País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Olive oil; Soya oil
Baxter Healthcare Ltd
Olive oil; Soya oil
160gram/1litre ; 40gram/1litre
Infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5413760207902
OBJECT 1 CLINOLEIC 20% Summary of Product Characteristics Updated 01-Apr-2015 | Baxter Healthcare Ltd 1. Name of the medicinal product ClinOleic 20% 2. Qualitative and quantitative composition Composition per 100 ml Refined olive oil and refined soybean oil* 20.00g corresponding to a content of essential fatty acids 4.00g *Mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) Energy content 2000 kcal/l (8.36 MJ/l) Lipid content (olive and soybean oil) 200 g/l Osmolarity 270 mOsm/l pH 6-8 Density 0.986 ClinOleic contains 47 milligrams or 1.5 mmol of phosphorus per 100 ml 3. Pharmaceutical form Emulsion for infusion. ClinOleic 20% contains 200 g/l of lipids corresponding to 200 mg/ml. 4. Clinical particulars 4.1 Therapeutic indications ClinOleic 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition. 4.2 Posology and method of administration The emulsion is for administration by intravenous infusion as part of a parenteral nutrition regimen. Posology The posology depends on energy expenditure, the patient's clinical status, body weight, and ability to metabolize ClinOleic 20%, as well as additional energy given orally/enterally. Therefore, the dosage should be individualized and the bag size chosen accordingly. The maximum daily dose of ClinOleic 20% should be based on individual total nutritional requirements and patient tolerance. _Adult patients_ Up to 60% of the energy requirements of the patient can be provided by ClinOleic 20%. The infusion should be started at a rate of 0.5ml per minute for the first 15-30 minutes. The rate can then be increased to allow 500ml of ClinOleic 20% to be administered on the first day. On subsequent days the dose may be increased to a maximum of 2.5g lipids/kg of body weight with a maximum infusion rate of 0.25g lipids/kg/hour. _Paediatric patients_ Up to 60% of the energy requirements of the patient can be provided by ClinOleic 20%. The infusion should be started at a rate of 0.05ml per Llegiu el document complet