Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen (unii: gb6adz2asn) (influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen - unii:gb6adz2asn), influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen (unii: 7vj7x8pkx3) (influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen - unii:7vj7x8pkx3), influenza b virus b/austria/1359417/2021 recombinant hemagglutinin antigen (unii: m48387n67g) (influenza b virus b/aust - flublok quadrivalent is a vaccine indicated for active immunization against disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. flublok quadrivalent is approved for use in persons 18 years of age and older [see clinical studies (14)] . flublok quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine [see postmarketing experience (6.2) and description (11)] . pregnancy exposure pregnancy outcomes in women who have been exposed to flublok quadrivalent during pregnancy are being monitored. sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with flublok quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive flublok quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pre

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated) (unii: 0qk4u2v88l) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:re1mnp1ne6), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated) (unii: al8g7d406d) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:mu3in5k1yc), influenza b virus b/maryland/15/2016 antigen (propiolacto - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated ba

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

chiron vaccines limited - a/singapore686 - like strain (h1n1) a/wuhan /359/95 (h3n2)-like strain b/beijing /184/93-like strain - suspension for injection

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (formaldehyde inactivated) (unii: 2j002y0b0w) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:mz5g0f0san), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated) (unii: p8orn3uom6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:thg3pu0kok), influenza b virus b/victoria/705/2018 bvr-11 - 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

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (unii: wd5e5vym2e) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:erb9sj9vmq), influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) antigen (formaldehyde inactivated) (unii: yy2tbu8yqs) ( iinfluenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:33qej7v9bf), influenza b virus b/victoria/705/201 - 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

Ισραήλ - Αγγλικά - Ministry of Health

sanofi israel ltd - a/michigan/45/2015 (h1n1)pdm09 – like strain; a/singapore/infimh-16-0019/2016 (h3n2) - like virus; b/colorado/06/2017- like virus (b/victoria/2/87 lineage); b/phuket/3073/2013 like strain - suspension for injection - b/phuket/3073/2013 like strain 60 mcg / 0.7 ml; b/colorado/06/2017- like virus (b/victoria/2/87 lineage) 60 mcg / 0.7 ml; a/singapore/infimh-16-0019/2016 (h3n2) - like virus 60 mcg / 0.7 ml; a/michigan/45/2015 (h1n1)pdm09 – like strain 60 mcg / 0.7 ml - influenza, inactivated, split virus or surface antigen - active immunisation in adults 65 years of age and older for the prevention of influenza disease. בקשה לשינוי משטר מינון: 9/3/2022active immunisation in adults 60 years of age and older for the prevention of influenza disease.

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009 (h1n1)v like strain (x-179a) a/california/7/2009 (h1n1) - derived strain used nymc x-181 reass b/brisbane/60/2008 - like strain (b/brisbane/60/2008) - suspension for injection - 7.5 mcg ea %v/v

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus haemagglutinin 15ug (a h1n1 - strain to be confirmed prior to marketing); influenza virus type a haemagglutinin 15ug (h3n2 - strain to be confirmed prior to marketing); influenza virus type b haemagglutinin 15ug (strain to be confirmed prior to marketing) - suspension for injection - 15 mcg - active: influenza virus haemagglutinin 15ug (a h1n1 - strain to be confirmed prior to marketing) influenza virus type a haemagglutinin 15ug (h3n2 - strain to be confirmed prior to marketing) influenza virus type b haemagglutinin 15ug (strain to be confirmed prior to marketing) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - influenza virus haemagglutinin type a/vietnam/1194/2004 nibrg-14 (h5n1) 3.75ug - suspension for injection - 3.75 mcg - active: influenza virus haemagglutinin type a/vietnam/1194/2004 nibrg-14 (h5n1) 3.75ug excipient: dibasic sodium phosphate dodecahydrate magnesium chloride monobasic potassium phosphate octoxinol polysorbate 80 potassium chloride sodium chloride thiomersal water for injection d-alpha tocoferol dibasic sodium phosphate dodecahydrate monobasic potassium phosphate polysorbate 80 potassium chloride sodium chloride squalene water for injection - indicated for prophylaxis of influenza in an officially declared pandemic situation. the vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the new zealand influenza pandemic action plan.

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (ha per dose a(h5n1)(a/vietnam/1203/2004)) - suspension for injection - 7.5 mcg/0.5ml - active: influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (ha per dose a(h5n1)(a/vietnam/1203/2004)) excipient: polysorbate 80 sodium chloride trometamol water for injection - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards as well as immunocompromised and chronically ill subjects following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel may only be marketed or distributed in accordance with the directives contained in the current version of the new zealand influenza pandemic action plan.