DACARBAZINE SANDOZ Dacarbazine 200 mg powder for injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

dacarbazine

Disponible des:

Sandoz Pty Ltd

Designació comuna internacional (DCI):

Dacarbazine

Estat d'Autorització:

Registered

Informació per a l'usuari

Dacarbazine Sandoz
®
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DACARBAZINE SANDOZ

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DACARBAZINE POWDER FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Dacarbazine Sandoz.
It does not contain all the available information. It does not take
the place of talking to your
doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this
medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT DACARBAZINE SANDOZ IS USED FOR
This medicine is used to treat some types of melanomas (skin cancers)
and a type of cancer called
sarcoma.
It contains the active ingredient, dacarbazine. Dacarbazine belongs to
a group of medicines
known as antineoplastic or cytotoxic agents. You may also hear it
referred to as a
chemotherapy medicine. Dacarbazine also belongs to a group of
cytotoxics known as
“alkylating agents”.
It works by killing cancer cells and stopping cancer cells from
growing and multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it for another reason.
This medicine may be used in combination with other medicines to treat
cancer.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
Dacarbazine Sandoz
®
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BEFORE YOU ARE GIVEN DACARBAZINE SANDOZ
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO:

dacarbazine, the active ingredient, or to any of the ingredients
listed at the end of this leaflet
under Product Description
Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing or swallowing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin
YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE OR HAVE

Fitxa tècnica

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_Dacarbazine Sandoz 200 mg powder for injection _
_December 2015 _
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PRODUCT INFORMATION
DACARBAZINE SANDOZ
®
200 MG POWDER FOR INJECTION
NAME OF THE MEDICINE
Dacarbazine Sandoz powder for injection contains the active ingredient
dacarbazine.
_Chemical Name: _
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5-(3,3-dimethyltriazeno)imidazole-4-carboxamide
_Structural Formula: _
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_Molecular Formula:_
C
6
H
10
N
6
O
_Molecular Weight:_
182.2
_CAS Number_:
4342-03-4
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DESCRIPTION
Each vial of Dacarbazine Sandoz powder for injection contains
dacarbazine, which occurs as
a white or very pale yellow crystalline powder. Dacarbazine is light
sensitive and is slightly
soluble in water and alcohol. The reconstituted solution appears as a
clear, pale yellow to
colourless solution and has a pH of 3.0 to 4.0.
Dacarbazine Sandoz powder for injection also contains citric acid and
mannitol as excipients.
PHARMACOLOGY
Pharmacological Actions
Dacarbazine inhibits cell replication by an unknown mechanism.
However, the following
three possible mechanisms have been postulated.
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
biosynthesis.
This
appears
to
be
true
at
high
concentrations
of
the
drug,
but
low
concentrations appear to enhance DNA, RNA and protein biosynthesis.
One metabolite of dacarbazine, diazomethane, is an alkylating agent
and may act in the same
way as the nitrogen mustards.
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_Dacarbazine Sandoz _
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_December 2015 _
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The drug might act as a sulfydryl reagent since the inhibition of
bacterial growth by
dacarbazine can be prevented by glutathione.
Pharmacokinetics
_Absorption_. Dacarbazine is poorly and erratically absorbed from the
gastrointestinal tract,
which
could
result
in
unp