SMOFLIPID 200 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

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

Available from:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

B05BA10

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

TRIGLYCERIDES, MEDIUM-CHAIN 60 G/L; SOYA OIL 60 G/L; REFINED OLIVE OIL 50 G/L; PURIFIED FISH OIL 30 G/L

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AB, SWEDEN

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

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

Authorization date:

2022-12-31

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
)
ךיראת :
07.03.16
תילגנאב רישכת םש
םושירה רפסמו
:
)
137 75 31387 )
SMOFLIPID
םושירה לעב םש :
יילפוס לקינקט דנא לקידמ רויק
מ"עב
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
QUALITATIVE AND
QUANTITATIVE
COMPOSITION
--------------
Excipients with known effect:
1000 ml emulsion contains up to 5 mmol
sodium (as sodium hydroxide and
sodium oleate).
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
--------
---
Smoflipd contains up to 5 mmol sodium
per 1000 ml. To be taken into
consideration by patients on a controlled
sodium diet. ב"צמ
נמוסמ ובש ,ןולעה
תו תורמחהה
שקובמה תו
בוהצ עקר לע
.
ונמוס תורמחה רדגב םניאש םייוניש
)ןולעב(
תוהמ ןכות קר ןמסל שי .הנוש עבצב
םוקימב םייוניש אלו י
.טסקטה

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SMOFlipid 200 mg/ml emulsion for infusion
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
contraindicated.
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 birthweight neonates, Smoflipid should be infused
continuously over
about 24 hours.
The duration of treatment should not exceed 30 days.
Children
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