PeriOlimel N4-600E

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Alanine 9.16 g/L (per litre of amino acid solution);  ; Arginine 6.2 g/L (per litre of amino acid solution); Aspartic acid 1.83 g/L (per litre of amino acid solution);  ; Glutamic acid 3.16 g/L (per litre of amino acid solution); Glycine 4.39 g/L (per litre of amino acid solution);  ; Histidine 3.77 g/L (per litre of amino acid solution); Isoleucine 3.16 g/L (per litre of amino acid solution);  ; Leucine 4.39 g/L (per litre of amino acid solution);  ;  ; Lysine acetate 7.02 g/L equivalent to lysine 4.98 g/L;  ; Magnesium chloride hexahydrate 1.12 g/L (per litre of amino acid solution);  ; Methionine 3.16 g/L (per litre of amino acid solution);  ; Phenylalanine 4.39 g/L (per litre of amino acid solution);  ; Potassium chloride 2.98 g/L (per litre of amino acid solution);  ;  ; Proline 3.77 g/L (per litre of amino acid solution); Serine 2.5 g/L (per litre of amino acid solution); Sodium acetate trihydrate 2.89 g/L (per litre of amino acid solution);  ; Sodium glycerophosphate 4.78 g/L (per litre of amino acid solution (hydrated)); Threonine 3.16 g/L (per litre of amino acid solution); Tryptophan 1.06 g/L (per litre of amino acid solution); Tyrosine 0.16 g/L (per litre of amino acid solution);  ; Valine 4.05 g/L (per litre of amino acid solution);  ; Calcium chloride dihydrate 0.74 g/L (per litre glucose solution);  ; Glucose monohydrate 206.25 g/L equivalent to glucose 187.5 g/L;  ;  ; Olive oil 120 g/L (per litre lipid emulsion); Soya oil 30 g/L (per litre lipid emulsion);  

Tersedia dari:

Baxter Healthcare Ltd

INN (Nama Internasional):

Alanine 9.16 g/L (per litre of amino acid solution)

Bentuk farmasi:

Emulsion for infusion

Komposisi:

Active: Alanine 9.16 g/L (per litre of amino acid solution)   Arginine 6.2 g/L (per litre of amino acid solution) Aspartic acid 1.83 g/L (per litre of amino acid solution)   Glutamic acid 3.16 g/L (per litre of amino acid solution) Glycine 4.39 g/L (per litre of amino acid solution)   Histidine 3.77 g/L (per litre of amino acid solution) Isoleucine 3.16 g/L (per litre of amino acid solution)   Leucine 4.39 g/L (per litre of amino acid solution)     Lysine acetate 7.02 g/L equivalent to lysine 4.98 g/L   Magnesium chloride hexahydrate 1.12 g/L (per litre of amino acid solution)   Methionine 3.16 g/L (per litre of amino acid solution)   Phenylalanine 4.39 g/L (per litre of amino acid solution)   Potassium chloride 2.98 g/L (per litre of amino acid solution)     Proline 3.77 g/L (per litre of amino acid solution) Serine 2.5 g/L (per litre of amino acid solution) Sodium acetate trihydrate 2.89 g/L (per litre of amino acid solution)   Sodium glycerophosphate 4.78 g/L (per litre of amino acid solution (hydrated)) Threonine 3.16 g/L (per litre of amino acid solution) Tryptophan 1.06 g/L (per litre of amino acid solution) Tyrosine 0.16 g/L (per litre of amino acid solution)   Valine 4.05 g/L (per litre of amino acid solution)   Excipient: Glacial acetic acid Water for injection Active: Calcium chloride dihydrate 0.74 g/L (per litre glucose solution)   Glucose monohydrate 206.25 g/L equivalent to glucose 187.5 g/L     Excipient: Hydrochloric acid Water for injection Active: Olive oil 120 g/L (per litre lipid emulsion) Soya oil 30 g/L (per litre lipid emulsion)   Excipient: Egg phosphatidyl esters Glycerol Sodium hydroxide Sodium oleate Water for injection

Unit dalam paket:

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

Kelas:

General sale

Jenis Resep:

General sale

Diproduksi oleh:

Kyowa Hakko Bio Co., Ltd

Indikasi Terapi:

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

Ringkasan produk:

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 - Bag, plastic, 3 compartment non-PVC lipid-compatible plastic bag in plastic overwrap with O2 absorber + indicator - 2500 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

Tanggal Otorisasi:

2010-11-19

Karakteristik produk

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