OLIMEL N9-840 Emulsion for Intravenous Infusion

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Soya Oil, Quantity: 8 g/L; Olive Oil, Quantity: 32 g/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Alanine,Arginine,Aspartic acid,glucose,Glutamic acid,Glycine,Histidine,Isoleucine,Leucine,Lysine acetate,Methionine,Olive Oil,Ph

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1500 mL, 1000 mL, 2000 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

OLIMEL/PeriOLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Visual Identification: smallest outside compartment containing a homogeneous liquid with a milky substance; Container Type: Multiple containers; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-08-09

Patient Information leaflet

OLIMEL / PERIOLIMEL
Emulsion for Intravenous Infusion
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
_ _
This leaflet answers some
common questions about
OLIMEL/PeriOLIMEL. 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
OLIMEL/PeriOLIMEL 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 OLIMEL/PERIOLIMEL IS
USED FOR AND HOW IT WORKS
OLIMEL/PeriOLIMEL is a
sterile mixture of fat (soya_ _oil
and olive oil), amino acids and
glucose (with/without
electrolytes depending on the
formulation). It is used as a
source of energy, maintaining
the nitrogen/energy balance
and correcting essential fatty
acids deficiency. It is given as
an infusion directly into your
veins. OLIMEL/PeriOLIMEL is
intended to provide you with
nourishment (essential fatty
acids, proteins, glucose) whilst
you are unable to consume
food by mouth.
BEFORE YOU ARE GIVEN
OLIMEL/PERIOLIMEL
_OLIMEL/PERIOLIMEL SHOULD _
_NOT BE GIVEN TO YOU IF: _
•
you have had an allergic
reaction to egg or soya
proteins, peanut protein,
corn/corn products or to
any of the active or inactive
ingredients (listed at the
end of this leaflet).
•
you have any of the
following medical
conditions:
-
problems in processing
amino acids (congenital
abnormalities of amino
acid metabolism)
-
severe problems
metabolising/breaking
down fat resulting in
abnormally high blood
fat levels (severe
hyperlipidaemia or
hypertriglyceridaemia)
-
abnormally high blood
sugar levels (severe
hyperglycaemia)
-
abnormally high blood
levels of the electrolytes
- sodium, potassium,
magnesium, calcium
and/or phosphorus.
•
after the expiry date
printed on the pack or if the
packaging is torn or shows
signs of tampering.
OLIMEL/PeriOLIMEL should
not be used for newborn
ba

Summary of Product characteristics

Olimel/PeriOlimel
Version 1.4
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
OLIMEL
®
/PERIOLIMEL
®
Emulsion for Intravenous Infusion
1.
NAME OF THE MEDICINE
OLIMEL/PeriOLIMEL with Electrolytes
Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine,
isoleucine, leucine, lysine acetate,
methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, valine, sodium acetate
trihydrate, sodium glycerophosphate hydrate, potassium chloride,
magnesium chloride hexahydrate,
calcium chloride dihydrate, glucose monohydrate, olive oil and soya
oil.
OLIMEL without Electrolytes
Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine,
isoleucine, leucine, lysine acetate,
methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, valine, glucose
monohydrate, olive oil and soya oil.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL/PeriOLIMEL is presented in the form of a 3-compartment bag. The
individual compartments
contain a glucose solution, a lipid emulsion and an amino acid
solution (with/without electrolytes).
In products containing electrolytes, calcium is included in the
glucose solution compartment and
other electrolytes are in the amino acid solution compartment. There
are 7 different formulations
of OLIMEL (4 with electrolytes and 3 without electrolytes) and one
formulation of PeriOLIMEL.
The general composition of the formulations are summarised below:
WITH
ELECTROLYTES (E)
WITHOUT
ELECTROLYTES
NITROGEN
1
AMINO
ACID
SOLUTION
2
GLUCOSE
SOLUTION
3
LIPID
EMULSION
4
PeriOLIMEL
N4-600E
_-_
_ _
4.0g/L
6.3%
18.75%
15%
OLIMEL
N5-860E
_-_
_ _
5.2g/L
8.2%
28.75%
20%
OLIMEL
N7-960E
OLIMEL
N7-960
7.0g/L
11.1%
35%
20%
OLIMEL
N9-840E
OLIMEL
N9-840
9.0g/L
14.2%
27.5%
20%
OLIMEL
N12-640E
OLIMEL
N12-640
12g/L
14.2 %
27.5 %
17.5 %
1
prefixes N4, N5, N7, N9 refer to approx nitrogen content in g/L
2
contains 17 amino acids (and electrolytes if present)
3
contains calcium if present
4
contains refined olive oil (80%) and refined soya oil (20%)
OLIMEL/PeriOLIMEL contains egg lecithi