SMOFLIPID 20 %

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

OLIVE OIL, SOYBEAN OIL, PURIFIED FISH OIL, MEDIUM CHAIN TRIGLYCERIDE

Tilgængelig fra:

FRESENIUS KABI COMBIPHAR - Indonesia

INN (International Name):

OLIVE OIL, SOYBEAN OIL, PURIFIED FISH OIL, MEDIUM CHAIN TRIGLYCERIDE

Dosering:

50 MG /60 MG /30 MG /60 MG

Lægemiddelform:

INFUS

Enheder i pakken:

BOTOL @ 50 ML

Fremstillet af:

FRESENIUS KABI AUSTRIA GMBH - AUSTRIA

Autorisation dato:

2020-02-17

Produktets egenskaber

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