Intralipid 20% w/v Emulsion for Infusion, Glass Bottle

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Soya bean oil

थमां उपलब्ध:

Fresenius Kabi Deutschland GmbH

ए.टी.सी कोड:

B05BA; B05BA02

INN (इंटरनेशनल नाम):

Soya bean oil

डोज़:

20 percent weight/volume

फार्मास्यूटिकल फॉर्म:

Emulsion for infusion

चिकित्सीय क्षेत्र:

Solutions for parenteral nutrition; fat emulsions

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

1989-04-27

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
INTRALIPID 20% W/V EMULSION FOR INFUSION
Purified soya-bean oil
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Intralipid 20% is and what it is used for
2.
What you need to know before you are given Intralipid 20%
3.
How you are given 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 complete nutritional needs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN INTRALIPID 20% DO NOT USE INTRALIPID 20% IF YOU:
•are allergic (hypersensitive) to Intralipid 20% or any of the
ingredients of Intralipid 20% mentioned in
section 6 (for symptoms of an allergic reaction, please refer to
section 4)
•have a disorder of fat metabolism such as in severe liver damage or
if you have suffered from shock
•have hypersensitivity to egg, soya or peanut protein or to any of
the active substances or excipients.
•have acute shock or severe hyperlipidaemia
•have hemophagocytic syndrome
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Intralipid 20% if you
suffer from:
• an allergy to products containing egg, soya or peanut oil.
Your doctor will carry out an allergy test to make sure you can
receive this medicine.
•
REDUCED LIVER
function
• a condition where your body has
PROBLEMS USING FAT
pro

उत्पाद विशेषताएं

Health Products Regulatory Authority
04 February 2020
CRN009D22
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Intralipid 20% w/v Emulsion for Infusion, Glass Bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Purified soybean oil 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
Osmolality 350 mosmol/kg water
pH 6.0 – 8.5
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 10% 500-1500 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.
_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 maint