RIBOMUSTIN 25MG/VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Manufacturer
Oncotec Pharma Produktion GmbH(GERMANY)

Registraction Number
MAL15045159ACRZ

Content:
Ribomustin 25mg/vial Powder for Concentrate for Solution for Infusion contains the active ingredient bendamustine hydrochloride. Each 25 mg vial contains 25 mg of bendamustine hydrochloride and 30 mg of mannitol1.
Indications:
Ribomustin is used for the treatment of:
-Chronic lymphocytic leukemia (CLL)
-Relapsed/refractory indolent Non-Hodgkin's lymphoma (NHL)
-Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin's lymphoma, in combination with rituximab
-Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma, in combination with rituximab, in patients ineligible for autologous stem cell transplantation.
Instructions:
-Reconstitution: Reconstitute each vial containing 25 mg bendamustine hydrochloride in 10 mL water for injection by shaking.
-Dilution: Once a clear solution is obtained (usually after 5-10 minutes), dilute the total recommended dose of Ribomustin immediately with 0.9% NaCl solution to produce a final volume of about 500 mL.
-Administration: The solution is administered by intravenous infusion over 30-60 minutes.