VIDAZA Powder for suspension for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vidaza 25 mg/mL powder for suspension for injection.
Qualitative and quantitative composition
Each vial contains 100 mg azacitidine. After reconstitution, each mL of suspension contains 25 mg azacitidine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for suspension for injection. White lyophilised powder.
Therapeutic indications
Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according ...
Posology and method of administration
Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Advanced malignant hepatic tumours (see section 4.4). Breast-feeding (see section 4.6).
Special warnings and precautions for use
Haematological toxicity Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles (see section 4.8). Complete blood counts should be ...
Interaction with other medicinal products and other forms of interaction
Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing potential and men have to use effective contraception during and up to 3 months after treatment. Pregnancy There ...
Effects on ability to drive and use machines
Azacitidine has minor or moderate influence on the ability to drive and use machines. Fatigue has been reported with the use of azacitidine. Therefore, caution is recommended when driving or operating ...
Undesirable effects
Summary of the safety profile Adult population with MDS, CMML and AML (20-30% marrow blasts) Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred ...
Overdose
One case of overdose with azacitidine was reported during clinical trials. A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m<sup> ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07 Mechanism of action Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including ...
Pharmacokinetic properties
Absorption Following subcutaneous administration of a single 75 mg/m² dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first ...
Preclinical safety data
Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro. The potential carcinogenicity of azacitidine was evaluated in mice and rats. Azacitidine ...
List of excipients
Mannitol (E421)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Unopened powder vial: 4 years. After reconstitution: When Vidaza is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted ...
Special precautions for storage
Unopened vials: This medicinal product does not require any special storage conditions. Reconstituted suspension: For storage conditions after reconstitution of the medicinal product, see section 6.3. ...
Nature and contents of container
Colourless type I glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button, containing 100 mg of azacitidine. Pack size: 1 vial.
Special precautions for disposal and other handling
Recommendations for safe handling Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions. ...
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Marketing authorization number(s)
EU/1/08/488/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 December 2008 Date of latest renewal: 13 November 2013
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