Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Vinflunine ditartrate 34.18 mg/mL equivalent to vinflunine 25 mg/mL
New Zealand Medical & Scientific Ltd
Vinflunine ditartrate 34.18 mg/mL (= vinflunine 25 mg/mL)
25 mg/mL
Concentrate for injection
Active: Vinflunine ditartrate 34.18 mg/mL equivalent to vinflunine 25 mg/mL Excipient: Nitrogen Water for injection
Vial, glass, single dose, type 1, with rubber stopper and Al seal, 50mg, 2 mL
Prescription
Prescription
Pierre Fabre Medicament - Plantes et Industrie
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.
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)
2009-12-21
Version: A01-1109 Page 1 of 26 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. Version: A01-1109 Page 2 of 26 Supercedes: NIL _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 Olvassa el a teljes dokumentumot