Fludarabin Actavis 25 mg/ml Koncentrat till injektions-/infusionsvätska, lösning

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

fludarabinfosfat

Available from:

Actavis Group PTC ehf.

ATC code:

L01BB05

INN (International Name):

fludarabine phosphate

Dosage:

25 mg/ml

Pharmaceutical form:

Koncentrat till injektions-/infusionsvätska, lösning

Composition:

fludarabinfosfat 25 mg Aktiv substans

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Fludarabin

Product summary:

Förpacknings: Injektionsflaska, 2 ml; Injektionsflaska, 5 x 2 ml

Authorization status:

Godkänd

Authorization date:

2013-06-27

Patient Information leaflet

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_ _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUDARABIN ACTAVIS 25 MG/ML CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
Fludarabine phosphate
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What /…/ is and what it is used for
2.
What you need to know before you use /…/
3.
How to use /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FOR
/…/ is an anti-cancer drug.
/…/ is used to treat chronic B-cell lymphocytic leukaemia (B-CLL) in
patients with sufficient healthy
blood cell production. This is a type of cancer of white blood cells
(the cells are called lymphocytes).
First treatment for chronic lymphocytic leukaemia with /…/ 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 USE /…/
DO NOT USE /…/:
-
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 your kidney function is severely impaired.
-
If you have a low number of red blood cells, because of a certain type
of anaemia
(decompensated haemolytic anaemia). Your doctor will have told you if
you have this
condition.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Fludarabine Phosphate if:
-
Your liver does not work properly, as your doctor may give you this
medicine with caution.
-
You have any form of kidney disease, as your kidney function should be
checked regularly. If it
is found that your kidneys do not work properly you may be given this
medicine at a reduc

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Fludarabin Actavis 25mg/ml concentrate for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for injection/infusion contains 25
mg fludarabine phosphate.
Each vial of 2 ml contains 50 mg fludarabine phosphate.
Excipient with known effect:
Contains sodium (from sodium hydroxide) at amounts up to 23 mg per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion.
Clear, colourless or almost colourless solution, pH 7.3-7.7.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients
with sufficient bone marrow
reserves. First line treatment with /.../ should only be initiated in
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
/.../ should be administered under the supervision of a qualified
physician experienced in the use of
antineoplastic therapy.
Posology
_Adults _
The recommended dose is 25 mg fludarabine phosphate/m² body surface
given daily for 5 consecutive
days every 28 days by the intravenous route. The required dose
(calculated on the basis of the patient's
body surface) is drawn up into a syringe. For intravenous bolus
injection this dose is diluted in 10 ml
of 0.9 % sodium chloride. Alternatively, for infusion, the required
dose may be diluted in 100 ml 0.9
% sodium chloride and infused over approximately 30 minutes (see also
section 6.6). The optimal
duration of treatment has not been clearly established. The duration
of treatment depends on the
treatment success and the tolerability of the drug. It is recommended
that /.../ be administered up to the
achievement of response (usually 6 cycles) and then the drug should be
discontinued.
_Hepatic impairment _
No data