DBL™ Vinblastine

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Vinblastine sulfate 1 mg/mL

Beschikbaar vanaf:

Pfizer New Zealand Limited

INN (Algemene Internationale Benaming):

Vinblastine sulfate 1 mg/mL

Dosering:

1 mg/mL

farmaceutische vorm:

Solution for injection

Samenstelling:

Active: Vinblastine sulfate 1 mg/mL Excipient: Sodium chloride Sodium hydroxide Sulfuric acid Water for injection

Eenheden in pakket:

Vial, glass, 10ml, 1 dose unit

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Fine Chemicals Corporation (Pty) Limited

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, 10ml - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 10ml - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisatie datum:

1990-09-04

Productkenmerken

Version: pfdvinbi11221
Supersedes: pfdvinbi10821
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Vinblastine Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION
DBL Vinblastine Sulfate B.P. is the sulfate of an alkaloid, occurring
in the
VINCA ROSEA
LINN.,
(a common, flowering herb).
Vinblastine Injection is a sterile solution of DBL Vinblastine Sulfate
B.P. in Sodium Chloride
0.9% Injection.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
The pH of the solution is 3.5 -5.0.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Vinblastine is effective as a single agent, but its therapeutic effect
is enhanced when used in
combination with other antineoplastic drugs.
Vinblastine has been used in the treatment of Hodgkin’s disease
(Stages III and IV) in
combination therapy (with adriamycin (doxorubicin), bleomycin and
dacarbazine as ABVD)
and in the treatment of advanced testicular carcinoma (with cisplatin
and bleomycin).
Vinblastine has been used in the palliative treatment of lymphocytic
lymphoma, histiocytic
lymphoma, advanced stages of mycosis fungoides, Kaposi's sarcoma and
Histiocytosis X.
Vinblastine
may
be
used
in
the
treatment
of
choriocarcinoma
resistant
to
other
chemotherapeutic agents; carcinoma of the breast, unresponsive to
appropriate endocrine
surgery and hormonal therapy.
One of the most effective single agents for treatment of Hodgkin’s
disease is vinblastine. A
protocol substituting cyclophosphamide for nitrogen mustard and
vinblastine for vincristine in
MOPP [mechlorethamine hydrochloride (nitrogen mustard), vincristine
sulfate, prednisone and
procarbazine] is an alternative therapy for previously untreated
patients with advanced
Hodgkin’s disease. Patients suffering relapse have also responded to
combination therapy that
included vinblastine.
Version: pfdvinbi11221
Supersedes: pfdvinbi10821
Page 2 of 13
Advanced testicular germ-cell cancers are sensitive to vinblastine
alone but the administration
of vinblastine c