DBL™ Dacarbazine for Injection 200mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DACARBAZINE

Available from:

HOSPIRA MALAYSIA SDN BHD

INN (International Name):

DACARBAZINE

Units in package:

200gm1Units Units

Manufactured by:

Zydus Hospira Oncology Private Limited (ZHOPL)

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
DBL
®
DACARBAZINE FOR INJECTION 200 MG
1.
NAME OF THE MEDICINE
Dacarbazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains dacarbazine 200 milligrams.
When reconstituted as directed each mL of the solution contains
dacarbazine 10 milligrams.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Powder for Injection.
White or very pale yellow powder or plug.
The diluted solution for injection should be visually inspected and
only clear solutions practically free from
particles should be used.
4.
PHARMACOLOGICAL PROPERTIES
4.1 PHARMACODYNAMIC PROPERTIES
Relationship to other drugs: Dacarbazine is a structural analogue of
5-amino-imidazole-4-carboxamide which
is an intermediate in purine biosynthesis.
MECHANISM OF ACTION
This drug inhibits cell replication by an unknown mechanism. However,
three possible mechanisms have
been postulated:
1. Since dacarbazine is an analogue of
5-amino-imidazole-4-carboxamide, an intermediate in the _de novo_
biosynthesis of purine, it might interfere with purine biosynthesis
and hence DNA bio-synthesis. This appears
to be true at high concentrations of the drug, but low concentrations
appear to enhance DNA, RNA and
protein biosynthesis.
2. One metabolite of dacarbazine, diazomethane, is an alkylating agent
and may act in the same way as the
nitrogen mustards.
3. The drug might act as a sulphydryl reagent since the inhibition of
bacterial growth by dacarbazine can be
prevented by glutathione.
CLINICAL TRIALS
No data available.
4.2 PHARMACOKINETIC PROPERTIES
ABSORPTION
Dacarbazine is poorly and erratically absorbed from the
gastrointestinal tract, which could result in
unpredictable tumour responses and possible increased toxicity.
Therefore the drug is recommended for
intravenous administration only. Peak plasma concentrations of about 8
micrograms per mL are reached
immediately following administration of dacarbazine 4.5 milligrams/kg
by intravenous push.
2
DISTRIBUTION
The volume of distribution of dacarbazine exceeds total body