Intralipid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Soya oil 30%{relative};  ;  

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Soya oil 30% w/v

Dosage:

30 %

Pharmaceutical form:

Solution for infusion

Composition:

Active: Soya oil 30%{relative}     Excipient: Egg lecithin Glycerol Water for injection

Units in package:

Bag, Excel 333ml, 250 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Fresenius Kabi AB

Therapeutic indications:

Part of the intravenous diet in all parenteral nutrition indications including: - Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required; - Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis); - Burns, to reduce the frequently excessive nitrogen losses; - Prolonged unconsciousness, eg following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible; - Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown; - Cachexia and - Patients with Essential Fatty Acid Deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Biofine-1 - 250 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

NEW ZEALAND CMI
Page 1 of 2
INTRALIPID
®
10%, 20% & 30%
Sterile fat emulsions containing soya oil, egg lecithin and glycerol
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Intralipid. 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 taking
Intralipid
against
any
benefits
they expect it will have for you.
Please read this leaflet carefully
before using Intralipid 10%, 20%
and
30%.
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
IS
INTRALIPID
USED
FOR
AND
HOW
DOES IT WORK?
Intralipid is a sterile fat emulsion,
which
provides
your
body
with
energy
and
fatty
acids.
The
active
ingredient
in
Intralipid
is
soya oil. Soya oil consists of a
mixture
of
mainly
polyunsaturated
fatty
acids.
It
also contains egg lecithin as an
emulsifier, which is isolated from
egg
yolk.
It
is
available
in
3
strengths namely 10%, 20% and
30%.
When the intake of nutrients or
food into the mouth or directly
into the gut is not possible, or it is
not enough to supply the body’s
needs, then intravenous nutrients
or foods can be given. This is
especially
important
for
people
whose bodies are under physical
stress
from
illness
or
recent
surgery. During illness or after
surgery
the
body
requires
nutrition
or
food.
It
is
usually
given
together
with
carbohydrates,
amino
acids,
salts,
trace
elements
and
vitamins to provide a complete
intravenous diet.
BEFORE
YOU
ARE
GIVEN INTRALIPID
You should not be given Intralipid
if

You have an allergy to soya
oil, eggs, peanuts or any of
the ingredients listed at the
end of this leaflet.

You
have
an
inability
to
break down fats
If you are not sure whether any
of these apply to you, check with
your doctor.
You
should
tell
your
doctor
BEFORE
using
Intralipid
if
the
answer to any of t

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 11
1 PRODUCT MEDICINE
Intralipid
®
10%, 20% and 30%, intravenous infusion for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Soya oil is a mixture of triglycerides, i.e. triacylglycerols. The
triglycerides, triacylglycerols, are fatty
acid triesters of glycerol (propane-1, 2, 3-triol). The main fatty
acids are linoleic acid (C18:2), oleic acid
(C18:1) and palmitic acid (C16:0). The number of double bonds in the
different fatty acids can vary
from zero (saturated) to three (unsaturated). As with most vegetable
oils, the saturated acids are
preferably esterified in sn-1 and sn-3 position. The molecular
structure is well known from general
literature on lipid chemistry.
Soya oil structural formula. General structure of a triglyceride, R1,
R2 and R3 are long-chain alkyl
groups.
Molecular weight: 871 g/mol (typical mean value, the molecular weight
depends on the fatty acid
pattern of the triglyceride). CAS number 8001-22-7.
Sterile fat emulsions for intravenous infusion containing:
Content
per 1000 mL
Intralipid 10%
Intralipid 20%
Intralipid 30%
Active
Soya oil
100 g
200 g
300 g
Osmolality
(mOsmol/kg water)
300
350
310
Energy Content
kcal (kJ)
1100 (4600)
2000 (8400)
3000 (12600)
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Intravenous infusion for Injection.
A milky white liquid.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Part of the intravenous diet in all parenteral nutrition indications
including:
1)
Preoperative and postoperative nutritional disturbances where an
improved nitrogen balance
is required;
2)
Nutritional disorders or disturbances of nitrogen balance due to
inadequate or failing
intestinal absorption caused by tumours in the gastrointestinal tract,
acute or chronic
intestinal diseases (peritonitis, ulcerative colitis, terminal
ileitis);
3)
Burns, to reduce the frequently excessive nitrogen losses;
NEW ZEALAND DATA SHEET
Page 2 of 11
4)
Prolonged unconsciousness, eg following cranial trauma or poisoning in
case