IMFIZI Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
IMFINZI 50 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL of concentrate for solution for infusion contains 50 mg of durvalumab. One vial of 2.4 mL of concentrate contains 120 mg of durvalumab. One vial of 10 mL of concentrate contains 500 mg of durvalumab. ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to slightly yellow solution, free from visible particles. The solution has a pH of approximately 6.0 and an ...
Therapeutic indications
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease ...
Posology and method of administration
Treatment must be initiated and supervised by a physician experienced in the treatment of cancer. PD-L1 testing for patients with locally advanced NSCLC Patients with locally advanced NSCLC should be evaluated ...
Contraindications
Hypersensitivity to the active substance(s) 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 tradename and the batch number of the administered product should be clearly recorded. Immune-mediated pneumonitis ...
Interaction with other medicinal products and other forms of interaction
The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equivalent), is not recommended because ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab. Pregnancy ...
Effects on ability to drive and use machines
Durvalumab has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety of IMFINZI (10 mg/kg) has been evaluated in the PACIFIC Study (n=475) in patients with locally advanced, unresectable NSCLC who had completed treatment with at ...
Overdose
There is no information on overdose with durvalumab. 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: L01XC28 Mechanism of action Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response ...
Pharmacokinetic properties
The PK of durvalumab was studied in 1902 patients with solid tumours with doses ranging from 0.1 to 20 mg/kg administered intravenously once every two, three or four weeks. PK exposure increased more than ...
Preclinical safety data
Carcinogenicity and mutagenicity The carcinogenic and genotoxic potential of durvalumab has not been evaluated. Reproductive toxicology As reported in the literature, the PD-1/PD-L1 pathway plays a central ...
List of excipients
Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Unopened vial: 3 years. Diluted solution: If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original package in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab. Pack size of 1 vial. 10 mL of concentrate in a Type 1 glass vial ...
Special precautions for disposal and other handling
Preparation of solution IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed. Visually inspect the medicinal product for particulate matter ...
Marketing authorization holder
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Marketing authorization number(s)
EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 September 2018
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