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

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

glaxosmithkline biologicals sa - human rotavirus a type g1p(8) strain rix4414 live antigen (unii: kz3l01d2pc) (human rotavirus a type g1p(8) strain rix4414 live antigen - unii:kz3l01d2pc) - human rotavirus a type g1p(8) strain rix4414 live antigen 1000000 [ccid_50] in 1 ml - rotarix is indicated for the prevention of rotavirus gastroenteritis caused by g1 and non-g1 types (g3, g4, and g9) when administered as a 2-dose series [see clinical studies (14.3)] . rotarix is approved for use in infants 6 weeks and up to 24 weeks of age. a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotarix should not receive further doses of rotarix. infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as meckel’s diverticulum) that would predispose the infant for intussusception should not receive rotarix. infants with a history of intussusception should not receive rotarix [see warnings and precautions (5.5)] . in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see adverse reactions (6.2)] . infants with severe combined immunodeficiency disease (scid) should not receive rotarix. postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having scid [see adverse reactions (6.2)] . safety and effectiveness of rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated. the effectiveness of rotarix in pre-term infants has not been established. safety data are available in pre-term infants (rotarix = 134, placebo = 120) with a reported gestational age ≤36 weeks. these pre-term infants were followed for saes up to 30 to 90 days after dose 2. saes were observed in 5.2% of recipients of rotarix as compared with 5.0% of placebo recipients. no deaths or cases of intussusception were reported in this population.

Ireland - English - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - equine rotavirus h2 strain - emulsion for injection - unknown - equine rotavirus vaccine - equine - food - immunological - inactivated vaccine

Ireland - English - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - equine rotavirus h2 strain - emulsion for injection - equine rotavirus - equine - food - immunological - inactivated vaccine

Uganda - English - National Drug Authority

serum institute of india ltd. - live attenuated bovine - human rotavirus reassortant [g1, g2, g3, g4 and g9] - parenteral ordinary vials - ?105.6 ffu / serotype

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences inc.; distributor: n/a - rotavirus vaccine (live, attenuated) - freeze-dried powder for oral suspension - formulation: after reconstitution, each dose (2.5 ml) contains: live attenuated bovine-human rotavirus reassortant [g1, g2, g3, g4 and g9]* >10^5.6 ffu/serotype *grown on vero cells

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences, inc.; distributor: faberco life sciences, inc. - rotavirus vaccine, (live attenuated) - oral suspension - formulation: each dose (2 ml) contains: live, attenuated bovine - human rotavirus reassortant [g1, g2, g3, g4, and g9]* *grown on vero cells **ffu= focus-forming unit ***ccid= cell culture infectious disease ≥105.6 ffu**/serotype (nlt 6.30 log10 ccid 50*** per dose)

Kenya - English - Pharmacy and Poisons Board

serum institute of india pvt. ltd 212/2 hadapsar, off soli-poonawalla road, pune- - live attenuated rotavirus vaccine (oral) - oral drops - each dose of 2.5 ml contains live attenuated… - rota virus pentavalent live reassorted

Kenya - English - Pharmacy and Poisons Board

live attenuated rotavirus vaccine (oral) - oral drops, liquid - each dose of 2.5 ml contains: live attenuated… - rota virus pentavalent live reassorted

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 -