Cytarabine 100mg/ml solution for injection or infusion (5ml)

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

CYTARABINE

Tersedia dari:

Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

Kode ATC:

L01BC01

INN (Nama Internasional):

CYTARABINE 100 mg/ml

Bentuk farmasi:

SOLUTION FOR INFUSION OR INJECTION

Komposisi:

CYTARABINE 100 mg/ml

Jenis Resep:

POM

Area terapi:

ANTINEOPLASTIC AGENTS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2013-01-10

Selebaran informasi

1
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. Your doctor might n

Karakteristik produk

1 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 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
Cytotoxic. 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.
2
Dosage recommendation may be converted from those in terms of
bodyweight to those related to
surface area by means of nomograms.
1) REMISSION INDUCTION: ADULTS
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.
b) Intermittent treatment:
3-5 mg/kg/day are administered intravenously on each of five
consecutive days. After a two to nine-
day rest period, a furt