Spojené státy - angličtina - 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

Spojené státy - angličtina - 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.

Singapur - angličtina - HSA (Health Sciences Authority)

eu yan sang - tea

Singapur - angličtina - HSA (Health Sciences Authority)

yi shi yuan pte ltd - tea

Singapur - angličtina - HSA (Health Sciences Authority)

yi shi yuan pte ltd - capsules

Evropská unie - angličtina - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/6/2021(h3n2)-like strain (a/darwin/11/2021, wild type) / a/wisconsin/67/2022 (h1n1)pdm09-like strain (a/georgia/12/2022 cvr-167) / b/austria/1359417/2021-like strain (b/singapore/wuh4618/2021) / b/phuket/3073/2013-like virus (b/singapore/inftt-16-0610/2016, wild type) - influenza, human - influenza, inactivated, split virus or surface antigen - prophylaxis of influenza in adults and children from 2 years of age.flucelvax tetra should be used in accordance with official recommendations.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))); influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))) influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) excipient: dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - flucelvax quad is indicated for the prevention of influenza caused by influenza virus types a and b contained in the vaccine. the vaccine is indicated for use in individuals 6 months of age and above. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Indie - angličtina - Central Drugs Standard Control Organization

wiscon - cap - 10

Indie - angličtina - Central Drugs Standard Control Organization

wiscon - gamma benzene hexachloride,cetrimide - lot - 1,0.1;% - 50/100;ml

Indie - angličtina - Central Drugs Standard Control Organization

wiscon - azithromycin - sus/ds sus - 15ml/n.i.