United States - English - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/switzerland/9715293/2013 (h3n2) recombinant hemagglutinin antigen (unii: d2053d6yqu) (influenza a virus a/switzerland/9715293/2013 (h3n2) recombinant hemagglutinin antigen - unii:d2053d6yqu), influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen (unii: poq8dqo9s3) (influenza b - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 years of age and older. in persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with flublok. in persons 50 years of age and older, this indication is based on the immune response elicited by flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with flublok are not available. (see clinical studies [ 14] ) flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see description [11] and postmarketing experience [6.2] ). reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm t

United States - English - 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

United States - English - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/victoria/361/2011 (h3n2) recombinant hemagglutinin antigen (unii: k5313h4vgs) (influenza a virus a/victoria/361/2011 (h3n2) recombinant hemagglutinin antigen - unii:k5313h4vgs), influenza b virus b/wisconsin/1/2010 recombinant hemagglutinin antigen (unii: n9c76986u2) (influenza b virus b/wisco - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 through 49 years of age. flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis), to any component of the vaccine (see description [11]).  reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to flublok. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed. the effect of flublok on embryo-fetal and pre-weaning development was evaluated in pregnant rats. animals were administered flublok by intramuscular injection twice prior to gestation and once during the period of organ

United States - English - NLM (National Library of Medicine)

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/california/7/2009(h1n1)-like antigen (formaldehyde inactivated) (unii: 5i5hvc73i8) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) - unii:euj84un96z) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. do not administer influenza a (h1n1) 2009 monovalent vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [see warnings and precautions (5) and description (11) ] sanofi pasteur's influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluzone vaccine) are manufactured by the same process. available information for fluzone vaccine is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluzone vaccine. it is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

United States - English - 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/austria/1359417/2021 recombinant hemagglutinin antigen - unii:m48387n67g) - flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza a virus subtypes and influenza type b virus contained in the vaccine. flublok is approved for use in persons 18 years of age and older. do not administer flublok to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. [see postmarketing experience [6.2] and description (11) ]. pregnancy exposure there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to flublok. healthcare providers are encouraged to enroll women who receive flublok during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. available data on flublok and flublok quadrivalent administered to pregnant women are limited and insufficient to inform vaccine-associated risks in pregnant women. a developmental study of flublok has been performed in rats administered 0.5 ml (divided, a single human dose is 0.5 ml) of flublok prior to mating and during gestation. this study revealed no evidence of harm to the fetus due to flublok (see data ). clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. data animal in a developmental toxicity study, female rats were administered flublok by intramuscular injection twice prior to mating (35 days and 14 days prior to mating) and on gestation day 6. the total dose was 0.5 ml (divided) on each occasion (a human dose is 0.5 ml). no vaccine-related fetal malformations or variations and no adverse effects on pre-weaning development or female fertility were observed in the study. risk summary it is not known whether flublok is excreted in human milk. data are not available to assess the effects of flublok on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for flublok and any potential adverse effects on the breastfed child from flublok or from the underlying maternal condition. for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. data from a randomized, controlled trial demonstrated that children 6 months to less than 3 years of age had diminished hemagglutinin inhibition (hi) responses to flublok compared to a u.s.-licensed influenza vaccine approved for use in this population, strongly suggesting that flublok would not be effective in children younger than 3 years of age (6). safety and effectiveness of flublok have not been established in children 3 years to less than 18 years of age. data from an efficacy study (study 6), which included 1759 subjects ≥65 years and 525 subjects ≥75 years who received flublok quadrivalent, are insufficient to determine whether elderly subjects respond differently from younger subjects (see clinical studies [14] ). data for flublok quadrivalent are relevant to flublok because both vaccines are manufactured using the same process and have overlapping compositions.

United States - English - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t), influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen (unii: 2i1eol437m) (influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen - unii:2i1eol437m), influenza b virus b/brisbane/60/2008 recombinant hemagglutinin antigen (unii: 058u2312cr) (influenza b virus b/bri - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml - flublok is a vaccine indicated for active immunization against disease caused by influenza a virus subtypes and influenza type b virus contained in the vaccine. flublok is approved for use in persons 18 years of age and older. flublok 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 outcomes in women who have been exposed to flublok during pregnancy are being monitored. contact: protein sciences corporation by calling 1-888-855-7871. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. available data on flublok administered to pregnant women are insufficient to inform vaccine-associated risks in pregnant women. a developmental study of flublok has been performed in

United States - English - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated) (unii: 8ksk0802bp) (influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:116749898h) - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 9 ug in 0.1 ml

United States - English - NLM (National Library of Medicine)

boiron - influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) (unii: k329ycd1n9) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:k329ycd1n9), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) (unii: m691j375mm) (influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) - unii:m691j375mm), influenza a virus a/brisbane/02/2018 (h1n1) recombinant hemagglutinin antigen - after effects of flu or flu-like symptoms* stop use and ask a doctor if symptoms persist for more than 3 days or worsen