Den europeiske union - dansk - EMA (European Medicines Agency)

vbi vaccines b.v. - hepatitis b overflade antigen - hepatitis b - vacciner - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Den europeiske union - svensk - EMA (European Medicines Agency)

vbi vaccines b.v. - hepatit b-ytantigen - hepatit b - vacciner - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Den europeiske union - gresk - EMA (European Medicines Agency)

vbi vaccines b.v. - επιφανειακό αντιγόνο ηπατίτιδας Β - Ηπατίτιδα Β - Εμβόλια - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

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

fmc - mcpa as ehe(600g/l) - emulsifiable - group i herbicide - barley - see label for exceptions | cereal rye - see label | oats - see label for varieties | triticale - see label | wheat - se - bathurst burr | capeweed | charlock | dandelion - taraxacum officinale | fat hen | fumitory | hedge or wild mustard | lincoln weed, sand rocket or mustard | london rocket | noogoora burr | paterson's curse | saffron thistle | scotch thistle | skeleton weed | slender, shore or sheep thistle | spear or black thistle | stinkwort | turnip weed | variegated thistle | volunteer canola | volunteer safflower | volunteer sunflower | wild radish or radish weed | wild sage | wild turnip | blessed thistle | brassica campestris | brassica kaber | brassica rapa ssp. sylvestris | brassica rapa var. sylvestris | brassica sinapistrum | bull thistle | cabbage thistle | carduus marianus | cockleburr | common dandelion | cotton thistle | crambling mustard | echium lycopsis | echium spp. | english dandelion | european dandelion | false star thistle | giant mustard | hedge mustard | heraldic thistle | holy thistle | jointed charlock | lady's thistle | milk thistle | pink weed | purple bugloss | purple viper's bugloss | radish (wil

Den europeiske union - italiensk - EMA (European Medicines Agency)

vbi vaccines b.v. - antigene di superficie dell'epatite b. - epatite b - vaccini - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Den europeiske union - bulgarsk - EMA (European Medicines Agency)

vbi vaccines b.v. - повърхностен антиген на хепатит В - Хепатит Б - Ваксини - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

vbi vaccines b.v. - antigen tal-wiċċ ta 'l-epatite b - epatite b - vaċċini - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

USA - engelsk - NLM (National Library of Medicine)

vbi vaccines (delaware) inc. - recombinant hepatitis b surface antigen (isoform s) (unii: 2u8266yw9l) (recombinant hepatitis b surface antigen (isoform s) - unii:2u8266yw9l), recombinant hepatitis b surface antigen (isoform m) (unii: snd8hl4kqg) (recombinant hepatitis b surface antigen (isoform m) - unii:snd8hl4kqg), recombinant hepatitis b surface antigen (isoform l) (unii: c6pfs5dx5y) (recombinant hepatitis b surface antigen (isoform l) - unii:c6pfs5dx5y) - prehevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. prehevbrio is approved for use in adults 18 years of age and older. do not administer prehevbrio to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b vaccine or to any component of prehevbrio [see description ( 11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prehevbrio during pregnancy. women who receive prehevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in clinically recognized pregnancies in the us general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. there are no adequate and well-controlled studies of prehevbrio in pregnant women. available human data on prehevbrio administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of prehevbrio on four occasions; twice prior to mating, twice during gestation. the study revealed no evidence of harm to the fetus due to the vaccine [see animal data below]. data animal data a developmental toxicity study has been performed in female rats using a dose equivalent to the adult human dose. in the study, female rats received 0.5 ml (2 x 0.25 ml injections) of a vaccine formulation containing 10 mcg hbsag (s, pre-s1, pre-s2) adsorbed on to aluminum hydroxide by intramuscular injection 30 days and 15 days prior to mating and on gestation days 4 and 15. no adverse effects of pre-weaning development were observed. there was no evidence of fetal malformations or variations. risk summary it is not known whether prehevbrio is excreted in human milk. data are not available to assess the effects of prehevbrio on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prehevbrio and any potential adverse effects on the breastfed child from prehevbrio or from the underlying maternal condition. for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of prehevbrio have not been established in individuals less than 18 years of age. study 1 included 296 adults 65 through 86 years of age who received prehevbrio. among subjects who received prehevbrio, a seroprotective level of antibody to hbsag was achieved in 83.6% of those ≥ 65 years of age compared to 94.8% in adults 45 through 64 years of age and 99.2% in adults 18 through 44 years of age [see evaluation of immunogenicity ( 14.1)]. frequencies of local and systemic solicited adverse reactions were generally lower in elderly subjects ≥65 years of age than in younger subjects [see adverse reactions ( 6)]. safety and effectiveness of prehevbrio have not been established in adults on hemodialysis.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

alfasigma s.p.a. - methylthioninium chloride - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Den europeiske union - tsjekkisk - EMA (European Medicines Agency)

alfasigma s.p.a. - methylthioniniumchloridu - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.