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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Levact 2.5 mg/ml powder for concentrate for solution for infusion (2010)

Εκδότης

Εκδότης Napp Pharmaceuticals Limited
Διεύθυνση Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
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

Levact 2.5 mg/ml powder for concentrate for solution for infusion.

Qualitative and quantitative composition

One vial contains 25 mg bendamustine hydrochloride. One vial contains 100 mg bendamustine hydrochloride. ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White, microcrystalline powder.

Therapeutic indications

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine ...

Posology and method of administration

For intravenous infusion over 30 60 minutes (see section 6.6). Infusion must be administered under the ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). During breast ...

Special warnings and precautions for use

Myelosuppression Patients treated with bendamustine hydrochloride may experience myelosuppression. In ...

Interaction with other medicinal products and other forms of interaction

No in-vivo interaction studies have been performed. When Levact is combined with myelosuppressive agents, ...

Pregnancy and lactation

Pregnancy There are insufficient data from the use of Levact in pregnant women. In nonclinical studies ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, ataxia, ...

Undesirable effects

The most common adverse reactions with bendamustine hydrochloride are hematological adverse reactions ...

Overdose

After application of a 30 min infusion of Levact once every 3 weeks the maximum tolerated dose (MTD) ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, alkylating agents ATC code: L01AA09 Bendamustine hydrochloride ...

Pharmacokinetic properties

Distribution The elimination half-life t1/2ß after 30 min i.v. infusion of 120 mg/m2 area to 12 subjects ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to ...

List of excipients

Mannitol

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

3 years. The powder should be reconstituted immediately after opening of the vial. The reconstituted ...

Special precautions for storage

Keep the vial in the outer carton in order to protect from light. For storage conditions of the reconstituted ...

Nature and contents of container

Type I brown glass vials of 26 ml or 60 ml with rubber stopper and an aluminium flip-off cap. 26 ml-vials ...

Special precautions for disposal and other handling

When handling Levact, inhalation, skin contact or contact with mucous membranes should be avoided (wear ...

Marketing authorization holder

Astellas Pharma GmbH Postfach 50 01 66 80971 München Germany Phone: +49(0)89454401 Fax: +49(0)8945441329 ...

Marketing authorization number(s)

PL 14427/0026

Date of revision of the text

3rd August 2010
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.