ABD - İngilizce - NLM (National Library of Medicine)

sanofi pasteur 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/california/122/2022 san-022 (h3n2) antigen (formaldehyde inactivated) (unii: n7cb2u8hac) (influenza a virus a/california/122/2022 san-022 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:8l9r8s52vv), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) (unii: b93bqx9789) (influenza b virus b/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated) - unii:9hb0xus9tm), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) (unii: ff9yp4d23c) (influenza b virus b/michigan/01/2021 hemagglutinin antigen (formaldehyde inactivated) - unii:cqv855h5fg) - fluzone® high-dose quadrivalent southern hemisphere is a vaccine indicated for active immunization for the prevention of influenza caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone high-dose quadrivalent southern hemisphere is indicated for use in persons 65 years of age and older. a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)] , including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of fluzone high-dose quadrivalent southern hemisphere. fluzone high-dose quadrivalent southern hemisphere and fluzone high-dose quadrivalent are manufactured using the same process. data in this section were obtained in studies with fluzone high-dose quadrivalent. fluzone high-dose quadrivalent southern hemisphere is not approved for use in persons <65 years of age. there are limited human data on fluzone high-dose and no animal data available on fluzone high-dose quadrivalent southern hemisphere to establish whether there is a vaccine-associated risk with use of fluzone high-dose quadrivalent in pregnancy. fluzone high-dose quadrivalent southern hemisphere is not approved for use in persons <65 years of age. no human or animal data are available to assess the effects of fluzone high-dose quadrivalent southern hemisphere on the breastfed infant or on milk production/excretion. safety and effectiveness of fluzone high-dose quadrivalent southern hemisphere in children younger than 18 years of age have not been established. safety, immunogenicity, and efficacy of fluzone high-dose quadrivalent have been evaluated in adults 65 years of age and older [see adverse reactions (6.1) and clinical studies (14)].

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/wellington/i/2004(h3n2)-like strain 10ug ([influenza virus a/wellington/i/2004 ivr-139(10 µg/ha)]);  ; influenza virus b/shanghai/361/2002-like strain 15ug ([b/jiangsu/10/2003 (15µg/ha)]);  ; influenza virus haemagglutinin type a/new caledonia/20/99 h1n1-like strain 15ug ([a/new caledonia/20/99 ivr-116 (15µg/ha)]);   - solution for injection - 10µg/15µg/15µg per dose - active: influenza virus a/wellington/i/2004(h3n2)-like strain 10ug ([influenza virus a/wellington/i/2004 ivr-139(10 µg/ha)])   influenza virus b/shanghai/361/2002-like strain 15ug ([b/jiangsu/10/2003 (15µg/ha)])   influenza virus haemagglutinin type a/new caledonia/20/99 h1n1-like strain 15ug ([a/new caledonia/20/99 ivr-116 (15µg/ha)])   excipient: dibasic sodium phosphate dihydrate monobasic potassium phosphate neomycin sodium chloride water for injection

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

split virion, inactivated) high dose suspension for injection 0.5ml pre-filled syringes (sanofi pasteur - influenza virus inactivated split (h1n1, h3n2-like, b/brisbane/60/2008-like, strains) - suspension for injection

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - pandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted)  - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation.pandemic-influenza vaccine should be used in accordance with official guidance.

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a); influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a); influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) - suspension for injection - 9 mcg - active: influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a) influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a) influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection - intanza 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. the use of intanza 9mcg in new zealand should be based on the ministry of health recommendations for influenza vaccination as published in the current new zealand immunisation handbook.

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - a/california/7/2009 (h1n1) pdm09-like strain used nib-74xp derived from a/christchurch/16/2010, a/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b), b/brisbane/60/2008 - like strain (b/brisbane/60/2008) - suspension for injection - 15/15/15mc microgram - influenza vaccines

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009 (h1n1)pdm09 - derived strain used nymc x-179a a/victoria/361/2011 (h3n2) - derived strain used ivr-165 b/massachusetts/2/2012 - suspension for injection - 7.5 mcg ea %v/v

ABD - İngilizce - NLM (National Library of Medicine)

seqirus pty ltd - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) (unii: a5wli8wk8a) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:37h6eg2naq), influenza b vi - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - 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 5 years 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 backg

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - influenza virus haemagglutinin -

ABD - İngilizce - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (propiolactone inactivated) (unii: ytl6a60f5i) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:540gm6ll7u), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (propiolactone inactivated) (unii: oat4h11zt6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:pc99fhq5w6), influenza b virus b/victoria/705/2018 bv - 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