Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

moderna us, inc. - elasomeran (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4), cx-034476 omicron (ba.4/ba.5) (unii: tyf7yw7enf) (cx-034476 omicron (ba.4/ba.5) - unii:tyf7yw7enf) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is hereafter referred to as moderna covid-19 vaccine, bivalent. moderna covid-19 vaccine, bivalent is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the united states under certain circumstances including, but not limited to, when t

Australija - engleski - Department of Health (Therapeutic Goods Administration)

catalent australia pty ltd - colecalciferol, quantity: 12.5 microgram; calcium carbonate, quantity: 875 mg (equivalent: calcium, qty 350 mg) - capsule, soft - excipient ingredients: safflower oil; polysorbate 80; hydrogenated vegetable oil; yellow beeswax; lecithin; gelatin; titanium dioxide; colloidal anhydrous silica; glycerol; purified water; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; iron oxide black; macrogol 400; polyvinyl acetate phthalate

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

id biomedical corporation of quebec - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (uv, formaldehyde inactivated) (unii: a5pts27urj) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:9ha5c4xl36), influenza a virus a/darwin/9/2021 ivr-228 (h3n2) antigen (uv, formaldehyde inactivated) (unii: p483j7gx6d) (influenza a virus a/darwin/9/2021 ivr-228 (h3n2) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:grn94tp8yv), influenza b virus b/austria/1359417/2021 - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) 15 ug in 0.5 ml - flulaval quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. flulaval quadrivalent is approved for use in persons aged 6 months and older. do not administer flulaval quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are insufficient data on flulaval quadrivalent in pregnant women to inform vaccine-associated risks. a developmental toxicity study was performed in female rats administered flulaval quadrivalent prior to mating and during gestation and lactation p

Australija - engleski - Department of Health (Therapeutic Goods Administration)

catalent australia pty ltd - calcium carbonate, quantity: 875 mg (equivalent: calcium, qty 350 mg); menaquinone 7, quantity: 60 microgram; colecalciferol, quantity: 12.5 microgram - capsule, soft - excipient ingredients: polysorbate 80; purified water; allura red ac; brilliant blue fcf; yellow beeswax; gelatin; hydrogenated vegetable oil; lecithin; colloidal anhydrous silica; medium chain triglycerides; soya oil; glycerol; fractionated coconut oil; titanium dioxide; propylene glycol; ethyl acetate; isopropyl alcohol; ethanol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400 - maintain/support general health and wellbeing

Australija - engleski - Department of Health (Therapeutic Goods Administration)

catalent australia pty ltd - calcium carbonate, quantity: 875 mg (equivalent: calcium, qty 350 mg); colecalciferol, quantity: 12.5 microgram; menaquinone 7, quantity: 60 microgram - capsule, soft - excipient ingredients: colloidal anhydrous silica; lecithin; hydrogenated vegetable oil; yellow beeswax; polysorbate 80; gelatin; allura red ac; brilliant blue fcf; titanium dioxide; glycerol; purified water; soya oil; medium chain triglycerides; propylene glycol; ethyl acetate; isopropyl alcohol; ethanol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/nebraska/14/2019 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: ezq32tf2as) (influenza a virus a/nebraska/14/2019 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:jtd2pe1hfr), influenza a virus a/delaware/39/2019 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 5mir93vlg8) (influenza a virus a/delaware/39/2019 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:jx3jfh4h9s), influe - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 2 years of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female ra

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [see description (13)] . risk summary no data are available regarding the use of pfizer-biontech covid-19 vaccine, bivalent during pregnancy. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, t

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 5 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent, supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

medimmune, llc - influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen (unii: fv9fgc9yzw) (influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen - unii:fv9fgc9yzw), influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen (unii: l7z42hp5rz) (influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen - unii:l7z42hp5rz), influenza b virus b/austria/1359417/2021 live (attenuated) antigen (unii: jv6nd6vmy5) (influenza b virus b/austria/1359417/2021 live (attenuated) - influenza a virus a/slovenia/2903/2015 (h1n1) live (attenuated) antigen 10000000 [ffu] in 0.2 ml - 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 (11)] . flumist quadrivalent is approved for use in persons 2 through 49 years of age. do not administer flumist quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)] including egg protein, or after a previous dose of any influenza vaccine. do not administer flumist quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of reye’s syndrome with aspirin and wild-type influenza infection [see drug interactions (7.1)] . risk summary flumist quadrivalent is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations disease-ass