Pfizer (Australia) VINCRISTINE SULFATE 2mg/2mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vincristine sulfate, Quantity: 1 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; water for injections; sodium hydroxide; sulfuric acid

Administration route:

Intravenous

Units in package:

5 X 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vincristine is used primarily in the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. It has also been used as part of combination therapy in the treatment of Hodgkin's disease, non-Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, Wilm's tumour, osteogenic sarcoma, mycosis fungoides, Ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. Vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but not recommended as primary treatment for this disorder

Product summary:

Visual Identification: Clear and colourless solution.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-06-22

Patient Information leaflet

VINCRISTINE SULFATE
INJECTION
_Vincristine Sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vincristine Sulfate
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 benefits and
risks. Your doctor has weighed the
risks of you taking Vincristine
Sulfate Injection against the benefits
this medicine is expected to have for
you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VINCRISTINE
SULFATE INJECTION IS
USED FOR
Vincristine sulfate belongs to a group
of anticancer medicines called Vinca
alkaloids. It is used for the treatment
of various cancers. Vincristine stops
the cancer cells growing and
eventually kills them.
Vincristine is used to treat certain
cancers, including:
•
acute leukaemia
•
Hodgkin’s disease
•
non-Hodgkin’s disease
•
rhabdomyosarcoma
•
neuroblastoma
•
Wilm’s tumour
•
bone cancer
•
mycosis fungoides
•
Ewing’s sarcoma
•
uterine or cervical cancer
•
breast cancer
•
malignant melanoma
•
lung cancer
•
gynaecological childhood
tumours
Your doctor may have prescribed
vincristine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
VINCRISTINE SULFATE
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE VINCRISTINE SULFATE
INJECTION IF:
•
you have an allergy to vincristine
or any of the ingredients listed at
the end of this leaflet
•
you have an allergy to any of the
Vinca Alkaloids medicines eg.
Vinblastine and Vindesine
•
you suffer from Charcot-Marie-
Tooth-Syndrome. This is a type
o

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
VINCRISTINE SULFATE INJECTION
1.
NAME OF THE MEDICINE
Vincristine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vincristine Sulfate Injection contains 1 mg/mL of vincristine sulfate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Vincristine Sulfate Injection is a sterile, hypertonic,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vincristine is used primarily in the treatment of acute leukaemia,
usually as a component of
various chemotherapeutic regimens. It has also been used as part of
combination therapy in the
treatment of Hodgkin’s disease, non-Hodgkin’s malignant lymphomas,
rhabdomyosarcoma,
neuroblastoma, Wilm’s tumour, osteogenic sarcoma, mycosis fungoides,
Ewing’s sarcoma,
carcinoma of the uterine cervix, breast cancer, malignant melanoma,
oat-cell carcinoma of the
lung and gynaecological tumours of childhood.
Vincristine may be useful in patients with true idiopathic
thrombocytopenic purpura resistant
to the usual treatment, but is not recommended as primary treatment
for this disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
This preparation is for intravenous use only and is usually
administered at weekly intervals. It
can be fatal if administered intrathecally (see sections 4.3
Contraindications and 4.4 Special
warnings and precautions for use).
Vincristine should not be given intramuscularly, subcutaneously or
intrathecally. Intrathecal
use of vincristine usually results in death. When dispensed, flexible
plastic containers
containing this product should be labelled:
FOR INTRAVENOUS USE ONLY. FATAL IF
GIVEN BY ANY OTHER ROUTE.
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Page 2 of 16
DOSAGE
Neurotoxicity appears to be dose related. Extreme care must be used in
calculating and
administrating the dose of vincristine since overdosage may have very
serious or fatal outcome
(see section 4.9 O