Cytarabine Strides 20mg/ml, solution for injection/infusion (25ml)

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

CYTARABINE

थमां उपलब्ध:

Strides Arcolab International Limited Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD 189 SS, United Kingdom

ए.टी.सी कोड:

L01BC01

INN (इंटरनेशनल नाम):

CYTARABINE 20 mg/ml

फार्मास्यूटिकल फॉर्म:

SOLUTION FOR INFUSION OR INJECTION

रचना:

CYTARABINE 20 mg/ml

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTINEOPLASTIC AGENTS

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2014-01-13

सूचना पत्रक

 
Page 1 of 10 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CYTARABINE STRIDES 20 MG/ML, SOLUTION FOR INJECTION/INFUSION  
CYTARABINE STRIDES 100 MG/ML, SOLUTION FOR INJECTION/INFUSION  
CYTARABINE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, please ask your doctor or
pharmacist. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1.  What Cytarabine Strides is and what it is used for 
2.  Before you are given Cytarabine Strides 
3.  How to use Cytarabine Strides 
4.  Possible side effects 
5.  How to store Cytarabine Strides 
6. Further 
information 

1.  WHAT CYTARABINE STRIDES IS AND WHAT IT IS USED FOR 

  Cytarabine Strides is used in adults and children. The active
ingredient is cytarabine. 

  Cytarabine is one of a group of medicines known as cytotoxics,
these medicines are used in 
the treatment of acute leukaemias (cancer of blood where you have too
many white blood 
cells) including prophylaxis and treatment of CNS involvement
(meningeal 
leukaemia).Cytarabine interferes with the growth of cancer cells,
which are eventually 
destroyed. 

  Remission induction is an intensive treatment to force
leukaemia into retreat. When it works, 
the balance of cells in your blood becomes more normal and your health
improves. This 
relatively healthy period is called a remission. 

  Maintenance therapy is a milder treatment to make your
remission last as long as possible. 
Quite low doses of cytarabine are used to keep the leukaemia under
control and stop it 
flaring up again. 

2. 
BEFORE YOU ARE GIVEN CYTARABINE DO NOT USE CYTARABINE STRIDES IF
YOU: 

  are allergic (hypersensitive) to cytarabine, or any of the
other ingredients of cytarabine. 

  If the cell c

उत्पाद विशेषताएं

 
Page 1 of 13 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Cytarabine Strides 20 mg/ml, solution for injection/infusion 
Cytarabine Strides 100 mg/ml solution for injection/infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Cytarabine Strides 20 mg/ml: 1 ml solution contains 20 mg 
cytarabine. Each 5 ml vial contains 100 mg of cytarabine. 
Each 25 ml vial contains 500 mg of cytarabine 
Each 50 ml vial contains 1000 mg of cytarabine. 
Cytarabine Strides 100 mg/ml: 1 ml solution contains 100 mg 
cytarabine. Each 20 ml vial contains 2000 mg of cytarabine. 

Excipients: 

Cytarabine Strides 20 mg/ml: 1 ml solution contains 6,8
mg sodium chloride equivalent to 
2,67 mg/ml sodium. 
To be taken into consideration by patients on a CONTROLLED SODIUM
DIET. For a full list of 
excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM  

Solution for Injection or Infusion. Clear, colourless solution. pH-
7.0 - 9.5 
Osmolarity: 250 to 400 mOsm/L 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

For induction of remission in acute myeloid leukaemia in adults and
for other acute 
leukaemias of adults and children including prophylaxis and treatment
of CNS 
involvement (meningeal leukaemia). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Cytarabine Strides 20 mg/ml, solution for injection/infusion is
intended for intravenous, 
intramuscular, subcutaneous or intrathecal use. 
Cytarabine Strides 100 mg/ml, solution for injection/infusion is
intended for intravenous 
use. 

Subcutaneous injection is generally well tolerated, and may be
recommended when used 
in maintenance therapy. 

CYTARABINE 100 MG/ML SHOULD NOT BE ADMINISTERED BY THE INTRATHECAL
ROUTE. 

Page 2 of 13 
Treatment with cytarabine should be initiated by, or be in
consultation with, a doctor with 
extensive experience in treatment with cytostatics. Only general
recommendations can be 
given, as acute leukae