LIPOFUNDIN MCTLCT 10 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SOYA OIL; TRIGLYCERIDES, MEDIUM-CHAIN

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

B05BA10

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

TRIGLYCERIDES, MEDIUM-CHAIN 50 MG/ML; SOYA OIL 50 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

Therapeutic indications:

Source of calories and essential fatty oils for patients requiring parenteral nutrition

Authorization date:

2023-08-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lipofundin MCT/LCT 20 %
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml emulsion for infusion contain:
Soya-bean oil
100.0 g
Medium-chain triglycerides (MCT)
100.0 g
_ _
_Essential fatty acid content per 1000 ml: _
Linoleic acid
48.0
–
58.0 g

-Linolenic acid
5.0
–
11.0 g
Excipient(s) with known effect
Lipofundin MCT/LCT 20% contains less than 1 mmol (23 mg) sodium per
litre.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Emulsion for infusion
Milky-white emulsion
Energy [kJ/l (kcal/l)]
8095 (1935)
Theoretical osmolarity [mOsm/l]
380
Acidity or alkalinity (titration to pH 7.4) [mmol/l]
< 0.5
pH
6.0 - 8.5
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Lipofundin MCT/LCT is indicated as a source of calories and essential
fatty oils for
patients requiring parenteral nutrition.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage and infusion rate should be within the ranges recommended
below and
should be governed by the patient’s
ability to utilise fat.
1.
Adults and school-age children
1-2 g fat per kg body weight per day, corresponding to 10-20 ml of
Lipofundin
MCT/LCT 10% or 5-10 ml of Lipofundin MCT/LCT 20% per kg body weight
per
day.
2.
Neonates, infants and pre-school children.
Dosage is governed by the maturity and birth-weight of the infant.
Neonates
2.5-3 g (up to 4 g) of fat per kg body weight per day, corresponding
to 25-
30 ml (up to 40 ml) of Lipofundin MCT/LCT 10% or 12.5-15 ml (up to 20
ml) of
Lipofundin MCT/LCT 20% per kg body weight per day.
Especially in preterm infants and low-birth-weight neonates, the
ability to eliminate
infused lipids is not yet fully developed. Therefore maximum fat doses
should not be
administered
to these patients. The infant’s ability to e
liminate infused fat from the
circulation should be checked daily. Measuring serum triglycerides is
the only reliable
method. If lipaemia is present re-testing should be carried out after
an interval of four
hours.
At