Cerubidin 20 mg Powder for Concentrate for Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-12-2023
Summary of Product characteristics
(SPC)
21-12-2023
Active ingredient:
DAUNORUBICIN HYDROCHLORIDE
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
L01DB; L01DB02
INN (International Name):
DAUNORUBICIN HYDROCHLORIDE
Dosage:
20 milligram(s)
Pharmaceutical form:
Powder for concentrate for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Anthracyclines and related substances; daunorubicin
Authorization status:
Marketed
Authorization date:
1995-04-20
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CERUBIDIN® 20MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
_Daunorubicin hydrochloride _
Is this leaflet hard to see or read? Phone 01 403 5600 for help.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cerubidin is and what it is used for
2. What you need to know before you have Cerubidin
3. How you will be given Cerubidin
4. Possible side effects
5. How to store Cerubidin
6. Contents of the pack and other information
1. WHAT CERUBIDIN IS AND WHAT IT IS USED FOR
The name of your medicine is Cerubidin 20mg Powder for Concentrate for
Solution for Infusion
(called Cerubidin in this leaflet). It belongs to a group of medicines
used to treat acute leukaemia.
Cerubidin is an immunosuppressant drug that works by attacking and
destroying the abnormal white
blood cells which are present in a person with leukaemia. Sometimes
immunosuppressant drugs can
make you susceptible to serious infections.
Daunorubicin in combination with other medicinal products can be used
in children with acute
lymphocytic blood cancer (acute lymphocytic leukemia) and acute
myeloid blood cancer (acute
myeloid leukemia).
INFORMATION ABOUT LEUKAEMIA
Leukaemia is the name for a number of diseases of the white blood
cells, which form part of your
blood. These cells are produced in your bone marrow. In leukaemia, the
white blood cells multiply in
an uncontrolled and abnormal way.
The most common signs of leukaemia are:
•
Increased number of white cells in the blood. This
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 December 2023
CRN00DK8S
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cerubidin 20 mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Daunorubicin Hydrochloride equivalent to Daunorubicin 20 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for Solution for Infusion.
A microcrystalline, orange-red, sterile powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antimitotic and cytotoxic for the induction of remissions in
acute lymphocytic and myelogenous leukaemias.
Daunorubicin, as part of combination regimen, is indicated for the
treatment of acute lymphocytic leukemia and acute myeloid
leukemia in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The effect of Cerubidin/Daunorubicin on the disease process and on
normal blood precursors cannot be exactly predicted for
any particular case. The difference between the incomplete treatment,
a satisfactory remission and overdosage with possible
irreversible aplasia of the bone marrow depends on the correct choice
of dosage, time intervals and total number of doses.
Daunorubicin should be administered with caution when the neutrophil
count is <1,500/mm3. Daunorubicin dose reduction
should be considered in case of severe neutropenia.
The number of infusions required varies widely from patient to patient
and must be determined in each case according to
response and tolerance.
Adults:
40 - 60mg/m
2
on alternate days for a course of up to three infusions.
_Acute Myelogenous Leukaemia: _
45mg/m
2
/day is the recommended dose.
_Acute Lymphocytic Leukaemia:_
45mg/m
2
/day is the recommended dose.
Special populations
Pediatric population:
Cerubidin dose for children (over 2 years) is usually calculated based
on the body surface area and adjusted to meet individual
requirements of each patient, on the basis of clinical response and
the patient's haematological status. Courses may be
repeated a
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