Uniunea Europeană - engleză - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, inactivated bordetella pertussis, hepatitis b surface antigen (rdna), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaccines - quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis b and invasive disease caused by haemophilus influenzae type b and for booster immunisation of young children during the second year of life.the use of quintanrix should be determined on the basis of official recommendations.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, hepatitis b surface antigen, bordetella pertussis (inactivated), tetanus toxoid - hepatitis b; tetanus; immunization; whooping cough; diphtheria - vaccines - tritanrix hepb is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis b (hbv) in infants from six weeks onwards (see section 4.2).

Australia - engleză - 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 -

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

sanofi pasteur - diphtheria toxoid; tetanus toxoid; pertussis toxoid; filamentous haemagglutinin; pertactin (prn); fimbriae types 2 and 3 - suspension for injection in pre-filled syringe - 0 international unit(s) - pertussis vaccines; pertussis, purified antigen, combinations with toxoids

Singapore - engleză - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid; filamentous haemagglutinin; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t); hepatitis b surface antigen; pertussis toxoid; poliovirius (inactivated) type 1 (mahoney); poliovirus (inactivated) type 2 (mef-1); poliovirus (inactivated) type 3 (saukett); tetanus toxoid - injection, suspension - diphtheria toxoid 30 lf (>= 20 iu)/0.5 ml; filamentous haemagglutinin 25 μg/0.5 ml; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t) 12 μg/0.5 ml; hepatitis b surface antigen 10 μg/0.5 ml; pertussis toxoid 25 μg/0.5 ml; poliovirius (inactivated) type 1 (mahoney) 40 du/0.5 ml; poliovirus (inactivated) type 2 (mef-1) 8 du/0.5 ml; poliovirus (inactivated) type 3 (saukett) 32 du/0.5 ml; tetanus toxoid 10 lf (>= 40 iu)/0.5 ml

Namibia - engleză - Namibia Medicines Regulatory Council

serum institute of india ltd - diphtheria, tetanus, ; pertussis, hepatitis b; haemophilus influenzae type b conjugate - injection - each dose of 0.5 ml contains diphtheria ; toxoid ? 30 iu, tetanus toxoid ? 40 iu, ; haemophilus influenzae type b.pertussis

Malta - engleză - Medicines Authority

bilthoven biologicals b.v. antonie van leeuwenhoeklaan 9 3721 ma, bilthoven, netherlands - suspension for injection - diphtheria toxoid >5 iu poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 4 dagu poliovirus (inactivated) type 3 (saukett strain) 7.5 dagu tetanus toxoid >20 iu - vaccines

Statele Unite ale Americii - engleză - 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) .]

Statele Unite ale Americii - engleză - 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