- Approval Id
- f0fd6001fe7324a7
- Drug Name
- SMOFKABIVEN EMULSION FOR INFUSION
- Product Name
- SMOFKABIVEN EMULSION FOR INFUSION
- Approval Number
- SIN14286P
- Approval Date
- 2013-01-08
- Registrant
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Licence Holder
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, EMULSION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The appearance of the product after mixing the 3 chambers is a white emulsion.</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>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.</p>
<p>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).</p>
<p><em>Adults</em></p>
<p>The requirements are 0.6–0.9 g amino acids/kg bw/day (0.10–0.15 g nitrogen/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 0.9–1.6 g amino acids/kg bw/day (0.15–0.25 g nitrogen/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.</p>
<p>Dosage:<br>
The dosage range of 13–31 ml SmofKabiven/kg bw/day will provide 0.6–1.6 g amino acids/kg bw/day (corresponds to 0.10–0.25 g nitrogen/kg bw/day) and 14–35 kcal/kg bw/day of total energy (12–27 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.</p>
<p>Infusion rate:<br>
The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.</p>
<p>The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.10 g amino acids, 0.25 g glucose and 0.08 g lipids/kg bw/h). The recommended infusion period is 14–24 hours.</p>
<p>Maximum daily dose:<br>
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 35 ml/kg bw/day.</p>
<p>The recommended maximum daily dose of 35 ml/kg bw/day will provide 1.8 g amino acids/kg bw/day (corresponding to 0.28 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g lipids/kg bw/day and a total energy content of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).</p>
<p><em>Paediatric population</em></p>
<p><em>Children (2–11 years)</em></p>
<p>Dosage:<br>
The dose up to 35 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.</p>
<p>Infusion rate:<br>
The recommended maximum infusion rate is 2.4 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.30 g/glucose/kg/h and 0.09 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 14 hours 30 minutes, except in exceptional cases and with careful monitoring.</p>
<p>The recommended infusion period is 12–24 hours.</p>
<p>Maximum daily dose:<br>
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 35 ml/kg bw/day.</p>
<p>The recommended maximum daily dose of 35 ml/kg bw/day will provide 1.8 g amino acids/kg bw/day (corresponding to 0.28 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g lipids/kg bw/day and a total energy content of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).</p>
<p><em>Adolescents (12–16/18 years)</em></p>
<p>In adolescents, SmofKabiven can be used as in adults.</p>
<p><u>Method of administration</u><br>
Intravenous use, infusion into a central vein.</p>
<p>The five different package sizes of SmofKabiven 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 according to the patient’s need.</p>
<p>For instructions on preparation of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>Severe hyperlipidemia</li>
<li>Severe liver insufficiency</li>
<li>Severe blood coagulation disorders</li>
<li>Congenital errors of amino acid metabolism</li>
<li>Severe renal insufficiency without access to hemofiltration or dialysis</li>
<li>Acute shock</li>
<li>Uncontrolled hyperglycaemia</li>
<li>Pathologically elevated serum levels of any of the included electrolytes</li>
<li>General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency</li>
<li>Hemophagocytotic syndrome</li>
<li>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)</li>
<li>Infants and children under 2 years of age</li>
</ul>
- Atc Code
- B05BA10
- Atc Item Name
- combinations
- Pharma Manufacturer Name
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/fresenius-kabi-singapore-pte-ltd
