DBL Vincristine Sulfate Injection
País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Informació per a l'usuari
(PIL)
11-06-2024
Fitxa tècnica
(SPC)
11-06-2024
ingredients actius:
Vincristine sulfate
Disponible des:
Hospira Australia Pty Ltd
clase:
Medicine Listed (Export Only)
Informació per a l'usuari
Page 1
DBL
™
VINCRISTINE SULFATE INJECTION
Vincristine sulfate _(vin-KRIS-teen)_
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CONSUMER MEDICINE INFORMATION_ _
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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 IN A SAFE PLACE.
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 presc
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Fitxa tècnica
Product Information – Australia
Version 5.0
Page 1
DBL
™
VINCRISTINE SULFATE INJECTION
NAME OF THE MEDICINE
Vincristine sulfate, the salt of an alkaloid obtained from the
periwinkle plant (Cantharanthus roseus).
The chemical structure of Vincristine is shown below:
The CAS registry number is 2068-78-2.
DESCRIPTION
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.
The chemical formula of Vincristine is
C
46
H
56
N
4
O
10
, H
2
SO
4.
Its molecular weight is 923.1.
DBL
™
Vincristine Sulfate Injection:
1 milligram/1 mL and 2 milligrams/2 mL injections: A sterile
solution of vincristine sulfate 1
milligram/mL and mannitol in Water for Injections.
2 milligrams/10 mL injection: A sterile solution of vincristine
sulfate 0.2 milligrams/mL and sodium
chloride in Water for Injections.
The solutions do not contain any preservative.
PHARMACOLOGY
The precise mechanism of action of vincristine sulfate remains under
investigation. It appears to bind to
or crystallise critical microtubular proteins of the mitotic spindle,
thus preventing their proper
polymerisation and causing metaphase arrest. The antineoplastic
effects of the vinca alkaloids are
related to their ability to bind specifically with the intracellular
protein tubulin, a key component of cellular
microtubules.
PHARMACOKINETICS
Distribution of vincristine and its metabolites into human body tissue
and fluids has not been fully
characterised, but the drug is rapidly and apparently widely
distributed following intravenous
administration.
Vincristine sulfate is extensively protein bound (75%) and is reported
to be concentrated in blood
platelets. Within 15 to 30 minutes after injection, over 90% of the
drug is distributed from the blood into
tissue, where it remains tightly, but not irreversibly, bound.
Vincristine sulf
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