European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vaccines - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz.the use of shingrix should be in accordance with official recommendations.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: glaxosmithkline philippines, inc.; distributor: glaxosmithkline philippines, inc. - herpes zoster vaccine (recombinant, adjuvanted) - powder and suspension for suspension for injection (im) - formulation: after reconstitution, one dose (0.5 ml) contains: varicella zoster virus' glycoprotein e antigen23 50 micrograms. varicella zoster virus = vzv 2adjuvanted with as01b containing plant extract quillaja saponaria molina, fraction 21 (qs-21) 50 micrograms and 3-o-desacyl-4'-monophosphoryl lipid a (mpl) from salmonella minnesota 3glycoprotein e (ge) produced in chinese hamster ovarian (cho) cells by recombinant dna technology 50 micrograms

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

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - ge: recombinant varicella zoster virus (vzv) glycoprotein e 50 ug in 0.5 ml - shingrix is a vaccine indicated for prevention of herpes zoster (hz) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of hz due to immunodeficiency or immunosuppression caused by known disease or therapy. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the data are insufficient to establish if there is vaccine-associated risk with shingrix in pregnant women. a developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during g

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

a-s medication solutions - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - shingrix is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no available human data to establish whether there is vaccine-associated risk with shingrix in pregnant women. a reproductive and developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during gestation, and during lactation. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). this study revealed no adverse e

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

a-s medication solutions - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - shingrix is a vaccine indicated for prevention of herpes zoster (hz) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of hz due to immunodeficiency or immunosuppression caused by known disease or therapy. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the data are insufficient to establish if there is vaccine-associated risk with shingrix in pregnant women. a developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during gestation, and during lactation. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). this study revealed no adverse effects on fetal or pre-weaning development due to shingrix (see data) . data animal data: in a developmental toxicity study, female rats were administered shingrix or the as01b adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation days 3, 8, 11, and 15, and on lactation day 7. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no vaccine-related fetal malformations or variations. risk summary it is not known whether shingrix is excreted in human milk. data are not available to assess the effects of shingrix 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 shingrix and any potential adverse effects on the breastfed child from shingrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness in individuals younger than 18 years have not been established. shingrix is not indicated for prevention of primary varicella infection (chickenpox). adults aged 60 years and older of the total number of subjects who received at least 1 dose of shingrix in studies 1 and 2 (n = 14,645), 2,243 (15%) were aged 60 to 69 years, 6,837 (47%) were aged 70 to 79 years, and 1,921 (13%) were aged 80 years and older. there were no clinically meaningful differences in efficacy across the age groups. [see clinical studies (14.1, 14.2, 14.3).] the frequencies of solicited local and general adverse reactions in subjects aged 70 years and older were lower than in younger adults (aged 50 through 69 years). [see adverse reactions (6.1).] immunocompromised adults aged 65 years and older of the total number of subjects who received at least 1 dose of shingrix in the auhsct study (n = 922), 172 (18.7%) were aged 65 years and older [see clinical studies (14.5)] . there were no clinically meaningful differences in efficacy between these subjects and younger adults (aged 18 through 64 years). of the total number of subjects who received at least 1 dose of shingrix across the 6 studies in immunocompromised subjects (n = 1,587), 337 (21.2%) were aged 65 years and older. the frequencies of solicited local and general adverse reactions in subjects aged 65 years and older were generally similar to or lower than those reported by younger adults (aged 18 through 64 years).

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: aluminium; borax; sodium chloride; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: borax; water for injections; sodium chloride; aluminium - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 40 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: aluminium; water for injections; sodium chloride; borax - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.