Regulatory Information
FRESENIUS KABI (SINGAPORE) PTE LTD
FRESENIUS KABI (SINGAPORE) PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION, EMULSION
**4.2 Posology and method of administration** Posology The appearance of the product after mixing the 3 chambers is a white emulsion. The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake. The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism). _Adults_ The requirements are 0.10‐0.15 g nitrogen/kg bw/day (0.6‐0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15‐0.25 g nitrogen/kg bw/day (0.9‐1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher. Dosage: The dosage range of 13‐31 ml SmofKabiven extra Nitrogen/kg bw/day corresponds to 0.14‐0.32 g nitrogen/kg bw/day (0.85‐2.0 g amino acids/kg bw/day) and 12‐28 kcal/kg bw/day of total energy (8‐19 kcal/kg bw/day of non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight. Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h. The infusion rate should not exceed 1.5 ml/kg bw/h (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 g lipids/kg bw/h). The recommended infusion period is 14‐24 hours. Maximum daily dose: The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day. The recommended maximum daily dose of 31 ml/kg bw/day will provide 2.0 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy). _Paediatric population_ _Children (2‐11 years)_ Dosage: The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients. Infusion rate: The recommended maximum infusion rate is 1.8 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.15 g/glucose/kg/h and 0.05 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 17 hours, except in exceptional cases and with careful monitoring. The recommended infusion period is 12–24 hours. Maximum daily dose: The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day. The recommended maximum daily dose of 31 ml/kg bw/day will provide 2 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy). _Adolescents (12–16/18 years)_ In adolescents, SmofKabiven extra Nitrogen can be used as in adults. Method of administration Intravenous use, infusion into a central vein. The five different package sizes of SmofKabiven extra Nitrogen are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to SmofKabiven extra Nitrogen according to the patients need. For instructions on preparation of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAVENOUS
Medical Information
**4.1 Therapeutic indications** Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
**4.3 Contraindications** - Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - Severe hyperlipidemia - Severe liver insufficiency - Severe blood coagulation disorders - Congenital errors of amino acid metabolism - Severe renal insufficiency without access to hemofiltration or dialysis - Acute shock - Uncontrolled hyperglycaemia - Pathologically elevated serum levels of any of the included electrolytes - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency - Hemophagocytotic syndrome - Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma) - Neonates and infants under 2 years of age
B05BA10
combinations
Manufacturer Information
FRESENIUS KABI (SINGAPORE) PTE LTD
Fresenius Kabi AB, Site Uppsala