Kraj: Izrael
Język: angielski
Źródło: 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
NASAL SPRAY, SUSPENSION
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
INTRANASAL
Required
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 11.2 Nursing Mothers Risk Summary FluMist is not absorbed systemically by the mother following intranasal administration and breastfeeding is not expected to result in exposure of the child to FluMist. 11.3 Pediatric Use Safety and effectiveness of FluMist Quadrivalent in children 24 months of age and older is based on data from FluMist clinical studies and a comparison of post-vaccination antibody titers between persons who received FluMist Quadrivalent and those who received FluMist [see _Clinical Studies (15.2 ,15.1)_]. FluMist Quadrivalent is not approved for use in children younger than 24 months of age because use of FluMist in children 6 through 23 months has been associated with increased risks of hospitalization and wheezing in clinical trials [see _Warnings and Precautions (8)_ and _Adverse Reactions (9)_]. 11.4 Geriatric Use FluMist Quadrivalent is not approved for use in persons 65 years of age and older because in a clinical study (AV009), effectiveness of FluMist to prevent febrile illness was not demonstrated in adults 50 through 64 years of age [see _Clinical Studies (15.3)_]. In this study, solicited events among individuals 50 through 64 years of age were similar in type and frequency to those reported in younger adults. In a clinical study of FluMist in persons 65 years of age and older, subjects with underlying high-risk medical conditions (N = 200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat. 12. DESCRIPTION FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is a live quadrivalent vaccine for administration by intranasal spray. FluMist Quadrivalent contains four vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and two B strains. FluMist Quadrivalent contains B strains fr Przeczytaj cały dokument
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 (each sprayer contains 0.2 mL of vaccine). Refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e.g., sharps container or biohazard containe Przeczytaj cały dokument