Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLIVE OIL, SOYBEAN OIL, PURIFIED FISH OIL, MEDIUM CHAIN TRIGLYCERIDE
FRESENIUS KABI COMBIPHAR - Indonesia
OLIVE OIL, SOYBEAN OIL, PURIFIED FISH OIL, MEDIUM CHAIN TRIGLYCERIDE
50 MG /60 MG /30 MG /60 MG
INFUS
BOTOL @ 50 ML
FRESENIUS KABI AUSTRIA GMBH - AUSTRIA
2020-02-17
M0xxxxx/01 ID SMOFLIPID 20 % SOYA-BEAN OIL, MEDIUM CHAIN TRIGLYCERIDES, REFINED OLIVE OIL, PURIFIED FISH OIL EMULSION FOR INFUSION 1000 ML CONTAIN : Soya-bean oil, refined 60.0 g Medium chain triglycerides 60.0 g Olive oil, refined 50.0 g Purified fish oil, rich in Omega 3 acids 30.0 g Total energy : 8.4 MJ/l (= 2000 kcal/l) pH- value approx. 8 Osmolality approx. 380 mosm/kg PHARMACODYNAMIC PROPERTIES The fat emulsion has a particle size and biological properties similar to those of endogenous chylomicrons. The constituents of SMOFlipid; soya – bean oil, medium – chain triglycerides, olive oil and fish oil have, except for their energy contents, their own pharmacodynamic properties. Soya – bean oil has a high content of essential fatty acids. The omega – 6 fatty acid linoleic acid is the most abundant (approx. 55 – 60 %). Alpha-linolenic acid, an omega – 3 fatty acid, constitutes about 8 %. This part of SMOFlipid provides the necessary amount of essential fatty acids. Medium – chain fatty acids are rapidly oxidized and provide the body with a form of immediately available energy. Olive oil mainly provides energy in the form of mono – unsaturated fatty acids, which are much less prone to peroxidation than the corresponding amount of poly – unsaturated fatty acids. Fish oil is characterized by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as prostaglandins, thromboxanes and leucotrienes. Vitamin E protects unsaturated fatty acids against lipid peroxidation. Exploratory studies have been conducted in infants and children_ _but confirmatory pivotal studies have not been provided. Twenty eight infants and children aged from 5 months to 2 years and from 2 to 11.5 years with stable disease requiring parenteral nutrition for at least 4 weeks received SMOFlipid or Intralipid 20% in a randomized, double-blind study. SMOFlipid or Intralipid were to be given as approx. 2 g fa Olvassa el a teljes dokumentumot