AMINOPLASMAL-15% INFUSION [SIN08352P]

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Last updated 16 September 2026

Product Info

AMINOPLASMAL-15% INFUSION

[SIN08352P]

Product information

Active Ingredient and Strength	ACETYLCYSTEINE EQV CYSTEINE - 0.5 G/L ALANINE - 22.35 G/L ARGININE - 16.05 G/L ASPARTIC ACID - 7.95 G/L GLUTAMIC ACID - 16.2 G/L GLYCINE - 19.2 G/L HISTIDINE - 5.25 G/L ISOLEUCINE - 5.85 G/L LEUCINE - 11.4 G/L LYSINE MONOHYDRATE EQV LYSINE - 8.93 G/L METHIONINE - 5.7 G/L PHENYLALANINE - 5.7 G/L PROLINE - 7.35 G/L SERINE - 3 G/L THREONINE - 5.4 G/L TRYPTOPHAN - 2.1 G/L TYROSINE - 0.5 G/L VALINE - 7.2 G/L
Dosage Form	INJECTION
Manufacturer and Country	B BRAUN MELSUNGEN AG - GERMANY
Registration Number	SIN08352P
Licence Holder	B. BRAUN SINGAPORE PTE LTD
Forensic Classification	GENERAL SALE LIST
Anatomical Therapeutic Chemical (ATC) code	B05BA01
Prescription-only Medicines with Exemptions for Supply without Prescription	NA

Indication

4.1 Therapeutic indications

Supply of amino acids for parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. For adults, adolescents and children over 2 years of age.

Dosing

4.2 Posology and method of administration

Posology

The dosage has to be adjusted according to the individual need of amino acids and fluid, depending on the clinical condition of the patient (nutritional status and/or degree of nitrogen catabolism due to underlying disease).

Adults and adolescents from 14 to 17 years

Table caption

Daily dose:
1.0 – 2.0 g amino acids/kg body weight	≙ 6.7 – 13.3 ml/kg body weight ≙ 469 – 931 ml for a 70 kg patient
Maximum infusion rate:
0.1 g amino acids/kg body weight/h	≙ 0.67 ml/kg body weight/h ≙ 0.78 ml/min for a 70 kg patient

Paediatric population

Newborn infants, infants and toddlers less than two years of age

Aminoplasmal 15% is contraindicated in newborn infants, infants and toddlers less than 2 years of age (see section 4.3).

Children and adolescents 2 to 13 years

The dosages for the age groups stated below are average values for guidance. The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease.

Daily dose for children 2 to 4 years:
1.5 g amino acids/kg body weight ≙ 10 ml/kg body weight

Daily dose for children 5 to 13 years:
1.0 g amino acids/kg body weight ≙ 6.7 ml/kg body weight

Critically ill children: For critically ill patients the advisable amino acid intake may be higher (up to 3.0 g amino acids/kg body weight per day).

Maximum infusion rate:
0.1 g amino acids/kg body weight/h ≙ 0.67 ml/kg body weight /h

In the case of amino acid requirements of 1.0 g/kg body weight/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 hepatic or renal insufficiency (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Aminoplasmal 15% is contraindicated in severe hepatic insufficiency and severe renal insufficiency in absence of renal replacement therapy (see section 4.3).

Duration of use

This solution can be administered as long as parenteral nutrition is indicated.

Method of administration

Intravenous use.
For central venous infusion only.

Contraindications

4.3 Contraindications

Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information
Inborn errors of amino acid metabolism
Severe circulation disorders with vital risk (e.g. shock)
Hypoxia
Metabolic acidosis
Severe hepatic insufficiency
Severe renal insufficiency in absence of renal replacement therapy
Decompensated cardiac insufficiency
Acute pulmonary oedema
Disturbances of the electrolyte and fluid balance

The medicinal product must not be administered to newborn infants, infants and toddlers less than two years of age, because the amino acid composition does not properly meet the special requirements of this paediatric age group.