Fludarabine phosphate 25mg/ml Concentrate for solution for Injection or Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUDARABINE PHOSPHATE

Available from:

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

ATC code:

L01BB05

INN (International Name):

FLUDARABINE PHOSPHATE 25 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

FLUDARABINE PHOSPHATE 25 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2014-08-19

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE
FLUDARABINE PHOSPHATE 25 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION
OR INFUSION
Fludarabine phosphate
The name of your medicine is Fludarabine phosphate 25 mg/ml
Concentrate for Solution for
Injection or Infusion. In the rest of this leaflet your medicine is
called Fludarabine phosphate
Injection.
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 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, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Fludarabine phosphate Injection is and what it is used for
2.
What you need to know before you use Fludarabine phosphate Injection
3.
How to use Fludarabine phosphate Injection
4.
Possible side effects
5.
How to store Fludarabine phosphate Injection
6.
Contents of the pack and other information
1.
WHAT
Fludarabine phosphate Injection IS AND WHAT IT IS USED FOR
Fludarabine phosphate Injection 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.
Fludarabine phosphate Injection 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, sever

Summary of Product characteristics

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1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
1.3.1.1 SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection
or Infusion. 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 25 mg fludarabine phosphate.
2 ml of solution contains 50 mg fludarabine phosphate.
Excipient with known effect:
Each mL contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for injection or infusion.
Clear, colourless or slightly brownish-yellow solution, essentially
free from particles.
pH: 6.0 – 7.1
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 Fludarabine 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/m
2
body surface area given daily for 5
consecutive days every 28 days by intravenous route (See also 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
Page 2 of 16
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, Fludarabine should be administered up to the
achievement of best response (complete
or partial remission, usually 6 cycles) and then the drug should be
discontinued.
_ Special populations _
_ _
_Patients with renal impairm