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 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 of substrate 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 is contraindicated in newborn infants, infants and toddlers < 2 years of age (see section 4.3). Safety and efficacy in children > 2 years and adolescents have not been established. _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 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 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 thrombo-embolic events, lipid embolism On account of its composition, Nutriflex Omega special 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 Special PI.pdf
Approved: April 13, 2020