Cytarabine 100 mg/ml Solution for Injection or Infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Cytarabine

から入手可能:

Fresenius Kabi Oncology Plc

ATCコード:

L01BC; L01BC01

INN（国際名）:

Cytarabine

投薬量:

100 milligram(s)/millilitre

医薬品形態:

Solution for injection/infusion

処方タイプ:

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

治療領域:

Pyrimidine analogues; cytarabine

認証ステータス:

Marketed

承認日:

2012-11-23

情報リーフレット

Ver.: 09
Last modified: 23 January 2017 10:55 AM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 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.
You should consult your doctor if you are unsure why you have
been given Cytarabine, if y

製品の特徴

Health Products Regulatory Authority
30 November 2018
CRN008L5K
Page 1 of 15
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 medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e.
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
POSOLOGY
By intravenous infusion or injection or subcutaneous injection.
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.
Health Products Regulatory Authority
30 November 2018
CRN008L5K
Page 2 of 15
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 leukaemia is almost exclusively
treated with
combinations of cytostatics. Dosage recommendations, may be made
according to
body weight (mg/kg) or according to BSA(mg/m2). Dose recommendation
may be
converted from those in terms of bodyweight to those related to
surface area by
means of nomograms.
1) REMISSION INDUCTION:
Induction therapy dosage and schedule vary depending on the regimen
used.
_a) Continuous treatment_:
The following dose regimens have been used for continuous treatment in
remission
induction.
i) Rapid injectio