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.

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.

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 - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme australia pty ltd - rotavirus g2 human-bovine reassortant; rotavirus g1 human-bovine reassortant; rotavirus g4 human-bovine reassortant; rotavirus g3 human-bovine reassortant; rotavirus p1 [8] human-bovine reassortant -

Canada - English - Health Canada

merck canada inc - human-bovine rotavirus reassortant type g1; human-bovine rotavirus reassortant type g2; human-bovine rotavirus reassortant type g3; human-bovine rotavirus reassortant type g4; human-bovine rotavirus reassortant type p1(8) - solution - 2210000unit; 2840000unit; 2220000unit; 2040000unit; 2290000unit - human-bovine rotavirus reassortant type g1 2210000unit; human-bovine rotavirus reassortant type g2 2840000unit; human-bovine rotavirus reassortant type g3 2220000unit; human-bovine rotavirus reassortant type g4 2040000unit; human-bovine rotavirus reassortant type p1(8) 2290000unit - vaccines

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

ecolab pty ltd - hydrogen peroxide; peroxyacetic acid - liquid - hydrogen peroxide ungrouped active 308.0 g/l; peroxyacetic acid acid-general active 65.0 g/l - disinfectant - dairy or milking shed | farm | pig sheds | poultry farm | pig shed - bovine rootavirus | bovine viral diarrhoea virus | clostridium perfringens | escherichia coli (e. coli) | feline calicivirus | human coronavirus | infectious bovine rhinotracheitis (ibr) | infectious bronchitis | infectious bursal disease | influenza a (h10n7), (h1n1), (h3n2) | influenza b | newcastle disease | proteus spp. | reovirus (c08) | salmonella enteridis | salmonella spp. | salmonella typhimurium | staphylococcus aureus | streptococcus spp. | bursal disease | calicivirus (feline) | fcv | including b-lactamase producin | infectious bronchitis nephriti

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

intervet australia pty limited - bovine rotavirus (ncdv); clostridium perfringens type c toxoid; escherichia coli k99 pilus antigens; clostridium perfringens type d toxoid; bovine coronavirus (inactivated) - misc. vaccines or anti sera - bovine rotavirus (ncdv) biological-virus active 1.0 rp; clostridium perfringens type c toxoid vaccine-toxoid active 10.0 iu/ml; escherichia coli k99 pilus antigens vaccine-microbial active 1.0 rp; clostridium perfringens type d toxoid vaccine-toxoid active 2.0 iu/ml; bovine coronavirus (inactivated) vaccine-viral active 1.0 rp - immunotherapy - cow | healthy pregnant heifer | bovine | female cattle - bovine rotaviruses | neonatal calf diarrhea | neonatal enterotoxemia | raise colostral antibodies | against bovine rotavirus and | coronavirus | enterotoxigenic e.coli pilus | g6 and g10 | type k99

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

merck sharp & dohme llc - human rotavirus a type g1p7(5) strain wi79 live antigen (unii: 25vc15141q) (human rotavirus a type g1p7(5) strain wi79 live antigen - unii:25vc15141q), human rotavirus a type g2p7(5) strain sc2 live antigen (unii: ju499is53h) (human rotavirus a type g2p7(5) strain sc2 live antigen - unii:ju499is53h), human rotavirus a type g3p7(5) strain wi78 live antigen (unii: 236ygp181o) (human rotavirus a type g3p7(5) strain wi78 live antigen - unii:236ygp181o), human rotavirus a type g4p7(5) strain brb live antigen - human rotavirus a type g1p7(5) strain wi79 live antigen 2200000 [iu] in 2 ml - 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 [see dosage and administration (2)] . a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotateq should not receive further doses of rotateq. infants with severe combined immunodeficiency disease (scid) should not receive rotateq. post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered rotateq and later identified as having scid [see adverse reactions (6.2)] . infants with a history of intussusception should not receive rotateq. rotateq is not approved for individuals 32 weeks of age and older. no human or

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

merck sharp & dohme b.v. waarderweg 39 - rotavirus type g1, rotavirus type g2, rotavirus type g3, rotavirus type g4, rotavirus type p1a - solution oral - not less than 2,2x10^6iu+ not less than 2,8x106iu+ not less than 2,2x10^6iu+ not less than 2x10^6iu+ not less than 2,3x10^6iu