CLINOLEIC 20% soya oil and olive oil emulsion for injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Olive Oil, Quantity: 0 QS; Soya Oil, Quantity: 0 QS

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, emulsion

Composition:

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

Administration route:

Intravenous

Units in package:

250mL, 350mL, 500mL, 100mL, 1000mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Visual Identification: Milky white emulsion.; Container Type: Bag; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-02-19

Patient Information leaflet

CLINOLEIC CMI
Page 1 of 2
Baxter
CLINOLEIC
_soya oil and olive oil emulsion _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some
common questions about
CLINOLEIC 20%. It does not
contain all of the available
information. All medicines
have risks and benefits. Your
doctor has weighed the risks
of you using ClinOleic against
the benefit they expect it will
have for you.
It does not take the place of
talking to your doctor or
pharmacist.
If you have any concerns
about being_ _administered this
medicine, ask your doctor or
pharmacist.
WHAT CLINOLEIC IS USED FOR
ClinOleic
is
a
sterile
fat
emulsion containing soya_ _ oil
and
olive
oil
as
active
components. It is used as a
source
of
energy
and
for
correction
of
essential
fatty
acids deficiency, and is given
as
an
infusion
directly
into
your
veins.
ClinOleic
is
intended to provide you with
nourishment
(essential
fatty
acids) whilst you are unable
to consume food by mouth.
BEFORE YOU ARE GIVEN
CLINOLEIC
_CLINOLEIC SHOULD NOT BE _
_GIVEN TO YOU IF: _

you have an allergy to
any ingredient listed at
the end of this leaflet;

you have had an
allergic reaction to
egg-yolk containing
foodstuffs or soybean
products. Some of the
symptoms of an allergic
reaction may include
skin rash, peeling of the
skin and swelling of the
face, lips or tongue
causing difficulty
swallowing or shortness
of breath;

you have one of the
following conditions:
-
an abnormal level of
lipids in the blood
-
uncontrolled diabetes,
lactic acidosis
-
a blood or other
infection
-
severe liver disease
-
blood clotting problems
-
kidney disease
-
heart attack

The expiry date printed
on the pack has
passed.
_ _
_YOU MUST TELL YOUR DOCTOR IF _
_YOU: _

are fluid overloaded or
overhydrated;

have diabetes;

have liver disease

are taking any prescription
medicine

are taking any other
medicines including
nutritional supplements,
purchased from your
pharmacy, supermarket or
health food stores, , in
particular warfarin;

are pregnant;_ _

are breas

Summary of Product characteristics

ClinOleic 20%
Version 2.0 Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – CLINOLEIC 20% (SOYA OIL
AND OLIVE OIL) EMULSION FOR INJECTION
1
NAME OF THE MEDICINE
Olive oil and Soya oil.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ClinOleic is a sterile fat emulsion [containing a mixture of refined
Olive oil (approximately 80%)
and refined Soya oil (approximately 20%)] 200 g, Egg lecithin
(purified egg phospholipids) 12 g,
Glycerol 22.5 g, Sodium oleate 0.3 g and Water for Injections to 1,000
mL (final pH between 6.0-
8.0).
One of the active ingredients, Soya oil, contains ascorbyl palmitate
as an antioxidant (free radical
scavenger), in the concentration of 0.15 mg/g of oil.
3
PHARMACEUTICAL FORM
ClinOleic is an emulsion for intravenous injection.
ClinOleic 20% is a milk-like homogeneous liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Parenteral nutrition when oral or enteral nutrition is impossible,
insufficient or contraindicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage depends on energy expenditure, the patient’s clinical
status, body weight, and ability
to metabolise ClinOleic 20%, as well as additional energy given
orally/enterally. Therefore, the
dosage should be individualised and the bag size chosen accordingly.
The maximum daily dose
of ClinOleic 20% should be based on individual total nutritional
requirements and patient
tolerance.
_DOSAGE _
_Note_: the percentage (%) of lipid in the ClinOleic 20% formulation
is expressed in weight by
volume (w/v). That is, 5 mL of ClinOleic 20% contains 1 g of lipid.
•
_Adult_:
The dosage is 1 to a maximum of 2 g lipids/kg/day.
Never exceed 0.15 g lipids/kg/hour (0.75 mL/kg/hour).
ClinOleic 20%
Version 2.0 Page 2 of 16
TABLE 1: CLINOLEIC DOSAGE OF ADULTS
ADULTS PER KG OF BODY WEIGHT
70 KG ADULT
Usual lipid dosage
1 to 2 g/kg/day
70 to 140 g/day
Infused volume of
ClinOleic 20%
5 to 10 mL/kg/day
350 to 700 mL/day
•
_Children_:
It is recommended not to exceed a daily dose of 3g lipids/kg of body
weight and an infusion
rate of 0.15 g lipids/kg of bo