PATIENT INFORMATION LEAFLET

Aminoven Infant 10%
Infusion Solution

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-isoleucine8,000 g

L-leucine 13,000 g

L-lysine monoacetate 12,000 g =L-lysine 8,51 g

L-methionine3,120 g

L-phenylalanine3,750 g

L-threonine4,400 g

L-tryptophan2,010 g

L-valine9,000 g

L-arginine7,500 g

L-histidine4,760 g

Glycine4,150 g

L-alanine9,300 g

L-proline9,710 g

L-serine7,670 g

Taurine0,400 g

N-acetyl-L-tyrosine5,176 g =L-tyrosine 4,20 g

N-acetyl-L-cysteine0,700 g =L-cysteine 0,52 g

Malic acid2,620 g

10% amino acid solution for partial parenteral nutrition in pediatric patients.

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

Do not administer AMINOVEN INFANT 10%, if you have:

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

You should not receive infusions if you have:

–decompensated heart failure

–fluid accumulation in your lungs (pulmonary edema)

–excessive water in your body (hyperhydration)

If you have any of the situations mentioned above, do not administer AMINOVEN INFANT 10%. Inform your healthcare professional, so they do not administer this treatment.

Be especially careful with AMINOVEN INFANT 10%

If you experience an allergic reaction while receiving Aminoven Infant 10%, 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
• Respiratory difficulty

Be attentive in case of low sodium levels (hyponatremia).

Patients with renal or hepatic insufficiency require individualized dosing.

Monitor daily, at the infusion site, for possible signs of inflammation or infection.

When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light 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 if the product is protected from light exposure.

Use of other medications

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

Aminoven Infant 10% will be administered into your blood through an infusion set.

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

For medical professionals and healthcare workers, please refer to “Dosage and administration method” at the end of this leaflet, where details regarding dosage and administration are specified.

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) must be protected from exposure to light 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 symptoms may occur: chills, vomiting, nausea, and increased renal losses 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 administered more slowly or discontinued.

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

Like all medications, Aminoven Infant 10% may have 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 of every 1000 treated patients may experience headaches, chills, fever, nausea, or vomiting, although these effects are not related to this solution, they can occur in general parenteral nutrition, especially at the beginning.

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

• Keep out of reach and sight of children
• Do not store at a temperature above 25°C
• Do not freeze
• Store protected from light.
• Do not use AMINOVEN INFANT 10% after the expiration date indicated on the label after the CAD initials. The expiration 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.

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 unused containers and medicines. This will help protect the environment.

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

Composition of AMINOVEN INFANT 10% by 1000 ml:

The other components are: Water for injection and nitrogen

Aspect of the product and content of the packaging

Aminoven Infant 10% is a transparent solution.

Packaging sizes:

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

Holder of the marketing authorization and responsible for manufacturing

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 holder of the marketing authorization:

Fresenius Kabi España S.A.U.

C/ Marina 16-18,

08005-Barcelona (Spain)

This leaflet has been reviewed in

September 2019

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The following information is only for the doctor or healthcare professional:

Dosage 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.

Administration form:

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

Warnings and precautions for use

In parenteral nutrition in children, it is recommended to perform frequent evaluations and determinations of the following laboratory values: urea nitrogen, ammonia, electrolytes, glucose, and triglycerides (in the case of administering a lipid emulsion), acid-base balance, and fluid balance, liver enzymes, and serum osmolality.

Infusion through peripheral veins may cause irritation of the intima of the vein, and thrombophlebitis. To minimize the risk of vein irritation, it is recommended to perform daily checks of the infusion site.

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

Exposure to light of parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements or vitamins, may 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 losses 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 may be possible to continue with a reduced dose. In the case of hyperkalemia, it is recommended to infuse 200 to 500 ml of 10% glucose solution, adding 1-3 U of modified insulin / 3-5 g of glucose.

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

Incompatibilities

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other medications. Therefore, if 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 in particular knowing the compatibility.

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

Instructions for use/manipulation

For exclusive intravenous use.

Use immediately after opening the bottle.

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

Use only transparent solutions and intact packaging.

Keep out of the reach and sight of children.

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

When used in newborns and children under 2 years, it should be protected from exposure to light 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 if the product is protected from exposure to light.

Validity period

1. Validity period of the packaged medication for sale

Aminoven Infant 10% has a validity period of 2 years.

1. Validity period after opening the packaging

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

1. Validity period after mixing with other components

The addition of other components to the Aminoven Infant 10% solution before administration should be carried out under hygienic conditions to ensure that the solution is dispensed correctly. Unless more data is available, the mixtures should be used within the next 24 hours from their preparation.