Velcade 3.5 mg powder for solution for injection (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Janssen-Cilag Ltd |
---|---|
Διεύθυνση | 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG |
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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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 is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for ...
Posology and method of administration
Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. VELCADE must be reconstituted by a healthcare professional. ...
Contraindications
Hypersensitivity to bortezomib, boron or to any of the excipients. Acute diffuse infiltrative pulmonary and pericardial disease.
Special warnings and precautions for use
Intrathecal administration There have been fatal cases of inadvertent intrathecal administration of VELCADE. VELCADE 1 mg is for intravenous use only, while VELCADE 3.5 mg is for intravenous or subcutaneous ...
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, ...
Fertility, pregnancy and lactation
Contraception in males and females No clinical data are available for bortezomib with regard to exposure during pregnancy. Male and female patients of childbearing potential must use effective contraceptive ...
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 The most commonly reported adverse reactions during treatment with VELCADE are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, ...
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 (E 421) 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 authorization: 26 Apr 2004 Date of latest renewal: 26 Apr 2009
Date of revision of the text
20 Sep 2012