Fludarabine Phosphate 25mg/ml Concentrate for Solution for Injection or Infusion

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Fludarabine phosphate

Доступна с:

Accord Healthcare Limited

код АТС:

L01BB; L01BB05

ИНН (Международная Имя):

Fludarabine phosphate

дозировка:

25 milligram(s)/millilitre

Фармацевтическая форма:

Concentrate for solution for infusion

Тип рецепта:

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

Терапевтические области:

Purine analogues; fludarabine

Статус Авторизация:

Not marketed

Дата Авторизация:

2014-09-19

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 pharma-
cist 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, severe bleeding or even organ

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fludarabine Phosphate 25mg/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
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 impairment
Doses should be adjusted for patients with reduced kidney function.
If creatinine cleara