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

a-s medication solutions - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 10 ug in 1 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . 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 designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

European Union - English - 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.

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

mcm vaccine co. - 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 toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37), - vaxelis™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, and invasive disease due to haemophilus influenzae (h. influenzae ) type b. vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). do not administer vaxelis to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of vaxelis, any ingredient of vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis b vaccine, or h. influenzae type b vaccine [see description (11) .] do not administer vaxelis to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause. do not administer vaxelis to anyone with a history of progressive neurologic disorder, includ

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

msp vaccine company - 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 toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - vaxelis® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, and invasive disease due to haemophilus influenzae (h. influenzae ) type b. vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). do not administer vaxelis to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of vaxelis, any ingredient of vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis b vaccine, or h. influenzae type b vaccine [see description (11) .] do not administer vaxelis to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause. do not administer vaxelis to anyone with a history of progressive neurologic disorder, inclu

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - varicella vaccine 1350 pfu (oka/merck);   - injection with diluent - 1350 pfu - active: varicella vaccine 1350 pfu (oka/merck)   excipient: dibasic sodium phosphate dodecahydrate gelatin monobasic potassium phosphate monosodium glutamate potassium chloride sodium chloride sucrose urea water for injection - varivax is indicated for vaccination against varicella in individuals 12 months of age and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis b vaccine, rdna 10 µg/ml - suspension for injection - 10 mcg/dose - active: hepatitis b vaccine, rdna 10 µg/ml excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax formaldehyde potassium thiocyanate sodium chloride water for injection - indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. should also prevent hepatitis d (caused by delta virus) since hepatitis d does not occur in the absence of hepatitis b infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)); mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)); rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ); varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose));   - injection with diluent - 0.5 ml - active: measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)) mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)) rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ) varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose))   excipient: dibasic potassium phosphate dibasic sodium phosphate gelatin minimum essential medium eagle medium 199 monosodium glutamate phenolsulfonphthalein potassium chloride sodium bicarbonate sodium chloride sorbitol sucrose urea water for injection - proquad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

European Union - English - 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.

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

merck sharp & dohme (australia) pty ltd - measles virus, quantity: 3 tcid50; mumps virus, quantity: 4.3 tcid50; rubella virus, quantity: 3 tcid50; live varicella vaccine, quantity: 3.99 pfu - injection, powder for - excipient ingredients: potassium chloride; hydrolysed gelatin; urea; neomycin; sodium bicarbonate; albumin; sodium chloride; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; phenolsulfonphthalein; monosodium glutamate monohydrate; monobasic potassium phosphate; dibasic potassium phosphate; sorbitol; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; 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; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - proquad is indicated for simultaneous immunisation against measles, mumps, rubella and varicella in individuals 12 months through 12 years of age.

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

merck sharp & dohme (australia) pty ltd - measles virus, quantity: 3 tcid50; rubella virus, quantity: 3 tcid50; mumps virus, quantity: 4.3 tcid50; live varicella vaccine, quantity: 3.99 pfu - injection, powder for - excipient ingredients: monobasic sodium phosphate; sodium bicarbonate; albumin; hydrolysed gelatin; sucrose; phenolsulfonphthalein; monobasic potassium phosphate; neomycin; potassium chloride; urea; sorbitol; dibasic potassium phosphate; monosodium glutamate monohydrate; sodium chloride; dibasic sodium phosphate; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; 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; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - proquad is indicated for simultaneous immunisation against measles, mumps, rubella and varicella in individuals 12 months through 12 years of age.