Israel - anglès - Ministry of Health

sanofi israel ltd - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); pertactin (prn); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - tetanus toxoid 5 lf / 1 doses; pertussis toxoid vaccine 2.5 mcg/dose; filamentous haemagglutinin (fha) 5 mcg/dose; fimbrae tupes 2 + 3 (fim) 5 mcg/dose; pertactin (prn) 3 mcg/dose; diphtheria toxoid 2 lf / 1 doses - diphtheria-pertussis-poliomyelitis-tetanus - active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. adacel is not indicated for treating diseases caused by b.pertussis, c.diphtheriae or c. tetani infections.

Singapur - anglès - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid protein; meningococcal (serogroup a) polysaccharide (monovalent conjugate); meningococcal (serogroup c) polysaccharide (monovalent conjugate); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate); meningococcal (serogroup y) polysaccharide (monovalent conjugate) - injection, solution - 48 microgram (diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio) - diphtheria toxoid protein 48 mcg/dose (0.5 ml) (diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); meningococcal (serogroup a) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup c) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup y) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml)

Armènia - anglès - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin - suspenion for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose

Armènia - anglès - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, hepatitis b surface antigen, inactivated poliovirus type 1, inactivated poliovirus type 2, inactivated poliovirus type 3, haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid) - powder and suspension for suspension for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose+ 10mcg/dose+ 40d-antigen unit/dose+ 8d-antig

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 30 [iu]; tetanus toxoid 40 [iu] - solution for injection - active: diphtheria toxoid, adsorbed 30 [iu] tetanus toxoid 40 [iu] excipient: aluminium hydroxide sodium chloride thiomersal water for injection

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 30 [iu] (minimum per dose; 15 lf (not less than 1 usphs unit per dose)); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 10ug; tetanus toxoid, adsorbed 40 [iu] (minimum per dose; 5 lf (not less than 1 usphs unit per dose)) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (minimum per dose; 15 lf (not less than 1 usphs unit per dose)) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 10ug tetanus toxoid, adsorbed 40 [iu] (minimum per dose; 5 lf (not less than 1 usphs unit per dose)) excipient: aluminium phosphate phenoxyethanol water for injection - tripacel® is indicated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age; tripacel® is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.

Filipines - anglès - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc.; distributor: sanofi pasteur, inc. - diphtheria, tetanus, pertussis (whole cell), hepatitis b (idna) and haemophilus influenzae type b conjugate vaccine (adsorbed) - suspension for injection (im) - formulation: each dose (0.5 ml) contains: diphtheria toxoid->30iu tetanus toxoid->60iu bordetella pertussis (whole cell)-> 4 iu hepatitis b (r-dna) surface antigen-10ug purified capsular polysaccharide of hib conjugated to 20-40 mcg tetanus toxoid (carrier protein)-10ug

Unió Europea - anglès - EMA (European Medicines Agency)

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

Unió Europea - anglès - EMA (European Medicines Agency)

mcm vaccine b.v. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, hepatitis b surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.