VITALIPID N INFANT 10mL injection emulsion ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
22-06-2022
Public Assessment Report
(PAR)
01-12-2017
Active ingredient:
dl-alpha-tocopherol, Quantity: 0.64 mg/mL; retinol palmitate, Quantity: 135.3 microgram/mL; phytomenadione, Quantity: 20 microgram/mL; ergocalciferol, Quantity: 1 microgram/mL
Available from:
Fresenius Kabi Australia Pty Ltd
INN (International Name):
dl-alpha-Tocopherol,Ergocalciferol,Phytomenadione,retinol palmitate
Pharmaceutical form:
Injection, concentrated
Composition:
Excipient Ingredients: sodium hydroxide; water for injections; glycerol; egg lecithin; Soya Oil
Administration route:
Intravenous
Units in package:
10 x 10mL ampoules
Prescription type:
Not scheduled. Not considered by committee
Therapeutic indications:
Vitalipid N Infant is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat- soluble Vitamins A, D2, E and K1 in paediatric patients up to 11 years of age.
Product summary:
Visual Identification: A milky white emulsion.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
1992-08-21
Patient Information leaflet
Page 1 of 2
VITALIPID N
® INFANT AND ADULT
Retinol Palmitate, Ergocalciferol, dl-alpha-tocopherol and
Phytomenadione
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
VITALIPID N. 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 or your child given
VITALIPID N against any benefits
they expect it will have for you or
your child.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU ARE GIVEN VITALIPID
N. IF YOU HAVE ANY QUESTIONS OR
ARE
UNSURE
ABOUT
ANYTHING,
PLEASE
ASK
THE
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. YOU MAY NEED TO READ
IT AGAIN.
WHAT
IS
VITALIPID
N
USED FOR
VITALIPID N is a sterile emulsion
which provides the body with fat-
soluble
multivitamins
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.
BEFORE
YOU
ARE
GIVEN
VITALIPID N
You or your child should not be
given VITALIPID N if:
You
have
an
allergy
to
soya oil, eggs, peanuts or
any
of
the
ingredients
listed
at
the
end
of
this
leaflet.
You have very high levels
of vitamins in your system.
You
have
a
sudden,
dangerous
drop
in
your
blood pressure.
You
have
an
inability
to
break down fats.
If you are not sure whether any of
these apply to you, check with your
doctor.
You
should
tell
your
doctor
BEFORE given VITALIPID N if the
answer
to
any
of
the
following
questions is YES.
Are you pregnant or trying
to become pregnant?
Are you breastfeeding?
Are you allergic to soya-,
egg- or peanut protein?
Do
you
have
liver
or
kidney disease?
Are
you
taking
anticoagulants
(med
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION - VITALIPID
® N ADULT AND
VITALIPID
® N INFANT (RETINOL PALMITATE, ERGOCALCIFEROL,
DL-ALPHA-TOCOPHEROL, PHYTOMENADIONE)
Page 1 of 6
1 NAME OF MEDICINE
Retinol palmitate (Vitamin A palmitate)
Ergocalciferol (Vitamin D
2
)
dl-alpha-tocopherol (Vitamin E)
Phytomenadione (Vitamin K
1
)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mL ampoule contains:
Adult
Infant
Retinol palmitate 1.941 mg
1.353 mg
_corresponding to retinol (Vitamin A) _
_ 990 _
_g (3300 IU) _
_ 690 _
_g (2300 IU)_
Ergocalciferol (Vitamin D
2
)
5
g (200 IU)
10
g (400 IU)
dl-alpha-tocopherol (Vitamin E)
9.1 mg 10 IU)
6.4 mg (7.0 IU)
Phytomenadione (Vitamin K
1
)
150
g
200
g
Excipients with known effect: Soya oil, Egg lecithin
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Concentrated Emulsion for Injection.
A milky white emulsion. Sterile oil/water emulsion with pH: approx..8
and osmolality: approx.
300 mOsm/kg water.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vitalipid N Adult is indicated as a supplement in complete intravenous
nutrition to meet the
daily requirements of the fat-soluble vitamins A, D
2
, E and K
1
.
Vitalipid N Infant is indicated as a supplement in complete
intravenous nutrition to meet the
daily requirements of the fat-soluble vitamins A, D
2
, E and K
1
in paediatric patients up to
11 years of age.
4.2
DOSE AND METHOD OF ADMINISTRATION
Must be diluted before use: Adults and children aged 11 years and
above.
Vitalipid N Adult should be added aseptically within one hour of the
commencement of the
infusion and should be used within 24 hours.
Must be diluted before use: Infants and children under 11 years.
Vitalipid N Infant in a dosage of 1 mL per kg bodyweight per day is
added to Intralipid 10% or
20%. The daily dose must not exceed 10 mL. After mixing by gentle
agitation the emulsion is
infused as described for Intralipid.
Page 2 of 6
Vitalipid N Infant should be added aseptically within one hour of the
commencement of th
Read the complete document
