BLENAMAX bleomycin sulfate 15000IU powder for injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

bleomycin sulfate

Dostupno od:

Teva Pharma Australia Pty Ltd

Status autorizacije:

Registered

Uputa o lijeku

Blenamax- Consumer Medicine Information
Page 1 of 3
BLENAMAX ®
_bleomycin sulfate _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BLENAMAX®. 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 taking BLENAMAX®
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 BLENAMAX IS
USED FOR
BLENAMAX® is used to treat some
types of cancers, and is also used to
prevent or treat build-up of fluid
around the lungs which can result
from cancer. BLENAMAX® belongs
to a group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines. BLENAMAX® is thought
to work by stopping cancer cells
from growing and multiplying. Your
doctor may have prescribed
BLENAMAX® for another reason.
Ask your doctor if you have any
questions about why BLENAMAX®
has been prescribed for you.
BLENAMAX® may be used in
combination with other medicines to
treat cancer.
BLENAMAX® is not addictive.
This medicine is available only with
a doctor's prescription.
BLENAMAX® is not recommended
for use in children, as there is not
enough information on its effects in
children.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT HAVE BLENAMAX® IF YOU
HAVE AN ALLERGY TO BLEOMYCIN
SULFATE OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction to
BLENAMAX may include:-

shortness of breath

wheezing

difficulty breathing or a tight
feeling in your chest

swelling of the face, lips, tongue
or other parts of the body

rash

itching

hives or flushed, red skin

dizziness or light headedness

back pain
Your doctor may give you a small
test dose to see how you react to

Svojstava lijeka

BLENAMAX- Product Information
Page 1 of 8
PRODUCT INFORMATION
BLENAMAX
®
POWDER FOR INJECTION
NAME OF THE DRUG
BLENAMAX
®
(bleomycin sulfate) 15,000 IU powder for injection
DESCRIPTION
Bleomycin sulfate is an antineoplastic antibiotic. It is the sulfate
of a mixture of glycopeptides isolated
from a strain of _Streptomyces verticillus _; the two principal
components of the mixture are bleomycin A2
and B2. The CAS No. of bleomycin sulfate is 9041-34-4. The chemical
structure of bleomycin is as
follows
:
Each vial of BLENAMAX
®
contains a lyophilised powder, consisting of 15,000 IU bleomycin
sulfate, and
sodium hydroxide/hydrochloric acid for pH adjustment
.
PHARMACOLOGY
The exact mechanism of action of bleomycin is not known, but it is
thought that the main action is to
produce single and double strand breaks in DNA, causing 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
G2 (premitotic) phase of the cell cycle. It has not been shown to have
an immunosuppressive effect _in _
BLENAMAX- Product Information
Page 2 of 8
_vitro _and shows no significant inhibition of immune response in
patients treated with the drug. The
mechanism of action of bleomycin in the treatment of malignant pleural
effusion is not completely known.
The most likely mechanism is a local inflammatory effect resulting in
fibrous adhesion as it resolves;
however, a local cytotoxic effect cannot be entirely excluded.
Bleomycin-inactivating enzyme has been
detected in both normal and malignant cells and is particularly
prominent
in the liver. The enzyme is not
found in lung or skin, two normal tissues, which are sensitive to
bleomycin action
.
PHARMACOKINETICS
ABSORPTION: Bleomycin is well absorbed in animals after intramuscular,
intraperitoneal and subcutaneous
administration. Intramuscular injection of 15,000 IU in humans
resulted in a maximum serum
concentration of 1 IU /mL 30 minutes after administration.
Intra-venous injection of 15,000 IU in