PERIOLIMEL N4E emulsion for infusion

Country: Malaysia

Language: English

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

Active ingredient:

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

Available from:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International Name):

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

Units in package:

1000ml mL; 1500ml mL; 2000ml mL

Manufactured by:

BAXTER S.A,

Summary of Product characteristics

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Bar code
1.
NAME OF THE MEDICINAL PRODUCT
PERIOLIMEL N4E, emulsion for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PERIOLIMEL N4E 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.
CONTENT PER BAG
1 000 ML
1 500 ML
2 000 ML
18.75% Glucose solution
(corresponding to 18.75 g/100 ml)
400 ml
600 ml
800 ml
6.3% Amino acid solution (corresponding
to 6.3 g/100 ml)
400 ml
600 ml
800 ml
15% Lipid emulsion
(corresponding to 15 g/100 ml)
200 ml
300 ml
400 ml
Composition of the reconstituted emulsion after mixing the content of
the 3 compartments:
ACTIVE SUBSTANCES
1000 ML
1500 ML
2000 ML
Refined olive oil + refined soybean oil
a
30.00 g
45.00 g
60.00 g
Alanine
3.66 g
5.50 g
7.33 g
Arginine
2.48 g
3.72 g
4.96 g
Aspartic acid
0.73 g
1.10 g
1.46 g
Glutamic acid
1.26 g
1.90 g
2.53 g
Glycine
1.76 g
2.63 g
3.51 g
Histidine
1.51 g
2.26 g
3.02 g
Isoleucine
1.26 g
1.90 g
2.53 g
Leucine
1.76 g
2.63 g
3.51 g
Lysine
(equivalent to Lysine acetate)
1.99 g
(2.81 g)
2.99 g
(4.21 g)
3.98 g
(5.62 g)
Methionine
1.26 g
1.90 g
2.53 g
Phenylalanine
1.76 g
2.63 g
3.51 g
Proline
1.51 g
2.26 g
3.02 g
Serine
1.00 g
1.50 g
2.00 g
Threonine
1.26 g
1.90 g
2.53 g
Tryptophan
0.42 g
0.64 g
0.85 g
Tyrosine
0.06 g
0.10 g
0.13 g
Valine
1.62 g
2.43 g
3.24 g
Sodium acetate, trihydrate
1.16 g
1.73 g
2.31 g
Sodium glycerophosphate, hydrated
1.91 g
2.87 g
3.82 g
Potassium chloride
1.19 g
1.79 g
2.38 g
Magnesium chloride, hexahydrate
0.45 g
0.67 g
0.90 g
Calcium chloride, dihydrate
0.30 g
0.44 g
0.59 g
Glucose anhydrous
(equivalent to Glucose monohydrate)
75.00 g
(82.50 g )
112.50 g
(123.75 g )
150.00 g
(165.00 g )
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a
Mixture of refined olive oil (approximately 80%) and refined soybean
oil (approximately 20%)
corresponding to a ratio essential fatty acids / total fat