TECENTRIQ Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Tecentriq 1,200 mg concentrate for solution for infusion.
Qualitative and quantitative composition
Each 20 mL vial of concentrate contains 1,200 mg atezolizumab*. After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab. * Atezolizumab is an Fc-engineered, humanised ...
Pharmaceutical form
Concentrate for solution for infusion. Clear, colourless to slightly yellowish liquid.
Therapeutic indications
Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): after prior platinum-containing chemotherapy, ...
Posology and method of administration
Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer. PD-L1 testing for patients with UC Patients with previously untreated UC should be selected for treatment ...
Contraindications
Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file. Immune-related ...
Interaction with other medicinal products and other forms of interaction
No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab. Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception during and for 5 months after treatment with atezolizumab. Pregnancy There are no data from the use of ...
Effects on ability to drive and use machines
Tecentriq has minor influence on the ability to drive and use machines. Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Undesirable effects
Summary of the safety profile The safety of atezolizumab as monotherapy is based on pooled data in 3,178 patients across multiple tumour types. The most common adverse reactions (>10%) were fatigue (35.9%), ...
Overdose
There is no information on overdose with atezolizumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC32 Mechanism of action Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating ...
Pharmacokinetic properties
Exposure to atezolizumab increased dose proportionally over the dose range 1 mg/kg to 20 mg/kg including the fixed dose 1,200 mg administered every 3 weeks. A population analysis that included 472 patients ...
Preclinical safety data
Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of atezolizumab. Mutagenicity Mutagenicity studies have not been performed to establish the mutagenic ...
List of excipients
L-histidine Glacial acetic acid Sucrose Polysorbate 20 Water for injections
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 Unopened vial: 3 years. Diluted solution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤30°C and for up to 30 days at 2°C to 8°C from the time of preparation. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion. Pack of one vial.
Special precautions for disposal and other handling
Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions. ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/17/1220/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 September 2017
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