Olimel N12-640

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Alanine 20.6 g;  ; Arginine 13.95 g/L; Aspartic acid 4.12 g/L;  ; Glutamic acid 7.11 g/L; Glycine 9.87 g/L;  ; Histidine 8.49 g/L; Isoleucine 7.11 g/L;  ; Leucine 9.87 g/L;  ; Lysine acetate 15.8 g/L equivalent to lysine 11.20 g/L; Methionine 7.11 g/L;  ; Phenylalanine 9.87 g/L;  ; Proline 8.49 g/L; Serine 5.62 g/L; Threonine 7.11 g/L; Tryptophan 2.37 g; Tyrosine 0.37 g;  ; Valine 9.11 g;  ; Glucose monohydrate 302.5 g equivalent to glucose anhydrous 275 g;  ;  ; Olive oil 140 g/L (refined, 80% for a total content of 175g/l to reach linoleic acid and alpha-linoleic acid ratio); Soya oil 35 g/L (refined, 20% for a total content of 175g/l to reach linoleic acid and alpha-linoleic acid ratio)

Sẵn có từ:

Baxter Healthcare Ltd

Dạng dược phẩm:

Emulsion for infusion

Thành phần:

Active: Alanine 20.6 g   Arginine 13.95 g/L Aspartic acid 4.12 g/L   Glutamic acid 7.11 g/L Glycine 9.87 g/L   Histidine 8.49 g/L Isoleucine 7.11 g/L   Leucine 9.87 g/L   Lysine acetate 15.8 g/L equivalent to lysine 11.20 g/L Methionine 7.11 g/L   Phenylalanine 9.87 g/L   Proline 8.49 g/L Serine 5.62 g/L Threonine 7.11 g/L Tryptophan 2.37 g Tyrosine 0.37 g   Valine 9.11 g   Excipient: Glacial acetic acid Water for injection Active: Glucose monohydrate 302.5 g equivalent to glucose anhydrous 275 g     Excipient: Hydrochloric acid Water for injection Active: Olive oil 140 g/L (refined, 80% for a total content of 175g/l to reach linoleic acid and alpha-linoleic acid ratio) Soya oil 35 g/L (refined, 20% for a total content of 175g/l to reach linoleic acid and alpha-linoleic acid ratio) Excipient: Egg phosphatidyl esters Glycerol Sodium hydroxide Sodium oleate Water for injection

Loại thuốc theo toa:

General sale

Chỉ dẫn điều trị:

Olimel is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient, or contraindicated.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Bag, plastic, 3-compartment non-PVC plastic bag - 650 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). followed by 48 hours at or below 25°C - Bag, plastic, 3-compartment non-PVC plastic bag - 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). followed by 48 hours at or below 25°C - Bag, plastic, 3-compartment non-PVC plastic bag - 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). followed by 48 hours at or below 25°C - Bag, plastic, 3-compartment non-PVC plastic bag - 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). followed by 48 hours at or below 25°C

Ngày ủy quyền:

2018-08-22

Đặc tính sản phẩm

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