Aminoven Infant 10%

Package Leaflet: Information for the User

Aminoven Infant 10%, Solution for Infusion

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Aminoven Infant 10% and what is it used for
• 2. Important information before using Aminoven Infant 10%
• 3. How to use Aminoven Infant 10%
• 4. Possible side effects
• 5. How to store Aminoven Infant 10%
• 6. Contents of the package and other information

1. What is Aminoven Infant 10% and what is it used for

Aminoven Infant 10% is an amino acid solution for parenteral nutrition in children. It should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins, and trace elements.
The medicine is administered by intravenous infusion.
Indications for use:
Aminoven Infant 10% is indicated as a source of amino acids in parenteral nutrition for children.

2. Important information before using Aminoven Infant 10%

When not to use Aminoven Infant 10%

Do not use the medicine:

• if the patient has amino acid metabolism disorders (components of proteins);
• if the patient has metabolic acidosis (accumulation of excessive amounts of acidic substances in the blood or decreased concentration of basic substances);
• if the patient is overhydrated (excess water in the body);
• if the patient has decreased potassium levels in the blood (hypokalemia).

Warnings and precautions

The medicine should be used with caution in patients with decreased sodium levels in the blood (hyponatremia).
During the administration of Aminoven Infant 10%, the doctor will order blood tests (determination of urea nitrogen, ammonia, electrolytes, glucose, triglycerides, liver enzymes, and serum osmolality).
The doctor will also order fluid balance control (amount of fluids ingested and excreted from the body) and acid-base balance control (proper ratio of acidic and basic compounds in the body).
During administration into a peripheral vein (especially during infusion at a rate greater than recommended), vein irritation and thrombophlebitis may occur. Therefore, frequent checks of the infusion site are recommended.
The doctor will ensure the proper administration of this medicine.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Aminoven Infant 10% and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interaction between Aminoven Infant 10% and other medicines has been found.

Pregnancy and breastfeeding

This information does not apply to Aminoven Infant 10%, as it is intended for use in children.

Driving and using machines

Not applicable.

3. How to use Aminoven Infant 10%

This medicine is administered exclusively by medical personnel. The medicine must not be used by itself.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on their age, body weight, laboratory test results, and taking into account any renal or hepatic insufficiency.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Using a higher dose of Aminoven Infant 10% than recommended

In case of using a higher dose of the medicine, tell the doctor or nurse immediately.
In case of overdose or administration at a rate greater than recommended, nausea, vomiting, chills, and increased loss of amino acids through the kidneys may occur.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of administration at a rate greater than recommended, nausea, vomiting, chills, and disturbances in amino acid balance in the body and their increased excretion through the kidneys may occur.
During proper administration of the medicine, no other side effects are known.
Reporting side effects
If any side effects occur, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aminoven Infant 10%

Store the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
The packaging should not be stored after opening. Any unused remainder of the medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not use this medicine if visible particles are present or if the packaging is damaged.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).
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 package and other information

What Aminoven Infant 10% contains

• The active substances of the medicine are:

1000 ml solution contains:
L-isoleucine
8.00 g
L-leucine
13.00 g
L-lysine acetate
(equivalent to L-lysine
12.00 g
8.51 g)
L-methionine
3.12 g
L-phenylalanine
3.75 g
L-threonine
4.40 g
L-tryptophan
2.01 g
L-valine
9.00 g
L-arginine
7.50 g
L-histidine
4.76 g
Glycine
4.15 g
L-alanine
9.30 g
L-proline
9.71 g
L-serine
7.67 g
Taurine
0.40 g
N-acetyl-L-tyrosine
(equivalent to L-tyrosine
5.176 g
4.20 g)
N-acetyl-L-cysteine
(equivalent to L-cysteine
0.70 g
0.52 g)
malic acid
2.62 g

• Other ingredient (excipient): water for injections.

Theoretical osmolality
885 mOsm/l
Acidity of the solution

• 27 – 40 mmol NaOH/l pH 5.5 – 6.0

What Aminoven Infant 10% looks like and what the package contains

The medicine is a solution for infusion.
The packaging of the medicine is a colorless glass bottle containing 100 ml, 250 ml, or 1000 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Dosage and administration

Aminoven Infant 10% should be administered in continuous intravenous infusion into central veins.
Maximum infusion rate:
up to 0.1 g amino acids/kg body weight/hour = 1.0 ml/kg body weight/hour.
Maximum daily dose:

• children from 0 to 2 years of age: 1.5 to 2.5 g amino acids/kg body weight/day = 15 to 25 ml/kg body weight/day;
• children from 2 to 5 years of age: 1.5 g amino acids/kg body weight/day = 15 ml/kg body weight/day;
• children from 6 to 14 years of age: 1.0 g amino acids/kg body weight/day = 10 ml/kg body weight/day.

The medicine can be administered for as long as parenteral nutrition is necessary.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration.

Overdose

Similarly to other amino acid solutions, in case of overdose or administration at a rate greater than recommended, chills, nausea, vomiting, and increased loss of amino acids through the kidneys may occur. Infusion should be stopped immediately. Infusion can be continued at a reduced dose. In case of hyperkalemia, infusion of 200 to 500 ml of 10% glucose solution with the addition of 1 to 3 units of modified insulin/3–5 g glucose is recommended.

Preparation of the medicine for use

After opening, the contents of the bottle should be used immediately.
Do not use Aminoven Infant 10% after the expiry date.
Use only clear solutions free from particles, from undamaged containers.
Store in a place out of sight and reach of children.
When using Aminoven Infant 10% for long-term parenteral nutrition, the patient should also be administered the necessary fatty acids, vitamins, and trace elements.
Data on pharmaceutical compatibility are available on request from the representative of the marketing authorization holder.

Special warnings and precautions for use

Exposure to light of parenteral nutrition solutions, especially after the addition of trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, Aminoven Infant 10% should be protected from light until the end of administration.

Pharmaceutical incompatibilities

Do not mix the medicine with other medicines, except for parenteral nutrition products, due to the risk of microbiological contamination and pharmaceutical incompatibilities.
In case of necessity to add other nutrients, such as carbohydrates, fat emulsions, electrolytes, vitamins, or trace elements, to Aminoven Infant 10% in order to ensure complete parenteral nutrition, follow the rules of asepsis during addition, ensure thorough mixing, and, in particular, establish compatibility.
Aminoven Infant 10% should not be stored after the addition of other components.

Storage conditions

Store in a temperature below 25°C.
Store in the original packaging to protect from light.

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.

Special precautions for disposal and preparation of the medicinal product for use

When used in newborns and children under 2 years of age, protect from light until the end of administration. Exposure of Aminoven Infant 10% to light, especially after the addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by protecting from light.