AMINOVEN 15% SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMINOVEN 15% Solution for infusion

Amino acids

Contents of the pack:

1. What Aminoven 15% is and what it is used for
2. What you need to know before you use Aminoven 15%
3. How to use Aminoven 15%
4. Possible side effects
5. Storage of Aminoven 15%
6. Contents of the pack and other information

1. What Aminoven 15% is and what it is used for

Aminoven 15% is a solution for intravenous infusion. It is available in glass bottles of 250 ml, 500 ml, and 1000 ml, and in polypropylene bags with an overbag of 500 ml and 1000 ml.

Aminoven 15% provides nutrition through your bloodstream when you cannot eat normally. It provides amino acids that your body will use to make proteins (to create and repair muscles, organs, and other body structures).

Normally, Aminoven 15% is mixed with lipids, carbohydrates, salts, and vitamins, which together serve to cover your total nutritional needs.

2. What you need to know before you use Aminoven 15%

Do not use Aminoven 15%:

• if you are allergic (hypersensitive) to any of the components of Aminoven 15%.

• if you have disorders of protein or amino acid metabolism
• if you have metabolic acidosis (the levels of acids in your body fluids and tissues are too high)
• if you have untreated renal failure without dialysis treatment or other form of blood filtration
• if you have advanced liver failure
• if you have fluid retention
• if you have shock
• if you have hypoxia (low oxygen levels)
• if you have decompensated heart failure

Aminoven 15% should not be administered to children or adolescents under 18 years of age.

For children under 2 years of age, pediatric preparations of amino acids should be used, which are formulated to meet the different metabolic requirements.

Warnings and precautions

Tell 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 professional will check before use that the solution is free of particles.

Using Aminoven 15% with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant, think you may be pregnant, or are breastfeeding. Your doctor will decide whether you should be given Aminoven 15%.

Driving and using machines

Aminoven 15% does not affect your ability to drive or use machines.

3. How to use Aminoven 15%

Follow exactly the administration instructions of Aminoven 15% indicated by your doctor.

Ask your doctor or pharmacist if you have any doubts.

This medicine 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 15% than you should:

It is very unlikely that you will be administered more infusion than you should since your doctor or healthcare professional will monitor you during treatment.

The effects of an overdose may include nausea, vomiting, and chills. If you experience these symptoms or think you have been administered too much Aminoven 15%, inform your doctor or nurse immediately.

If you have used more Aminoven 15% than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

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

4. Possible side effects

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

The following side effects have been observed when the infusion is administered too quickly:

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

The following side effects may appear at the injection site:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoven 15%

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

Your doctor and hospital pharmacist are responsible for the correct storage, use, and administration of Aminoven 15%.

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

Do not use this medicine after the expiry date which is stated on the packaging.

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 Aminoven 15%

Each 1000 ml of Aminoven 15% contains the following active ingredients:

Active ingredients Quantity (g)

Isoleucine 5.20

Leucine 8.90

Lysine acetate 15.66 (corresponding to 11.1 g of Lysine)

Methionine 3.80

Phenylalanine 5.50

Threonine 8.60

Tryptophan 1.60

Valine 5.50

Arginine 20.00

Histidine 7.0

Alanine 25.00

Glycine 18.50

Proline 17.00

Serine 9.60

Tyrosine 0.40

Taurine 2.00

Aminoven 15% also contains glacial acetic acid, water for injectables, and malic acid.

Appearance of the product and pack contents

Aminoven 15% is available in colorless glass bottles with a rubber stopper/aluminum cap containing 250 ml, 500 ml, or 1000 ml of solution.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Manufacturers:

Aminoven in glass bottles is manufactured by:

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Local representative:

Fresenius Kabi España SAU

Marina 16-18

08005 Barcelona

Spain

Date of last revision of this leaflet: November 2017.

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

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This information is intended only 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 even change from day to day.

The recommended infusion period is to provide continuous infusion for at least 14 hours up 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.

Aminoven 15%

For administration through a central vein as a continuous infusion.

The usual daily dose of Aminoven 15% is 6.7-13.3 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 470-930 ml of Aminoven 15% for a body weight of 70 kg. The maximum infusion rate is 0.67 ml of Aminoven 15% 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

13.3 ml of Aminoven 15% per kg of body weight/day (equivalent to 2.0 g of amino acids per kg of body weight), e.g., corresponding to 140 g of amino acids in 70 kg of body weight.

Aminoven 15% is contraindicated in children.

Overdose (symptoms, emergency procedure, antidotes)

As with other amino acid solutions, chills, vomiting, nausea, and increased renal loss of amino acids may occur when an overdose of Aminoven is administered or when the infusion rate is exceeded. In this case, the infusion should be stopped immediately. It is then possible to continue with a reduced dose.

Too rapid infusion can also cause fluid overload and electrolyte disturbances.

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

Close biochemical monitoring and appropriate treatment of specific abnormalities will be essential.

There is no specific antidote in case of overdose.

Storage

Keep out of the reach and sight of children.

Store the pack in the carton. Do not store above 25°C. Do not freeze.

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

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month stated.

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

Aminoven can be aseptically mixed 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 non-validated conditions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2° to 8°C, unless the mixture has been prepared in controlled and validated aseptic conditions.