AMINOVEN INFANT 10% SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminoven Infant 10%Solution for infusion

In this leaflet:

1. What AMINOVEN INFANT 10% is and what it is used for
2. Before you use AMINOVEN INFANT 10%
3. How to use AMINOVEN INFANT 10%
4. Possible side effects
5. Storage of AMINOVEN INFANT 10%
6. Further information

Each liter of solution contains:

L-isoleucine 8,000 g

L-leucine 13,000 g

L-lysine monoacetate 12,000 g = L-lysine 8.51 g

L-methionine 3,120 g

L-phenylalanine 3,750 g

L-threonine 4,400 g

L-tryptophan 2,010 g

L-valine 9,000 g

L-arginine 7,500 g

L-histidine 4,760 g

Glycine 4,150 g

L-alanine 9,300 g

L-proline 9,710 g

L-serine 7,670 g

Taurine 0,400 g

N-acetyl-L-tyrosine 5,176 g = L-tyrosine 4.20 g

N-acetyl-L-cysteine 0,700 g = L-cysteine 0.52 g

L-malic acid 2,620 g

1. What AMINOVEN INFANT 10% is and what it is used for

Solution of amino acids at 10% for partial parenteral nutrition in pediatric patients.

This solution can be used for total parenteral nutrition in conjunction with the corresponding amounts of carbohydrates and lipids as an energy source, as well as vitamins, electrolytes, and trace elements.

2. Before you use AMINOVEN INFANT 10%

Do not administer AMINOVEN INFANT 10% if you have:

• allergy to any of the components present in the solution
• any congenital anomaly in amino acid metabolism
• severe circulatory disorders with vital risk (shock)
• insufficient oxygen supply (hypoxia)
• accumulation of acidic substances in the blood (metabolic acidosis)
• potassium levels too low (hypokalemia)

You should not receive infusions if you have:

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

If you have any of the above conditions, you should not be given AMINOVEN INFANT 10%. Inform your healthcare professional so that they do not administer this treatment.

Be careful with AMINOVEN INFANT 10%

If you experience an allergic reaction while being administered Aminoven Infant 10%, 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
• Rash
• Difficulty breathing

Attention should be paid to low sodium levels (hyponatremia).

Patients with renal or hepatic insufficiency require individualized dosing.

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

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until the end of administration. Exposure of Aminoven Infant 10% to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.

Using other medicines

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

3. How to use AMINOVEN INFANT 10%

Aminoven Infant 10% will be administered into your blood through a drip.

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

For doctors and healthcare professionals, please consult "Posology and method of administration" at the end of this leaflet, which provides details on dosing and administration.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until the end of administration (see section 2).

If you receive more AMINOVEN INFANT 10% than you should

As with other amino acid solutions, the following may occur: chills, vomiting, nausea, and increased renal loss of amino acids when an overdose of Aminoven Infant 10% is administered or if the recommended infusion rate is exceeded.

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.

4. Possible side effects

Like all medicines, Aminoven Infant 10% 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 with parenteral nutrition, especially at the start.

If you experience any of the following side effects, or any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of AMINOVEN INFANT 10%

• Keep out of the reach and sight of children
• Do not store above 25°C
• Do not freeze
• Protect from light
• Do not use AMINOVEN INFANT 10% after the expiry date stated on the label after the letters CAD. The expiry date refers to the last day of the month indicated
• Use AMINOVEN INFANT 10% only if the solution is transparent, 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

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until the end of administration (see section 2).

6. Further information

Composition of AMINOVEN INFANT 10% per 1000 ml:

The other components are: Water for injection and nitrogen

Appearance and packaging of the product

Aminoven Infant 10% is a transparent solution.

Container sizes:

100 ml, 250 ml, and 1000 ml glass bottles. Not all container sizes may be marketed.

Marketing authorization holder and manufacturer

Fresenius Kabi España S.A.U. C/ Marina 16-18, 08005-Barcelona (Spain)

For any information about this product, please contact the local representative and marketing authorization holder:

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005-Barcelona (Spain)

This leaflet was last revised in

September 2019

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The following information is intended for healthcare professionals only:

Posology and method of administration

Aminoven Infant 10% should be administered by continuous intravenous infusion through a central vein.

Maximum infusion rate:

Up to 0.1 g amino acids/kg body weight/hour = 1.0 ml/kg body weight/hour

Maximum daily dose:

-1 year of age: 1.5-2.5 g amino acids/kg body weight = 15-25 ml/kg body weight

-2-5 years of age: 1.5 g amino acids/kg body weight = 15 ml/kg body weight

-6-14 years of age: 1.0 g amino acids/kg body weight = 10 ml/kg body weight

The solution should be administered for as long as parenteral nutrition is required.

Method of administration:

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until the end of administration.

Special warnings and precautions for use

In pediatric parenteral nutrition, it is recommended to frequently evaluate and determine the following laboratory values: nitrogen-urea, ammonia, electrolytes, glucose, and triglycerides (in the case of lipid emulsion administration), acid-base balance, and serum osmolality, hepatic enzymes.

Infusion through peripheral veins can cause irritation of the vein intima and thrombophlebitis. To minimize the risk of vein irritation, daily checks of the infusion site should be carried out.

Aminoven Infant 10% can be used as part of a total parenteral nutrition regimen, in combination with adequate amounts of energy (carbohydrate solutions, lipid emulsions), electrolytes, vitamins, and trace elements.

Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with oligoelements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, Aminoven Infant 10% should be protected from ambient light until the end of administration.

Overdose

As with other amino acid solutions, the following may occur: chills, vomiting, nausea, and increased renal loss of amino acids when an overdose of Aminoven Infant 10% is administered or if the recommended infusion rate is exceeded.

In this case, the infusion should be stopped immediately. It is possible to continue with a reduced dose. In the case of hyperkalemia, it is recommended to infuse 200-500 ml of 10% glucose solution with 1-3 units of modified insulin/3-5 g glucose.

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

Incompatibilities

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other medicines. Therefore, when it is necessary to add other nutrients such as carbohydrates, lipid emulsions, electrolytes, vitamins, or trace elements to Aminoven Infant 10% for complete parenteral nutrition, precautions should be taken, such as performing a hygienic mixture, carrying out a good mixture, and knowing the compatibility.

Aminoven Infant 10% should not be stored after the addition of other components.

Instructions for use/handling

For exclusive intravenous use.

Use immediately after opening the bottle.

Do not use Aminoven Infant 10% after the expiry date.

Use only transparent solutions with intact containers.

Keep out of the reach and sight of children.

For long-term parenteral nutrition with Aminoven Infant 10%, essential fatty acids, vitamins, and trace elements should be provided.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until the end of administration. Exposure of Aminoven Infant 10% to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.

Shelf life

1. Shelf life of the medicinal product as packaged for sale

Aminoven Infant 10% has a shelf life of 2 years.

1. Shelf life after opening of the container

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

1. Shelf life after mixing with other components

The addition of other components to the Aminoven Infant 10% solution prior to administration should take place under hygienic conditions to ensure that the solution is dispensed correctly. Unless more data are available, mixtures should be used within 24 hours of preparation.