Intralipid 10% Emulsion for Infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Soya bean oil, refined

Dostupné z:

Fresenius Kabi Deutschland GmbH

ATC kód:

B05BA; B05BA02

INN (Medzinárodný Name):

Soya bean oil, refined

Dávkovanie:

10 percent

Forma lieku:

Emulsion for infusion

Terapeutické oblasti:

Solutions for parenteral nutrition; fat emulsions

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2001-02-23

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leafl
See section 4 .
In this leaflet:
1.
What Intralipid 10% is and what it is used for
2.
What you need to know before you use Intralipid 10%
3.
How to use Intralipid 10%
4.
Possible side effects
•
any problems with your pancreas
•
untreated diabetes mellitus
•
thyroid problems- hypothyroidism
•
sepsis (a condition in which your body is fighting a severe
infection)
•
metabolic disorders
If Intralipid 10% is given to your newborn baby, tell your doctor
if
they
have
been
born
prematurely
or
were
of
a
low
birth
weight
or
has
high
blood
pressure
in
the
lungs
(pulmonary
hypertension), so that they can be monitored closely.
This medicine may interfere with certain laboratory tests. It is
important
to
tell
any
doctor
doing
tests
that
you
are
using
Intralipid 10%.
Your doctor may want to do regular blood tests to make sure your
body is using Intralipid 10% correctly.
Other medicines and Intralipid 10%
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The following information is intended for healthcare professionals
only.
Instructions for use - Fresenius Kabi infusion bag
1.
2.
5.
How to store Intralipid 10%
6.
Contents of the pack and other information
1.
What Intralipid 10% is and what it is used for
Intralipid 10% is used as a source of calories and fatty acids when
you
cannot
eat
normally.
Intralipid
10%
is
particularly
useful
following trauma, infections or severe burns.
Intralipid 10% may be mixed with carbohydrates, amino acids,
salts, vitamins and trace elements which together provide your
complete nutritional needs.
2.
What you need to know before

Súhrn charakteristických

Health Products Regulatory Authority
18 April 2019
CRN008RX4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Intralipid 10% Emulsion for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains soya-bean oil, refined (Purified soybean oil)
10% w/v (100g/l).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for infusion.
Sterile, milky-white, oil-in-water emulsion.
Osmolality: 300 mosm/kg water. pH approximately 8.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the supply of caloric and essential fatty acids requirements in
parenteral nutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion.
Posology
The dosage and infusion rate should be within the ranges recommended
below and should be governed by the patient’s ability
to utilise fat.
_Recommended dosage for adults: _Intralipid 10%: 500-1000 ml per 24
hours in conjunction with amino acid and carbohydrate
solutions. For greater energy requirements Intralipid 20% 500-1000 ml
per 24 hours may be used instead of Intralipid 10%.
_Essential fatty acid deficiency (EFAD): _
When Intralipid is administered to prevent or correct essential fatty
acid deficiency, 4-8% of non protein calories should be
supplied as Intralipid to provide sufficient amounts of linoleic and
linolenic acids.
When EFAD is associated with stress, the amount of Intralipid needed
to correct the deficiency may be substantially increased.
_Recommended dosage for infants:_
Dosage is governed by the maturity and birth weight of the infant. In
mature infants dosage scheme 1 should be used. In
small for gestational age and low birth-weight infants where the
ability to handle fat may be impaired, dosage scheme 2
should be utilised.
To all cases, the infant's ability to eliminate infused fat from the
circulation should be checked daily. Measuring serum
triglycerides is the only reliable method. If lipaemia is present
re-testing should be carried out after an interval of four hours.
When administered to infants Int