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

novartis vaccines and diagnostics limited - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (formaldehyde inactivated) (unii: 872508x6jg) (influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:5cl7878s2q) - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (formaldehyde inactivated) 15 ug in 0.5 ml

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

glaxosmithkline biologicals sa - rabies virus strain flury lep antigen (propiolactone inactivated) (unii: fk894q51ye) (rabies virus strain flury lep antigen (propiolactone inactivated) - unii:fk894q51ye) - rabies virus strain flury lep antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - rabavert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. usually an immunization series is initiated and completed with 1 vaccine product. no clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. however, for booster immunization, rabavert was shown to elicit protective antibody level responses in persons tested who received a primary series with hdcv.4,11 preexposure vaccination: see table 1 and dosage and administration. preexposure vaccination consists of 3 doses of rabavert 1.0 ml given intramuscularly (deltoid region), 1 each on days 0, 7, and 21 or 281 (see also table 1 for criteria for preexposure vaccination). preexposure vaccination does not eliminate the need for additional therapy after a known rabies exposure (see dosage and administration: postexposure prophylaxis of previously im

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

novartis vaccines and diagnostics limited - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated) (unii: h41xp0e6g8) (influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:w3d48fdo26) - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml

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

sanofi pasteur inc. - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) (unii: c4hqf74xmw) (rabies virus strain pm-1503-3m antigen (propiolactone inactivated) - unii:c4hqf74xmw) - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - imovax rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. imovax rabies vaccine is approved for use in all age groups. physicians must evaluate each possible rabies exposure. local or state public health officials should be consulted if questions arise about the need for prophylaxis. (11) the following factors should be considered before antirabies prophylaxis is initiated. rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of rabies virus transmitted to humans. transmission of rabies virus can occur from minor, seemingly underappreciated or unrecognized bites from bats (see table 2). (11) raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the united states. suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. all bites by such wildlife should be considered possible exposures to rabies virus. post-exposu

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

sanofi pasteur inc. - 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) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - tenivac® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of tenivac or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of tenivac. [see description (11) .] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. there are no adequate and well-controlled studies of tenivac administration in pregnant women in the u.s. there are insufficient human data from tenivac administered during pregnancy to establish the presence or absence of a vaccine-associated risk. a developmental toxicity study has been performed in female rabbits administered a single human dose of tenivac prior to mating and during gestation. this study revealed no evidence of harm to the fetus due to tenivac. (see animal data ) data animal data in a developmental toxicity study, female rabbits received a single human dose (0.5 ml) of tenivac by intramuscular injection 17 and 10 days prior to mating, and on gestation days 6 and 29. no adverse effects on pre-weaning development up to post-natal day 35 were observed. there were no vaccine-related fetal malformations or variations observed. it is not known whether tenivac components are excreted in human milk. data are not available to assess the effect of administration of tenivac 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 tenivac and any potential adverse effects on the breastfed child from tenivac or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. tenivac is not approved for use in infants and children younger than 7 years of age. safety and effectiveness of tenivac in this age group have not been established. in one clinical study, (tdc01) 449 participants 65 years of age and over, including 192 participants who were 75 years of age and over received a dose of tenivac. a lower proportion of participants 65 years of age and over had a pre-vaccination seroprotective level of antibody to tetanus toxoid and diphtheria toxin compared to adolescents and adults less than 65 years of age. the proportion of participants 65 years of age and over with a seroprotective level of antibody following tenivac was marginally lower for tetanus and lower for diphtheria compared to younger participants. in general, rates of solicited adverse events were not higher in participants 65 years of age and over compared to younger participants. [see adverse reactions (6) , clinical pharmacology (12.1), and clinical studies (14.2) .]

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi pasteur msd ltd - human poliovirus type 3 inactivated; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; diphtheria toxoid; haemophilus influenzae type b polysaccharide protein conjugate - suspension for injection

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

a-s medication solutions - rabies virus strain flury lep antigen (propiolactone inactivated) (unii: fk894q51ye) (rabies virus strain flury lep antigen (propiolactone inactivated) - unii:fk894q51ye) - rabies virus strain flury lep antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - rabavert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. usually, an immunization series is initiated and completed with one vaccine product. no clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. however, for booster immunization, rabavert was shown to elicit protective antibody level responses in persons tested who received a primary series with hdcv (4,11). (see also dosage and administration section below) preexposure vaccination consists of three doses of rabavert 1.0 ml, intramuscularly (deltoid region), one each on days 0, 7, and 21 or 28 (1) (see also table 1 for criteria for preexposure vaccination). preexposure vaccination does not eliminate the need for additional therapy after a known rabies exposure (see also dosage and administration section, subsection c). preexposure vaccina

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - cpcv 1-2 inactivated suspension - misc. vaccines or anti sera - cpcv 1-2 inactivated suspension vaccine-virus active 1.0 rp - immunotherapy

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

seqirus, inc. - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (formaldehyde inactivated) (unii: q3p251c5mt) (influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:ld80h821hf), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (formaldehyde inactivated) (unii: kmo6tk08j4) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:w929z18nv6), influenza b virus b/ - fluad is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b contained in the vaccine. fluad is approved for use in persons 65 years of age and older. approval is based on the immune response elicited by fluad. data demonstrating a decrease in influenza disease after vaccination with fluad are not available. [see clinical studies (14)] do not administer fluad to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad is not approved for use in persons <65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad in pregnancy. a developmental toxicity study has been performed in female rabbits administered fluad prior to mating and during gestation. a 0.5 ml dose was injected on each occasion (a single human dose i