Each 1000 ml of Aminoven 10% contains the following active principles:

Active principlesQuantity (g)

Isoleucine5.00

Leucine7.40

Lysine acetate9.31 (corresponding to 6.60 g of Lysine)

Methionine4.30

Phenylalanine5.10

Threonine4.40

Tryptophan2.00

Valine6.20

Arginine12.00

Histidine3.00

Alanine14.00

Glycine11.00

Proline11.20

Serine6.50

Thyrosine0.40

Taurine1.00

Aminoven 10% also contains glacial acetic acid and water for injectable preparations.

Appearance of the product and contents of the container

Aminoven 10% is an intravenous infusion solution. It is presented in colourless glass bottles with rubber stoppers and aluminium caps with volumes of 500 ml and 1000 ml.

Not all container sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder:

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Manufacturers:

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Local Representative:

Fresenius Kabi España SAU

Marina 16-18

08005 Barcelona

Spain

Fecha de the last revision of this prospectus:November 2014

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.

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This information is intended solely for healthcare professionals:

Dosage and administration

The daily requirements of amino acids depend on the patient's body weight and metabolic conditions.

The maximum daily dose varies with the patient's clinical condition and may change from day to day.

The recommended infusion period is to provide continuous infusion for at least 14 hours to 24 hours, depending on the clinical situation. Bolus administration is not recommended.

The solution will be administered as long as parenteral nutrition is required.

For administration through a central route such as continuous infusion.

The usual daily dose of Aminoven 10% is 10-20 ml per kg of body weight (equivalent to 1.0 – 2.0 g of amino acids per kg of body weight), e.g. corresponding to 700-1400 ml of Aminoven 10% for a body weight of 70 kg.

The maximum infusion rate is 1.0 ml of Aminoven 10% per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight and hour).

Maximum daily dose in adults, adolescents and children (from 2 years)

20 ml of Aminoven 10% per kg of body weight per day (equivalent to 2.0 g of amino acids per kg of body weight)e.g. corresponds to 1400 ml of Aminoven 10% or 140 g of amino acids in 70 kg of body weight.

Overdose (symptoms, emergency procedure, antidotes)

Similar to other amino acid solutions, shivering, vomiting, nausea, and increased renal losses of amino acids may occur when Aminoven 10% is overdosed or when the infusion rate is exceeded. In this case, the infusion should be stopped immediately. It may be possible to continue with a reduced dose afterwards.

A too rapid infusion may also cause fluid overload and electrolyte disturbances.

Emergency procedures should be general supportive measures, with special attention to the respiratory and cardiovascular systems.

It will be essential to closely monitor biochemical parameters and provide appropriate treatment for specific abnormalities.

There is no specific antidote in case of overdose.

Storage

Keep out of the reach and sight of children.

Store the container within the box. Do not store above 25°C. Do not freeze.

Use only if the solution is clear, there are no particles in suspension, and the container remains intact.

Do not use this medicine after the expiry date appearing on the container under the heading CAD. The expiry date is the last day of the month indicated.

It should be used immediately with a sterile infusion set once the container is opened. Any remaining mixture should be discarded after infusion.

Aminoven 10% can be mixed aseptically with other nutrients such as lipid emulsions, carbohydrates, and electrolytes. On request, the manufacturer has available data on the chemical and physical stability of mixtures stored at 4°C for 9 days.

From a microbiological point of view, NPT mixtures prepared in uncontrolled or unvalidated conditions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not to exceed 24 hours at a temperature of 2°C to 8°C, unless the mixture has been prepared in controlled and validated aseptic conditions.