Cytarabine 100 mg/ml Solution for Injection or Infusion

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Cytarabine

Dostępny od:

Fresenius Kabi Deutschland GmbH

Kod ATC:

L01BC; L01BC01

INN (International Nazwa):

Cytarabine

Dawkowanie:

100 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection/infusion

Dziedzina terapeutyczna:

Pyrimidine analogues; cytarabine

Status autoryzacji:

Marketed

Data autoryzacji:

2012-11-23

Ulotka dla pacjenta

Ver 004, July 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE AND ASSOCIATED NAMES 100 MG/ML SOLUTION FOR INJECTION OR
INFUSION
CYTARABINE
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, please 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 Cytarabine
is and what it is used for
2.
What you need to know before you are given Cytarabine
3.
How Cytarabine is given to you
4.
Possible side effects
5.
How to store Cytarabine
6.
Contents of the pack and other information
1.
WHAT CYTARABINE IS AND WHAT IT IS USED FOR

Cytarabine is used in adults and children.

This medicine contains cytarabine, which 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). Cytarabine
interferes with the growth
of cancer cells, which are eventually destroyed.

Cytarabine is also used for the induction and maintenance of remission
of leukaemia.

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.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYTARABINE
DO NOT USE CYTARABINE IF YOU:

are allergic to cytarabine, or any of the other ingredients of this
medicine (listed in
section 6).

if your blood cell count (number of cells in your blood) is very low
due to some cause
other than cancer. Yo

Charakterystyka produktu

Health Products Regulatory Authority
22 April 2021
CRN009VNN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine 100 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 100 mg of cytarabine.
Each 1 ml vial contains 100 mg of cytarabine.
Each 5 ml vial contains 500 mg of cytarabine.
Each 10 ml vial contains 1 g of cytarabine.
Each 20 ml vial contains 2 g of cytarabine.
Excipients:
This medicine contains less than 1 mmol sodium (23 mg) per dose, that
is to say essentially 'sodium-free'.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By intravenous infusion or injection or subcutaneous injection.
Only general recommendations can be given, as acute leukaemia is
almost exclusively treated with combinations of cytostatics.
Dosage recommendation may be converted from those in terms of
bodyweight to those related to surface area by means of
nomograms.
1) REMISSION INDUCTION: ADULT
a) Continuous treatment:
i) Rapid injection - 2 MG/KG/DAY is a judicious starting dose.
Administer for 10 days. Obtain daily blood counts. If no
antileukaemic effect is noted and there is no apparent toxicity,
increase to 4 MG/KG/DAY and maintain until therapeutic
response or toxicity is evident. Almost all patients can be carried to
toxicity with these doses.
ii) 0.5-1.0 MG/KG/DAY may be given in an infusion of up to 24 hours
duration. Results from one-hour infusions have been
satisfactory in the majority of patients. After 10 days this initial
daily dose may be increased to 2 MG/KG/DAY subject to toxicity.
Continue to toxicity or until remission occurs.
Health Products Regulatory Authority
22 April 2021
CRN0