AMINOPLASMAL PAED 10% SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aminoplasmal Paed 10% solution for infusion

For use in children (0-11 years)

amino acids

Read the entire leaflet carefully before starting to use this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for your child only, and you should not give it to other people, even if they have the same symptoms as your child, because it may harm them.
• If your child experiences any adverse effects, consult your doctor or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Aminoplasmal Paed 10% is and what it is used for
2. What you need to know before your child starts using Aminoplasmal Paed 10%
3. How to use Aminoplasmal Paed 10%
4. Possible adverse effects
5. How to store Aminoplasmal Paed 10%
6. Contents of the pack and other information

1. What Aminoplasmal Paed 10% is and what it is used for

Aminoplasmal Paed 10% is a solution administered to your child through a small tube with a cannula inserted into a vein (intravenous infusion).

The solution contains amino acids, which are essential for growth and bodily recovery.

The formulation is adapted to meet the specific needs of newborns, both premature and full-term, infants, and children.

This medicine will be given if your child cannot take food normally and cannot be fed through a tube placed into the stomach. Your child may also receive other nutrients such as glucose solutions or fat emulsions in combination with Aminoplasmal Paed 10%.

2. What you need to know before your child starts using Aminoplasmal Paed 10%

Do not use Aminoplasmal Paed 10% if your child

• is allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• has a congenital disorder in amino acid and/or protein metabolism,
• has a severe disorder (i.e., potentially life-threatening circulatory disorder [circulatory shock]),
• has insufficient oxygen supply (hypoxia),
• has an accumulation of acidic substances in the blood (metabolic acidosis),
• has severe liver disease (severe hepatic insufficiency),
• has severe renal failure (severe renal insufficiency) not adequately treated with hemodialysis or similar treatments,
• has severe heart failure with significant circulatory impairment (decompensated heart failure),
• has fluid accumulation in the lungs (acute pulmonary edema),
• has a disturbance in the body's electrolyte or water balance.

Warnings and precautions

When used in children from premature birth up to 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete. Exposure to light of parenteral nutrition solutions containing Aminoplasmal Paed 10%, especially after mixing with trace elements or vitamins, may produce peroxides and other degradation products. These can be minimized by protecting the product from light.

Consult your doctor or nurse before using Aminoplasmal Paed 10% if your child

• has a disorder in protein and amino acid metabolism due to a condition other than those mentioned above (see section "Do not use Aminoplasmal Paed 10% if your child..."),
• has impaired liver or kidney function,
• has impaired heart function,
• has abnormally high blood serum concentration (elevated serum osmolarity).

If your child's body water or electrolyte balance is disturbed, this disorder must be corrected before administering this medicine. Examples of such disturbances include simultaneous deficiency of water and electrolytes (hypotonic dehydration), or lack of sodium (hyponatremia) or potassium (hypokalemia).

Before and during administration of this solution, the doctor will monitor blood electrolyte and glucose levels, fluid balance, and acid-base balance. The doctor will also monitor blood proteins and liver and kidney function. For this purpose, blood and urine samples will be taken for analysis.

Amino acid solutions are only one component of parenteral nutrition. Typically, children will receive Aminoplasmal Paed 10% as part of intravenous feeding, which also includes non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, vitamins, fluids, and trace elements.

Other medicines and Aminoplasmal Paed 10%

Inform your doctor or nurse if your child is taking, has recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Aminoplasmal Paed 10% is intended solely for use in infants and children.

Driving and use of machines

Not applicable, as Aminoplasmal Paed 10% is intended solely for use in infants and children.

3. How to use Aminoplasmal Paed 10%

Aminoplasmal Paed 10% is administered by healthcare professionals.

In children, the doctor will carefully adjust the dose according to the child's age, stage of development, and individual medical condition.

The administered volume will be:

First day of life: ≥ 15 ml per kg of body weight per day
From the second day onwards: 25–35 ml per kg of body weight per day
Term newborns (0 to 27 days): 15–30 ml per kg of body weight per day
Infants (1 month to less than 3 years): 10–25 ml per kg of body weight per day
Children (3 to less than 12 years): 10–20 ml per kg of body weight per day

For critically ill children, the administered volume may be higher (up to 30 ml per kilogram of body weight per day).

Patients with renal or hepatic disease

Dosages will be adjusted according to the individual needs of the child if he or she suffers from liver or kidney disease.

Duration of treatment

This medicine may be used as long as the child requires intravenous nutrition.

Method of administration

This medicine will be given to your child through a small tube inserted into a vein (intravenous infusion).

When used in children from premature birth up to 2 years of age, the solution (in the bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).

If your child receives more Aminoplasmal Paed 10% than they should

This is unlikely to occur, as the doctor will determine the daily doses for your child.

However, if your child receives an overdose or the infusion rate of the solution is too fast, your child may experience nausea, vomiting, chills, or headache.

In addition, the blood may contain too many acidic substances (metabolic acidosis) or too much ammonia (hyperammonaemia), and your child may lose amino acids in the urine.

Your child may also have too much fluid in the body (hyperhydration), the body's electrolyte balance may be disturbed (electrolyte imbalance), and your child may develop fluid in the lungs (pulmonary edema). If this occurs, the infusion will be stopped and resumed at a lower infusion rate after a short interval.

If you have any further questions about the use of this medicine, ask your doctor or nursing staff.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

These adverse effects are not specifically related to Aminoplasmal Paed 10%, but may occur with any type of intravenous nutrition, especially at the beginning.

The following adverse effects may be serious. If your child experiences any of the following, inform your doctor immediately, who will stop administering this medicine to your child:

Frequency not known (cannot be estimated from available data)

? Allergic reactions

Other adverse effects

Uncommon (may affect up to 1 in 100 people)

? Vomiting, nausea

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal Paed 10%

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

When used in children from premature birth up to 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).

Do not use this medicine after the expiry date stated on the bag and carton labels. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not freeze.

After infusion, any remaining solution must never be stored for later use.

6. Contents of the container and other information

Composition of Aminoplasmal Paed 10%

The active substances are amino acids.

This medicine contains:

The other components are citric acid monohydrate (for pH adjustment) and water for injections.

Appearance of the medicinal product and content of the container

Aminoplasmal Paed 10% is a clear, colourless to slightly yellow solution.

It is supplied in single-chamber plastic bags made from a transparent multilayer sheet (polypropylene, styrene ethylene butylene styrene [SEBS] and copolyester ether). The inner layer in contact with the solution consists of polypropylene. The bags contain 100 ml or 250 ml.

The bag is packaged in a protective overwrap. An oxygen absorber and an oxygen indicator are placed between the bag and the overwrap; the oxygen indicator is a thermoformed blister containing sodium resorufin, an oxygen-sensitive dye; the oxygen absorber sachet is composed of an inert material and contains powdered iron (activated), electrolytic materials and activated carbon (Figure A).

Different pack sizes are presented in cartons of 12 bags. Pack sizes: 12 x 100 ml and 12 x 250 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

• Braun Melsungen AG
  Carl-Braun-Straße 1
  34212 Melsungen, Germany

Postal address:
34209 Melsungen, Germany
Telephone: +49/5661/71-0
Fax: +49/5661/71-4567

This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:

Austria, Germany: Aminoplasmal Paed 10% Infusionslösung
Czech Republic, Denmark, Italy, Norway, Slovakia: Amiped
Luxembourg, Poland: Aminoplasmal Paed 10%
Portugal: Aminoplasmal Paed
Spain: Aminoplasmal Paed 10% solution for perfusion
United Kingdom (Northern Ireland): Aminoplasmal Paediatric 10% Solution for Infusion

Date of the latest revision of this leaflet: August 2025.

This information is intended for healthcare professionals only:

Dosage

Paediatric population

The doses for the groups indicated below are average guidance values. The exact dose must be individually adjusted according to age, degree of development, and underlying disease.

Administration should be initiated below the target infusion rate and gradually increased to the target rate over the first hour.

The recommended parenteral amino acid supply considered adequate for most paediatric patients is as follows:

Daily dose for preterm neonates:
First day of life:
≥ 1.5 g amino acids/kg body weight → ≥ 15 ml/kg body weight
From the second day onwards:
2.5–3.5 g amino acids/kg body weight → 25–35 ml/kg body weight

Daily dose for term neonates (0 to 27 days):
1.5–3.0 g/kg body weight → 15–30 ml/kg body weight

Daily dose for infants (1 month to less than 3 years):
1.0–2.5 g/kg body weight → 10–25 ml/kg body weight

Daily dose for children (3 to less than 12 years):
1.0–2.0 g/kg body weight → 10–20 ml/kg body weight

Method of administration:

Intravenous route.

For central venous infusion only.

When used in children from premature birth up to 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete.

Special warnings and precautions for use:

Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with trace elements and/or vitamins, may have adverse effects on the clinical outcome of neonates due to the formation of peroxides and other degradation products. When used in children from premature birth up to 2 years of age, Aminoplasmal Paed 10% must be protected from light until administration is complete.

Special precautions for disposal and other handling

The containers are intended for single use only. Discard the wrapper, oxygen indicator, oxygen absorber, container, and any remaining contents after use.

Before opening the protective wrapper, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow. The product must not be used if the solution is not clear and colourless to pale yellow, if it contains particles, or if the bag or its closure is damaged.

When used in children from premature birth up to 2 years of age, parenteral nutrition solutions containing Aminoplasmal Paed 10% must be protected from light exposure until the end of administration. Exposure of these solutions to ambient light, especially after mixing with trace elements and/or vitamins, may lead to the formation of peroxides and other degradation products, which can be minimized by protecting the product from light.

Use a sterile administration set for the administration of Aminoplasmal Paed 10%.

If, in the context of total parenteral nutrition, additional nutrients such as carbohydrates, lipids, vitamins, electrolytes, and trace elements need to be added to this medicinal product, the mixture must be prepared under strict aseptic conditions. Mix thoroughly after addition of any additive. Pay special attention to compatibility.

• Glucose: Stability has been demonstrated up to a total concentration of 150 g/L of glucose in the mixture.

• Electrolytes:

  • Without lipids: Stability has been demonstrated up to a total concentration of 200 mmol/L of sodium + potassium (sum), 5 mmol/L of magnesium, and 20 mmol/L of calcium in the mixture.
  • With lipids: Stability has been demonstrated up to a total concentration of 200 mmol/L of sodium + potassium (sum), 5 mmol/L of magnesium, and 10 mmol/L of calcium in the mixture.

• Lipids: Stability has been demonstrated up to a total concentration of 25 g/L of lipid emulsion in the mixture.

• Trace elements and vitamins: Stability has been demonstrated with commercially available multi-trace element and multivitamin products (e.g., Peditrace, Vitalipid Infant, Soluvit N) up to the recommended usual dose specified by the manufacturer of the corresponding micronutrient.

Shelf-life after addition of additives

From a microbiological standpoint, mixtures should be administered immediately after preparation. If not administered immediately, the storage conditions and duration prior to use are the user's responsibility and should normally not exceed 24 hours at a temperature of 2°C to 8°C, unless the mixture was prepared under controlled and validated aseptic conditions.

For complete information about this medicinal product, consult the Summary of Product Characteristics or the Technical Data Sheet.

Aminoplasmal Paed 10%: Handling

Figure A: Bag and wrapper

Figure B: Bag

To open:

Remove the bag from its protective wrapper at the tear notches on the top and take out the solution container (Figure 1). Discard the wrapper, oxygen absorber, and oxygen indicator.

Check for leaks. Discard the product if the bag is leaking, as sterility may have been compromised.

To add medication:

Mixtures must be prepared using strict aseptic techniques.

Compatible supplementary medications may be added through the medication port (transparent in colour).

1. Prepare the medication port (transparent in colour) by removing the aluminium foil (Figure 2a). Note that the area beneath the medication port foil is sterile.
2. Pierce the resealable medication port and inject the additive(s) (Figure 2b).
3. Mix the solution and medication thoroughly (Figure 3a).
4. The medication port may be cleaned with a disinfectant (e.g., isopropanol) before subsequent punctures.
5. Visually inspect the mixture for particles (Figure 3b).

Preparation for administration:

1. Remove the aluminium foil from the infusion port (green in colour) at the bottom of the container (Figure 4a) and connect the administration set (Figure 4b): use an administration set without an air vent, or close the air vent if the set has one. Follow the administration set manufacturer's instructions. Note that the area beneath the infusion port foil is sterile.
2. Hang the bag on an IV pole (Figure 5).

Additional information:

The container does not contain PVC, DEHP, or latex.