Fludarabine phosphate 50mg powder for solution for injection vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Fludarabine phosphate

可用日期:

Actavis UK Ltd

ATC代码:

L01BB05

INN（国际名称）:

Fludarabine phosphate

剂量:

50mg

药物剂型:

Powder for solution for injection

给药途径:

Intravenous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 08010300; GTIN: 5012617016904

资料单张

Fludarabine 50mg leaflet - UK
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TECHNICAL APPROVAL
AAAG4477
1
17.01.14
jh
Sindan
130 x 550
7.5
17.01.14
17.01.14
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to
read it again.
•
If you have any further questions,
ask your doctor.
•
This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1
WHAT FLUDARABINE ACTAVIS IS AND
WHAT IT IS USED FOR
2
BEFORE YOU USE FLUDARABINE
ACTAVIS
3
HOW TO USE FLUDARABINE ACTAVIS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE FLUDARABINE ACTAVIS
6
FURTHER INFORMATION
1
WHAT FLUDARABINE ACTAVIS IS AND
WHAT IT IS USED FOR
Fludarabine Actavis is an anti-cancer drug.
Fludarabine Actavis 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 Fludarabine Actavis should
only be started in patients with advanced
disease having disease related symptoms or
evidence of disease progression.
All cells of the body produce new cells like
themselves by dividing. For this purpose, the
cell’ genetic material (DNA) must be copied
and reproduced. Fludarabine Actavis works
by hindering the production of new DNA.
Therefore, when Fludarabine Actavis is taken
up by the cancer cells, it stops the growth of
new cancer cells.
In cancers of the white blood cells (as chronic
lymphocytic leukaemia) many abnormal
lymphocytes are produced. The abnormal
lymphocytes either do not

产品特点

OBJECT 1
FLUDARABINE 50MG LYOPHILISATE FOR SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 23-Jun-2011 | Accord-UK Ltd
1. Name of the medicinal product
Fludarabine Actavis 50mg Lyophilisate For Solution For Injection Or
Infusion
2. Qualitative and quantitative composition
Each vial contains 50 mg fludarabine phosphate.
1ml of reconstituted solution contains 25 mg fludarabine phosphate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
White or almost white lyophilisate.
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 Fludarabine Actavis 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
Fludarabine Actavis should be administered under the supervision of a
qualified physician experienced in
the use of antineoplastic therapy.
It is strongly recommended that Fludarabine Actavis should be only
administered intravenously. No cases
have been reported in which paravenously administered fludarabine led
to severe local adverse reactions.
However, the unintentional paravenous administration must be avoided.
_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. Each vial is to be made
up in 2 ml water for injection. Each
ml of the resulting reconstituted solution will contain 25 mg
fludarabine phosphate. The required dose
(calculated on the basis of the patient's body surface) of the
reconstituted solution is drawn up into a
syringe. For intravenous bolus injection this dose is further diluted
in 10 ml of 0.9 % sodium chloride.
Alternatively, for infusion, the required dose may be diluted in 10