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

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - protein c, quantity: 1000 iu - injection, intravenous infusion - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - protein c, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

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

takeda pharmaceuticals america, inc. - protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw) - protein c 500 [iu] in 5 ml - ceprotin, protein c concentrate (human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital protein c deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. none. risk summary there are no data with ceprotin use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ceprotin. it is also not known whether ceprotin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ceprotin has not been studied for use during labor and delivery. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively, regardless of drug exposure. risk summary there is no information regarding the presence of ceprotin in human milk, the effect on the breastfed infant, or the effects on milk production. ceprotin has not been studied for use in nursing mothers

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)

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)

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/texas/50/2012 (h3n2) recombinant hemagglutinin antigen (unii: 1iqz1wce3y) (influenza a virus a/texas/50/2012 (h3n2) recombinant hemagglutinin antigen - unii:1iqz1wce3y), influenza b virus b/massachusetts/2/2012 recombinant hemagglutinin antigen (unii: ayr0wzx7jh) (influenza b virus b/massachus - 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)

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/texas/50/2012 (h3n2) recombinant hemagglutinin antigen (unii: 1iqz1wce3y) (influenza a virus a/texas/50/2012 (h3n2) recombinant hemagglutinin antigen - unii:1iqz1wce3y), influenza b virus b/massachusetts/2/2012 recombinant hemagglutinin antigen (unii: ayr0wzx7jh) (influenza b virus b/massachus - 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 to

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)

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/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/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