What it is and what it is used for

for

Aminoplasmal 15% is a solution which is given to you through a small tube placed in a vein (intravenous infusion). The solution contains amino acids that are essential for the body to grow or to recover. You will receive this medicine if you are unable to eat food normally and you cannot be fed through a tube placed into your stomach either. This solution can be given to adults, adolescents and children over 2 years of age. 2.

What you need to know before you take it

e Aminoplasmal 15%

Do not use Aminoplasmal 15% ● if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6) ● if you suffer from an inborn error of your metabolism of proteins and amino acids ● if you have a severe (i.e. life-threatening) circulation disorder (shock) ● if you have insufficient oxygen supply (hypoxia) ● if acidic substances accumulate in your blood (metabolic acidosis) ● if you have a severe liver disease (severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy grades III and IV) ● if you have severe kidney failure (severe renal insufficiency) not adequately treated by artificial kidney or similar therapies ● if you suffer from a poorly controlled heart failure with marked impairment of your blood circulation (decompensated cardiac insufficiency)

1

● ●

if you have accumulation of fluid in your lungs (acute pulmonary oedema) if your body's salt (electrolyte) or water balance is disturbed

This solution must not be given to newborn babies and children infants and toddlers less than two years of age because the composition of the solution does not properly meet the special nutrition requirements of this age group. Warnings and precautions Talk to your doctor or pharmacist before using Aminoplasmal 15%

• if you suffer from an impairment of your metabolism of proteins and amino acids caused by any condition other than mentioned above (see section "Do not use…")
• if you have mild to moderate impairment of your liver or decompensated liver cirrhosis with hepatic encephalopathy (grades I and II)
• if you have mild to moderate impairment of kidney function
• if you have an impairment of your heart function
• if you have abnormally highly concentrated blood serum (high serum osmolarity) If your body's water or salt balance is disturbed, this condition should be corrected before you receive 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 you are receiving this medicine, your blood salt levels, blood sugar levels, the water balance, the acid-base balance, your blood proteins and kidney and liver function will be monitored. For this purpose blood samples will be taken and your urine will be collected and both will be analysed. Usually you will receive Aminoplasmal 15% 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 15% Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. Pregnancy If you are pregnant, you will only be given this medicine if your doctor considers it necessary for your recovery, after careful consideration. Breast-feeding At therapeutic doses of Aminoplasmal 15% no harmful effects on the breastfed newborn/infant are anticipated. Nevertheless, breast-feeding is not recommended if you need intravenous feeding at the same time. Driving and using machines

2

This medicine is normally given to immobile patients in a controlled setting (emergency treatment, acute treatment in a hospital or a day therapy unit). This will exclude driving and using machines. Important information about some of the ingredients of Aminoplasmal 15% This medicine contains 122 mg sodium (main component of cooking/table salt) in each 1000 ml. This is equivalent to 6.1 % of the recommended maximum daily dietary intake of sodium for an adult. 3.

How to take it

Aminoplasmal 15%

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dosage Adults Your doctor will determine the amount of solution you need each day. In general, this will be 6.7 – 13.3 ml per kg of your body weight per day. The solution will flow in at a rate of not more than 0.67 ml per kg of your body weight per hour. Children from 2 to 18 years old 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 approximately: 2 to less than 3 years old: 6.64 – 16.6 ml per kg of body weight per day 3 to 18 years old: 6.64 – 13.3 ml per kg of body weight per day For critically ill children the amount to be given may be higher (up to 20 ml per kg body weight per day). The solution will run in at a rate of not more than 0.67 ml per kg body weight per hour. Patients with kidney or liver disease The doses will be adjusted according to your individual requirements if you have liver (hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy grades I and II) or kidney disease. When given during dialysis amino acid losses into the dialysate have to be considered. Duration of use This medicine may be used as long as you need intravenous feeding. Method of administration This medicine will be administered to you through a small tube inserted into one of your large veins (central venous infusion). If you received more Aminoplasmal 15% than you should It is unlikely that this occurs because your doctor will determine your daily doses. However, if you receive an overdose or the solution is flowing too fast, you may feel sick, may have to vomit and/or have a headache. Also, your blood may contain too much ammonia (hyperammonaemia) and you may lose amino acids in the urine. You may also suffer from too much fluid in your body (hyperhydration), your body's salt balance may be disturbed (electrolyte imbalance) and you may have water on your lungs (pulmonary oedema). If this happens, the infusion will be stopped and started again at a lower infusion rate some time later.

3

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 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 15% but may occur with any kind of intravenous feeding, especially at the beginning. The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, he will stop giving you this medicine: 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 15%

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle and carton labels. The expiry date refers to the last day of that month. Do not store above 30 °C. Do not freeze. Cool storage of the solution, below 15 °C, may lead to formation of crystals, that can, however, be easily dissolved by gentle warming at 25 °C until dissolution is complete. Shake container gently to ensure homogeneity. Only to be used if the solution is clear and colourless up to faintly straw-coloured and the bottle and its closure are undamaged. After infusion, any remaining solution should never be stored for later use. 6.

Contents of the pack and other information

4

What Aminoplasmal 15% contains The active substances are amino acids. This medicine contains: Isoleucine Leucine Lysine monohydrate (equivalent to lysine) Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Aspartic acid Glutamic acid Proline Serine Tyrosine Acetylcysteine (equivalent to cysteine)

per 1 ml 5.850 mg 11.40 mg 8.930 mg (7.950 mg) 5.700 mg 5.700 mg 5.400 mg 2.100 mg 7.200 mg 16.05 mg 5.250 mg 22.35 mg 19.20 mg 7.950 mg 16.20 mg 7.350 mg 3.000 mg 0.500 mg 0.500 mg (0.370 mg)

per 500 ml 2.925 g 5.700 g 4.465 g (3.975 g) 2.850 g 2.850 g 2.700 g 1.050 g 3.600 g 8.025 g 2.625 g 11.175 g 9.600 g 3.975 g 8.100 g 3.675 g 1.500 g 0.250 g 0.250 g (0.185 g)

per 1000 ml 5.850 g 11.40 g 8.930 g (7.950 g) 5.700 g 5.700 g 5.400 g 2.100 g 7.200 g 16.05 g 5.250 g 22.35 g 19.20 g 7.950 g 16.20 g 7.350 g 3.000 g 0.500 g 0.500 g (0.370 g)

The other ingredients are sodium hydroxide, citric acid monohydrate (for pH-adjustment) and water for injections. Electrolyte concentrations Citrate Sodium Total amino acids Total nitrogen Energy [kJ/l (kcal/l)] Theoretical osmolarity [mOsm/l] Acidity (titration to pH 7.4) [mmol NaOH/l] pH

1.0 – 1.9 mmol/l 5.3 mmol/l 150 g/l 24.0 g/l 2505 (600) 1290 approx. 31 5.7 – 6.3

What Aminoplasmal 15% looks like and contents of the pack Aminoplasmal 15% is a clear, colourless up to faintly straw-coloured solution, practically free from visible particles.

5

The product comes in colourless glass bottles of 500 ml and 1000 ml, which are each closed by rubber stoppers. The 500 ml bottles are available in packs of 1 and 10. The 1000 ml bottles are available in packs of 1 and 6. 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: France Germany Poland Spain United Kingdom (GB and NI)

AMINOPLASMAL 25, solution pour perfusion Aminoplasmal – 15 % elektrolyt- und kohlenhydratfrei AMINOPLASMAL 15 % AMINOPLASMAL B.BRAUN 15% solución para perfusión Aminoplasmal 15% solution for infusion

This leaflet was last revised in February 2026 The following information is intended for healthcare professionals only: Dosage In the case of amino acid requirements of 1.0 g per kg body weight per day or more, particular attention should be paid to the limitations of fluid input. To avoid fluid overload, amino acid solutions with higher amino acid content may have to be used in such situations. Patients with renal/hepatic impairment The doses should be adjusted individually in patients with mild to moderate renal insufficiency. The doses should be adjusted individually in patients with mild to moderate hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy (grades I and II). When given during dialysis amino acid losses into the dialysate have to be considered. Aminoplasmal 15% is contraindicated in severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy (grades III and IV) and severe renal insufficiency in absence of renal replacement therapy. Instructions for handling Use a sterile giving set for infusion of Aminoplasmal 15%.

6

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. Aminoplasmal 15% can only be mixed with other nutrients for which compatibility has been documented (see section 6.6 of the SmPC). Special care must be taken when using inorganic phosphate sources: Mixtures containing inorganic phosphate are incompatible with concentrations of amino acids less than 20 g/l and glucose less than 50 g/l and should be strictly avoided. Pay special attention to compatibility. Special precaution for storage Do not store above 30 °C. The solution should only be used if the closure of the container is not damaged and if the solution is clear colourless to faintly straw-coloured, practically free from visible particles. Containers are for single use only. Discard container and any unused contents after use. Shelf life after admixture of additives From a microbiological point of view, mixtures should be administered immediately after preparation. If not administered 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 2 °C to 8 °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.

7