DBL™ Vincristine Sulfate

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Vincristine sulfate 1 mg/mL;  ;  

Beszerezhető a:

Pfizer New Zealand Limited

INN (nemzetközi neve):

Vincristine sulfate 1 mg/mL

Adagolás:

1 mg/mL

Gyógyszerészeti forma:

Solution for injection

Összetétel:

Active: Vincristine sulfate 1 mg/mL     Excipient: Mannitol Sodium hydroxide Sulfuric acid Water for injection

db csomag:

Syringe, 1mL (not marketed), 1 mL

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Fine Chemicals Corporation (Pty) Limited

Termék összefoglaló:

Package - Contents - Shelf Life: Syringe, - 1 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, - 2 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, 2mL - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, 1mL - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Engedély dátuma:

1986-08-04

Termékjellemzők

Version: pfdvindi11222
Supersedes: pfdvindi10421
Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Vincristine Sulfate Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vincristine sulfate is the salt of an alkaloid obtained from the
periwinkle plant (Cantharanthus
roseus).
DBL Vincristine Sulfate Injection:
A sterile solution of vincristine sulfate 1 milligram/mL and mannitol
100 milligrams/mL in Water
for Injections. The solution does not contain any preservative.
Vincristine sulfate occurs as a white or slightly yellow, hygroscopic,
amorphous or crystalline
powder and is freely soluble in water and slightly soluble in alcohol.
EXCIPIENT(S) WITH KNOWN EFFECT

Mannitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vincristine sulfate is indicated in acute leukaemia.
Current practices of cancer chemotherapy involve the simultaneous use
of several agents. For
enhanced therapeutic effect without additive toxicity, agents with
different dose-limiting clinical
toxicities and different mechanisms of action are generally selected.
It is rarely possible to
achieve equally good results with single agent treatment. Thus
vincristine sulfate is often chosen
as part of polychemotherapy because of lack of significant bone-marrow
suppression (at
recommended doses) and because of its unique clinical toxicity
(neuropathy). See SECTION 4.2
for possible increased toxicity when used in combination therapy.
It has been shown to be useful in combination with other oncolytic
agents in Hodgkin’s disease,
non-Hodgkin’s malignant lymphomas (lymphocytic, mixed-cell,
histiocytic, undifferentiated,
nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, Wilm’s
tumour, osteogenic
sarcoma, mycosis fungoides, Ewing’s sarcoma, carcinoma of the
uterine cervix, breast cancer,
malignant melanoma, oat-cell carcinoma of the lung, and gynaecological
tumours of childhood.
Version: pfdvindi11222
Supersedes: pfdvindi10421
Pa