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NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION [SIN16734P]
Active ingredients: NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION
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Product Info
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION
[SIN16734P]
Product information
Active Ingredient and Strength | ALANINE - 6.792 G/1,000 ML |
Dosage Form | INJECTION, EMULSION |
Manufacturer and Country | B. BRAUN MELSUNGEN AG - GERMANY |
Registration Number | SIN16734P |
Licence Holder | B. BRAUN SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B05BA10 |
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.
4.2 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
Table caption
2.0 g amino acids | /kg body weight per day |
5.04 g glucose | /kg body weight per day |
1.4 g lipid | /kg body weight per day. |
The maximum rate of infusion is 1.7 ml/kg body weight per hour, corresponding to
Table caption
0.1 g amino acids | /kg body weight per hour |
0.24 g glucose | /kg body weight per hour |
0.07 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.
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.
