DBL™ Dacarbazine

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Dacarbazine 200mg;  ;  

Dostępny od:

Pfizer New Zealand Limited

INN (International Nazwa):

Dacarbazine 200 mg

Dawkowanie:

200 mg

Forma farmaceutyczna:

Powder for injection

Skład:

Active: Dacarbazine 200mg     Excipient: Citric acid monohydrate Mannitol

Sztuk w opakowaniu:

Vial, glass, 200 mg

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Heraeus Deutschland GmbH & Co. KG

Wskazania:

Chemotherapy of metastatic malignant melanoma and various sarcomas. In other cancers, the available evidence shows dacarbazine to be ineffective or less effective than established regimens.

Podsumowanie produktu:

Package - Contents - Shelf Life: Vial, glass, - 200 mg - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Data autoryzacji:

1989-11-29

Charakterystyka produktu

Version: pfddacav21122
Supersedes: pfddacav11122
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL
™
Dacarbazine 200 mg Powder for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
Dacarbazine for Injection is a sterile parenteral dosage form for
reconstitution. When
reconstituted as directed each mL of the solution in the 200 milligram
vial contains dacarbazine
10 milligrams, citric acid monohydrate 10 milligrams and mannitol 3.75
milligrams.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for injection.
White or very pale yellow powder or plug.
The pH of the reconstituted solution is 3.0 – 4.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chemotherapy of metastatic malignant melanoma and various sarcomas. In
other cancers, the
available evidence shows dacarbazine to be ineffective or less
effective than established
regimens.
Note:
The use of dacarbazine is restricted to hospitals with an oncology
service.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULT
There are two commonly used dose regimens:
1.
4.5 milligrams/kg/day for 10 days; the 10 day course may be repeated
every 4 weeks.
Note: 2 milligrams/kg/day for 10 days has been used by one
investigator and found to
be equally as effective as the higher dose.
2.
250 milligrams/m
2
/day for 5 days; the 5 day course may be repeated every 3 weeks.
In general, effectiveness is likely to be evident after the second
course of dacarbazine. Of the
1427 patients with metastatic malignant melanoma treated with
dacarbazine, 81 patients (5.7%)
had complete remissions and 208 patients (14.6%) had partial
remissions with a total response
rate of 20.3%. The duration of remissions (partial and complete
combined) varied from 5 to
Version: pfddacav21122
Supersedes: pfddacav11122
Page 2 of 10
100 weeks. The median remission duration obtained by three principle
investigators was about
6 months. Once a patient has relapsed it is unlikely that subsequent
courses of dacarbazine will
be effective.
COMBINATION THERAPY
Combinations