INTRALIPID INFUSION 20%

Fresenius Kabi SSPC (CHINA)Fresenius Kabi AB (SWEDEN)🇸🇬 Health Sciences Authority

Approval Date: Dec 15, 1990
Approval ID: bce2c0ffe9d2f7c8
Company: Fresenius Kabi SSPC (CHINA)Fresenius Kabi AB (SWEDEN)
Type: Therapeutic

Approval Details

Approval Id: bce2c0ffe9d2f7c8
Drug Name: INTRALIPID INFUSION 20%
Product Name: INTRALIPID INFUSION 20%
Approval Number: SIN05269P
Approval Date: 1990-12-15
Registrant: FRESENIUS KABI (SINGAPORE) PTE LTD
Licence Holder: FRESENIUS KABI (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: General Sale List
Dosage Form: INJECTION
Dosage: Infusion Bottle Posology and method of administration The ability to eliminate INTRALIPID should govern the dosage and infusion rate. See below Fat elimination. DOSAGE Intralipid 10% 1g triglycerides corresponds to 10 ml INTRALIPID 10%. Adults. The recommended maximum dosage is 3 g triglycerides/kg body weight/day. Within this upper limit, INTRALIPID can be given to contribute up to 70% of the energy requirements, also in patients with highly increased energy requirements. The infusion rate for INTRALIPID 10% should not exceed 500 ml in 5 hours. Neonates and infants. The recommended dosage range in neonates and infants is 0.5–4 g triglycerides/kg bw/day. The rate of infusion should not exceed 0.17 g triglycerides/kg bw/hour (4 g in 24 hours). In prematures and low birthweight neonates, INTRALIPID should preferably be infused continuously over 24 hours. The initial dosage should be 0.5–1 g/kg bw/day followed by a successive increase by 0.5–1 g/kg bw/day up to 2g/kg bw/day. Only with close monitoring of serum triglyceride concentration, liver tests and oxygen saturation may the dosage be increased to 4 g/kg bw/day. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses. When used in neonates and children below 2 years, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed. DOSAGE Intralipid 20% 1g triglycerides corresponds to 5 ml INTRALIPID 20%. Adults. The recommended maximum dosage is 3 g triglycerides/kg body weight/day. Within this upper limit, INTRALIPID can be given to contribute up to 70% of the energy requirements, also in patients with highly increased energy requirements. The infusion rate for INTRALIPID 20% should not exceed 500 ml in 5 hours. Neonates and infants. The recommended dosage range in neonates and infants is 0.5–4 g triglycerides/kg bw/day. The rate of infusion should not exceed 0.17 g triglycerides/kg bw/hour (4 g in 24 hours). In prematures and low birthweight neonates, INTRALIPID should preferably be infused continuously over 24 hours. The initial dosage should be 0.5–1 g/kg bw/day followed by a successive increase by 0.5–1 g/kg bw/day up to 2g/kg bw/day. Only with close monitoring of serum triglyceride concentration, liver tests and oxygen saturation may the dosage be increased to 4 g/kg bw/day. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses. When used in neonates and children below 2 years, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed. Essential fatty acid deficiency (EFAD). To prevent or correct essential fatty acid deficiency, 4 to 8% of the nonprotein energy should be supplied as INTRALIPID to provide sufficient amounts of linoleic and linolenic acid. When EFAD is associated with stress, the amount of INTRALIPID needed to correct the deficiency may be substantially increased. Administration. INTRALIPID may be infused into the same central or peripheral vein as carbohydrates/amino acid solutions by means of a Y-connector near infusion site. INTRALIPID can also be given in a phthalate-free plastic bag as one part of an All in One admixture containing also carbohydrates, amino acids, electrolytes, vitamins and trace elements. The admixtures must be approved for physical stability according to Fresenius Kabi standards. Fat Elimination Adults. The ability to eliminate fat should be closely monitored in patients with conditions mentioned in section “Special warnings and special precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, and in patients given Intralipid for more than one week. This is done by collecting a blood sample after a fat-free clearance period of 5–6 hours. Blood cells are then separated from plasma by centrifugation. If the plasma is opalescent, the infusion should be postponed. The sensitivity of this method is such that hypertriglyceridaemia can pass undetected. Therefore, it is recommended that serum triglyceride concentrations should be measured in patients who are likely to have impaired fat tolerance. Neonates and infants. The ability to eliminate fat should be tested regularly in neonates and infants. Measuring serum triglyceride levels is the only reliable method. Excel Bag Posology and method of administration The ability to eliminate INTRALIPID should govern the dosage and infusion rate. See below Fat elimination. DOSAGE Intralipid 10% 1g triglycerides corresponds to 10 ml INTRALIPID 10%. Adults. The recommended maximum dosage is 3 g triglycerides/kg body weight/day. Within this upper limit, INTRALIPID can be given to contribute up to 70% of the energy requirements, also in patients with highly increased energy requirements. The infusion rate for INTRALIPID 10% should not exceed 500 ml in 5 hours. Neonates and infants. The recommended dosage range in neonates and infants is 0.5–4 g triglycerides/kg bw/day. The rate of infusion should not exceed 0.17 g triglycerides/kg bw/hour (4 g in 24 hours). In prematures and low birthweight neonates, INTRALIPID should preferably be infused continuously over 24 hours. The initial dosage should be 0.5–1 g/kg bw/day followed by a successive increase by 0.5–1 g/kg bw/day up to 2g/kg bw/day. Only with close monitoring of serum triglyceride concentration, liver tests and oxygen saturation may the dosage be increased to 4 g/kg bw/day. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses. When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. DOSAGE Intralipid 20% 1g triglycerides corresponds to 5 ml INTRALIPID 20%. Adults. The recommended maximum dosage is 3 g triglycerides/kg body weight/day. Within this upper limit, INTRALIPID can be given to contribute up to 70% of the energy requirements, also in patients with highly increased energy requirements. The infusion rate for INTRALIPID 20% should not exceed 500 ml in 5 hours. Neonates and infants. The recommended dosage range in neonates and infants is 0.5–4 g triglycerides/kg bw/day. The rate of infusion should not exceed 0.17 g triglycerides/kg bw/hour (4 g in 24 hours). In prematures and low birthweight neonates, INTRALIPID should preferably be infused continuously over 24 hours. The initial dosage should be 0.5–1 g/kg bw/day followed by a successive increase by 0.5–1 g/kg bw/day up to 2g/kg bw/day. Only with close monitoring of serum triglyceride concentration, liver tests and oxygen saturation may the dosage be increased to 4 g/kg bw/day. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses. When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. Essential fatty acid deficiency (EFAD). To prevent or correct essential fatty acid deficiency, 4 to 8% of the nonprotein energy should be supplied as INTRALIPID to provide sufficient amounts of linoleic and linolenic acid. When EFAD is associated with stress, the amount of INTRALIPID needed to correct the deficiency may be substantially increased. Administration. INTRALIPID may be infused into the same central or peripheral vein as carbohydrates/amino acid solutions by means of a Y-connector near infusion site. INTRALIPID can also be given in a phthalate-free plastic bag as one part of an All in One admixture containing also carbohydrates, amino acids, electrolytes, vitamins and trace elements. The admixtures must be approved for physical stability according to Fresenius Kabi standards. Fat Elimination Adults. The ability to eliminate fat should be closely monitored in patients with conditions mentioned in section “Special warnings and special precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, and in patients given Intralipid for more than one week. This is done by collecting a blood sample after a fat-free clearance period of 5–6 hours. Blood cells are then separated from plasma by centrifugation. If the plasma is opalescent, the infusion should be postponed. The sensitivity of this method is such that hypertriglyceridaemia can pass undetected. Therefore, it is recommended that serum triglyceride concentrations should be measured in patients who are likely to have impaired fat tolerance. Neonates and infants. The ability to eliminate fat should be tested regularly in neonates and infants. Measuring serum triglyceride levels is the only reliable method.
Route Of Administration: INTRAVENOUS
Indication Info: Therapeutic Indications INTRALIPID is indicated in patients needing intravenous nutrition to supply energy and essential fatty acids. INTRALIPID is also indicated in patients with essential fatty acid deficiency (EFAD) who cannot maintain or restore a normal essential fatty acid pattern by oral intake.
Contraindications: Contra-indications INTRALIPID is contraindicated in patients with acute shock and those with severe disturbances in lipid metabolism such as pathologic hyperlipemia. INTRALIPID is also contraindicated in patients with severe liver insufficiency, hemophagocytotic syndrome, hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. INTRALIPID also should not be used in patients with acute myocardial infarction until the condition has stabilized.
Atc Code: B05BA02
Atc Item Name: fat emulsions
Pharma Manufacturer Name: FRESENIUS KABI (SINGAPORE) PTE LTD

Active Ingredients

SOYABEAN OIL (FRACTIONATED)

200 mg/ml

SOYABEAN OIL (FRACTIONATED)

200 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 15, 1990

Approval ID

bce2c0ffe9d2f7c8

Type

Therapeutic

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