CLINOLEIC EMULSION FOR INFUSION 20%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MIXTURE OF OLIVE OIL (80%) AND SOYBEAN OIL (20%)

Available from:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC code:

B05BA02

Dosage:

20 g/100 ml

Pharmaceutical form:

EMULSION

Composition:

MIXTURE OF OLIVE OIL (80%) AND SOYBEAN OIL (20%) 20 g/100 ml

Administration route:

INTRAVENOUS

Prescription type:

General Sale List

Manufactured by:

BAXTER SA

Authorization status:

ACTIVE

Authorization date:

2003-10-08

Patient Information leaflet

CONFIDENTIAL DOCUMENT 

1
BAXTER 

1. NAME OF THE MEDICINAL PRODUCT 

CLINOLEIC

20%, emulsion for infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Refined olive oil and refined soya bean oil*  
 .. 
20.00 g 
corresponding to a content of essential fatty acids 
 ........................................... 
4.00 g 

Per 100 ml 

* Mixture of refined olive oil (approximately 80%) and
refined soya bean oil (approximately 20%) 

Energy content
 .......................................................................... 
2000 kcal/l (8.36 MJ/l) 
Lipid content (olive and soya bean oil) 
 ............................................................. 
200 g/l 
Osmolarity 
 ................................................................................................ 
270 mOsm/l 
pH 
 ........................................................................................................................... 
6 -8 
Density
 .................................................................................................................. 
0.986 

Phospholipids provide 47 milligrams or 1.5 mmol of phosphorus per
100 ml 

For excipients, see section 6.1 

3. PHARMACEUTICAL FORM 

 Emulsion  for  infusion 
Milk-like homogeneous liquid 

4. CLINICAL PARTICULARS 

4.1.

THERAPEUTIC INDICATIONS 

Indicated as a source of lipids for patients requiring parenteral
nutrition, when oral or enteral nutrition is 
impossible, insufficient or contraindicated. 

4.2.

POSOLOGY AND METHOD OF ADMINISTRATION 

CLINOLEIC 20% contains 200 mg/ml of lipids 
_ _
_Route of administration _
Intravenous infusion: 
  when administered as part of a complete nutrition
admixture (with glucose and amino acids) the central 
or peripheral venous route should be chosen depending on the
osmolarity of the final admixture. 
  in rare cases, when infused alone
as a com

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ClinOleic
®
20%, emulsion for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 100ml
Refined olive oil and refined soya bean oil*
20.00 g
corresponding to a content of essential fatty acids
4.00 g
* Mixture of refined olive oil (approximately 80%) and refined soya
bean oil (approximately 20%)
Energy content
2000 kcal/l (8.36 MJ/l)
Lipid content (olive and soya bean oil)
200 g/l
Osmolarity
270 mOsm/l
pH
6 -8
Density
0.986
Phospholipids provide 47 milligrams or 1.5mmol of phosphorus per 100
ml
For excipients, see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for infusion
Milk-like homogenous liquid
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated as a source of lipids for patients requiring parenteral
nutrition, when oral or enteral nutrition 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: _
The posology is 1 to a maximum of 2 g lipids/kg/day. The initial
infusion rate must be slow and not exceed
0.1 g lipids or 0.5 ml (10 drops) per minute for 10 minutes then
gradually increased until reaching the
required rate after half an hour.
Never exceed 0.15 g lipids/kg/hour (0.75 ml/kg/hour)
Adults per kg
of body weight
Adults for 70 kg
Usual lipid dosage
1 to 2 g/kg/day
70 to 140 g/day
Infused volume of ClinOleic 20%
5 to 10 ml/kg/day
350 to 700 ml/day
_In children_
:
_ _
ClinOleic 20% should be administered as a continuous 24h/day infusion.
It is recommended not to exceed a daily dose of 3g-lipids/kg b.w.
(body weight) and an infusion rate of
0.15 g lipids/kg b.w./h.
Daily dose should be increased gradually during the first week of
administration.
_In premature newborns and