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)

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).

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

seqirus pty ltd - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) (unii: a5wli8wk8a) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:37h6eg2naq), influenza b vi - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 5 years of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated backg

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

boehringer ingelheim animal health australia pty. ltd. - canine parainfluenza; bordetella bronchiseptica; canine adeno virus type 2 - misc. vaccines or anti sera - canine parainfluenza vaccine active 0.0 p; bordetella bronchiseptica vaccine-microbial active 0.0 p; canine adeno virus type 2 vaccine-viral active 0.0 p - immunotherapy - dog - over 8 weeks - bordetella bronchiseptica | canine adenovirus - type 2 | canine parainfluenza | canine cough syndrome | infectious tracheobronchitis

European Union - English - EMA (European Medicines Agency)

idt biologika gmbh - inactivated influenza a virus/human - immunologicals, inactivated viral vaccines for pigs, porcine influenza virus - pigs - active immunisation of pigs from the age of 8 weeks onwards against pandemic h1n1 porcine influenza virus to reduce viral lung load and viral excretion.

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

merck sharp & dohme llc - measles virus strain enders' attenuated edmonston live antigen (unii: mfz8i7277d) (measles virus strain enders' attenuated edmonston live antigen - unii:mfz8i7277d), mumps virus strain b level jeryl lynn live antigen (unii: 47qb6mx9ku) (mumps virus strain b level jeryl lynn live antigen - unii:47qb6mx9ku), rubella virus strain wistar ra 27/3 live antigen (unii: 52202h034z) (rubella virus strain wistar ra 27/3 live antigen - unii:52202h034z), varicella-zoster virus strain oka/merck live antigen (unii: gpv - measles virus strain enders' attenuated edmonston live antigen 1000 [tcid_50] in 0.5 ml - proquad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. do not administer proquad to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {1} or to a previous dose of m-m-r ii (measles, mumps, rubella, live), proquad or varivax (varicella virus vaccine live) vaccine, or any other measles, mumps, and rubella or varicella-containing vaccine. do not administer proquad to individuals with a history of anaphylaxis to neomycin [see description (11)] . do not administer proquad vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. measles inclusion body encephalitis {2} (mibe), pneumonitis {3} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. in this population, disseminated mump

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

deseret biologicals, inc. - influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated) (unii: xqo8062u6r) (influenza a virus a/california/7/2009 x-179a (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c8e791ro82) - influenza a virus a/california/7/2009 x-179a (h1n1) hemagglutinin antigen (formaldehyde inactivated) 9 [hp_x] in 1 ml

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

biocsl pty ltd. - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (propiolactone inactivated) (unii: bh0r06yxfz) (influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:mhg4xw7big), influenza a virus a/south australia/55/2014 ivr-175 (h3n2) antigen (propiolactone inactivated) (unii: 5087bpo79o) (influenza a virus a/south australia/55/2014 ivr-175 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:9a68j3t9te), influenza b virus b/phuket/3073/2013 ant - influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b present in the vaccine. afluria is approved for use in persons 5 years of age and older. afluria is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy category b: a reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to afluria. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, afluria should be given to a pregnant woman only if clearly needed. in the reproductive and developmental toxicity study, the effect

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

seqirus pty ltd - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) (unii: a5wli8wk8a) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:37h6eg2naq), influenza b vi - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b present in the vaccine. afluria is approved for use in persons 5 years of age and older. afluria is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy category b: a reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to afluria. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, afluria should be given to a pregnant woman only if clearly needed. in the reproductive and developmental toxicity study, the effect

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - measles, live attenuated; rubella, live attenuated -