OLIMEL N12E Emulsion for Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE; SODIUM ACETATE, TRIHYDRATE; SODIUM GLYCEROPHOSPHATE, HYDRATED; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE, HEXAHYDRATE; GLUCOSE MONOHYDRATE; CALCIUM CHLORIDE DIHYDRATE; REFINED OLIVE OIL; SOYA BEAN OIL REFINED

Available from:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International Name):

ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE; SODIUM ACETATE, TRIHYDRATE; SODIUM GLYCEROPHOSPHATE, HYDRATED; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE, HEXAHYDRATE; GLUCOSE MONOHYDRATE; CALCIUM CHLORIDE DIHYDRATE; REFINED OLIVE OIL; SOYA BEAN OIL REFINED

Units in package:

650 ml; 1000 ml

Manufactured by:

BAXTER S.A,

Summary of Product characteristics

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: BE3003426_LABEL
Date: 30JUN22
Proofread No.: 05
Designer: Z.B.
Page: 1 of 16
Colour Reference:
BLACK
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BE-30-03-426
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OLIMEL N12E, emulsion for infusion
1.
NAME OF THE MEDICINAL PRODUCT
OLIMEL N12E, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL N12E is presented in the form of a 3-compartment bag.
Each bag contains a glucose solution with calcium, a lipid emulsion
and an amino acid solution
with other electrolytes
Contents per bag
650 mL
1,000 mL
27.5% Glucose solution
(corresponding to 27.5 g/100 mL)
173 mL
267 mL
14.2% Amino acid solution
(corresponding to 14.2 g/100 mL)
347 mL
533 mL
17.5% Lipid emulsion
(corresponding to 17.5 g/100 mL)
130 mL
200 mL
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
Active substances
650 mL
1,000 mL
Refined olive oil+ refined soya-bean oil
a
22.75 g
35.00 g
Alanine
7.14 g
10.99 g
Arginine
4.84 g
7.44 g
Aspartic acid
1.43 g
2.20 g
Glutamic acid
2.46 g
3.79 g
Glycine
3.42 g
5.26 g
Histidine
2.94 g
4.53 g
Isoleucine
2.46 g
3.79 g
Leucine
3.42 g
5.26 g
Lysine
(equivalent to lysine acetate)
3.88 g
(5.48 g)
5.97 g
(8.43 g)
Methionine
2.46 g
3.79 g
Phenylalanine
3.42 g
5.26 g
Proline
2.94 g
4.53 g
Serine
1.95 g
3.00 g
Threonine
2.46 g
3.79 g
Tryptophan
0.82 g
1.26 g
Tyrosine
0.13 g
0.20 g
Valine
3.16 g
4.86 g
Sodium acetate, trihydrate
0.97 g
1.5 g
Sodium glycerophosphate, hydrated
2.39 g
3.67 g
DRAFT FOR REVIEW
COPY NOT PROOFREAD
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: BE3003426_LABEL
Date: 30JUN22
Proofread No.: 05
Designer: Z.B.
Page: 2 of 16
Colour Reference:
BLACK
2
BE-30-03-426
Potassium chloride
1.45 g
2.24 g
Magnesium chloride, hexahydrate
0.53 g
0.81 g
Calcium chloride, dihydrate
0.34 g
0.52 g
Glucose
(equivalent to glucose monohydrate)
47.67 g
(52.43 g)
73.33 g
(80.67 g)
a
Mixture of refined olive oil (approximately 80%) and refined soybean
oil (approximately 20%)
corresponding to a ratio essential fatty acids / total fatt