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

grifols usa, llc - 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) 2.0 [lf] in 0.5 ml - massbiologics' tdvax is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. this vaccine is approved for use in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of massbiologics' tdvax vaccine. (see description ). because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

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 States - English - 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

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) 10 [iu] in 0.5 ml - infanrix is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of infanrix is a contraindication [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered. 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 infanrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including infanrix. pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of infanrix in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. infanrix is not approved for use in these age groups.

United States - English - 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 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), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), 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 - a single dose of kinrix is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (dtap) vaccine series and the fourth dose in the inactivated poliovirus vaccine (ipv) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous dtap vaccine doses have been with infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or pediarix [diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine] for the first 3 doses and infanrix for the fourth dose. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of kinrix, including neomycin and polymyxin b, is a contraindication to administration of kinrix [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. 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 kinrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including kinrix. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of kinrix in children younger than 4 years and children aged 7 to 16 years have not been evaluated. kinrix is not approved for use in persons in these age groups.

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

virbac (australia) pty ltd - hydroxocobalamin acetate; moxidectin; moxidectin concentrate; selenium as sodium selenate; blackleg = clostridium chauvoei; enterotoxaemia = pulpy kidney = c perfringens; clostridium novyi type b; malignant oedema = clostridium septicum; cla = corynebacterium pseudotuberculosis ovis; tetanus = clostridium tetani; thiomersal - parenteral liquid/solution/suspension - hydroxocobalamin acetate vitamin-b12 active 1.0 mg/ml; moxidectin anthelmintic active 2.5 mg/ml; moxidectin concentrate anthelmintic active 0.0 undefined; selenium as sodium selenate mineral-selenium active 0.5 mg/ml; blackleg = clostridium chauvoei vaccine-microbial active 0.0 undefined; enterotoxaemia = pulpy kidney = c perfringens vaccine-microbial active 0.0 undefined; clostridium novyi type b vaccine-microbial active 0.0 undefined; malignant oedema = clostridium septicum vaccine-microbial active 0.0 undefined; cla = corynebacterium pseudotuberculosis ovis vaccine-microbial active 0.0 undefined; tetanus = clostridium tetani vaccine-toxoid active 0.0 undefined; thiomersal mercury other 0.13 mg/ml - immuno+parasite+nutrition - lamb | ovine - barber's pole worm-haemonchus contortus | black scour worm - trichostrongylus spp. | brown stomach worm - ostertagia lyrata | cooperia curticei | cooperia oncophora | intestinal hair worm - t. colubriformis | intestinal threadworm - s. papillosus | large bowel worm - o. venulosum | large lungworm - dictyocaulus filaria | large mouthed bowel worm | nasal bot | nematodirus abnormalis | nematodirus battus | nematodirus filicollis | nematodirus helvetianus | nodule worm - o. columbianum | ostertagia circumcincta | ostertagia trifurcata | sheep itch mite | small brown stomach worm-ostertagia spp. | small intestinal worm - cooperia spp. | stomach hair worm | thin necked intestinal worm | thin necked intestinal worm-n. spathiger | trichostrongylus rugatus | trichostrongylus vitrinus | whipworm - trichuris ovis | black scour worm | psorobia ovis | sheep nasal bot fly | small brown stomach worm | small intestinal worm | teladorsagia | thin necked intestinal worm | thin necked intestinal worm-ad | trichostrongylus colu

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; tetanus toxoid, quantity: 20 lfu/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

Spain - English - HMA (Heads of Medicines Agencies)

ceva salud animal - clostridium chauvoei 90 %, clostridium novyi alpha toxoid 3.5 iu/ml, clostridium perfringens a 1.1 iu/ml, clostridium perfringens type c toxoid 10 iu/ml, clostridium perfringens type d toxoid 5 iu/ml, clostridium septicum 2.5 iu/ml, clostridium sordelli 100 %, clostridium tetani toxoid 2.5 iu/ml - suspension for injection - sheep food - clostridium vaccine

Italy - English - HMA (Heads of Medicines Agencies)

ceva salud animal - clostridium chauvoei 90 %, clostridium novyi alpha toxoid 3.5 iu/ml, clostridium perfringens a 1.1 iu/ml, clostridium perfringens type c toxoid 10 iu/ml, clostridium perfringens type d toxoid 5 iu/ml, clostridium septicum 2.5 iu/ml, clostridium sordelli 100 %, clostridium tetani toxoid 2.5 iu/ml - suspension for injection - sheep food - clostridium vaccine