OLIMEL N7E Emulsion for Infusion

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

(Compartment 1) Alanine; (Compartment 1) Arginine; (Compartment 1) Aspartic Acid; (Compartment 1) Glutamic Acid; (Compartment 1) Glycine; (Compartment 1) Histidine; (Compartment 1) Isoleucine; (Compartment 1) Leucine; (Compartment 1) Lysine Acetate eqv Lysine; (Compartment 1) Magnesium Chloride Hexahydrate; (Compartment 1) Methionine; (Compartment 1) Phenylalanine; (Compartment 1) Potassium Chloride; (Compartment 1) Proline; (Compartment 1) Serine; (Compartment 1) Sodium Acetate Trihydrate; (Compartment 1) Sodium Glycerophosphate, Hydrated; (Compartment 1) Threonine; (Compartment 1) Tryptophan; (Compartment 1) Tyrosine; (Compartment 1) Valine; (Compartment 2) Calcium Chloride Dihydrate; (Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous; (Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20)

Commercializzato da:

BAXTER HEALTHCARE (ASIA) PTE LTD

Codice ATC:

B05BA10

Forma farmaceutica:

EMULSION

Composizione:

(Compartment 1) Alanine 6.41g/L; (Compartment 1) Arginine 4.34g/L; (Compartment 1) Aspartic Acid 1.28g/L; (Compartment 1) Glutamic Acid 2.21g/L; (Compartment 1) Glycine 3.07g/L; (Compartment 1) Histidine 2.64g/L; (Compartment 1) Isoleucine 2.21g/L; (Compartment 1) Leucine 3.07g/L; (Compartment 1) Lysine Acetate eqv Lysine 3.48g/L; (Compartment 1) Magnesium Chloride Hexahydrate 0.81g/L; (Compartment 1) Methionine 2.21g/L; (Compartment 1) Phenylalanine 3.07g/L; (Compartment 1) Potassium Chloride 2.24g/L; (Compartment 1) Proline 2.64g/L; (Compartment 1) Serine 1.75g/L; (Compartment 1) Sodium Acetate Trihydrate 1.50g/L; (Compartment 1) Sodium Glycerophosphate, Hydrated 3.67g/L; (Compartment 1) Threonine 2.21g/L; (Compartment 1) Tryptophan 0.74g/L; (Compartment 1) Tyrosine 0.11g/L; (Compartment 1) Valine 2.83g/L; (Compartment 2) Calcium Chloride Dihydrate 0.52g/L; (Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 140g/L; (Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 40g/L

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Ajinomoto Health & Nutrition North America Inc. (Intermediate)

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2023-10-20

Scheda tecnica

Bar code
1.
NAME OF THE MEDICINAL PRODUCT
OLIMEL N7E, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL N7E 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
35% Glucose solution
(corresponding to 35 g/100 ml)
400 ml
600 ml
800 ml
11.1% Amino acid solution
(corresponding to 11.1 g/100 ml)
400 ml
600 ml
800 ml
20% Lipid emulsion
(corresponding to 20 g/100 ml)
200 ml
300 ml
400 ml
Composition of the reconstituted emulsion after mixing the content of
the 3 compartments:
a.
Mixture of refined olive oil (approximately 80%) and refined soybean
oil (approximately 20%)
corresponding to a ratio essential fatty acids / total fatty acids of
20%.
ACTIVE SUBSTANCES
1 000 ML
1 500 ML
2 000 ML
Refined olive oil+ refined soybean oil
a
40.00 g
60.00 g
80.00 g
Alanine
6.41 g
9.61 g
12.82 g
Arginine
4.34 g
6.51 g
8.68 g
Aspartic acid
1.28 g
1.92 g
2.56 g
Glutamic acid
2.21 g
3.32 g
4.42 g
Glycine
3.07 g
4.60 g
6.14 g
Histidine
2.64 g
3.97 g
5.29 g
Isoleucine
2.21 g
3.32 g
4.42 g
Leucine
3.07 g
4.60 g
6.14 g
Lysine
(equivalent to Lysine acetate)
3.48 g
(4.88 g)
5.23 g
(7.31 g)
6.97 g
(9.75 g)
Methionine
2.21 g
3.32 g
4.42 g
Phenylalanine
3.07 g
4.60 g
6.14 g
Proline
2.64 g
3.97 g
5.29 g
Serine
1.75 g
2.62 g
3.50 g
Threonine
2.21 g
3.32 g
4.42 g
Tryptophan
0.74 g
1.10 g
1.47 g
Tyrosine
0.11 g
0.17 g
0.22 g
Valine
2.83 g
4.25 g
5.66 g
Sodium acetate, trihydrate
1.50 g
2.24 g
2.99 g
Sodium glycerophosphate, hydrated
3.67 g
5.51 g
7.34 g
Potassium chloride
2.24 g
3.35 g
4.47 g
Magnesium chloride, hexahydrate
0.81 g
1.22 g
1.62 g
Calcium chloride, dihydrate
0.52 g
0.77 g
1.03 g
Glucose anhydrous
(equivalent to Glucose monohydrate)
140.00 g
(154.00 g)
210.00 g
(231.00 g)
280.00 g
(308.00 g)
For a full list of excipients, see section 6.1.
Nutritional intakes of reconstituted emulsion for each of the bag
sizes:
1 000 ML
1 500 ML
2 000 ML
Lipids
40 g
60 g
80 g