Canada - English - Health Canada

id biomedical corporation of quebec - haemagglutinin-strain a (h1n1); haemagglutinin-strain a (h3n2); haemagglutinin-strain b - suspension - 15mcg; 15mcg; 15mcg - haemagglutinin-strain a (h1n1) 15mcg; haemagglutinin-strain a (h3n2) 15mcg; haemagglutinin-strain b 15mcg - vaccines

Canada - English - Health Canada

id biomedical corporation of quebec - haemagglutinin-strain a (h1n1); haemagglutinin-strain a (h3n2); haemagglutinin-strain b - suspension - 15mcg; 15mcg; 15mcg - haemagglutinin-strain a (h1n1) 15mcg; haemagglutinin-strain a (h3n2) 15mcg; haemagglutinin-strain b 15mcg - vaccines

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

glaxosmithkline biologicals sa - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [iu] in 0.5 ml - boostrix is indicated for:     •    active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,     •    immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. do not administer boostrix to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of boostrix or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine [see description (11)] . encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including boostrix. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to boostrix during pregnancy. healthcare providers are encouraged to register women by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. in a randomized, controlled clinical study (nct02377349), in which the non-u.s. formulation of boostrix was administered during the third trimester of pregnancy, there were no identified vaccine-related adverse effects on pregnancy or on the fetus/newborn child (see data) . available data from the pregnancy registry and from spontaneous and postmarketing reports suggest that the rates of major birth defects and miscarriage in women who received boostrix within 28 days prior to conception or during pregnancy are consistent with estimated background rates (see data) . a developmental toxicity study was performed in female rats administered infanrix prior to mating and boostrix during gestation, 0.1 ml at each occasion (a single human dose is 0.5 ml). in a second study, female rats were administered 0.2 ml of boostrix prior to mating and during the gestation and lactation period. in a third study, female new zealand white rabbits were given 0.5 ml (full human dose) of boostrix (non-u.s. formulation) prior to mating and during gestation. these studies revealed no evidence of harm to the fetus due to boostrix (see data). data human data: safety data from a randomized (1:1), controlled clinical study (nct02377349) (341 non-u.s. formulation of boostrix, 346 placebo pregnancy outcomes) in which the non-u.s. formulation of boostrix was administered to pregnant women during the third trimester did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child. safety data from prospective clinical studies on the use of boostrix during the first and second trimester of pregnancy are not available. an assessment of data from the u.s. pregnancy exposure registry over approximately 17 years (2005-2022) included 1,523 prospective reports of exposure to boostrix within 28 days prior to conception or during pregnancy. among the 256 reports with known pregnancy outcomes, 19 women were exposed to boostrix in the first trimester with no major birth defects reported and 3 spontaneous abortions with no apparent birth defect; 28 women were exposed to boostrix in the second trimester, and 199 women were exposed to boostrix in the third trimester with no major birth defects reported; 10 women were exposed to boostrix at an unknown timing in pregnancy with no major birth defects reported. an assessment of u.s. spontaneous reports and postmarketing data included 810 prospective reports of exposure to boostrix during pregnancy since may 2005 through 31 august 2022. among the 138 reports with known pregnancy outcomes, 17 women were exposed to boostrix in the first trimester with no major birth defects reported and 2 spontaneous abortions with no apparent birth defect; 26 women were exposed to boostrix in the second trimester, and 92 women were exposed to boostrix in the third trimester with no major birth defects reported; 3 women were exposed to boostrix at an unknown timing in pregnancy with no major birth defects reported. animal data: developmental toxicity studies were performed in female rats and new zealand white rabbits. in one study, female rats were administered 0.1 ml of infanrix (a single human dose is 0.5 ml) by intramuscular injection 30 days prior to mating and 0.1 ml of boostrix (a single human dose is 0.5 ml) by intramuscular injection on gestation days 6, 8, 11, and 15. the antigens in infanrix are the same as those in boostrix, but infanrix is formulated with higher quantities of these antigens. in a second study, female rats were administered 0.2 ml of boostrix by intramuscular injection 28 days and 14 days prior to mating, on gestation days 3, 8, 11, and 15, and on lactation day 7. in these studies, no adverse effects on embryo-fetal or pre-weaning development up to postnatal day 25 were observed; there were no fetal malformations or variations observed. in a third study, female new zealand white rabbits were administered 0.5 ml (full human dose) of boostrix (non-u.s. formulation) by intramuscular injection on premating days -28 and -14 and on gestation days 3, 8, 11, 15, and 24. in this study, no adverse effects on embryo-fetal development related to boostrix were observed; postnatal development was not evaluated. risk summary it is not known whether the vaccine components of boostrix are excreted in human milk. data are not available to assess the effect of administration of boostrix on breastfed infants or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for boostrix and any potential adverse effects on the breastfed child from boostrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. boostrix is not indicated for use in children aged younger than 10 years. safety and effectiveness of boostrix in this age group have not been established. in the initial-dose clinical trials, 1,104 subjects aged 65 years and older received boostrix; of these subjects, 299 were aged 75 years and older. adverse events following boostrix were similar in frequency to those reported with the comparator td vaccine [see adverse reactions (6.1)] . a revaccination study of boostrix in adults aged 28 to 73 years [see clinical studies (14.4)] did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad vaccine is indicated for use in persons aged 3 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) - suspension for injection - 0.5 ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) excipient: calcium chloride dihydrate dibasic sodium phosphate as dihydrate 0.67 mg magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines. influvac tetra is indicated in adults and children from 6 months of age and older.

Canada - English - Health Canada

id biomedical corporation of quebec - haemagglutinin-strain a (h1n1); haemagglutinin-strain a (h3n2); haemagglutinin-strain b - suspension - 15mcg; 15mcg; 15mcg - haemagglutinin-strain a (h1n1) 15mcg; haemagglutinin-strain a (h3n2) 15mcg; haemagglutinin-strain b 15mcg - vaccines

Canada - English - Health Canada

id biomedical corporation of quebec - haemagglutinin-strain b (victoria); haemagglutinin-strain b (yamagata); haemagglutinin-strain a (h3n2); haemagglutinin-strain a (h1n1) - suspension - 15mcg; 15mcg; 15mcg; 15mcg - haemagglutinin-strain b (victoria) 15mcg; haemagglutinin-strain b (yamagata) 15mcg; haemagglutinin-strain a (h3n2) 15mcg; haemagglutinin-strain a (h1n1) 15mcg - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 7.5ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))); influenza virus a (h3n2) haemagglutinin 7.5ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))); influenza virus b (victoria) haemagglutinin 7.5ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))); influenza virus b (yamagata) haemagglutinin 7.5ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) - suspension for injection - 30 mcg/0.25ml - active: influenza virus a (h1n1) haemagglutinin 7.5ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))) influenza virus a (h3n2) haemagglutinin 7.5ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))) influenza virus b (victoria) haemagglutinin 7.5ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))) influenza virus b (yamagata) haemagglutinin 7.5ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad junior vaccine is indicated for use in children aged 6 months to 35 months inclusive. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.