Omegaven

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Egg lecithin 1.2%{relative} (As a component in fish oil);  ; Fish oil 10%{relative} (highly refined); Glycerol 2.5%{relative} (As a component in fish oil)

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Egg lecithin 1.2% w/v (As a component in fish oil)

Pharmaceutical form:

Emulsion for infusion

Composition:

Active: Egg lecithin 1.2%{relative} (As a component in fish oil)   Fish oil 10%{relative} (highly refined) Glycerol 2.5%{relative} (As a component in fish oil) Excipient: Sodium hydroxide Sodium oleate Water for injection

Units in package:

Bottle, glass, 100 mL, 10 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Fresenius Kabi AB

Therapeutic indications:

For use as a fraction of the lipid emulsion component for total parenteral nutrition, providing supplements of long chain omega-3-fatty acids especially eicosapentanoic and docosahexanoic acid when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 100 mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C - Bottle, glass, 50 mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C - Bottle, glass, - 50 mL - 18 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 mL - 18 months from date of manufacture stored at or below 25°C

Authorization date:

2002-09-20

Patient Information leaflet

Page 1 of 2
OMEGAVEN
Emulsion for infusion
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Omegaven. It does not contain all
the available information. It does
not take the place of talking to your
doctor or pharmacist. All medicines
have
risks
and
benefits.
Your
doctor
has weighed the
risks of
you given Omegaven against any
benefits they expect it will have for
you.
Please
read
this
leaflet
carefully
before given Omegaven. If you
have any questions or are unsure
about
anything,
please
ask
your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT
OMEGAVEN
IS
USED FOR
Omegaven
is
a
sterile
fat
emulsion,
which
provides
your
body with energy and fatty acids.
The active ingredient in Omegaven
is fish oil. It also contains other
ingredients like egg lecithin which
is isolated from egg yolk, glycerol
and water for injections.
Omegaven
provides
the
energy
and
fatty
acids
in
patients
who
require intravenous nutrition.
BEFORE
YOU
ARE
GIVEN
OMEGAVEN
You
should
NOT
be
given
Omegaven if you answer YES to
any of the following:

You
have
an
inability
to
break down fats

You are suffering from a
very serious problem with
your blood circulation.

You have too much sugar
in your blood or diabetes
which is not under control.

You are suffering from a
severe
unstable
medical
condition.

You
are
experiencing
a
sudden decrease in blood
pressure.

You
have
certain
untreated heart problems.

You
have
severe
liver
failure.

You
have
severe
kidney
failure.

You are under 12 years of
age.

You have too much fluid in
your body.

You have an allergy to any
of
the
ingredients
contained in Omegaven as
listed
at
the
end
of
this
leaflet
e.g
fish
or
egg
protein.

You have too much acid in
your
blood,
also
called
metabolic acidosis.

There is not enough water
content in your body.
If you are not sure whether any of
these apply to you, check with your
doctor.
_BEFORE YOU START TO TAKE IT _
If
the
answer
to
any
of

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 7
1 PRODUCT MEDICINE
Omegaven, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Omegaven contains the following:
Content
Active Ingredients
g/100 mL
Fish oil - rich in Omega-3 acids
10.0
containing:
Eicosapentaenoic acid (EPA)
1.25-2.82
Docosahexaenoic acid (DHA)
1.44-3.09
dl-

-tocopherol (as antioxidant)
0.015-0.0296
Glycerol
2.5
Egg lecithin
1.2
Total energy per 100 mL
470 kJ (112 kcal)
pH value
7.5 to 8.7
Titration acidity
< 1 mmol HCl/L
Osmolality
308-376 mOsm/kg water
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Emulsion for Infusion.
White homogenous emulsion.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
For use as a fraction of the lipid emulsion component for total
parenteral nutrition, providing
supplements of long chain omega-3-fatty acids especially
eicosapentanoic and docosahexanoic acid
when oral or enteral nutrition is impossible, insufficient or
contraindicated.
4.2
Dose and method of administration
Daily dose:
1 mL up to maximum of 2 mL Omegaven/kg body weight
= 0.1 g up to a maximum of 0.2 g fish oil/kg body weight.
= 70 mL up to 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.
NEW ZEALAND DATA SHEET
Page 2 of 7
Omegaven should be administered simultaneously with other fat
emulsions. On the basis of a
recommended total daily lipid intake of 1-2 g/kg bodyweight, the fish
oil portion from Omegaven
should constitute 10-20% of this intake.
Method of administration
For infusion via central or peripheral vein.
When Omegaven is to be administered with other infusion solutions e.g.
amino acid solutions,
carbohydrate solutions) via a common infusion line (by-pass, y-tube),
the compatibility of the
solutions