Olimel N7-960

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Alanine 16.02 g/L (per litre of amino acid solution);  ; Arginine 10.85 g/L (per litre of amino acid solution); Aspartic acid 3.2 g/L (per litre of amino acid solution);  ; Glutamic acid 5.53 g/L (per litre of amino acid solution); Glycine 7.67 g/L (per litre of amino acid solution);  ; Histidine 6.61 g/L (per litre of amino acid solution); Isoleucine 5.53 g/L (per litre of amino acid solution);  ; Leucine 7.67 g/L (per litre of amino acid solution);  ;  ; Lysine acetate 12.19 g/L equivalent to lysine 8.71 g/L;  ; Methionine 5.53 g/L (per litre of amino acid solution);  ; Phenylalanine 7.67 g/L (per litre of amino acid solution);  ; Proline 6.61 g/L (per litre of amino acid solution); Serine 4.37 g/L (per litre of amino acid solution); Threonine 5.53 g/L (per litre of amino acid solution);  ;  ; Tryptophan 1.84 g/L (per litre of amino acid solution);  ; Tyrosine 0.28 g/L (per litre of amino acid solution);  ; Valine 7.08 g/L (per litre of amino acid solution);  ;  ; Glucose monohydrate 385 g/L equivalent to glucose 350 g/L;  ;  ; Olive oil 160 g/L (per litre lipid emulsion); Soya oil 40 g/L (per litre lipid emulsion);  

Διαθέσιμο από:

Baxter Healthcare Ltd

INN (Διεθνής Όνομα):

Alanine 16.02 g/L (per litre of amino acid solution)

Φαρμακοτεχνική μορφή:

Emulsion for infusion

Σύνθεση:

Active: Alanine 16.02 g/L (per litre of amino acid solution)   Arginine 10.85 g/L (per litre of amino acid solution) Aspartic acid 3.2 g/L (per litre of amino acid solution)   Glutamic acid 5.53 g/L (per litre of amino acid solution) Glycine 7.67 g/L (per litre of amino acid solution)   Histidine 6.61 g/L (per litre of amino acid solution) Isoleucine 5.53 g/L (per litre of amino acid solution)   Leucine 7.67 g/L (per litre of amino acid solution)     Lysine acetate 12.19 g/L equivalent to lysine 8.71 g/L   Methionine 5.53 g/L (per litre of amino acid solution)   Phenylalanine 7.67 g/L (per litre of amino acid solution)   Proline 6.61 g/L (per litre of amino acid solution) Serine 4.37 g/L (per litre of amino acid solution) Threonine 5.53 g/L (per litre of amino acid solution)     Tryptophan 1.84 g/L (per litre of amino acid solution)   Tyrosine 0.28 g/L (per litre of amino acid solution)   Valine 7.08 g/L (per litre of amino acid solution)     Excipient: Glacial acetic acid Water for injection Active: Glucose monohydrate 385 g/L equivalent to glucose 350 g/L     Excipient: Hydrochloric acid Water for injection Active: Olive oil 160 g/L (per litre lipid emulsion) Soya oil 40 g/L (per litre lipid emulsion)   Excipient: Egg phosphatidyl esters Glycerol Sodium hydroxide Sodium oleate Water for injection

Μονάδες σε πακέτο:

Bag, plastic, 3 compartment non-PVC lipid-compatible plastic bag in plastic overwrap with O2 absorber + indicator, 1000 mL

Kατηγορία:

General sale

Τρόπος διάθεσης:

General sale

Κατασκευάζεται από:

Kyowa Hakko Bio Co., Ltd

Θεραπευτικές ενδείξεις:

Parenteral nutrition for adults when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Bag, plastic, 3 compartment non-PVC lipid-compatible plastic bag in plastic overwrap with O2 absorber + indicator - 1000 mL - 24 months from date of manufacture stored at or below 25°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 48 hours reconstituted stored at or below 25°C - Bag, plastic, 3 compartment non-PVC lipid-compatible plastic bag in plastic overwrap with O2 absorber + indicator - 1500 mL - 24 months from date of manufacture stored at or below 25°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 48 hours reconstituted stored at or below 25°C - Bag, plastic, 3 compartment non-PVC lipid-compatible plastic bag in plastic overwrap with O2 absorber + indicator - 2000 mL - 24 months from date of manufacture stored at or below 25°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 48 hours reconstituted stored at or below 25°C

Ημερομηνία της άδειας:

2010-11-19

Αρχείο Π.Χ.Π.

NEW ZEALAND DATA SHEET
Olimel/PeriOlimel Data Sheet 17 September 2020
Page 1 of 23
Baxter Healthcare Ltd
1 Olimel® and PeriOlimel® (emulsions for infusion)
PeriOlimel N4‐600E
Olimel N5‐860E
Olimel N7‐960, Olimel N7‐960E
Olimel N9‐840, Olimel N9‐840E
Olimel N12‐640 and Olimel N12‐640E.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Composition _
Olimel/PeriOlimel with Electrolytes
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 hydrate, potassium chloride, magnesium chloride
hexahydrate, calcium chloride dihydrate,
glucose monohydrate, olive oil and soya oil.
Olimel without Electrolytes
Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine,
isoleucine, leucine, lysine acetate, methionine,
phenylalanine, proline, serine, threonine, tryptophan, tyrosine,
valine, glucose monohydrate, olive oil and soya
oil.
Olimel/PeriOlimel is presented in the form of a 3‐compartment bag.
The individual compartments contain a
glucose solution, a lipid emulsion and an amino acid solution
(with/without electrolytes). In products containing
electrolytes, calcium is included in the glucose solution compartment
and other electrolytes are in the amino acid
solution compartment. There are 7 different formulations of Olimel (4
with electrolytes and 3 without
electrolytes) and one formulation of PeriOlimel. The general
composition of the formulations are summarised
below:
WITH ELECTROLYTES (E)
WITHOUT
ELECTROLYTES
NITROGEN
1
AMINO ACID
SOLUTION
2
GLUCOSE
SOLUTION
3
LIPID
EMULSION
4
PERIOLIMEL N4‐600E
‐
4.0g/L
6.3%
18.75%
15.0%
OLIMEL N5‐860E
‐
5.2g/L
8.2%
28.75%
20.0%
OLIMEL N7‐960E
OLIMEL N7‐960
7.0g/L
11.1%
35.0%
20.0%
OLIMEL N9‐840E
OLIMEL N9‐840
9.0g/L
14.2%
27.5%
20.0%
OLIMEL N12‐640E
OLIMEL N12‐640
12.0g/L
14.2
27.5 %
17.5%
1
prefixes N4, N5, N7, N9 and N12 refer to approx. nitrogen content in
g