Regulatory Information
B. BRAUN SINGAPORE PTE LTD
B. BRAUN SINGAPORE PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION, EMULSION
**4.2 Posology and method of administration** Posology The dosage should be adapted to the patients’ individual requirements. It is recommended that Nutriflex® Omega Special B. Braun Emulsion for Infusion be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications. _Adults_ The maximum daily dose amounts to 35 mL/ kg body weight, corresponding to 2.0 g amino acids/kg body weight per day5.04 g glucose/kg body weight per day1.4 g lipid/kg body weight per day. The maximum rate of infusion is 1.7 ml/kg body weight per hour, corresponding to 0.1 g amino acids/kg body weight per hour0.24 g glucose/kg body weight per hour0.07 g lipid/kg body weight per hour. For a patient weighing 70 kg this corresponds to a maximum infusion rate of 119 mL per hour. The amount administered is then 6.8 g of amino acids per hour, 17.1 g of glucose per hour and 4.8 g of lipids per hour. _Paediatric population_ Nutriflex® Omega Special B. Braun Emulsion for Infusion is contraindi-cated in newborn infants, infants and toddlers under 2 years of age (see section 4.3). The safety and efficacy in children over 2 years and adolescents have not been established yet. No data are available. _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_). Duration of treatment The duration of treatment for the indications stated is not limited. During the administration of Nutriflex® Omega Special B. Braun Emulsion for Infusion it is necessary to provide an appropriate amount of trace elements and vitamins. _Duration of infusion of one single bag_ The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h. Method of administration Intravenous use. For central venous infusion only.
INTRAVENOUS
Medical Information
**4.1 Therapeutic indications** Supply of energy, essential fatty acids including omega-3 and omega-6 fatty acids, amino acids, electrolytes and fluids for parenteral nutrition of patients in states of moderate to severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated. Nutriflex® Omega Special B. Braun Emulsion for Infusion is indicated in adults.
**4.3 Contraindications** - hypersensitivity to the active substances, to egg, fish, peanut or soya protein 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 hypertriglyceridaemia (≥ 1000 mg/dL or 11.4 mmol/L) - severe coagulopathy - hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour - acidosis - intrahepatic cholestasis - severe hepatic insufficiency - severe renal insufficiency in absence of renal replacement therapy - aggravating haemorrhagic diatheses - acute thromboembolic events, lipid embolism On account of its composition Nutriflex® Omega Special B. Braun Emulsion for Infusion must not be used in newborn infants, infants and toddlers under 2 years of age. General contraindications to parenteral nutrition include: - unstable circulatory status with vital threat (states of collapse and shock) - acute phases of cardiac infarction and stroke - unstable metabolic condition (e.g. severe postaggression syndrome, coma of unknown origin) - inadequate cellular oxygen supply - disturbances of the electrolyte and fluid balance - acute pulmonary oedema - decompensated cardiac insufficiency.
B05BA10
combinations
Manufacturer Information
B. Braun Singapore Pte Ltd.
B. Braun Melsungen AG
Active Ingredients
Documents
Package Inserts
Nutriflex Omega Special B. Braun PI.pdf
Approved: March 7, 2023