Vitalipid N Adult

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

dl-Alpha tocopherol 0.91 mg/mL;  ; Ergocalciferol 0.5 µg/mL; Phytomenadione 15 µg/mL; Retinol palmitate 194.1 µg/mL (Corresponding to 99 ug retinol)

থেকে পাওয়া:

Fresenius Kabi New Zealand Limited

INN (International Name):

dl-Alpha tocopherol 0.91 mg/mL

ফার্মাসিউটিকাল ফর্ম:

Emulsion for injection

রচনা:

Active: dl-Alpha tocopherol 0.91 mg/mL   Ergocalciferol 0.5 µg/mL Phytomenadione 15 µg/mL Retinol palmitate 194.1 µg/mL (Corresponding to 99 ug retinol) Excipient: Egg lecithin Glycerol Sodium hydroxide Soya oil Water for injection

প্যাকেজ ইউনিট:

Ampoule, 1 x 10 mL, 10 mL

শ্রেণী:

General sale

প্রেসক্রিপশন টাইপ:

General sale

Manufactured by:

BASF SE

থেরাপিউটিক ইঙ্গিত:

Vitalipid N Adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, E and K1.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Ampoule, 10mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze

অনুমোদন তারিখ:

1988-09-08

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

NEW ZEALAND DATA SHEET
Page 1 of 6
1 PRODUCT MEDICINE
Vitalipid® N Adult, concentrated emulsion for injection
Vitalipid® N Infant, concentrated emulsion for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains:
Adult
Infant
Active Ingredients
Retinol palmitate
194.1

g
135.1

g
corresponding to retinol (Vitamin A)
99

g
69

g
Ergocalciferol (Vitamin D
2
)
0.5

g
1.0

g
dl-alpha-tocopherol (Vitamin E)
0.91 mg
0.64 mg
Phytomenadione (Vitamin K
1
)
15

g
20

g
10 mL ampoule contains:
Adult
Infant
Retinol palmitate
1.941 mg
1.351 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
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, D2, E and K1.
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
Dose:
Adults and children aged 11 years and above: 10 mL (1 ampoule) per day
Preterm infants and infants with low birth weight (bodyweight < 2.5
kg): 4 mL/kg body weight/day.
NEW ZEALAND DATA SHEET
Page 2 of 6
Newborns and children with weight over 2.5 kg to children aged up to
11 years: 10 mL (1 ampoule) per
day.
Method of administration
Intravenous administration after aseptic dilution. Must be diluted
before use. For instructions on dilutio
of the medicinal product before admi