Cytarabine 100 mg/ml Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cytarabine

Tersedia dari:

Pfizer Healthcare Ireland

Kode ATC:

L01BC; L01BC01

INN (Nama Internasional):

Cytarabine

Dosis:

100 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

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

Area terapi:

Pyrimidine analogues; cytarabine

Status otorisasi:

Marketed

Tanggal Otorisasi:

1990-05-21

Selebaran informasi

Page 1 of 9 2021-0073341
PACKAGE LEAFLET INFORMATION FOR THE USER
CYTARABINE 100 MG/ML SOLUTION FOR INJECTION
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, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cytarabine Solution for Injection is and what it is used for
2. What you need to know before you use Cytarabine Solution for
Injection
3. How to use Cytarabine Solution for Injection
4. Possible side effects
5. How to store Cytarabine Solution for Injection
6. Contents of the pack and information
1.
WHAT CYTARABINE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Cytarabine Solution for Injection is an anti-cancer medicine.
Treatment with an anti-cancer
medicine is sometimes called cancer chemotherapy.
Cytarabine Solution for Injection is used to treat some types of
leukaemia (cancer affecting
the blood) and lymphomas (cancer of the lymph glands). It may be used
in combination with
other anti-cancer medicines.
You must talk to a doctor if you do not feel better or if you feel
worse
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE SOLUTION FOR
INJECTION
DO NOT USE CYTARABINE SOLUTION FOR INJECTION
•
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 otherwise
•
if you have had severe effects on your brain (encephalopathy) are
feeling increasing
difficulties in body coordination after radiation treatment or
treatment with another
anticancer medicine

Karakteristik produk

Health Products Regulatory Authority
18 August 2021
CRN009ZMP
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine 100 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 100 mg of cytarabine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alone or in combination for the induction of clinical remission and/or
maintenance therapy in patients with acute myeloid
leukaemia, acute non-lymphoblastic leukaemias, lymphoblastic
leukaemia, erythroleukaemia, blast crises of chronic myeloid
leukaemia and non-Hodgkin lymphoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following doses are given as a guide, but the clinician should
consult relevant protocols for the appropriate dosage of
cytarabine and other antineoplastic agents given in combination. Most
doses are given in mg/kg but may be converted to
doses related to surface area by the use of standard nomograms.
REMISSION INDUCTION (ADULTS):
_Continuous Dosing: _The usual dose in leukaemia, is 2 mg/kg 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 to 4 mg/kg until a therapeutic
response or toxicity is evident. Daily blood counts should be taken.
Almost all patients can be carried to toxicity with these
doses.
Alternatively, 0.5 to 1 mg/kg may be infused daily in 1- 24 hours for
ten days, and then at a rate of 2 m g/kg/day until toxicity i
s observed . Continue totoxicity or until remission occurs . Results
from one hour infusions have been satisfactory in the
majority of patients.
_Intermittent dosing: _Cytarabine may be given as intermittent IV
doses of 3- 5 mg/kg daily, for five consecutive days. This course
of treatment can be repeated after an interval of 2 t o 9 days, and
repeated until the therapeutic response or toxicity is
exhibited.
Ev