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.

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

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.

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).

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

sanofi pasteur inc. - yellow fever virus strain 17d-204 live antigen (unii: py4eet359t) (yellow fever virus strain 17d-204 live antigen - unii:py4eet359t) - yellow fever virus strain 17d-204 live antigen 4.74 [pfu] in 0.5 ml - yf-vax is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: while the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. greater risk is associated with living in or traveling to areas of south america and africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone. some countries require an individual to have a valid international certificate of vaccination or prophylaxis (icvp) if the individual has been in countries either known or thought to harbor yellow fever virus. the certificate becomes valid 10 days after vaccination with yf-vax. (13) (14)

Kenya - English - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

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

merck sharp & dohme llc - varicella-zoster virus strain oka/merck live antigen (unii: gpv39zgd8c) (varicella-zoster virus strain oka/merck live antigen - unii:gpv39zgd8c) - varicella-zoster virus strain oka/merck live antigen 19400 [pfu] in 0.65 ml - zostavax® is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. limitations of use of zostavax: - zostavax is not indicated for the treatment of zoster or postherpetic neuralgia (phn). - zostavax is not indicated for prevention of primary varicella infection (chickenpox). do not administer zostavax to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. {1} do not administer zostavax to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, aids or other clinical manifestations of infection with human immunodeficiency

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - human rotavirus, live, attenuated, rix 4414 strain - suspension - not less than 10⁶ ccid₅₀/dose (1.5 ml) - human rotavirus, live, attenuated, rix 4414 strain not less than 10⁶ ccid₅₀/dose (1.5 ml)

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - human rotavirus, live, attenuated, rix 4414 strain - suspension - not less than 10⁶ ccid₅₀/dose (1.5 ml) - human rotavirus, live, attenuated, rix 4414 strain not less than 10⁶ ccid₅₀/dose (1.5 ml)