Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
MIXTURE OF OLIVE OIL (80%) AND SOYBEAN OIL (20%)
BAXTER HEALTHCARE (ASIA) PTE LTD
B05BA02
20 g/100 ml
EMULSION
MIXTURE OF OLIVE OIL (80%) AND SOYBEAN OIL (20%) 20 g/100 ml
INTRAVENOUS
General Sale List
BAXTER SA
ACTIVE
2003-10-08
CONFIDENTIAL DOCUMENT 1 BAXTER 1. NAME OF THE MEDICINAL PRODUCT CLINOLEIC 20%, emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Refined olive oil and refined soya bean oil* .. 20.00 g corresponding to a content of essential fatty acids ........................................... 4.00 g Per 100 ml * Mixture of refined olive oil (approximately 80%) and refined soya bean oil (approximately 20%) Energy content .......................................................................... 2000 kcal/l (8.36 MJ/l) Lipid content (olive and soya bean oil) ............................................................. 200 g/l Osmolarity ................................................................................................ 270 mOsm/l pH ........................................................................................................................... 6 -8 Density .................................................................................................................. 0.986 Phospholipids provide 47 milligrams or 1.5 mmol of phosphorus per 100 ml For excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for infusion Milk-like homogeneous liquid 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Indicated as a source of lipids for patients requiring parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION CLINOLEIC 20% contains 200 mg/ml of lipids _ _ _Route of administration _ Intravenous infusion: when administered as part of a complete nutrition admixture (with glucose and amino acids) the central or peripheral venous route should be chosen depending on the osmolarity of the final admixture. in rare cases, when infused alone as a com Olvassa el a teljes dokumentumot
1. NAME OF THE MEDICINAL PRODUCT ClinOleic ® 20%, emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 100ml Refined olive oil and refined soya bean oil* 20.00 g corresponding to a content of essential fatty acids 4.00 g * Mixture of refined olive oil (approximately 80%) and refined soya bean oil (approximately 20%) Energy content 2000 kcal/l (8.36 MJ/l) Lipid content (olive and soya bean oil) 200 g/l Osmolarity 270 mOsm/l pH 6 -8 Density 0.986 Phospholipids provide 47 milligrams or 1.5mmol of phosphorus per 100 ml For excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for infusion Milk-like homogenous liquid 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated as a source of lipids for patients requiring parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ClinOleic 20% contains 200 g/l of lipids corresponding to 200 mg/ml. _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. _In adults: _ The posology is 1 to a maximum of 2 g lipids/kg/day. The initial infusion rate must be slow and not exceed 0.1 g lipids or 0.5 ml (10 drops) per minute for 10 minutes then gradually increased until reaching the required rate after half an hour. Never exceed 0.15 g lipids/kg/hour (0.75 ml/kg/hour) Adults per kg of body weight Adults for 70 kg Usual lipid dosage 1 to 2 g/kg/day 70 to 140 g/day Infused volume of ClinOleic 20% 5 to 10 ml/kg/day 350 to 700 ml/day _In children_ : _ _ ClinOleic 20% should be administered as a continuous 24h/day infusion. It is recommended not to exceed a daily dose of 3g-lipids/kg b.w. (body weight) and an infusion rate of 0.15 g lipids/kg b.w./h. Daily dose should be increased gradually during the first week of administration. _In premature newborns and Olvassa el a teljes dokumentumot