البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUDARABINE PHOSPHATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
FLUDARABINE PHOSPHATE
1vial Vials; 5vial Vials
Fareva Unterach GmbH
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 اقرأ الوثيقة كاملة