Land: Israël
Taal: Engels
Bron: Ministry of Health
GLYCEROL; HIGHLY REFINED FISH OIL; PURIFIED EGG PHOSPHATIDE
CURE MEDICAL & TECHNICAL SUPPLY
B05BA02
EMULSION FOR INFUSION
GLYCEROL 2.5 G / 100 ML; PURIFIED EGG PHOSPHATIDE 1.2 G / 100 ML; HIGHLY REFINED FISH OIL 10 G / 100 ML
I.V
Required
FRESENIUS KABI DEUCTSCHLAND GmbH,GERMANY
FAT EMULSIONS
FAT EMULSIONS
Parenteral nutrition supplementation with long chain Omega-3-fatty acids, especially eicosapentaenoic and docosahexaenoic acids when oral or enternal nutrition is impossible, insufficient or contraindicated.
2021-08-31
1 (6) SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omegaven ® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml emulsion contains: Highly refined fish oil 10.0 g containing eicosapentaenoic acid (EPA) 1.25 - 2.82 g docosahexaenoic acid (DHA) 1.44 - 3.09 g dl- α -Tocopherol (as antioxidant) 0.015 - 0.0296 g Glycerol 2.5 g Purified egg phosphatide 1.2 g Total energy: 470 kJ/100 ml = 112 kcal/100 ml pH value: 7.5 to 8.7 Titration acidity: < 1 mmol HCl/l Osmolality: 308-376 mosm/kg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for infusion White homogenous emulsion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Parenteral nutrition supplementation with long chain omega-3-fatty acids, especially eicosapentaenoic and docosahexaenoic acid, when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Daily dose: 1 ml up to max. 2 ml Omegaven/kg body weight = 0.1 g up to max. 0.2 g fish oil/kg body weight = 70 ml up to max. 140 ml Omegaven for a patient with a body weight of 70 kg. Maximum infusion rate: The infusion rate should not exceed 0.5 ml Omegaven/kg body weight/hour corresponding to 0.05 g fish oil/kg body weight/hour. The maximum infusion rate should be strictly adhered to, otherwise a severe increase in the serum triglyceride concentration can be observed. 2 (6) Omegaven should be administered simultaneously with other fat emulsions. On the basis of a recommended total daily lipid intake of 1 - 2 g/kg body weight, the fish oil portion from Omegaven should constitute 10 - 20% of this intake. _Method of administration _ • For infusion via central or peripheral vein. • Containers should be shaken before use. • When Omegaven is to be administered with other infusion solutions (eg amino acid solutions, cabohydrate solutions) via a common infusion line (by-pass, y-tube), the compatibility of the solutions/emulsions used must be ensured. _Duration of administration _ The duration Lees het volledige document