Vincristine Sulfate 1mg/ml Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Vincristine sulfate

Available from:

Pfizer Healthcare Ireland

ATC code:

L01CA; L01CA02

INN (International Name):

Vincristine sulfate

Dosage:

1 micromole(s)

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Vinca alkaloids and analogues; vincristine

Authorization status:

Marketed

Authorization date:

1987-05-05

Patient Information leaflet

Page
1
of
9
2021-0073475
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 FOR 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
EITHER BY
INTR

Summary of Product characteristics

Health Products Regulatory Authority
09 October 2023
CRN00DW7C
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vincristine Sulfate 1mg/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 2 mg.
The dosage must always be adjusted individually because of the narrow
range between therapeutic and toxic levels, and
individual variations in response.
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. For children weighing 10 kg or less, the
starting dose should be 0.05 mg/kg, administered
once a week.
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.
Use in the elderly
As for use in adults.
Use in hepatic impairment
A 50% reduction in the dose of vincristine sulfate is recommended for
patients having a direct serum bilirubin value above
3 mg/100 ml (51 micromol/l) (see section 4.4).
Health Products Regulatory Authority
09 October 2023
CRN00DW7C
Page 2 of 11
Method of administ