AMINOPLASMAL-15% INFUSION [SIN08352P]
Active ingredients: AMINOPLASMAL-15% INFUSION
Last updated 24 April 2026
Product Info
AMINOPLASMAL-15% INFUSION
[SIN08352P]
Product information
Active Ingredient and Strength | ACETYLCYSTEINE EQV CYSTEINE - 0.5 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.