Cytarabine 20 mg/ml Solution for Injection/Infusion (2ml vial)

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

CYTARABINE

Sẵn có từ:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Mã ATC:

L01BC01

INN (Tên quốc tế):

CYTARABINE 20 mg/ml

Dạng dược phẩm:

SOLUTION FOR INJECTION/INFUSION

Thành phần:

CYTARABINE 20 mg/ml

Loại thuốc theo toa:

POM

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tình trạng ủy quyền:

Withdrawn

Ngày ủy quyền:

2018-04-16

Tờ rơi thông tin

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 20 MG/ML SOLUTION FOR INJECTION/INFUSION
cytarabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAIN IMPORT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this section. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cytarabine solution for injection/infusion is and what it is used
for
2.
What you need to know before you use Cytarabine solution for
injection/infusion
3.
How to use Cytarabine solution for injection/infusion
4.
Possible side effects
5.
How to store Cytarabine solution for injection/infusion
6.
Contents of the pack and other information
1. WHAT CYTARABINE SOLUTION FOR INJECTION/INFUSION IS AND WHAT IT IS
USED FOR
Cytarabine solution for injection/infusion 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
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE SOLUTION FOR
INJECTION/INFUSION
DO NOT USE CYTARABINE SOLUTION FOR INJECTION/INFUSION
•
if you are allergic to cytarabine, or any of the other ingredients of
this medicine (listed in section
6)
•
if the cell count in your blood report is very low due to some cause
other than cancer, unless your
doctor decides that it is safe to take cytarabine
•
if you are feeling increasing difficulties in body coordination after
radiation treatment or
treatment with another anticancer medicine such as methotrexate
•
if you are pregnant
WARNING AND PRECAUTIONS
Talk to your doc

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cytarabine 20 mg/ml Solution for Injection/Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 20 mg of Cytarabine.
Each vial of 2 ml of solution contains 40 mg of Cytarabine.
Each vial of 5 ml of solution contains 100 mg of Cytarabine.
Excipient with known effect:
Each vial contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution, free from visible particles.
pH: 7.0 to 9.5
Osmolarity: Approx. 300 mOsmol/kg
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the 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 20 mg/ml solution for injection/infusion is intended for
intravenous,
intramuscular, subcutaneous or intrathecal use.
Subcutaneous injection is generally well tolerated, and may be
recommended when used in
maintenance therapy.
Cytarabine 20 mg/ml solution for injection/infusion can be diluted
with Sterilised Water for
Injections, Glucose Intravenous Infusion or Sodium Chloride
Intravenous Infusion.
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/m
2
). Dose recommendation may be converted from those in terms of
bodyweight to
those related to surface area by means of nomograms.
REMISSION INDUCTION:
CONTINUOUS TREATMENT:
The usual dose in leukaemia is 2 mg/kg/day by rapid intravenous
injection daily for ten days. If after ten days neither therapeutic
response nor toxicity has been
observed, the dose may be increased