Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - rotavirus g1 reassortant; rotavirus g2 reassortant; rotavirus g3 reassortant; rotavirus g4 reassortant; rotavirus p1a[8] reassortant - oral solution - rotavirus p1a[8] reassortant 2.3 x10 ^6 iu/dose; rotavirus g2 reassortant 2.8 x10 ^6 iu/dose; rotavirus g4 reassortant 2.0 x10^ 6 iu/dose; rotavirus g3 reassortant 2.2 x10 ^6 iu/dose; rotavirus g1 reassortant 2.2 x10 ^6 iu/dose - rota virus diarrhea vaccines - rotateq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types g1, g2, g3, g4, and g9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. the first dose of rotateq should be administered between 6 and 12 weeks of age

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

merck sharp & dohme (australia) pty ltd - rotavirus g2 human-bovine reassortant, quantity: 1400000 infectious unit/ml; rotavirus g3 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g1 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g4 human-bovine reassortant, quantity: 1000000 infectious unit/ml; rotavirus p1 [8] human-bovine reassortant, quantity: 1150000 infectious unit/ml - oral liquid - excipient ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; monobasic sodium phosphate; glucose monohydrate; sodium ascorbate; sodium chloride; ammonium metavanadate; calcium chloride dihydrate; cupric sulfate pentahydrate; ferric nitrate nonahydrate; ferrous sulfate heptahydrate; magnesium chloride hexahydrate; dried magnesium sulfate; manganese sulfate tetrahydrate; ammonium molybdate; potassium chloride; sodium acetate; sodium bicarbonate; dibasic sodium phosphate; zinc sulfate heptahydrate; alanine; arginine hydrochloride; asparagine; aspartic acid; cysteine hydrochloride; cystine dihydrochloride; glutamic acid; glycine; histidine hydrochloride monohydrate; hydroxyproline; isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine disodium; valine; biotin; ergocalciferol; choline chloride; folic acid; inositol; menadione; nicotinamide; nicotinic acid; aminobenzoic acid; calcium pantothenate; pyridoxal hydrochloride; pyridoxine hydrochloride; retinol acetate; riboflavine; dl-alpha-tocopheryl phosphate disodium; thiamine hydrochloride; cyanocobalamin; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine monophosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride; sodium hypoxanthine; linoleic acid; alpha lipoic acid; phenolsulfonphthalein; putrescine dihydrochloride; sodium pyruvate; ribose; thymidine; thymine; uracil; sodium xanthine; monoethanolamine; 2-mercaptoethanol; adenosine; uridine; cytidine; guanosine; dexamethasone; epidermal growth factor; hydrocortisone; insulin; alprostadil; liothyronine; ascorbic acid; magnesium sulfate heptahydrate; monobasic sodium phosphate monohydrate; zinc sulfate; arginine; cysteine; cystine; histidine; lysine; tyrosine; adenosine triphosphate; guanine; putrescine - rotateq is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - equine rotavirus (inactivated); apramycin; amphotericin b; neomycin; thiomersal - misc. vaccines or anti sera - equine rotavirus (inactivated) biological active 1.0 rp; apramycin antibiotic other 0.0 p; amphotericin b antibiotic other 0.0 p; neomycin antibiotic other 0.0 p; thiomersal mercury other 0.1 % - immunotherapy - horse pregnant - rotavirus enteritis | vaccine | equine rotavirus

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; 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; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis. see section 5.1 pharmacodynamic properties - clinical trials.

Ireland - English - HPRA (Health Products Regulatory Authority)

zoetis belgium s.a. - equine rotavirus h2 strain - emulsion for injection - . - equine rotavirus - horses - immunological - inactivated vaccine

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; 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; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; 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; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirus serotype g1, serotype g2, serotype g3, serotype g4, serotype p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.rotateq is to be used on the basis of official recommendations.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

glaxosmithkline biologicals, s.a. - rotavirus humano, vivo atenuado, cepa rix4414 - rotavirus humano, vivo atenuado, cepa rix4414....no menos de 10x6 ccid50

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - rotavirus reassortant strain g1 2.2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g2 2.8e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g3 2.2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain g4 2e+006 [iu] (nlt, at expiry); rotavirus reassortant strain p1 2.3e+006 [iu] (nlt, at expiry) - oral solution - 2 ml - active: rotavirus reassortant strain g1 2.2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g2 2.8e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g3 2.2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain g4 2e+006 [iu] (nlt, at expiry) rotavirus reassortant strain p1 2.3e+006 [iu] (nlt, at expiry) excipient: rotavirus diluent & lpkm-3 (from actives) to approx 0.3 ml. includes animal materials as below. monobasic sodium phosphate monohydrate polysorbate 80 purified water sodium citrate dihydrate sodium hydroxide sucrose - rotateq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes g1, g2, g3, g4, and g-serotypes that contain p1a[8] (e.g., g9). rotateq may be administered as early as six weeks of age.