Fludarabine Sandoz 50 mg2ml concentrate for solution for injection or infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

FLUDARABINE PHOSPHATE

Available from:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Name):

FLUDARABINE PHOSPHATE

Units in package:

1vial Vials; 5vial Vials

Manufactured by:

Fareva Unterach GmbH

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Fludarabine Sandoz 50 mg/2ml concentrate for solution for injection or
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 2 ml contains 50 mg fludarabine phosphate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection or infusion.
Clear, colourless to almost colourless solution.
The diluents that can be used for dilution are sodium chloride 0.9%.
A clear, colourless solution after dilution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of B-cell chronic lymphocytic leukemia (CLL) in patients
with sufficient bone marrow reserves.
First line treatment in patients with advanced disease, Rai stages
III/IV (Binet stages C), or Rai stages I/II
(Binet stages A/B) where the patient has disease-related symptoms or
evidence of progressive disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
Fludarabine Sandoz should be administered under the supervision of a
qualified physician
experienced in the use of antineoplastic therapy.
It is strongly recommended that Fludarabine Sandoz should only be
administered intravenously.
No cases have been reported in which paravenously administered
Fludarabine Sandoz led to severe local
adverse reactions. However, unintentional paravenous administration
must be avoided.
The recommended dose is 25 mg fludarabine phosphate/m
2
body surface given daily for 5 consecutive days
every 28 days by the intravenous route. Each vial contained 2 ml
solution, each ml of the solution will contain
fludarabine phosphate 25 mg (see section 6.5 Special precautions for
disposal and other handling).
The required dose (calculated on the basis of the patient's body
surface) of the solution is drawn up into a
syringe. For intravenous bolus injection, this dose is further diluted
into 10 ml of sodium chloride 0.9%.
Alternatively, for infusion, the required dose drawn up in a syringe
may be diluted into 100 ml of sodium
chloride 0.9% and infused over approximately 30 minutes.
The duration