Stati Uniti - inglese - 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.

Stati Uniti - inglese - NLM (National Library of Medicine)

a-s medication solutions - 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 in - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [iu] in 0.5 ml - boostrix is indicated for: 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

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid, diphtheria toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, adsorbed aluminium phosphate - suspension for injection - unknown - pertussis, purified antigen, combinations with toxoids

Stati Uniti - inglese - 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 t

Stati Uniti - inglese - 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), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - adacel® is a vaccine indicated for: - active booster immunization against tetanus, diphtheria and pertussis. adacel is approved for use in individuals 10 through 64 years of age. immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to administration of adacel. [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. encephalopathy (e.g., coma, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindicatio

Stati Uniti - inglese - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel. [see description (11). ] encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progres

Stati Uniti - inglese - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), 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), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - pediarix is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis b virus, and poliomyelitis. pediarix is approved for use as a 3-dose series in infants born of hepatitis b surface antigen (hbsag)-negative mothers. pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis b-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin b, is a contraindication to administration of pediarix [see description (11)] . encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pediarix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including pediarix. pediarix should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. safety and effectiveness of pediarix were established in the age group 6 weeks through 6 months on the basis of clinical studies [see adverse reactions (6.1), clinical studies (14.1, 14.2)] . safety and effectiveness of pediarix in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. safety and effectiveness of pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

Stati Uniti - inglese - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - daptacel® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of daptacel or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of daptacel. [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. encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, inclu

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu]; diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate sodium chloride water for injection active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate phenoxyethanol polysorbate 80 sodium chloride water for injection - infanrix (dtpa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. infanrix is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

Canada - inglese - Health Canada

connaught laboratories ltd. - diphtheria antitoxin - liquid - 1000unit - diphtheria antitoxin 1000unit - serums