Oliclinomel N6 - 900

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Alanine 17.6 g/L;  ;  ;  ; Arginine 9.78 g/L;  ;  ;  ; Glycine 8.76 g/L;  ; Histidine 4.08 g/L;  ;  ;  ; Isoleucine 5.1 g/L;  ;  ;  ;  ; Leucine 6.21 g/L;  ;  ;  ;  ; Lysine hydrochloride 6.16 g/L equivalent to lysine 4.93 g/L;  ;  ; Methionine 3.4 g/L;  ; Phenylalanine 4.76 g/L;  ;  ;  ; Proline 5.78 g/L;  ;  ;  ; Serine 4.25 g/L;  ;  ;  ; Threonine 3.57 g/L;  ;  ;  ; Tryptophan 1.53 g/L;  ;  ; Tyrosine 0.34 g/L;  ; Valine 4.93 g/L;  ;  ;  ;  ; Glucose monohydrate 330 g/L equivalent to glucose 300 g/L;  ;  ; Olive oil 160 g/L ((refined olive oil) as an 80/20 mixture of olive oil/soya oil); Soya oil 40 g/L ((refined soya bean oil) as an 80/20 mixture of olive oil/soya oil);  

Tilgjengelig fra:

Baxter Healthcare Ltd

INN (International Name):

Alanine 17.6 g/L

Legemiddelform:

Emulsion for infusion

Sammensetning:

Active: Alanine 17.6 g/L       Arginine 9.78 g/L       Glycine 8.76 g/L   Histidine 4.08 g/L       Isoleucine 5.1 g/L         Leucine 6.21 g/L         Lysine hydrochloride 6.16 g/L equivalent to lysine 4.93 g/L     Methionine 3.4 g/L   Phenylalanine 4.76 g/L       Proline 5.78 g/L       Serine 4.25 g/L       Threonine 3.57 g/L       Tryptophan 1.53 g/L     Tyrosine 0.34 g/L   Valine 4.93 g/L         Excipient: Acetic acid Water for injection Active: Glucose monohydrate 330 g/L equivalent to glucose 300 g/L     Excipient: Hydrochloric acid Water for injection Active: Olive oil 160 g/L ((refined olive oil) as an 80/20 mixture of olive oil/soya oil) Soya oil 40 g/L ((refined soya bean oil) as an 80/20 mixture of olive oil/soya oil)   Excipient: Egg phosphatidyl esters Glycerol Sodium hydroxide Sodium oleate Water for injection

Enheter i pakken:

Bag, plastic, 3 compt, with a clear plastic overpouch., 1 L

Klasse:

General sale

Resept typen:

General sale

Produsert av:

Kyowa Hakko Bio Co., Ltd

Produkt oppsummering:

Package - Contents - Shelf Life: Bag, plastic, 3 compt, with a clear plastic overpouch. - 1 L - 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. - Bag, plastic, 3 compt, with a clear plastic overpouch. - 1.5 L - 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. - Bag, plastic, 3 compt, with a clear plastic overpouch. - 2 L - 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. - Bag, plastic, 3 compt, with a clear plastic overpouch. - 2.5 L - 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C.

Autorisasjon dato:

2003-03-31

Preparatomtale

OLICLINOMEL
New Zealand Data Sheet
OLICLINOMEL Data Sheet 18 February 2015
Page 1 of 34
Baxter
OLICLINOMEL
OLICLINOMEL N4-550, OLICLINOMEL N5-800, OLICLINOMEL N6-900,
OLICLINOMEL N7-1000
OLICLINOMEL N4-550 E, OLICLINOMEL N5-800 E, OLICLINOMEL N6-900 E,
OLICLINOMEL N7-1000 E
COMPOSITION
Lipid emulsion, amino acid solution and glucose solution presented in
the form of a 3-
compartment bag.
There are eight different formulations of OLICLINOMEL, four with
electrolytes and four
without electrolytes. The general compositions of the formulations are
summarised in the
following table:
WITHOUT
ELECTROLYTES &
CALCIUM
WITH
ELECTROLYTES
NITROGEN
1
LIPID
EMULSION
2
AMINO ACID
SOLUTION
3
GLUCOSE
SOLUTION
4
OLICLINOMEL
N4-550
OLICLINOMEL
N4-550E
3.6g/L
10%
5.5%
20%
OLICLINOMEL
N5-800
OLICLINOMEL
N5-800E
4.6g/L
20%
7%
25%
OLICLINOMEL
N6-900
OLICLINOMEL
N6-900E
5.6g/L
20%
8.5%
30%
OLICLINOMEL
N7-1000
OLICLINOMEL
N7-1000E
6.6g/L
20%
10%
40%
1
Prefixes N4, N5, N6, N7 refer to rounded up content of nitrogen,
expressed as g/L.
2
Contains refined olive oil (80%) and soya oils (20%).
3
Contains 15 _L_-series amino acids and electrolytes if present.
4
Contains calcium if present.
For the detailed formulations, refer to APPENDIX 1.
There are four presentations of each formulation, which have the
following different
volumes:
OLICLINOMEL
New Zealand Data Sheet
OLICLINOMEL Data Sheet 18 February 2015
Page 2 of 34
Baxter
COMPARTMENT
1000ML
1500ML
2000ML
2500ML
LIPID EMULSION
200mL
300mL
400mL
500mL
AMINO ACID SOLUTION
400mL
600mL
800mL
1000mL
GLUCOSE SOLUTION
400mL
600mL
800mL
1000mL
DESCRIPTION
APPEARANCE PRIOR TO RECONSTITUTION
OLICLINOMEL is presented in the form of a 3-compartment bag, each
containing liquids:

The lipid emulsion is a homogeneous liquid with a milky appearance.

The amino acid and glucose solutions are clear and colourless or
slightly yellow.
AFTER RECONSTITUTION
OLICLINOMEL is a milk-like homogeneous liquid (see _PRESENTATION AND
STORAGE _
_CONDITIONS_ for further information).
OLICLINOMEL is a hypertonic emulsion