Flucelvax Tetra Suspension injectable
Maa: Sveitsi
Kieli: ranska
Lähde: Swissmedic (Swiss Agency for Therapeutic Products)
Pakkausseloste
(PIL)
30-05-2024
Valmisteyhteenveto
(SPC)
01-06-2023
Aktiivinen ainesosa:
haemagglutininum influenzae A (H3N2) (Virus Stamm A/Kansas/14/2017 (H3N2)-like: derived from A/Indiana/08/2018), haemagglutininum influenzae A (H1N1) (Virus Stamm A/Brisbane/02/2018 (H1N1)-like: derived from A/Idaho/07/2018), haemagglutininum influenzae B (Virus Stamm B/Colorado/06/2017-like: reassortant from B/Iowa/06/2017 (Victoria lineage))
Saatavilla:
Vifor (International) Inc.
ATC-koodi:
J07BB02
INN (Kansainvälinen yleisnimi):
haemagglutininum influenzae A (H3N2) (Virus Stamm A/Kansas/14/2017 (H3N2)-like: derived from A/Indiana/08/2018), haemagglutininum influenzae A (H1N1) (Virus Stamm A/Brisbane/02/2018 (H1N1)-like: derived from A/Idaho/07/2018), haemagglutininum influenzae B (Virus Stamm B/Colorado/06/2017-like: reassortant from B/Iowa/06/2017 (Victoria lineage))
Lääkemuoto:
Suspension injectable
Koostumus:
haemagglutininum influenzae A (H3N2) (Virus Stamm A/Kansas/14/2017 (H3N2)-like: derived from A/Indiana/08/2018) 15 µg, haemagglutininum influenzae A (H1N1) (Virus Stamm A/Brisbane/02/2018 (H1N1)-like: derived from A/Idaho/07/2018) 15 µg, haemagglutininum influenzae B (Virus Stamm B/Colorado/06/2017-like: reassortant from B/Iowa/06/2017 (Victoria lineage)) 15 µg, haemagglutininum influenzae B (Virus Stamm B/Phuket/3073/2013-like: reassortant from B/Singapore/INFTT-16-0610/2016 (Yamagata lineage)) 15 µg, natrii chloridum, kalii chloridum, magnesii chloridum hexahydricum, natrii dihydrogenophosphas dihydricus, kalii dihydrogenophosphas, aqua ad iniectabile q.s. ad suspensionem pro 0.5 ml corresp. natrium 1.7 mg, kalium 0.1 mg, residui: polysorbatum 80, cetrimidum, propiolactonum.
luokka:
B
Terapeuttinen ryhmä:
Les vaccins
Terapeuttinen alue:
aktive Immunisierung gegen Influenza , ab 9 Jahren
Valtuutuksen tilan:
zugelassen
Valtuutus päivämäärä:
2021-04-05
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