What it is and what it is used for

for

Aminoplasmal Paediatric 10% is a solution which is given to your child through a small tube with a cannula placed in a vein (intravenous infusion). The solution contains amino acids that are essential for the body to grow or to recover. The solution is adapted to meet the specific needs of newborn infants, preterm and term infants, toddlers and children. They will receive this medicine if they are unable to eat food normally and they cannot be fed through a tube placed into their stomach either. They may also receive other nutrients like glucose solutions or fat emulsions in combination with Aminoplasmal Paediatric 10%. 2.

What you need to know before your child receives Aminoplasmal Paediatric 10 %

Do not use Aminoplasmal Paediatric 10%, if your child

• is allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
• suffers from an inborn error of its metabolism of proteins and amino acids.
• has a severe (i.e. life-threatening) circulation disorders (shock).
• has insufficient oxygen supply (hypoxia).
• has acidic substances that accumulate in blood (metabolic acidosis).
• has a severe liver disease (severe hepatic insufficiency).
• has severe kidney failure (severe renal insufficiency) not adequately treated by artificial kidney or similar therapies.
• suffers from a poorly heart failure with marked impairment of its blood circulation (decompensated cardiac insufficiency).
• has an accumulation of fluid in lungs (acute pulmonary oedema).
• body's salt (electrolyte) or water balance is disturbed.

Warnings and precautions When used in infants aged from preterm to 2 years old, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. Exposure of parenteral nutrition solutions containing Aminoplasmal Paediatric 10% to light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.

–

Talk to your doctor or nurse before you use Aminoplasmal Paediatric 10%, if your child suffers from an impairment of metabolism of proteins and amino acids caused by any condition other than mentioned above (see section "Do not use Aminoplasmal Paediatric 10% if your child…").

• suffers from an impairment of liver or kidney function.
• has an impairment of heart function.
• has an abnormally high concentrated blood serum (high serum osmolarity). If the body's water or salt balance of your child is disturbed, this condition should be corrected before the child receives this medicine. Examples for this condition are a lack of water and salts at the same time (hypotonic dehydration) or a lack of sodium (hyponatraemia) or potassium (hypokalaemia). Before and while children are receiving this solution, the doctor will check levels of blood salts and blood sugar, the water balance and the acid-base balance. Also blood proteins and kidney and liver function will be monitored. For this purpose blood samples will be taken and urine will be collected and both will be analysed. Amino acid solutions are only one component of parenteral nutrition. Usually children will receive Aminoplasmal Paediatric 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 Paediatric 10% Tell your doctor or nurse, if your child is taking, has recently taken or might take any other medicines. Pregnancy and breast-feeding Aminoplasmal Paediatric 10% is intended for use in infants, toddlers and children only. Driving and using machines Not relevant, as Aminoplasmal Paediatric 10% is intended for use in infants, toddlers and children only. 3.

How to take it

Aminoplasmal Paediatric 10%

Aminoplasmal Paediatric 10% is given by health care professionals. In children the doctor will adjust the dosage carefully according to the individual child's age, status of development and actual disease. The amounts to be given will be: First day of life: From day 2 onwards: Term newborn infants (0 – 27 days): Infants and toddlers (1 month to less than 3 years): Children (3 to less than 12 years):

≥ 15 ml per kg of body weight per day 25 – 35 ml per kg of body weight per day 15 – 30 ml per kg of body weight per day 10 – 25 ml per kg of body weight per day 10 – 20 ml per kg of body weight per day

For critically ill children the amount to be given may be higher (up to 30 ml per kg body weight per day). Patients with kidney or liver disease The doses will be adjusted according to the child's individual requirements if it has liver or kidney disease.

Duration of use This medicine may be used as long as your child needs intravenous feeding. Method of administration This medicine will be administered to your child through a small tube inserted into a vein (intravenous infusion). When used in infants aged from preterm to 2 years old, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2). If your child receives more Aminoplasmal Paediatric 10% than it should It is unlikely that this occurs because the doctor will determine the daily doses for your child. However, if your child receives an overdose or the solution is flowing too fast, your child may feel sick, may have to vomit and may experience shivering or headache. Also, 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 suffer from too much fluid in their body (hyperhydration), your child body's salt balance may be disturbed (electrolyte imbalance) and your child may have water on their lungs (pulmonary oedema). If this happens, the infusion will be stopped and started again at a lower infusion rate some time later. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects are not specifically related to Aminoplasmal Paediatric 10% but may occur with any kind of intravenous feeding, especially at the beginning. The following side effects may be serious. If your child gets any of the following side effects, tell your doctor immediately, he will stop giving this medicine to your child: Not known (frequency cannot be estimated from the available data) ● Allergic reactions Other side effects Uncommon (may affect up to 1 in 100 people) ● Vomiting, feeling sick Reporting of side effects If your child gets any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Aminoplasmal Paediatric 10%

Keep this medicine out of the sight and reach of children. When used in infants aged from preterm to 2 years old, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2).

Do not use this medicine after the expiry date which is stated on the bag and carton labels. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not freeze. After infusion, any remaining solution should never be stored for later use. 6.

Contents of the pack and other information

What Aminoplasmal Paediatric 10% contains The active substances are amino acids. This medicine contains: Amino acids Isoleucine Leucine Lysine monohydrate (equivalent to lysine) Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Aspartic acid Glutamic acid Proline Serine N-Acetyltyrosine (equivalent to tyrosine) Acetylcysteine (equivalent to cysteine) Taurine Total amino acids Total nitrogen

per 1 ml 5.10 mg 7.60 mg 9.88 mg (8.80 mg) 2.00 mg 3.10 mg 5.10 mg 4.00 mg 6.10 mg 9.10 mg 4.60 mg 15.90 mg 2.00 mg 6.60 mg 9.30 mg 6.10 mg 2.00 mg 1.30 mg (1.06 mg)

per 100 ml 0.51 g 0.76 g 0.99 g (0.88 g) 0.20 g 0.31 g 0.51 g 0.40 g 0.61 g 0.91 g 0.46 g 1.59 g 0.20 g 0.66 g 0.93 g 0.61 g 0.20 g 0.13 g (0.11 g)

per 250 ml 1.28 g 1.90 g 2.47 g (2.20 g) 0.50 g 0.78 g 1.28 g 1.00 g 1.53 g 2.28 g 1.15 g 3.98 g 0.50 g 1.65 g 2.33 g 1.53 g 0.50 g 0.33 g (0.27 g)

0.700 mg (0.520 mg)

0.070 g (0.052 g)

0.175 g (0.13 g)

0.300 mg

0.030 g

0.075 g

per 1 ml 0.1 g 0.0152 g

per 100 ml 10 g 1.52 g

per 250 ml 25 g 3.8 g

Energy [kJ/l (kcal/l)] Theoretical osmolarity [mOsm/l] Acidity (titration to pH 7.4) [mmol NaOH/l] pH

1700 (406) 790 23 approx. 6.1

The other ingredients are citric acid monohydrate (for pH-adjustment) and water for injections. What Aminoplasmal Paediatric 10% looks like and contents of the pack Aminoplasmal Paediatric 10% is a clear, colorless up to light yellow solution.

It is supplied in mono chamber plastic bags made from a transparent multilayer foil (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 packed 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 and contains the oxygen sensitive dye resorufin sodium; the oxygen absorber sachet is made of inert material and contains iron powder (activated), electrolyte materials and activated carbon (Figure A). The different container sizes are presented in cartons containing 12 bags. Pack sizes: 12 x 100 ml and 12 x 250 ml Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany Postal address 34209 Melsungen, Germany

Phone: +49/5661/71-0 Fax: +49/5661/71-4567 This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (GB and NI) under the following names: Austria, Germany: Czech Republic, Denmark, Italy, Norway, Slovak Republic: Luxembourg, Poland: Portugal: Spain: United Kingdom (GB and NI): This leaflet was last revised in Last internal revision: 08.2025

Aminoplasmal Paed 10% Infusionslösung Amiped Aminoplasmal Paed 10% Aminoplasmal Paed Aminoplasmal Paed 10% solución para perfusión Aminoplasmal Paediatric 10% Solution for Infusion

The following information is intended for healthcare professionals only.

Posology Paediatric population The dosages for the age group stated below are average values for guidance. The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease. Dosing should be commenced below target infusion rate value and be increased to target value within the first hour. Parenteral amino acid supply considered adequate for most paediatric patients: Daily dose for preterm newborn infants: First day of life ≥ 1.5 g amino acids/kg body weight ≙≥15 ml /kg body weight

From day 2 onwards 2.5 – 3.5 g amino acids/kg body weight ≙ 25 – 35ml /kg body weight Daily dose for term newborn infants (0 – 27 days): 1.5 – 3.0 g /kg body weight ≙ 15 – 30 ml/kg body weight.

Daily dose for infants and toddlers (1 month to less than 3 years): 2.5 g /kg body weight ≙ 25 ml/kg body weight Daily dose for children (3 to less than to 12 years): 1.0 – 2.0 g/kg body weight ≙ 10 – 20ml/kg body weight

Method of administration: Intravenous use. For central venous infusion only. When used in infants aged from preterm to 2 years old, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. Special warnings and precautions for use Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in infants aged from preterm to 2 years old, Aminoplasmal Paediatric 10% should be protected from light until administration is completed. Special precautions for disposal and other handling Containers are for single use only. Discard overwrap, oxygen indicator, oxygen absorber, container and any unused contents after use. Before opening the overwrap, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator turned pink. Use only if the oxygen indicator is yellow. The product must not be used if the solution is not clear, colourless up to light yellow, practically free from visible particles or the bag or its closure are damaged. When used in infants aged from preterm to 2 years old, parenteral nutrition solutions containing Aminoplasmal Paediatric 10% should be protected from light exposure, until administration is completed. Exposure of such solutions to ambient light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure. Use a sterile giving set for infusion of Aminoplasmal Paediatric 10%.

If in the setting of complete parenteral nutrition it is necessary to add other nutrients such as carbohydrates, lipids, vitamins, electrolytes and trace elements to this medicinal product, admixing must be performed under strict aseptic conditions. Mix well after admixture of any additive. Pay special attention to compatibility.

• Glucose: stability has been demonstrated up to a total quantity of 150 g/l of glucose in the mixture.
• Electrolytes: ο Without containing lipids: stability has been demonstrated up to a total quantity of 200 mmol/l of sodium + potassium (sum), 5 mmol/l of magnesium and 20 mmol/l of calcium in the mixture. ο With containing lipids: stability has been demonstrated up to a total quantity 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 quantity of 25 g/l of lipid emulsion in the mixture.
• Trace elements and vitamins: stability has been demonstrated with commercially available multi-trace elements and multi-vitamins (e.g. Peditrace, Vitalipid Infant, Soluvit N) up to the standard dosage recommended by the respective manufacturer of the micronutrient. Shelf life after admixture of additives From a microbiological point of view, mixtures should be used immediately after preparation. If not used immediately, storage times and conditions of mixtures prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2o C to 8o C, unless mixing has taken place under controlled and validated aseptic conditions. For complete information on this medicinal product please refer to the Summary of Product Characteristics. Aminoplasmal Paediatric 10%:. Handling Figure A: Bag and Overwrap

Figure B: Bag

To Open:

Remove the bag from its protective overwrap starting from the tear notches on top and remove solution container (figure 1). Discard overwrap and oxygen indicator and oxygen absorber. Check for leakages. If bag leaks, discard product as sterility may be impaired.

To Add Medication: Admixtures must be prepared following strict aseptic techniques. Compatible supplemental medication may be added through the medication port (transparent colour). 1. Prepare medication port (transparent colour) by removal of aluminum foil (figure 2a). Please note: The area underneath the foil of the medication port is sterile. 2. Puncture resealable medication port and inject additive(s) (figure 2b). 3. Mix solution and medication thoroughly (figure 3a). 4. Medication port may be swabbed with disinfection agent (e.g. iso-propanol) before re-puncturing. 5. Check admixture visually for particulate matter (figure 3b).

Preparation for Administration: 1. Remove aluminum foil of infusion port (green colour) at the bottom of container (figure 4a) and attach administration set (figure 4b): use non-vented infusion set or close air vent on a vented set. Follow directions for use of the infusion set. Please note: The area underneath the foil of the infusion port is sterile. 2. Hang bag on an i.v. pole (figure 5).

Additional Information: Container is PVC-free, DEHP-free, latex-free