DBL BLEOMYCIN
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
09-05-2024
Summary of Product characteristics
(SPC)
09-05-2024
Active ingredient:
Bleomycin sulfate
Available from:
Hospira Australia Pty Ltd
Class:
Medicine Listed (Export Only)
Patient Information leaflet
W:\PI & CMI\Approved PI & CMI\Approved CMI\Bleomycin hcmi June
2012.doc
Page 1
DBL
™
BLEOMYCIN SULFATE FOR
INJECTION
Bleomycin Sulfate (blee-oh-MYE-sin)
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
™
Bleomycin
Sulfate for Injection (DBL
™
Bleomycin).
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 has weighed
the risks of you being given DBL™
Bleomycin 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
™
BLEOMYCIN
IS USED FOR
DBL
™
Bleomycin belongs to a
group of medicines known as
antineoplastic or cytotoxic agents.
You may hear it referred to as
chemotherapy medicine.
DBL
™
Bleomycin is classified as an
anti-tumour antibiotic. It interferes
with the growth of cancer cells,
which are eventually destroyed.
Your doctor may have prescribed
bleomycin for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BLEOMYCIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
DBL
™
Bleomycin is not
recommended for use in children,
as there have not been enough
studies of its effects in children.
BEFORE YOU ARE GIVEN
DBL
™
BLEOMYCIN
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL
™
BLEOMYCIN IF YOU HAVE AN ALLERGY
TO BLEOMYCIN OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Read the complete document
Summary of Product characteristics
Product Information – Australia
Version 5.0
Page 1
DBL™ BLEOMYCIN SULFATE FOR INJECTION
NAME OF THE MEDICINE
Bleomycin sulfate
The CAS number of bleomycin sulfate is
9041-93-4. The structure of bleomycin sulfate is shown
below:
DESCRIPTION
Bleomycin sulfate is an antineoplastic antibiotic which is a
purified mixture of glycopeptides produced
by a fermentation process employing the actinomycetes
Streptoverticillium species. The bleomycin
mixture contains predominantly the A
2
and B
2
peptides.
Bleomycin sulfate is a white or yellowish white
or cream coloured amorphous hygroscopic powder. It
is very soluble in water, slightly soluble in dehydrated alcohol,
and practically insoluble in acetone
and ether.
DBL™ Bleomycin Sulfate for Injection is a white to cream
coloured lyophilised powder or plug. When
reconstituted in Water for Injection, the pH of the solution is
approximately 5. Each vial contains
bleomycin sulfate as a lyophilised powder which is equivalent to
15,000 IU bleomycin activity. Each
vial contains 55-70% of bleomycin A
2
and 25-32% of bleomycin B
2
.
PHARMACOLOGY
Although the precise mechanism of action of bleomycin is not
fully known, it is thought that the
primary action is to produce single and
double-strand breaks in DNA, leading to inhibition of cell
division and growth, and inhibition of DNA synthesis in the cells.
Bleomycin is probably most effective against cells
in the M and G
2
(premitotic) phase of the cell cycle.
Bleomycin has not been shown to have an immunosuppressive
effect in vitro and shows no
significant inhibition of immune response in patients treated
with the drug.
Bleomycin-inactivating enzyme has been detected
in both normal and malignant cells and is
particularly prominent in liver. The enzyme is not found in lung
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