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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: DaunoXome Injection (liposomal daunorubicin) (2011)

Εκδότης

Εκδότης Galen Limited
Διεύθυνση Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA, Ireland
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

DaunoXome Injection (liposomal daunorubicin).

Qualitative and quantitative composition

Daunorubicin hydrochloride, Ph.Eur., present as citrate salt, equivalent to daunorubicin 2.0 mg/ml, (50 ...

Pharmaceutical form

Each vial contains a sterile, pyrogen free, preservative-free liposomal emulsion. This emulsion is red ...

Therapeutic indications

DaunoXome is indicated for the treatment of advanced HIV-related Kaposis Sarcoma.

Posology and method of administration

DaunoXome should be administered by intravenous infusion. The recommended initial dose of DaunoXome in ...

Contraindications

Hypersensitivity to DaunoXome, any of its excipients or other anthracyclines/anthracenediones. Pregnancy ...

Special warnings and precautions for use

Cardiotoxicity DaunoXome and other anthracyclines can cause cardiotoxicity, notably congestive heart ...

Interaction with other medicinal products and other forms of interaction

Protease Inhibitors and Non Nucleoside Reverse Transcriptase Inhibitors are known inhibitors of Cytochrome ...

Pregnancy and lactation

DaunoXome may cause serious birth defects when administered during pregnancy. DaunoXome is contraindicated ...

Effects on ability to drive and use machines

No studies have been performed on the effects of DaunoXome on the ability to drive and use machines. ...

Undesirable effects

The adverse reactions considered at least possibly related to treatment with DaunoXome are listed below, ...

Overdose

From experience with non-liposomal anthracycline preparations, the primary anticipated toxicity from ...

Pharmacodynamic properties

DaunoXome is a liposomal preparation of daunorubicin formulated to maximise the selectivity of daunorubicin ...

Pharmacokinetic properties

DaunoXome has a pharmacokinetic profile significantly different from that of conventional daunorubicin. ...

Preclinical safety data

Animal studies with tumour models in mice have demonstrated that DaunoXome can increase daunorubicin ...

List of excipients

Liposome: Distearoylphosphatidylcholine Cholesterol, USNF Citric acid, Ph.Eur. Buffer: Sucrose, Ph.Eur. ...

Incompatibilities

To date, no incompatibilities of DaunoXome with other drugs have been reported. However, it is known ...

Shelf life

The shelf-life is 52 weeks when stored at 2° - 8°C. Chemical and physical in-use stability has been demonstrated ...

Special precautions for storage

Store at 2° - 8°C. Do not freeze. Protect against exposure to light. Do not store partially used vials ...

Nature and contents of container

DaunoXome is presented in 50 ml, sterile, Type I glass vials. The closure consists of a butyl rubber ...

Special precautions for disposal and other handling

Use Aseptic Technique. Aseptic technique must be strictly observed in all handling, since no preservative ...

Marketing authorization holder

Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK

Marketing authorization number(s)

PL 27827/0007

Date of first authorization / renewal of the authorization

12 October 1995

Date of revision of the text

30 October 2011
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.