SMOFLIPID

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

SOYA OIL ; MEDIUM CHAIN TRIGLYCERIDES; REFINED OLIVE OIL; PURIFIED FISH OIL

זמין מ:

Fresenius Kabi Limited

INN (שם בינלאומי):

SOYA OIL ; MEDIUM CHAIN TRIGLYCERIDES; REFINED OLIVE OIL; PURIFIED FISH OIL

כמות:

20% Per Cent

טופס פרצבטיות:

Emulsion for Infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

05BA02

מצב אישור:

Marketed

תאריך אישור:

2007-08-03

עלון מידע

SMOFLIPID PIL - UK
(ersätter)
Tryckspecifikation
Format:
630 x 210 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
Fontsize:
8 pt
6:e korr 2016-11-01
Johanna Eriksson
v002/UP/BIO xxx xxx
_SMOFLIPID 200 MG/ML,_
_EMULSION FOR INFUSION_
SOYA-BEAN OIL, MEDIUM CHAIN TRIGLYCERIDES, OLIVE OIL, FISH OIL
-
if you are in an unstable condition, for example shortly after
serious injury, heart attack, stroke, blood clot (thrombosis),
metabolic acidosis (metabolic disturbance which results in high
acid levels in the blood), or untreated diabetes, blood poisoning
and dehydration.
Warnings and precautions
Talk to your doctor or nurse before having this medicine if you
have a problem with high levels of lipids in the blood due to
that your body cannot use fat properly (called ‘impaired lipid
metabolism’).
Allergic reactions
If you have an allergic reaction while having SMOFlipid, it needs to
be stopped straight away. Tell the doctor or nurse straight away
if you get any of the following while you are having the infusion:
-
fever (high temperature)
-
shivering
-
rash
-
difficulty breathing
Children
Talk to your doctor or nurse if this medicine is being given to your
newborn child and they have:
-
too
much
of
a
substance
called
“bilirubin”
in
their
blood
(hyperbiliribinemia)
-
a high pressure in their lungs (pulmonary hypertension)
If your newborn child has SMOFlipid for a long time the doctor will
take blood tests to see how it is working.
Other medicines and SMOFlipid
Tell your doctor if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking or have recently
taken drugs used to stop blood clotting, such as warfarin and
heparin.
-
SMOFlipid
naturally
contains
vitamin
K1,
which
can
affect
warfarin. However, the vitamin K1 content in SMOFlipid is so low
that such problems are unlikely.
-
Heparin given in clinical doses may at first cause higher levels
of fatty acids in the blood due to liberation of fatty acids from
the tissues into the bloodstream and then

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SMOFlipid 200 mg/ml emulsion for infusion, excel bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
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