OMEGAVEN

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

GLYCEROL; HIGHLY REFINED FISH OIL; PURIFIED EGG PHOSPHATIDE

Διαθέσιμο από:

CURE MEDICAL & TECHNICAL SUPPLY

Φαρμακολογική κατηγορία (ATC):

B05BA02

Φαρμακοτεχνική μορφή:

EMULSION FOR INFUSION

Σύνθεση:

GLYCEROL 2.5 G / 100 ML; PURIFIED EGG PHOSPHATIDE 1.2 G / 100 ML; HIGHLY REFINED FISH OIL 10 G / 100 ML

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

FRESENIUS KABI DEUCTSCHLAND GmbH,GERMANY

Θεραπευτική περιοχή:

FAT EMULSIONS

Θεραπευτικές ενδείξεις:

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.

Ημερομηνία της άδειας:

2014-07-15

Αρχείο Π.Χ.Π.

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