Vincristine Sulfate 1mg/ml Solution for Injection or Infusion (1mL volume)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VINCRISTINE SULFATE

Available from:

Pfizer Hellas S.A.

ATC code:

L01CA02

INN (International Name):

VINCRISTINE SULFATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

VINCRISTINE SULFATE 1 milligram(s)/millilitre

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2007-05-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VINCRISTINE SULFATE 1 MG/ML SOLUTION FOR INJECTION OR INFUSION
vincristine sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION OR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vincristine Sulfate is and what it is used for
2.
What you need to know before you use Vincristine Sulfate
3.
How to use Vincristine Sulfate
4.
Possible side effects
5.
How to store Vincristine Sulfate
6.
Contents of the pack and other information
1.
WHAT VINCRISTINE SULFATE IS AND WHAT IT IS USED FOR
Vincristine Sulfate is an anti-cancer medicine in the form of a
solution for injection or infusion.
Treatment with an anti-cancer medicine is sometimes called cancer
chemotherapy.
Vincristine Sulfate is mainly used in the treatment of cancers of the
blood (leukaemia). It may also
be given in combination with other anti-cancer medicines to treat
other types of cancer, for example
cancers of the breast, brain or lung and some cancers in children.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINCRISTINE SULFATE
VINCRISTINE SULFATE MUST NEVER BE INJECTED INTO THE SPINE
(INTRATHECALLY).
DO NOT USE VINCRISTINE SULFATE
•
if you are allergic to Vincristine Sulfate or any of the other
ingredients of this medicine
(listed in section 6)
•
if you have Charcot-Marie-Tooth syndrome (weakness in the leg muscles)
•
if you have an infection that is not being treated
•
for treatment of diseases that are not cancers, except for using to
reduce your immune
response
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Vincristine
Sulfate
•
TO MAKE SURE THAT THIS MEDICINE IS ONLY GIVEN TO YOU THROUGH A VEIN
(IT SHOULD NOT

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vincristine Sulfate 1 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1 mg of vincristine sulfate.
Each 2 ml contains 2 mg of vincristine sulfate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
A sterile colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vincristine Sulfate is used primarily as a component of various
chemotherapeutic regimens for
the treatment of acute leukaemias. It has also been used in
conjunction with other oncolytic drugs
in the treatment of Hodgkin's Disease, all forms of lymphoma, Wilm's
tumour, sarcomas and
tumours of the breast, brain and lung.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosage regimens have been used:
Acute Leukaemia
ADULTS:
The suggested dose is 1.4 - 1.5 mg/m
2
given on a weekly basis to a maximum weekly
total dose of 2mg.
CHILDREN:
The suggested dose is 1.4 – 2.0 mg/m
2
given on a weekly basis beginning with the
lowest dose in the range with a maximum weekly dose of 2 mg.
Once the remission has occurred, dosage may often be reduced for
maintenance therapy.
Other Tumours
25 micrograms/kg body weight weekly until a response is observed and
5-10 micrograms/kg body
weight thereafter for maintenance.
Method of administration
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Precautions to be taken before handling or administering the medicinal
product.
This preparation is for intravenous use only. It should only be
administered by individuals
experienced in vincristine administration.
FOR INTRAVENOUS USE ONLY.
FATAL IF GIVEN BY OTHER ROUTES
(see Warnings)
IN CASE OF MISTAKEN ADMINISTRATION BY THE INTRATHECAL ROUTE, SEE
SECTION 4.4.
Vincristine Sulfate is administered by intravenous infusion at weekly
intervals, the precise dose
being determined by body weight.
Great care should be exercised in calculating the dose as overdosage
may be extremely seriou