দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fludarabine phosphate
Sandoz Ltd
L01BB05
Fludarabine phosphate
25mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300
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 সম্পূর্ণ নথি পড়ুন