DBL VINBLASTINE INJECTION Vinblastine sulfate 10mg/10mL sulfate injection

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

vinblastine sulfate, Quantity: 1 mg/mL

Dostępny od:

Pfizer Australia Pty Ltd

Forma farmaceutyczna:

Injection, solution

Skład:

Excipient Ingredients: water for injections; sodium chloride

Droga podania:

Intravenous

Sztuk w opakowaniu:

1 vial per carton pack, 5x10mg/10mL, 5x10mg/10mL(E), 1x10mg/10mL(E)

Typ recepty:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Wskazania:

Used in the treatment of Hodgkins' Disease (Stages III and IV) in combination therapy (with Adriamycin, Bleomycin and Dacarbazine as ABVD) and in the treatment of advanced testicular carcinoma (with Cisplatin and Bleomycin). In the palliative treatment of lymphocytic lymphoma, histiocytic lymphoma, Kaposi's sarcoma and Histiocytosis X. Advanced stages of Mycosis fungoides. May be used in the treatment of choriocarcinoma resistant to other chemotherapeutic agents; carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy.

Podsumowanie produktu:

Visual Identification: A clear, colourless solution, free of visible particulate matter.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

1991-10-08

Ulotka dla pacjenta

DBL™ VINBLASTINE
INJECTION
_Vinblastine Sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Vinblastine
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 has weighed
the risks of you being given DBL
Vinblastine 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 IN A SAFE PLACE.
You may need to read it again.
WHAT DBL VINBLASTINE
INJECTION IS USED FOR
DBL Vinblastine Injection is used to
treat some types of cancers.
This medicine works by killing
cancer cells and stopping cancer cells
from growing and multiplying.
DBL Vinblastine Injection belongs to
a group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines.
DBL Vinblastine Injection is
classified as a ‘vinca alkaloid’ type
of cytotoxic.
It may be given alone, or used in
combination with other medicines to
treat cancer.
Your doctor may have prescribed
DBL Vinblastine Injection for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
DBL VINBLASTINE
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
VINBLASTINE INJECTION IF YOU IF YOU
HAVE AN ALLERGY TO:
•
vinblastine
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
DBL Vinblastine Injection 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 MUST NOT BE GIVEN DBL
VINBLASTINE INJECTION IF YOU HAVE
ANY OF THE FOLLOWING CONDITIONS:
•
any condition with a reduced
number of red blood cells, white
bl

Charakterystyka produktu

Version: pfpvinbi10821
Supersedes: pfpvinbi11020
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
VINBLASTINE
INJECTION
(VINBLASTINE
SULFATE)
1.
NAME OF THE MEDICINE
Vinblastine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Vinblastine Injection is a sterile solution of vinblastine sulfate
in sodium chloride 0.9%
injection.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
The pH of the solution is 3.5 to 5.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vinblastine is effective as a single agent, but its therapeutic effect
is enhanced when used in
combination with other antineoplastic drugs.
Vinblastine has been used in the treatment of Hodgkin’s Disease
(Stages III and IV) in
combination therapy [with adriamycin (doxorubicin), bleomycin and
dacarbazine as ABVD]
and in the treatment of advanced testicular carcinoma (with cisplatin
and bleomycin).
Vinblastine has been used in the palliative treatment of lymphocytic
lymphoma, histiocytic
lymphoma, advanced stages of mycosis fungoides, Kaposi's sarcoma and
Histiocytosis X.
Vinblastine
may
be
used
in
the
treatment
of
choriocarcinoma
resistant
to
other
chemotherapeutic agents; and carcinoma of the breast, unresponsive to
appropriate endocrine
surgery and hormonal therapy.
One of the most effective single agents for the treatment of
Hodgkin’s disease is vinblastine.
A protocol substituting cyclophosphamide for nitrogen mustard and
vinblastine for vincristine
in MOPP [mechlorethamine hydrochloride (nitrogen mustard), vincristine
sulfate, prednisone
and procarbazine] is an alternative therapy for previously untreated
patients with advanced
Hodgkin’s disease. Patients suffering relapse have also responded to
combination therapy that
included vinblastine.
Version: pfpvinbi10821
Supersedes: pfpvinbi11020
Page 2 of 10
Advanced testicular germ-cell cancers are sensitive to vinblastine
alone but the administration
of vinblastine concomitantly with other antineoplastic agents,
produc