Država: Izrael
Jezik: hebrejski
Izvor: Ministry of Health
A/DARWIN/9/2021 (H3N2)-LIKE VIRUS; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS; B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS
ASTRAZENECA (ISRAEL) LTD
J07BB02
ספריי לאף
B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; A/DARWIN/9/2021 (H3N2)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML
תוך-אפי
מרשם נדרש
MEDIMMUNE LLC, USA
INFLUENZA, PURIFIED ANTIGEN
INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN
FluMist quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses ad type B viruses contained in the vaccine. FluMist Quadrivalent is approved for use in persons 2 through 49 years of age.
2018-09-30
BODY TEXT SIZE 7.0 pt SMALLEST TEXT SIZE 7.0 pt Profile Technical Info N/A 7003400 MGI-22x20-4pc-v1 7003400 04-04-2023 108485405/403240037 0113 FLUMIST Leaflet combined 0.2ML-1X10 IL SGK is a Matthews International Corporation Black FLUMIST ® QUADRIVALENT PRESCRIBING INFORMATION 1. Name of the medicinal product FLUMIST ® QUADRIVALENT Intranasal spray 2. Qualitative and quantitative composition Each pre-filled refrigerated FluMist Quadrivalent sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 10 7.0±0.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the four strains: A/Victoria/4897/2022 (H1N1)pdm09 - like strain (A/Norway/31694/2022) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013) 3. PHARMACEUTICAL FORM NASAL SPRAY 4. Therapeutic indications FluMist ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see _Description (12)_]. FluMist Quadrivalent is approved for use in persons 2 through 49 years of age. 5. DOSAGE AND ADMINISTRATION FOR INTRANASAL ADMINISTRATION BY A HEALTHCARE PROVIDER. 5.1 Dosing Information Administer FluMist Quadrivalent according to the following schedule: Age Dose Schedule 2 years through 8 years 1 or 2 doses a , 0.2 mL b each If 2 doses, administer at least 1 month apart 9 years through 49 years 1 dose, 0.2 mL b - “-” indicates information is not applicable a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines. b Administer as 0.1 mL per nostril. 5.2 Administration Instructions Each sprayer contains a single dose (0.2 mL) of FluMist Quadrivalent; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril (eac Pročitajte cijeli dokument