DBL VINCRISTINE SULFATE 1mg/1mL Injection Vial

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

vincristine sulfate, Quantity: 1 mg/mL

Mevcut itibaren:

Pfizer Australia Pty Ltd

Farmasötik formu:

Injection, solution

Kompozisyon:

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

Uygulama yolu:

Intravenous

Paketteki üniteler:

5x1mg/1mL(E), 5x1mg/1mL, 1x1mg/1mL(E)

Reçete türü:

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

Terapötik endikasyonlar:

Vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. It is rarely possible to achieve equally good results with single agent treatment. Thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). See DOSAGE AND ADMINISTRATION for possible increased toxicity when used in combination therapy. It has been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, Wilm's tumour, osteogenic sarcoma, mycosis fungoides, Ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma

Ürün özeti:

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

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1991-10-08

Bilgilendirme broşürü

DBL™ VINCRISTINE
SULFATE INJECTION
_Vincristine Sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Vincristine
Sulfate Injection. This medicine is
also called vincristine.
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 or pharmacist
has weighed the risks of you being
given DBL Vincristine Sulfate
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 DBL VINCRISTINE
SULFATE INJECTION IS
USED FOR
Vincristine belongs to a group of
medicines known as antineoplastic or
cytotoxic agents. You may also hear
it referred to as chemotherapy.
Vincristine is classified as a vinca
alkaloid. It interferes with the growth
of cancer cells, which are eventually
destroyed. Since the growth of
normal body cells may also be
affected by vincristine, other effects
may also occur (see Side Effects).
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.
Vincristine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL VINCRISTINE
SULFATE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
VINCRISTINE SULFATE INJECTION IF YOU
HAVE AN ALLERGY TO VINCRISTINE OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction

Ürün özellikleri

Version: pfpvindi11121
Superscedes: hhpvindi10721
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™
VINCRISTINE
SULFATE
INJECTION
(VINCRISTINE SULFATE)
1.
NAME OF THE MEDICINE
Vincristine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Vincristine Sulfate Injection:
1 mg/1 mL and 2 mg/2 mL injections contains vincristine sulfate 1
mg/mL and mannitol in
Water for Injections. The solutions do not contain any preservative.
Vincristine sulfate occurs as a white or slightly yellow, hygroscopic,
amorphous or crystalline
powder and is freely soluble in water and slightly soluble in alcohol.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Vincristine Sulfate Injection is a clear colourless solution. The
solutions do not contain
any preservative.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vincristine sulfate is indicated in acute leukaemia.
Current practices of cancer chemotherapy involve the simultaneous use
of several agents. For
enhanced therapeutic effect without additive toxicity, agents with
different dose-limiting
clinical toxicities and different mechanisms of action are generally
selected. It is rarely
possible to achieve equally good results with single agent treatment.
Thus vincristine sulfate
is often chosen as part of polychemotherapy because of lack of
significant bone-marrow
suppression (at recommended doses) and because of its unique clinical
toxicity (neuropathy).
See section 4.2 Dose and method of administration for possible
increased toxicity when used
in combination therapy.
It has been shown to be useful in combination with other oncolytic
agents in Hodgkin’s disease,
non-Hodgkin’s malignant lymphomas (lymphocytic, mixed-cell,
histiocytic, undifferentiated,
nodular and diffuse types), 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 gynaecologi