BUSILVEX Concentrate for solution (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Busilvex 6 mg/ml concentrate for solution for infusion.
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.
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear, colourless solution.
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 ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).
Special warnings and precautions for use
The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia, or any combination ...
Interaction with other medicinal products and other forms of interaction
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole. From published studies in adults, administration of itraconazole ...
Fertility, pregnancy and lactation
Pregnancy HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy. Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations) ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile Busilvex in combination with cyclophosphamide or melphalan In adults Adverse events information is derived from two clinical trials (n=103) of Busilvex. Serious toxicities ...
Overdose
The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected. There is no known antidote to Busilvex ...
Pharmacodynamic properties
Pharmacotherapeutic group: Alkyl sulfonates ATC code: L01AB01 Mechanism of action Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent. In aqueous media, release of the methanesulphonate ...
Pharmacokinetic properties
The pharmacokinetics of Busilvex has been investigated. The information presented on biotransformation and elimination is based on oral busulfan. Pharmacokinetics in adults Absorption The pharmacokinetics ...
Preclinical safety data
Busulfan is mutagenic and clastogenic. Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley. Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and ...
List of excipients
Dimethylacetamide Macrogol 400
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Do not use polycarbonate syringes with Busilvex. ...
Shelf life
<u>Vials:</u> 3 years. <u>Diluted solution:</u> Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for: ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze the diluted solution. For storage conditions after dilution of the medicinal product see section 6.3.
Nature and contents of container
10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap. Multipack containing 8 (2 packs of 4) vials. ...
Special precautions for disposal and other handling
Preparation of Busilvex Procedures for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably ...
Marketing authorization holder
Pierre Fabre Médicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France
Marketing authorization number(s)
EU/1/03/254/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
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