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

Προτάσεις

SPC, UK: VELCADE 3.5 mg powder for solution for injection (2012)

Εκδότης

Εκδότης Janssen-Cilag Ltd
Διεύθυνση 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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

VELCADE 3.5 mg powder for solution for injection.

Qualitative and quantitative composition

Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution ...

Pharmaceutical form

Powder for solution for injection. White to off-white cake or powder.

Therapeutic indications

VELCADE as monotherapy is indicated for the treatment of adult patients with progressive multiple myeloma ...

Posology and method of administration

Treatment must be initiated and administered under the supervision of a physician qualified and experienced ...

Contraindications

Hypersensitivity to bortezomib, boron or to any of the excipients. Acute diffuse infiltrative pulmonary ...

Special warnings and precautions for use

Intrathecal administration There have been fatal cases of inadvertent intrathecal administration of ...

Interaction with other medicinal products and other forms of interaction

In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, ...

Fertility, pregnancy and lactation

Contraception in males and females No clinical data are available for bortezomib with regard to exposure ...

Effects on ability to drive and use machines

VELCADE may have a moderate influence on the ability to drive and use machines. VELCADE may be associated ...

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions during treatment with VELCADE ...

Overdose

In patients, overdose more than twice the recommended dose has been associated with the acute onset of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX32 Mechanism ...

Pharmacokinetic properties

Absorption Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients ...

Preclinical safety data

Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro ...

List of excipients

Mannitol (E 421) Nitrogen

Incompatibilities

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

Shelf life

Unopened vial: 3 years. Reconstituted solution: The reconstituted solution should be used immediately ...

Special precautions for storage

Do not store above 30°C. Keep the vial in the outer carton in order to protect from light. For storage ...

Nature and contents of container

Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing ...

Special precautions for disposal and other handling

General precautions Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling ...

Marketing authorization holder

JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg 30 B-2340 Beerse Belgium

Marketing authorization number(s)

EU/1/04/274/001

Date of first authorization / renewal of the authorization

Date of first authorization: 26 Apr 2004 Date of latest renewal: 26 Apr 2009

Date of revision of the text

20 Sep 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.