Javlor

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Vinflunine ditartrate 34.18 mg/mL equivalent to vinflunine 25 mg/mL

Tillgänglig från:

New Zealand Medical & Scientific Ltd

INN (International namn):

Vinflunine ditartrate 34.18 mg/mL (= vinflunine 25 mg/mL)

Dos:

25 mg/mL

Läkemedelsform:

Concentrate for injection

Sammansättning:

Active: Vinflunine ditartrate 34.18 mg/mL equivalent to vinflunine 25 mg/mL Excipient: Nitrogen Water for injection

Enheter i paketet:

Vial, glass, single dose, type 1, with rubber stopper and Al seal, 50mg, 2 mL

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Pierre Fabre Medicament - Plantes et Industrie

Terapeutiska indikationer:

Javlor is indicated as monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, single dose, type 1, with rubber stopper and Al seal, 50mg - 2 mL - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, type 1, with rubber stopper and Al seal, 100mg - 4 mL - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, type 1, with rubber stopper and Al seal, 250mg - 10 mL - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Tillstånd datum:

2009-12-21

Produktens egenskaper

Version: A01-1109 
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Supercedes: NIL  
NEW ZEALAND DATA SHEET 

JAVLOR
®

25  MG/ML CONCENTRATED INJECTION 

NAME OF THE MEDICINE 

vinflunine ditartrate 

N
H
N
F
N
H
H
N
C
H
3
OCOCH
3
OH
F
H
H
3
COOC
COOCH
3
CH
3
O
. 2 (C
4
 H
6
 O
6
)

CAS number: 194468-36-5 

DESCRIPTION 

Vinflunine ditartrate is a white to off-white powder with the molecular formula 
C
53
H
66
F
2
N
4
O
20
 and a molecular weight of 1117.09.
 Vinflunine ditartrate is freely 
soluble in water, soluble in ethanol and practically insoluble in dichloromethane.  It is 
very hygroscopic
with a pKa value of 5.67 and 8.17 in water at 26
o
C 
– 27
o
C.   

Javlor
®
 Concentrated Injection is presented as a clear, colourless
to pale yellow 
solution.  It is supplied as a sterile, endotoxin-free aqueous
solution intended for 
dilution with a suitable parenteral fluid (sodium chloride 0.9% solution or glucose 5% 
solution).  One mL of Javlor
®
 contains 25 mg of vinflunine (as vinflunine ditartrate).  
Javlor
®
 also contains the excipient, water for injections.  

PHARMACOLOGY 

PHARMACODYNAMICS 

Vinflunine is an antineoplastic drug.  Vinflunine binds
to tubulin at or near to the 
vinca binding sites inhibiting its polymerisation into microtubules, which results in 
treadmilling suppression, disruption of microtubule dynamics, mitotic arrest and 
apoptotic cell death. 
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_In vivo_, vinflunine displays significant antitumour activity against a broad spectrum of 
human xenographs in mice both in terms
of survival prolongation and tumour growth 
inhibition.  

PHARMACOKINETICS 

Vinflunine pharmacokinetics is linear up to 400 mg/m
2
 in cancer patients.  Blood 
exposure to vinflunine (AUC), significantly correlat