SMOFlipid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fish oil 30 g; Medium-chain triglycerides 60 g;  ; Olive oil 50 g;  ; Soya oil 60 g;  

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Fish oil 30 g

Dosage:

20 %

Pharmaceutical form:

Emulsion for infusion

Composition:

Active: Fish oil 30 g Medium-chain triglycerides 60 g   Olive oil 50 g   Soya oil 60 g   Excipient: dl-Alpha tocopherol Egg lecithin Glycerol Sodium hydroxide Sodium oleate Water for injection

Units in package:

Bag, plastic, Excel, 100 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Fresenius Kabi AB

Therapeutic indications:

Supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Biofine (1CBB) - 100 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Biofine (1CBB) - 250 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Biofine (1CBB) - 500 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Multipack containing 10 x 100 mL bags - 1000 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Multipack containing 20 x 100 mL bags - 2000 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Multipack containing 10 x 250 mL bags - 2500 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed. - Bag, plastic, Multipack containing 12 x 500 mL bags - 6000 mL - 24 months from date of manufacture stored at or below 25°C. Protect from light when used in neonates and children <2 years until infusion is completed.

Authorization date:

2010-04-08

Patient Information leaflet

Page 1 of 2
SMOFLIPID
® 20%
Emulsion for intravenous infusion
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
SMOFlipid. 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
SMOFlipid against any benefits
they expect it will have for you.
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You
may
need
to
read it again.
WHAT
IS
SMOFLIPID
USED FOR
SMOFlipid is a sterile emulsion
which provides your body with
nutrition
by
the
intravenous
route.
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.
SMOFlipid
contains
Soya
oil,
Medium
chain
triglycerides,
Olive oil and Fish oil.
SMOFlipid
is
usually
given
together
with
carbohydrates,
amino acids and salts to provide
an intravenous diet.
BEFORE YOU ARE GIVEN
SMOFLIPID
_WHEN YOU MUST NOT TAKE IT _

If
you
have
had
an
allergic
reaction
like
fever, shivering, rash or
breathing
difficulties
to
fish, egg-yolk containing
foods,
peanut
or
soy
products.

If you are allergic to any
of the ingredients in this
medicine.

If you have an inability
to break down fats

If you have severe liver
failure.

If
you
have
severe
kidney
failure
(when
dialysis facilities are not
available).

If you are suffering from
a very serious problem
with
your
blood
circulation.

If
you
have
too
much
fluid in your body.

If
you
have
too
much
acid in your blood, also
called
metabolic
acidosis.

If you have a build up of
fluid in your lungs and

If
you
have
certain
untreated
heart
problem

Summary of Product characteristics

Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SMOFlipid
®
20% emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SMOFlipid emulsion for infusion is a white homogenous emulsion.
Each 1000 mL contains:
Soya oil
60 g
Medium chain triglycerides
60 g
Olive oil
50 g
Fish oil - rich in Omega-3 acids
30 g
Total energy:
8400 kJ (2000kcal)
pH: approx. 8
Osmolality
380 mOsm/kg water
For the full list of excipients, (see section 6.1).
3.
PHARMACEUTICAL FORM
SMOFlipid is a white homogenous emulsion for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supply of energy and essential fatty acids to patients, as part of a
parenteral nutrition
regimen, when oral or enteral nutrition is impossible, insufficient or
contraindicated.
4.2
DOSE AND METHOD OF ADMINISTRATION
The patient’s ability to eliminate the fat infused should govern the
dosage and infusion
rate, (please also refer to section 4.4).
Adults
The standard dose is 1.0 – 2.0 g fat/kg body weight (b.w) / day,
corresponding to 5 – 10
mL / kg b.w / day.
The recommended infusion rate is 0.125 g fat / kg b.w / hour,
corresponding to 0.63 mL
SMOFlipid / kg b.w / hour, and should not exceed 0.15 g fat / kg b.w /
hour, corresponding
to 0.75 mL SMOFlipid / kg b.w / hour.
Neonates and infants
The initial dose should be 0.5 – 1.0 g fat / kg b.w / day followed
by a successive increase
Page 2 of 13
by 0.5 – 1.0 g fat / kg b.w / day up to 3.0 g fat / kg b.w / day.
It is recommended not to exceed a daily dose of 3g fat / kg b.w / day,
corresponding to
15 mL SMOFlipid / kg b.w / day.
The rate of infusion should not exceed 0.125 g fat / kg b.w / hour.
In premature and low birth weight neonates, SMOFlipid should be
infused continuously
over around 24 hours.
Children
It is recommended not to exceed a daily dose of 2g fat / kg b.w / day,
corresponding to 10
mL SMOFlipid / kg b.w / day. With increased requirements in the
youngest children a dose
up to a maximum of 3g fat / kg b.w / day can be considered.
The daily dose should be increased gradually