SMOFlipid (lipid emulsion) 20% emulsion for intravenous infusion 250 mL bag

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

Olive Oil, Quantity: 50 g; Fish oil - rich in Omega-3 acids, Quantity: 30 g; medium chain triglycerides, Quantity: 60 g; Soya Oil, Quantity: 60 g

可用日期:

Fresenius Kabi Australia Pty Ltd

INN（国际名称）:

Fish oil - rich in Omega-3 acids,medium chain triglycerides,Olive Oil,Soya Oil

药物剂型:

Injection, intravenous infusion

组成:

Excipient Ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide

给药途径:

Intravenous

每包单位数:

10 x 250mL bags

处方类型:

Not Scheduled after consideration by Committee

疗效迹象:

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 contra-indicated.

產品總結:

Visual Identification: White homogenous emulsion; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2015-12-14

资料单张

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

产品特点

AUSTRALIAN PRODUCT INFORMATION - SMOFLIPID
® (FISH OIL-RICH
IN OMEGA-3 ACIDS, MEDIUM CHAIN TRIGLYCERIDES, OLIVE OIL,
SOYA OIL)
Page 1 of 14
1 NAME OF MEDICINE
Fish oil - rich in Omega-3 acids
Medium chain triglycerides
Olive oil
Soya oil
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
Excipients with known effect: Egg lecithin
For the full list of excipients, see section 6.1 List of excipients.
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
see section 4.4 Special warnings and precautions for use.
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
by 0.5 - 1.0 g fat/kg b.w/day up to 3.0 g fat/kg b.w/day.
Page 2 of 14
It is recommended not to exceed a daily dose of 3 g 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 2 g fat/kg b.w/day,
corresponding to 10 mL
SMOFlipid/k