Új-Zéland - angol - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 30 lf u equivalent to not less than 20 iu; haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)); hepatitis b virus surface antigen 10ug; pertussis filamentous haemagglutinin 25ug (adsorbed); pertussis toxoid, adsorbed 25ug; polio virus type 1 40 dagu (mahoney); polio virus type 2 8 dagu (mef-1); polio virus type 3 32 dagu (saukett); tetanus toxoid, adsorbed 10 lf u equivalent to not less than 40 iu - suspension for injection - active: diphtheria toxoid, adsorbed 30 lf u equivalent to not less than 20 iu haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)) hepatitis b virus surface antigen 10ug pertussis filamentous haemagglutinin 25ug (adsorbed) pertussis toxoid, adsorbed 25ug polio virus type 1 40 dagu (mahoney) polio virus type 2 8 dagu (mef-1) polio virus type 3 32 dagu (saukett) tetanus toxoid, adsorbed 10 lf u equivalent to not less than 40 iu excipient: aluminium hydroxide amino acids dibasic sodium phosphate monobasic potassium phosphate sucrose trometamol water for injection - hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive infections caused by haemophilus influenzae type b. use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - diphtheria toxoid, adsorbed 2 [iu] (nlt); pertussis toxoid, adsorbed 20ug; tetanus toxoid, adsorbed 20 [iu] (nlt) - suspension for injection - active: diphtheria toxoid, adsorbed 2 [iu] (nlt) pertussis toxoid, adsorbed 20ug tetanus toxoid, adsorbed 20 [iu] (nlt) excipient: aluminium as aluminium hydroxide sodium chloride sodium hydroxide water for injection - for booster vaccination against tetanus, diphtheria and pertussis of individuals from the age of 4 years and onwards.

Kanada - angol - Health Canada

aventis pasteur limited - diphtheria toxoid; tetanus toxoid; pertussis vaccine - liquid - 25lf; 5lf; 12unit - diphtheria toxoid 25lf; tetanus toxoid 5lf; pertussis vaccine 12unit - toxoids

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - diphtheria toxoid, quantity: 48 microgram; meningococcal polysaccharide group y, quantity: 4 microgram; meningococcal polysaccharide group w135, quantity: 4 microgram; meningococcal polysaccharide group c, quantity: 4 microgram; meningococcal polysaccharide group a, quantity: 4 microgram - injection, solution - excipient ingredients: monobasic sodium phosphate; sodium chloride; dibasic sodium phosphate - menactra is indicated for active immunisation of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by n meningitidis serogroups a, c, y and w-135.,menactra is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by n meningitidis serogroup b.,menactra is not indicated for treatment of meningococcal infections.,menactra is not indicated for immunisation against diphtheria.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - diphtheria toxoid,pertactin,pertussis filamentous haemagglutinin,pertussis fimbriae 2 + 3,pertussis toxoid,poliovirus,tetanus toxoid -

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated - suspension for injection

Kenya - angol - Pharmacy and Poisons Board

serum instititute of india pvt. ltd. 212/2, hadapsar, pune- 411 028, india. - 1. purified diphtheria toxoid 2. purified tetanus… - injection - each single 0.5 ml human dose contains diphtheria… - tetanus toxoid combinations with diphtheria toxoid

Egyesült Államok - angol - NLM (National Library of Medicine)

massbiologics - 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.

Egyesült Államok - angol - 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.

Egyesült Államok - angol - 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.