Cytarabine 20 mg/ml Solution for Injection/Infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cytarabine

Tersedia dari:

Accord Healthcare Limited

Kode ATC:

L01BC; L01BC01

INN (Nama Internasional):

Cytarabine

Dosis:

20 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection/infusion

Jenis Resep:

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

Area terapi:

Pyrimidine analogues; cytarabine

Tanggal Otorisasi:

2018-06-22

Selebaran informasi

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 doctor, pharmacis

Karakteristik produk

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.
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