SMOFlipid 200 mg/ml emulsion for infusion, excel bag

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Soya bean oil ; Medium chain triglycerides; Refined olive oil; Purified fish oil

Beschikbaar vanaf:

Fresenius Kabi Deutschland GmbH

ATC-code:

B05BA; B05BA02

INN (Algemene Internationale Benaming):

Soya bean oil ; Medium chain triglycerides; Refined olive oil; Purified fish oil

Dosering:

200 milligram(s)/millilitre

farmaceutische vorm:

Emulsion for infusion

Therapeutisch gebied:

Solutions for parenteral nutrition; fat emulsions

Autorisatie-status:

Marketed

Autorisatie datum:

2007-08-03

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SMOFLIPID 200 MG/ML, EMULSION FOR INFUSION
Soya-bean oil, medium chain triglycerides, olive oil, fish 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 SMOFlipid is and what it is used for
2.
What you need to know before you are given SMOFlipid
3.
How you are given SMOFlipid
4.
Possible side effects
5.
How to store SMOFlipid
6.
Contents of the pack and other information
1.
WHAT SMOFLIPID IS AND WHAT IT IS USED FOR
SMOFlipid contains four different lipids (fats); soya-bean oil, medium
chain triglycerides, olive oil and fish
oil which is rich in omega-3 fatty acids. The liquid is a mixture of
fats and water which is called a ‘lipid
emulsion’.
-
It works by providing energy and fatty acids for your body
-
It is put into your blood by a drip or an infusion pump
A health care professional will give you SMOFlipid when other forms of
feeding are not good enough or
have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SMOFLIPID
YOU SHOULD NOT BE GIVEN SMOFLIPID:
-
if you are allergic to soya-bean oil, medium-chain tryglycerides,
olive oil, fish oil or any of the other
ingredients of this medicine (listed in section 6).
-
if you are allergic (hypersensitive) to any other products containing
fish, egg, soy or peanut.
-
if you have too much fat in the blood (called ‘severe
hyperlipemia’).
-
if you have serious kidney or liver problems.
-
if you have severe blood clotting problems (called ‘coagulation
disorders’).
-
if you are in acute shock.
-
f you have fluid in the lungs (called ‘pulmonary oedema’) , too
much body fluid (called
‘hyperhydration’) or have heart failure (due to too much body
fl

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Health Products Regulatory Authority
28 May 2020
CRN009CYW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SMOFlipid 200 mg/ml emulsion for infusion, excel bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of emulsion for infusion contain:
Soya-bean oil, refined
60.0 g
Triglycerides, medium-chain
60.0 g
Olive oil, refined
50.0 g
Fish oil, rich in omega-3-acids
30.0 g
Total energy:
8.4 MJ/l (= 2000kcal/l)
pH-value:
approx. 8
Osmolality
approx. 380 mosm/kg
Excipients with known effect:
1000 ml emulsion contains up to 5 mmol sodium (as sodium hydroxide and
sodium oleate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for infusion
White homogenous emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Supply of energy and essential fatty acids and omega-3 fatty acids to
patients, as part of a parenteral nutrition regimen, when
oral or enteral nutrition is impossible, insufficient or
contra-indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient’s ability to eliminate the fat infused, should govern
the dosage and infusion rate, see section 4.4.
_ADULTS_
The standard dose is 1.0 – 2.0 g fat/kg body weight (b.w.)/day,
corresponding to 5 – 10 ml/kg b.w./day.
The recommended infusion rate is 0.125 g fat/kg b.w./hour,
corresponding to 0.63 ml Smoflipid/kg b.w./hour, and should not
exceed 0.15 g fat/kg b.w./hour, corresponding to 0.75 ml Smoflipid/kg
b.w./hour.
_PAEDIATRIC POPULATION_
Neonates and infants
The initial dose should be 0.5 – 1.0 g fat/kg b.w./day followed by a
successive increase by 0.5 – 1.0 g fat/kg b.w./day up to 3.0
g fat/kg b.w./day.
It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d,
corresponding to 15 ml Smoflipid/kg b.w./day.
The rate of infusion should not exceed 0.125 g fat/kg b.w./hour.
In premature and low birth weight neonates, Smoflipid should be
infused continuously over about 24 hours.
Health Products Regulatory Authority
28 May 2020
CRN009CYW
Page 2 of 7
Children
It is recomme