Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, oka strain, live, attenuated - powder and solvent for solution for injection - varicella virus oka strain (live, attenuated) 10 pfu/dose - vaccines

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, vaccine live, oka, merck - powder and solvent for solution for injection - varicella virus vaccine live (oka/merck) 10 pfu/dose - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - live attenuated measles virus (schwarz strain); live attenuated mumps virus (rit 4385 strain); live attenuated rubella virus (wistar ra 27/3 strain); live attenuated varicella virus (oka strain) - powder and solvent for solution for injection in pre-filled syringe - unknown - measles vaccines; measles, combinations with mumps, rubella and varicella, live attenuated

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - live attenuated measles virus (schwarz strain); live attenuated mumps virus (rit 4385 strain); live attenuated rubella virus (wistar ra 27/3 strain); live attenuated varicella virus (oka strain) - powder and solvent for solution for injection - unknown - measles vaccines; measles, combinations with mumps, rubella and varicella, live attenuated

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - live attenuated measles virus; live attenuated mumps virus; live attenuated rubella virus; live attenuated varicella virus - powder and solvent for solution for injection - live attenuated measles virus 10^ 3.0 ccid50; live attenuated mumps virus 10^ 4.4 ccid50; live attenuated rubella virus 10^ 3.0 ccid50; live attenuated varicella virus 10^ 3.3 pfu - measles, combinations with mumps, rubella and varicella, live attenuated - measles, combinations with mumps, rubella and varicella, live attenuated - priorix-tetra is indicated for active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age.

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - immunology - a test system consisting of one or multiple reagents and other items intended to identify antibodies to or antigens from the varicella-zoster virus, a herpes virus, in serum. the identification aids in the diagnosis of chicken pox or shingles and provides epidemiological information on these diseases.

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).

Canada - English - Health Canada

merck frosst canada & cie, merck frosst canada & co. - varicella-zoster virus vaccine live attenuated (oka/merck strain) - powder for solution - 1350unit - varicella-zoster virus vaccine live attenuated (oka/merck strain) 1350unit - vaccines

Canada - English - Health Canada

merck frosst canada & cie, merck frosst canada & co. - varicella-zoster virus vaccine live attenuated (oka/merck strain) - powder for solution - 1350unit - varicella-zoster virus vaccine live attenuated (oka/merck strain) 1350unit - vaccines