Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Busulfan
Pierre Fabre Ltd
L01AB01
Busulfan
6mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010100; GTIN: 3573994000037
Busilvex 6mg/ml concentrate for solution for infusion Date last approved: 05/2017 1 PACKAGE LEAFLET: INFORMATION FOR THE USER BUSILVEX 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION. busulfan. _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What Busilvex is and what it is used for 2. What you need to know before you use Busilvex 3. How to use Busilvex 4. Possible side effects 5 How to store Busilvex 6. Contents of the pack and other information 1. WHAT BUSILVEX IS AND WHAT IT IS USED FOR Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents. Busilvex destroys the original bone marrow before the transplant. Busilvex is used in adults, new-born infants, children and adolescents as a TREATMENT PRIOR TO TRANSPLANTATION. In adults Busilvex is used in combination with cyclophosphamide or fludarabine. In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan. You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUSILVEX DO NOT USE BUSILVEX: if you are allergic to busulfan or any of the other ingredients of Busilvex listed in section 6, if you are pregnant, or think you may be pregnant. WARNINGS AND PRECAUTIONS Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells. At the recommended dose, this is the desired effect. Therefore careful monitoring will be performed. It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future. You should tell your doctor: if you have a liver, kidne Lugege kogu dokumenti
OBJECT 1 BUSILVEX 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 19-Sep-2017 | Pierre Fabre Limited 1. Name of the medicinal product Busilvex 6 mg/ml concentrate for solution for infusion 2. Qualitative and quantitative composition One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml). After dilution: 1 ml of solution contains 0.5 mg of busulfan For the full list of excipients see section 6.1 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). Clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients. 4.2 Posology and method of administration Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation. Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT). Posology _Busilvex in combination with cyclophosphamide or melphalan _ _In adults_ The recommended dose and schedule of administration is: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16 th dose of Busilvex (see section 4.5). _Paediatric population (0 to 17 years)_ The recommended dose of B Lugege kogu dokumenti