OLICLINOMEL N4-550 1500 mL IV emulsion for infusion without electrolytes bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Soya Oil; Olive Oil

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Alanine,Arginine,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine,Methionine,Olive Oil,Phenylalanine,Proline,Serine,Soya Oil,

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: glycerol; sodium hydroxide; water for injections; sodium oleate; egg lecithin; ascorbyl palmitate

Administration route:

Intravenous Infusion

Units in package:

1500 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Visual Identification: smallest outside compartment containing a homogeneous liquid with a milky appearance.; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-09-04

Patient Information leaflet

OLICLINOMEL
Consumer medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
OLICLINOMEL
Intravenous
(IV) Emulsion for Infusion
and OLICLINOMEL IV
Emulsion for Infusion with
Electrolytes (called
‘OLICLINOMEL’ hereafter)
.
It does not contain all of 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 using OLICLINOMEL
against the benefits he or
she may expect it will have
for you.
If you have any concerns
about being_ _administered
this medicine, ask your
doctor or pharmacist.
Keep this leaflet. You may
need to read it again.
WHAT OLICLINOMEL IS
USED FOR AND HOW IT
WORKS
OLICLINOMEL is a sterile
emulsion containing fat
(with soya_ _oil and olive oil
as active components),
amino acids and glucose.
It is used as a source of
energy, maintaining the
nitrogen/energy balance
and correcting essential
fatty acids deficiency.
OLICLINOMEL with
Electrolytes also helps
balance nutrient levels.
OLICLINOMEL products
are given as an infusion
directly into your veins.
They are intended to
provide you with
nourishment (essential fatty
acids, proteins, glucose and
other nutrients) whilst you
are unable to consume food
by mouth.
BEFORE YOU ARE GIVEN
OLICLINOMEL
_ _
_OLICLINOMEL MUST _
_NOT BE GIVEN TO YOU/ _
_YOUR CHILD IF:_
•
you/they have an
allergy to components
of the container or to
any ingredient listed at
the end of this leaflet;
•
you/they have had an
allergic reaction to egg
or soya protein
containing foodstuffs or
soybean products,
amino acids, olive
products components of
the container or to any
of the active or inactive
ingredients. Some of
the symptoms of an
allergic reaction may
include fever, shivering,
skin rash, swelling of
the face, lips or tongue,
which may cause
difficulty swallowing or
shortness of breath;
•
you /they are suffering
from one of the
following conditions:
•
have an abnormal
level of lipids in the
blood;
•
sugar diabetes
(requi

Summary of Product characteristics

OLICLINOMEL
Product Information
NAME OF THE MEDICINE
:
OLICLINOMEL
_Composition_:
Lipid emulsion, amino acid solution and glucose solution presented in
the form of a
3-compartment bag.
There are eight different formulations of OLICLINOMEL, four with
electrolytes and
four without electrolytes. The general compositions of the
formulations are
summarised in the following table:
WITHOUT ELECTROLYTES
& CALCIUM
WITH ELECTROLYTES
NITROGEN
1
LIPID
EMULSION
2
AMINO ACID
SOLUTION
3
GLUCOSE
SOLUTION
4
OLICLINOMEL N4-
550
OLICLINOMEL N4-
550E
3.6g/L
10%
5.5%
20%
OLICLINOMEL N5-
800
OLICLINOMEL N5-
800E
4.6g/L
20%
7%
25%
OLICLINOMEL N6-
900
OLICLINOMEL N6-
900E
5.6g/L
20%
8.5%
30%
OLICLINOMEL N7-
1000
OLICLINOMEL N7-
1000E
6.6g/L
20%
10%
40%
1
Prefixes N4, N5, N6, N7 refer to rounded up content of nitrogen,
expressed as g/L.
2
Contains refined olive oil (80%) and soya oils (20%)
3
Contains 15 L-series amino acids and electrolytes if present
4
Contains calcium, if present
For the detailed formulations, refer to
APPENDIX 1
.
There are four presentations of each formulation, which have the
following different
volumes:
COMPARTMENT
1000 ML
1500 ML
2000 ML
2500 ML
Lipid emulsion
200 mL
300 mL
400 mL
500 mL
Amino acid solution
400 mL
600 mL
800 mL
1000 mL
Glucose solution
400 mL
600 mL
800 mL
1000 mL
DESCRIPTION:
_Appearance prior to reconstitution: _
OLICLINOMEL is presented in the form of a 3-compartment bag, each
containing
liquids:
•
The lipid emulsion is a homogeneous liquid with a milky appearance
•
The amino acid and glucose solutions are clear and colourless or
slightly yellow
liquids.
After
reconstitution,
OLICLINOMEL
is
a
milk-like
homogeneous
liquid
(see
PRESENTATIONS AND STORAGE CONDITIONS
for further information).
OLICLINOMEL is a hypertonic emulsion. The osmolality and energy
contents of the
formulations are as follows:
OLICLINOMEL PI (
ccds40520140925)
Page 1 of 23
Baxter Healthcare
OLICLINOMEL
Product Information
FORMULATION
OSMOLALITY
MOSMOL/KG
ENERGY
CONTENT
KJ/L (KCAL/L)
FORMULATION
OSMOLALITY
MOSMOL/KG
ENERGY