Fludara 50 mg powder for solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fludarabine phosphate

Available from:

Genzyme Europe B.V.

ATC code:

L01BB; L01BB05

INN (International Name):

Fludarabine phosphate

Dosage:

50 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

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

Therapeutic area:

Purine analogues; fludarabine

Authorization status:

Marketed

Authorization date:

1994-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
powder for solution for injection or infusion
Fludarabine phosphate
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 pharmacist.

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 Fludara is and what it is used for
2.
What you need to know before you are given Fludara
3. How to use Fludara
4. Possible side effects
5. How to store Fludara
6. Contents of the pack and other information 1. WHAT FLUDARA IS AND WHAT IT IS USED FOR
Fludara contains the active substance fludarabine
phosphate which stops the growth of new cancer
cells. All cells of the body produce new cells like
themselves by dividing. Fludara is taken up by the
cancer cells and stops them dividing.
In cancers of the white blood cells _(such as chronic _
_lymphocytic leukaemia),_ the body produces many
abnormal white blood cells _(lymphocytes)_ and lymph
nodes start to grow in various parts of the body.
The abnormal white blood cells cannot carry out the
normal disease fighting functions and may push aside
healthy blood cells. This can result in infections,
a decrease in number of red blood cells _(anaemia)_,
bruising, severe bleeding or even organ failure.
Fludara is used in the treatment of B-cell chronic
lymphocytic leukaemia (B-CLL) in patients with
sufficient healthy blood cell production.
First treatment for chronic lymphocytic leukaemia
with Fludara should only be started in patients with
advanced disease having disease-related symptoms
or evidence of disease progression. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
FLUDARA
DO NOT USE FLUDARA:

if you are allergic to fludarabine phosphate or any
of the other ingredients of this medicine (listed in
section 6).

if you are breast-feeding.

if you

Summary of Product characteristics

Health Products Regulatory Authority
11 November 2019
CRN009FZ0
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fludara 50 mg powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg fludarabine phosphate.
One ml of reconstituted solution contains 25 mg fludarabine phosphate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White lyophilisate for reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult
patients with sufficient bone marrow reserves.
First line treatment with Fludara should only be initiated in adult
patients with advanced disease, Rai stages III/IV (Binet stage C)
or Rai stages I/II (Binet stage A/B) where the patient has disease
related symptoms or evidence of progressive disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 mg fludarabine phosphate/m² body surface
area given daily for 5 consecutive days every 28 days
by intravenous route. Each vial is to be made up in 2 ml water for
injection. Each ml of the resulting solution will contain 25 mg
fludarabine phosphate (see section 6.6).
The required dose (calculated on the basis of the patient's body
surface area) of the reconstituted solution is drawn up into a
syringe. For intravenous bolus injection this dose is further diluted
in 10 ml sodium chloride 9 mg/ml (0.9%). Alternatively, for
infusion, the required dose drawn up in a syringe may be diluted in
100 ml sodium chloride 9 mg/ml (0.9%) and infused over
approximately 30 minutes.
The duration of treatment depends on the treatment success and the
tolerability of the drug.
In CLL patients, Fludara should be administered up to the achievement
of best response (complete or partial remission, usually
6 cycles) and then the drug should be discontinued.
_Patients with renal impairment_
Doses should be adjusted for patients with reduce