ADCETRIS Powder for concentrate for solution (2019)
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Περιεχόμενα
Name of the medicinal product
ADCETRIS 50 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 50 mg of brentuximab vedotin. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. ADCETRIS is an antibody-drug conjugate composed of a CD30-directed ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white cake or powder.
Therapeutic indications
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(see sections 4.2 and 5.1). ADCETRIS ...
Posology and method of administration
ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. Posology Previously Untreated HL The recommended dose in combination with chemotherapy ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5).
Special warnings and precautions for use
Progressive multifocal leukoencephalopathy John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients. PML has ...
Interaction with other medicinal products and other forms of interaction
Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers) Co-administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased ...
Pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. Pregnancy There ...
Effects on ability to drive and use machines
ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.
Undesirable effects
Summary of the safety profile The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date. Frequencies of adverse reactions ...
Overdose
There is no known antidote for overdose of ADCETRIS. In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC12 Mechanism of action Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers ...
Pharmacokinetic properties
Monotherapy The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients. In all clinical trials, brentuximab vedotin ...
Preclinical safety data
MMAE has been shown to have aneugenic properties in an in vivo rat bone marrow micronucleus study. These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption ...
List of excipients
Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 4 years. After reconstitution/dilution, from a microbiological point of view, the product should be used immediately. However, chemical and physical in-use stability has been demonstrated for ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the original carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, ...
Nature and contents of container
Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder. Pack of 1 vial.
Special precautions for disposal and other handling
General precautions Procedures for proper handling and disposal of anticancer medicines should be considered. Proper aseptic technique throughout the handling of this medicinal product should be followed. ...
Marketing authorization holder
Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
Marketing authorization number(s)
EU/1/12/794/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 October 2012
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