DBL DACARBAZINE 200mg Powder for Injection

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

dacarbazine, Quantity: 200 mg

Verfügbar ab:

Pfizer Australia Pty Ltd

Darreichungsform:

Injection, powder for

Zusammensetzung:

Excipient Ingredients: mannitol; citric acid monohydrate

Verabreichungsweg:

Intravenous

Einheiten im Paket:

1 x 200mg vial

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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.

Produktbesonderheiten:

Visual Identification: White or very pale yellow powder or plug.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1992-07-20

Gebrauchsinformation

DBL
™ Dacarbazine for Injection CMI
Page 1
DBL
™ DACARBAZINE FOR INJECTION
Dacarbazine _(da-CAR-ba-zeen)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
DBL
™
Dacarbazine for Injection.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or
pharmacist has weighed the risks
of you being given DBL
™
Dacarbazine for Injection against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL
™
DACARBAZINE FOR
INJECTION IS USED FOR
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 belongs to a group
of cytotoxics known as ‘alkylating
agents’.
Dacarbazine works by killing
cancer cells and stopping cancer
cells from growing and
multiplying.
DBL
™
Dacarbazine for Injection is
used to treat some types of
melanomas (skin cancers) and a
type of cancer called sarcoma.
Your doctor may have prescribed
DBL
™
Dacarbazine for Injection
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
DBL
™
DACARBAZINE FOR INJECTION HAS
BEEN PRESCRIBED FOR YOU.
This medicine may be used in
combination with other medicines
to treat cancer.
DBL
™
Dacarbazine for Injection is
available only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DBL
™ DACARBAZINE FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL
™
DACARBAZINE FOR INJECTION IF YOU
HAVE AN ALLERGY TO DACARBAZINE
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
to DBL
™
Dacarbazine for Injection
may include:
•
shortness of breath, wheezing
or difficul

Fachinformation

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Supersedes Version: 8
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
DACARBAZINE
FOR
INJECTION
(DACARBAZINE)
1.
NAME OF THE MEDICINE
Dacarbazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Dacarbazine is a colourless to pale yellow solid, sensitive to light.
It is slightly soluble in
water and alcohol. DBL™
Dacarbazine for Injection is a sterile parenteral dosage form for
reconstitution. 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
DOSAGE
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
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Page 2 of 10
response rate of 20.3%. The duration of remissions (partial and
complete combined) varied
from
5
to
100
weeks.
The
median
remission
duration
obtained
by
three
principle
investigators was about 6 months. Once a patient has relapsed it is
unl