SMOFlipid 20%

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

Medium chain triglycerides; Purified fish oil; Refined olive oil; Soybean oil

Inapatikana kutoka:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC kanuni:

B05BA02

Kipimo:

60g per 1000ml

Dawa fomu:

INJECTION, EMULSION

Tungo:

Medium chain triglycerides 60g per 1000ml; Purified fish oil 30g per 1000ml; Refined olive oil 50g per 1000ml; Soybean oil 60g per 1000ml

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

General Sale List

Viwandani na:

Fresenius Kabi Austria GmbH

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2007-04-12

Taarifa za kipeperushi

PACKAGE INSERT 
_SM0FLIPID 200 MG/ML _
EMULSION FOR INFUSION 
1000 ml contain: 
Soybean oil, refined 
60.0 g 
Medium chain triglycerides 
60.0 g 
Olive oil, refined 
50.0 g 
Fish oil, rich in omega 3 acids 
30.0 g 
Total energy: 
8.4 MJ/1(= 2000kcal/l) 
pH-value: 
approx. 8 
Osmolality: 
approx. 380 mosm/kg 
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. 
CONTRAINDICATIONS 
-  Hypersensitivity to fish-, egg- soya, or peanut protein or to 
any of the active substances or excipients. 
-  Severe hyperlipidemia. 
-  Severe liver insufficiency. 
-  Severe blood coagulation disorders. 
-  Severe renal insufficiency without access to hemofiltration or 
dialysis. 
-  Acute shock. 
-  General contraindications to infusion therapy: acute 
pulmonary oedema, hyperhydration, decompensated cardiac 
insufficiency. 
Unstable conditions (e.g. severe post-traumatic conditions, 
uncompensated diabetes mellitus, acute myocardial 
infarction, stroke, embolism, metabolic acidosis and severe 
sepsis and hypotonic dehydration). 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
The capacity to eliminate fat is individual and should therefore 
be monitored according to the routines of the clinician. This is in 
general done by checking the triglyceride levels. Special caution 
should be taken in patients with a marked risk for hyperlipidemia 
(e.g. patients with high lipid dosage, severe sepsis and extremely 
low birth weight infants). The concentration of triglycerides in 
serum should in general not exceed 3 mmo1/1 during infusion. An 
overdose may lead to fat overload syndrome. 
. 
This medicinal product contains soya-bean oil, fish oil and egg 
phospholipids, which may rarely cause allergic reactions. Cross 
allergic reaction has been observed between soya-bean and 
peanut. 
Smoflipid should be given with cau

Tabia za bidhaa

2
Package Insert
SMOFlipid 20%
Emulsion for Infusion
1000 ml contain:
Soya-bean oil, refined
60.0 g
Medium-chain triglycerides
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 (= 2000 kcal/l)
pH-value:
approx. 8
Osmolality:
approx. 380 mosm/kg H O
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.
Light
exposure
of
solutions
for
intravenous
parenteral
nutrition, especially after admixture with trace elements and/
or vitamins, may have adverse effects on clinical outcome
in neonates, due to generation of peroxides and other
degradation products. When used in neonates and children
below 2 years, Smoflipid should be protected from ambient
light until administration is completed (see
Dosage and
administration, Storage and Shelf life and Instruction for use
and handling).
High levels of lipids in plasma may interfere with some
laboratory blood tests, e.g. haemoglobin.
The
addition
of
other
medicaments
or
substances
to
Smoflipid should generally be avoided unless compatibility
is known.
Interaction
Heparin given in clinical doses causes a transient increase
in lipoprotein lipase release into the circulation. This may
initially result in increased plasma lipolysis, followed by a
transient decrease in triglyceride clearance.
Soya-bean oil has a natural content of vitamin K .The
Contraindications
content is however so low in Smoflipid that it is not
1
expected
-
Hypersensitivity to fish-, egg-, soya or peanut protein
or to any of the active substances or excipients.
-
Severe hyperlipidemia.
-
Severe liver insufficiency.
-
Severe blood coagulation disorders.
-
Severe
renal
insufficiency
without
access
to
hemofiltration or dialysis.
-
Acute shock.
-
General contraindications to infusion therapy: acute
pulmonary oedema, hyperhydration, decompensated
cardiac insufficiency.
-
Unstable
conditions
(e.g.
severe
post-traumat