BAVENCIO Concentrate for solution (2018)
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Περιεχόμενα
Name of the medicinal product
Bavencio 20 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL of concentrate contains 20 mg of avelumab. One vial of 10 mL contains 200 mg of avelumab. Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear, colourless to slightly yellow solution. The solution pH is in the range of 5.0-5.6 and the osmolality is between 270 and 330 mOsm/kg. ...
Therapeutic indications
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the treatment of cancer. Posology The recommended dose of Bavencio is 10 mg/kg body weight administered intravenously over 60 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Infusion-related reactions Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8). Patients should be monitored for signs and symptoms of ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted with avelumab. Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions ...
Pregnancy and lactation
Women of childbearing potential/Contraception Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment ...
Effects on ability to drive and use machines
Avelumab has negligible influence on the ability to drive and use machines. Fatigue has been reported following administration of avelumab (see section 4.8). Patients should be advised to use caution when ...
Undesirable effects
Summary of the safety profile Avelumab is most frequently associated with immune-related adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate medical ...
Overdose
Three patients were reported to be overdosed with 5% to 10% above the recommended dose of avelumab. The patients had no symptoms, did not require any treatment for the overdose, and continued on avelumab ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies ATC code: L01XC31 Mechanism of action Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed ...
Pharmacokinetic properties
Distribution Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space. The volume of distribution at steady state was 4.72 L. Consistent with ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity in Cynomolgus monkeys administered intravenously doses of 20, 60 or 140 mg/kg once a week for1 ...
List of excipients
Mannitol Glacial acetic acid Polysorbate 20 Sodium hydroxide Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 2 years. After opening: From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately. After preparation of infusion: Chemical ...
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
10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap. Pack size of 1 vial.
Special precautions for disposal and other handling
Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with ...
Marketing authorization holder
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/17/1214/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 September 2017
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