Fludarabine phosphate 50mg/2ml concentrate for solution for injection vials

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Fludarabine phosphate

Dostępny od:

Sandoz Ltd

Kod ATC:

L01BB05

INN (International Nazwa):

Fludarabine phosphate

Dawkowanie:

25mg/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 08010300

Charakterystyka produktu

FLUDARABINE 25 MG/ML CONCENTRATE FOR SOLUTION
FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 10-Feb-2017 | Sandoz
Limited
1. Name of the medicinal product
Fludarabine 25 mg/ml Concentrate for Solution for Injection or
Infusion
2. Qualitative and quantitative composition
Each of 2 ml vial 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.
2 ml vial: a clear, colourless to almost colourless solution.
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 with Fludarabine should only be initiated 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
Fludarabine should be administered under the supervision of a
qualified physician experienced in the use
of antineoplastic therapy.
It is strongly recommended that Fludarabine should be only
administered intravenously. No cases have
been reported in which paravenously administered Fludarabine led to
severe local adverse reactions.
However, unintentional paravenous administration of Fludarabine must
be avoided.
• Adults
The recommended dose of Fludarabine is 25 mg/m
2
body surface given daily for 5 consecutive days (=
one cycle) 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 further diluted in10ml of
sodium chloride 9 mg/ml (0.9%) solution
for injection. Alternatively, for infusion, the required dose may be
diluted in 100ml of sodium chloride 9
mg/ml (0.9%) solution for injection and infused intravenously over a
period of approximately 30 minutes
(see also section 6.6).
The optimal duration of treatment ha