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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Busilvex 6 mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Pierre Fabre Limited
Διεύθυνση Hyde Abbey House, 23 Hyde Street, Winchester, Hampshire, SO23 7DR
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

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 ...

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 ...

Posology and method of administration

Busilvex administration should be supervised by a physician experienced in conditioning treatment prior ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy ...

Special warnings and precautions for use

The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, ...

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 ...

Fertility, pregnancy and lactation

Pregnancy HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy. ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Adverse reactions in adults Adverse events information is derived from two clinical trials (n=103) of ...

Overdose

The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Alkyl sulfonates ATC code: L01AB01 Mechanism of action Busulfan is a potent ...

Pharmacokinetic properties

The pharmacokinetics of Busilvex has been investigated. The information presented on metabolism and elimination ...

Preclinical safety data

Busulfan is mutagenic and clastogenic. Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster ...

List of excipients

Dimethylacetamide Macrogol 400

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Ημερομηνία λήξης

Vials: 2 years Diluted solution: Chemical and physical in-use stability after dilution in glucose 5% ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze the diluted solution. For storage conditions after ...

Nature and contents of container

10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper ...

Special precautions for disposal and other handling

Preparation of Busilvex Procedures for proper handling and disposal of anticancer medicinal products ...

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

Date of revision of the text

07/2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.