DBL BLEOMYCIN 15000 IU powder for injection

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

bleomycin sulfate, Quantity: 15000 IU

Dostupno od:

Pfizer Australia Pty Ltd

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients:

Administracija rute:

Intraarterial, Intravenous, Intramuscular, Subcutaneous

Jedinice u paketu:

1, 10 vials

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Bleomycin is used for palliation and/or treatment adjuvant to surgery and radiation therapy and in the management of the following neoplasms: squamous cell carcinoma of the skin, head and neck, and oesophagus is the primary indication for bleomycin. Tumour response has been obained in a number of patients with squamous cell carcinoma of the penis, larynx and uterine cervix. Infrequent response has been shown in squamous cell carcinoma of the bronchus. Treatment of choriocarcinoma and embryonal cell carcinoma of the testis is also indicated. Bleomycin has been effectively used in advanced Hodgkin's Disease and in some cases of other lymphomas such as non-Hodgkin's, and also in cases of mycosis fungoides.

Proizvod sažetak:

Visual Identification: A cream to white coloured lyophilised powder or plug.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

1994-09-12

Uputa o lijeku

DBL™ Bleomycin Sulfate for Injection CMI
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.
Symptoms of an allergic reaction to
DBL
™
Bleomycin 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 DBL
™
BLEOMYCIN IF YOU HAVE ANY OF THE
FOLLOWING CONDITIONS:
•
problems with blood clotting

Svojstava lijeka

Version: pfpbleov11220
Supersedes: 8.0
Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ BLEOMYCIN SULFATE FOR INJECTION
(BLEOMYCIN SULFATE)
1.
NAME OF THE MEDICINE
Bleomycin sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 A2 and
25-32% of bleomycin B2.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bleomycin is indicated for 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.
Version: pfpbleov11220
Supersedes: 8.0
Page 2 of 14
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
DOSAGE
Initial Treatment (intramuscular, intravenous or subcuta