VELCADE Powder for solution (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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 for subcutaneous injection contains 2.5 mg bortezomib. 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 or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least ...
Posology and method of administration
VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use ...
Contraindications
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1. Acute diffuse infiltrative pulmonary and pericardial disease. When VELCADE is given in combination ...
Special warnings and precautions for use
When VELCADE is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with VELCADE. ...
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, 2C9, 2C19, 2D6 and 3A4. Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, ...
Pregnancy and lactation
Contraception in males and females Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment. Pregnancy No clinical data are ...
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 with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension ...
Undesirable effects
Summary of the safety profile Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy ...
Overdose
In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes. For preclinical cardiovascular safety ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX32 Mechanism of action Bortezomib is a proteasome inhibitor. It is specifically designed to inhibit the chymotrypsin-like ...
Pharmacokinetic properties
Absorption Following intravenous bolus administration of a 1.0 mg/m² and 1.3 mg/m² dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose ...
Preclinical safety data
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 ...
List of excipients
Mannitol (E421) Nitrogen
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Unopened vial: 3 years. Reconstituted solution: The reconstituted solution should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the ...
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 conditions after reconstitution of the medicinal product, see section 6.3.
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 3.5 mg bortezomib. The vial is contained in a transparent blister pack consisting of a tray ...
Special precautions for disposal and other handling
General precautions Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of VELCADE. Use of gloves and other protective clothing to prevent skin contact is ...
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 authorisation: 26 April 2004 Date of latest renewal: 10 January 2014
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: