Intralipid 20 % 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:

20 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 leaflet.
See section 4 .
In this leaflet:
1.
What Intralipid 20% is and what it is used for
2.
What you need to know before you use Intralipid 20%
•
a condition where your body has problems using fat
properly
•
impaired kidneys
•
any problems with your pancreas
•
untreated diabetes mellitus
•
thyroid problems- hypothyroidism
•
sepsis (a condition in which your body is fighting a
severe infection)
If Intralipid 20% is given to your newborn baby, tell your
doctor if they have been born prematurely or were of a
low birth weight as they may become jaundiced (yellowing
of skin or eyes).If your child has high blood pressure in
the lungs (pulmonary hypertension) inform your doctor or
nurse 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 20%.
Your doctor may want to do regular blood tests to make
sure your body is using Intralipid 20% correctly.
Other medicines and Intralipid 20%
The following information is intended for healthcare professionals
only.
Instructions for use - Fresenius Kabi infusion bag
1.
2.
3.
How to use Intralipid 20%
4.
Possible side effects
5.
How to store Intralipid 20%
6.
Contents of the pack and other information
1.
What Intralipid 20% is and what it is used for
Intralipid 20% is used as a source of calories and fatty acids
when you cannot eat normally. Intralipid 20% is particularly
useful following trauma, infections or severe burns.
Intralipid 20% may be mixed with carbohydrates, amino
acids, salts, vitamins and trace elements which together
provide your compl

Súhrn charakteristických

Health Products Regulatory Authority
19 May 2020
CRN009RZG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Intralipid 20 % Emulsion for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains soya-bean oil, refined 20% w/v (200g/l)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for infusion
A milky white oil in a water emulsion
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.
A_dults:_
Intralipid 20% 500-1500 ml per 24 hours in conjunction with amino acid
and carbohydrate solutions. For lesser energy
requirements Intralipid 10% 500-1500 ml per 24 hours may be used
instead of Intralipid 20%.
_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.
_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.
In 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 Intralipid should, if possible, be
infused continuously over 24 hours and to maintain a constant
rate of infusion it is essential that an