Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

immunoglobulin g - human; immunoglobulin - tetanus; tetanus immunoglobulin -

Īrija - angļu - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid; diphtheria toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated; adsorbed aluminium phosphate; adsorbed fimbriae types 2 + 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus

Austrālija - angļu - APVMA (Australian Pesticides and Veterinary Medicines Authority)

padula serums pty. ltd. - equine immunoglobulin protein - equine tetanus antitoxin; phenol - misc. vaccines or anti sera - equine immunoglobulin protein - equine tetanus antitoxin antivenom-snake active 1500.0 iu/ml; phenol phenol other 2.2 mg/ml - immunotherapy

Kenija - angļu - Pharmacy and Poisons Board

biological e. ltd 18 / 1 & 3, azamabad, hyderabad, telangana - - diphtheria and tetanus vaccine (adsorbed, reduced… - suspension for injection - diphtheria toxoid 2 lf (>/ 2 iu), tetanus toxoid… - tetanus toxoid combinations with diphtheria toxoid

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen (unii: t4gyx3110d) (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen - unii:t4gyx3110d), neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen (unii: zt89e5a103) (neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen - unii:zt89e5a103), neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen (unii: 4wan8pqk15) (neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen - unii:4wan8pqk15), neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen (unii: l77ok410kw) (neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen - unii:l77ok410kw) - menquadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. menquadfi is indicated for use in individuals 2 years of age and older. menquadfi does not prevent n. meningitidis serogroup b disease. severe allergic reaction to any component of the vaccine, or after a previous dose of menquadfi or any other tetanus toxoid-containing vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menquadfi during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. 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 2-4% and 15-20%, respectively. there are no clinical studies of menquadfi in pregnant women. available human data on menquadfi administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study in female rabbits administered a full human dose (0.5 ml) prior to mating and during gestation period revealed no evidence of harm to the fetus due to menquadfi (see animal data ). data animal data in a developmental toxicity study, female rabbits received a human dose of menquadfi by intramuscular injection on five occasions: 30 days and 10 days prior to mating, gestation days 6, 12 and 27. 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. risk summary it is not known whether menquadfi is excreted in human milk. data are not available to assess the effects of menquadfi on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for menquadfi and any potential adverse effects on the breastfed child from menquadfi or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of menquadfi have not been established in individuals younger than 2 years of age in the us. a total of 249 participants 65 years of age and older, including 71 participants 75 years of age or older, in study 4 received one dose of menquadfi [see adverse reactions (6.1) and clinical studies (14.1) ]. menquadfi recipients ≥ 65 years of age had lower gmts and seroresponse rates for all serogroups compared to menquadfi recipients 56 through 64 years of age [see clinical studies (14.1) ].

Eiropas Savienība - angļu - EMA (European Medicines Agency)

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

Eiropas Savienība - angļu - EMA (European Medicines Agency)

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - hexyon (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

Austrālija - angļu - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - clostridium tetani - antitoxin; phenol - misc. vaccines or anti sera - clostridium tetani - antitoxin vaccine-toxoid active 1500.0 iu/ml; phenol phenol other 2.2 mg/ml - immunotherapy - calf | cattle | dog | goat | horse | horse foal | lamb | pig - piglet | pigs | sheep | beef | beef calf | billy | bitch | boar | - tetanus | tetanus vaccination

Izraēla - angļu - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); pertactin (prn or 69 kda omp); pertussis toxoid (pt); tetanus toxoid - suspension for injection - diphtheria toxoid nlt 2 iu / 0.5 ml; tetanus toxoid nlt 20 iu / 0.5 ml; filamentous haemagglutinin (fha) 8 mcg / 0.5 ml; pertussis toxoid (pt) 8 mcg / 0.5 ml; pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml - tetanus toxoid, combinations with diphtheria toxoid - tetanus toxoid, combinations with diphtheria toxoid - for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards.the administration of boostrix should be based on official recommendations

Izraēla - angļu - Ministry of Health

sanofi israel ltd - aluminium hydroxide; diphtheria toxoid; tetanus toxoid - suspension for injection - diphtheria toxoid 2 iu / 0.5 ml; tetanus toxoid 20 iu / 0.5 ml; aluminium hydroxide 0.6 mg / 0.5 ml - tetanus toxoid, combinations with diphtheria toxoid - tetanus toxoid, combinations with diphtheria toxoid - this vaccine is indicated for adults over 18 years of age in the following cases:- routine booster vaccinations against diphtheria and tetanus. the diphtheria toxoid content is reduced to one tenth of the normal dose to minimize the risks of a severe hypersensitivity reaction.- primary vaccination.- post-exposure prophylaxis following a tetanus-prone wound, if a booster diphtheria injection is required.this adsorbed diphtheria and tetanus vaccine may be administered as a booster vaccination in children over 10 years of age in whom poliomyelitis is prevented by separate administration of poliomyelitis vaccine.