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Busilvex 6 mg/ml concentrate for solution for infusion
2015-10-17 15:01:42 来源: 作者: 【 】 浏览:557次 评论:0
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 haematopoie

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