CLINOLEIC 20 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OLIVE OIL; SOYA OIL

Available from:

REMEDIX CARE LTD

ATC code:

A06AG06

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

OLIVE OIL 80 %; SOYA OIL 20 %

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER S.A., BELGIUM

Therapeutic group:

OIL

Therapeutic area:

OIL

Therapeutic indications:

Source of lipids during parenteral nutrition in situations where oral or enteral feeding is impossible, insufficient or contra-indicated.

Authorization date:

2023-03-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
________
MARCH 8, 2015
___
םש
רישכת
תילגנאב
רפסמו
םושירה
_
CLINOLEIC 20%
EMULSION FOR INFUSION REG NO: 122 09 30186 21
םש
לעב
םושירה
TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRA-
INDICATIONS
POSOLOGY,
DOSAGE &
ADMINISTRA-
TION
Method of administration
The administration flow rate must be adjusted taking into
account the dose being administrated, the daily volume
intake, and the duration of the infusion (see Section 4.9).
SPECIAL
WARNINGS
AND
SPECIAL
PRECAU-
TIONS FOR
USE
PRECAU-
TIONS
As other lipid emulsions, ClinOleic 20% should be used in
extremely premature and/or very low birth-weight infant
under the close supervision of a neonatologist. There is
clinical experience for ClinOleic 20% infusion time, up to
7 days in neonates and up to 2 months in children.
ClinOleic 20% should be administered with caution in case
of neonatal hyperbilirubinemia (total serum bilirubin > 200
µmol/ l). Total bilirubin levels should be monitored
closely.
Use of a vented intravenous administration set with the vent
in the open position could result in air embolism.
Parenteral nutrition should be used with caution in patients
with pre-existing liver disease or liver insufficiency. Liver
function parameters should be closely monitored in these
patients (see below).
Hepatobiliary
disorders
including
cholestasis,
hepatic
steatosis, fibrosis and cirrhosis, possibly leading to hepatic
failure, as well as cholecystitis and cholelithiasis are known
to develop in some patients on parenteral nutrition. The
etiology of these disorders in thought to be multifactorial and
may differ between patients. Patients developing abnorma

Summary of Product characteristics

CLINOLEIC 20% Emulsion for IV Infusion SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ClinOleic

20%, emulsion for intravenous infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per 100 ml
Refined olive oil and refined soybean oil*
..................................................... 20.00 g
corresponding to a content of essential fatty acids
........................................... 4.00 g
* Mixture of refined olive oil (approximately 80%) and refined soybean
oil (approximately 20%)
Energy content
..........................................................................
2000 kcal/l (8.36 MJ/l)
Lipid content (olive and soybean oil)
................................................................ 200
g/l
ClinOleic contains 47 milligrams or 1.5 mmol of phosphorus per 100 ml
Excipient with known effect:
Soybean oil- approximately 4g per 100 ml of emulsion.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for infusion
Milk-like, homogeneous liquid with odour of non-saturated glycerides
Osmolarity
................................................................................................
270 mOsm/l
pH
...........................................................................................................................
6 -8
Density
..................................................................................................................
0.986
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Source of lipids during parenteral nutrition in situations where oral
or enteral feeding
is impossible, insufficient or contraindicated.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ClinOleic 20% contains 200 g/l of lipids corresponding to 200 mg/ml.
_Posology _
The posology depends on energy expenditure, the patient’s clinical
status, body weight, and ability to
metabolize ClinOleic 20%, as well as additional energy given
orally/enterally. Therefore, the dosage should
be individualized and the bag size chosen accordingly.
_IN ADULTS: