VINCRISTINE SULPHATE 1 Micromol Solution for Inj/Inf

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

VINCRISTINE SULFATE

Fáanlegur frá:

Hospira UK Limited

ATC númer:

L01CA02

INN (Alþjóðlegt nafn):

VINCRISTINE SULFATE

Skammtar:

1 Micromol

Lyfjaform:

Solution for Inj/Inf

Gerð lyfseðils:

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

Lækningarsvæði:

Vinca alkaloids and analogues

Leyfisstaða:

Authorised

Leyfisdagur:

1987-05-05

Upplýsingar fylgiseðill

PATIENT INFORMATION LEAFLET 
VINCRISTINE SULPHATE 1 MG/ML SOLUTION FOR INJECTION OR INFUSION 

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.  

   If you get any side effects, talk to your doctor. This
includes any possible side effects not 
listed in this leaflet. See section 4.  

WHAT IS IN THIS LEAFLET:  
1.  What Vincristine Sulphate is and what it is used for  
2.  What you need to know before you use Vincristine Sulphate  
3.  How to use Vincristine Sulphate  
4.  Possible side effects  
5.  How to store Vincristine Sulphate  
6.  Contents of the pack and other information  

1.   WHAT VINCRISTINE SULPHATE IS AND WHAT IT IS USED  
FOR 

Vincristine Sulphate 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 Sulphate 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 SULPHATE  

VINCRISTINE SULPHATE MUST NEVER BE INJECTED INTO THE
SPINE (INTRATHECALLY). 

DO NOT USE VINCRISTINE SULPHATE 


  if  you  have  shown  signs  of  hypersensitivity  (severe  allergy)  to  this  medicine,  any  of  its 
ingredients or a similar medicine on previous occasions 

  if you have Charcot-Marie-Tooth syndrome (weakness in the
leg muscles) 

  if you have an infection that is not being treated 

  for treat

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vincristine Sulphate 1mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1mg of vincristine sulphate.
Each 2 ml presentation contains 2 mg of vincristine sulphate.
For a 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 Sulphate 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
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 Sulphate 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 serious or even fatal. The dose
should not be increased beyond the level, which produces therapeutic
benefit. In general, individual doses should not
exceed 2mg; and white cell counts should be carried out before and
after giving each dose.
It is recommended to infuse Vincristine Sulphate over 5 to 10 minutes
after dilution in a 50 ml infusion bag with
Sodium Chloride 9 mg/ml (0.9%) solution for injection. After
administration the vein must be flushed through
thoroughly. Care should be taken to avoid extravasation as this may
cause local ulceration.
Syringes containing this product should be overlabelled with the
warning label provided:
'FOR INTRAVENOUS
USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'.
Becaus