BLEO 15K bleomycin sulfate 15000 IU powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bleomycin sulfate, Quantity: 15000 IU

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

bleomycin sulfate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intramuscular, Subcutaneous, Intravenous, Intraarterial

Units in package:

1x15000 IU VIAL, 10X15000 IU vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: = Squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). = Squamous cell carcinoma of the larynx, penis and uterine cervix. = Squamous cell carcinoma of the bronchus (response infrequent). = Choriocarcinoma and embryonal cell carcinoma of the testis. = Advanced Hodgkin's disease and other lymphomas. = Mycosis fungoides.,Note. Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.

Product summary:

Visual Identification: A sterile freeze dried powder for reconstitution. White to off white crystalline powder, very hygroscopic.Clear, colourless solution on reconstitution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-09-30

Patient Information leaflet

BLEO 15K Consumer Medicines Information
Juno Pharmaceuticals Pty Ltd
Bleo 15K cmi v 2.0
1
_BLEO 15 K_
_ _
_ _
_BLEO 15K Sulfate for Injection _
_ _
_Consumer Medicine information _
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
BLEO
15K
for
Injection.
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 taking BLEO 15 K
for Injection 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
WITH
THE
MEDICINE.
You may need to read it again.
WHAT BLEO 15K FOR
INJECTION IS USED FOR
BLEO 15K belongs to a group of
medicines
known
as
antineoplastic or cytotoxic agents.
You may hear it referred to as
chemotherapy medicine.
BLEO
15K
is
classified
as
an
antitumour antibiotic. It interferes
with the growth of cancer cells,
which are eventually destroyed.
Your doctor may have prescribed
BLEO 15K for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BLEO 15K
HAS BEEN PRESCRIBED FOR YOU.
This
medicine
is
available
only
with a doctor’s prescription.
BLEO 15K is not recommended
for use in children, as there have
not
been
enough
studies
of
its
effects in children.
BEFORE YOU ARE GIVEN
BLEO 15K
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST BE GIVEN BLEO 15K
FOR INJECTION IF YOU HAVE ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
SYMPTOMS
OF
AN
ALLERGIC
REACTION
TO
BLEO
15K
MAY
INCLUDE:
•
shortness
of
breath,
wheezing
or
difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of
the body
•
rash, itching or hives on
the skin
YOU SHOULD NOT BE GIVEN BLEO
15K
IF
YOU
HAVE
ANY
OF
THE
FOLLOWING CONDITIONS:
•
low
white
blood
cell
(WBC) count
•
problems
with
blood
clotting
•
severe lung problems, a
lung infection or reduced
lung function._ _
_ _
TELL YOUR DOCTOR IF YOU HAVE AN
INFECTION OR HIGH TEMPERATURE.
Your d

Summary of Product characteristics

Australian Product Information
Bleo 15k PI v 2.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_ _
_BLEO 15K_
_ _
_(BLEOMYCIN SULFATE) _
_ _
1 NAME OF THE MEDICINE
Bleomycin sulfate.
2-3
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL
FORM
BLEO 15K contains bleomycin sulfate 15,000 IU per vial.
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.
It 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. When reconstituted in water for injection, the pH of the
solution is
approximately 5. Each vial contains 55 to 70% of bleomycin A
2
and 25 to 32% of bleomycin
B
2
.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
BLEO 15K is presented as vials containing a white to cream coloured
lyophilised powder for
reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palliation and treatment adjuvant to surgery and radiation therapy of
the following neoplasms:
•
Squamous cell carcinoma of the skin, head and neck, and oesophagus
(primary indication).
•
Squamous cell carcinoma of the larynx, penis and uterine cervix.
•
Squamous cell carcinoma of the bronchus (response infrequent).
•
Choriocarcinoma and embryonal cell carcinoma of the testis.
•
Advanced Hodgkin's disease and other lymphomas.
•
Mycosis fungoides.
NOTE. Use of bleomycin after radiation therapy is less successful than
use before radiation
therapy. Bleomycin is bone marrow sparing and may be used when other
cytotoxic agents are
contraindicated.
4.2 DOSE AND METHOD OF ADMINISTRATION
Bleomycin may be given by the intramuscular, intravenous, subcutaneous
or intra-arterial
routes.
_NOTE. _ Because of the possibility of an anaphylactoid reaction,
lymphoma patients should
Australian Product Information
Bleo 15k PI v 2.0