Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - varicella zoster virus glycoprotein e antigen - powder and suspension for suspension for injection - varicella zoster virus glycoprotein e antigen 50 mcg - zoster, purified antigen - 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.

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

glaxosmithkline australia pty ltd - recombinant varicella zoster virus glycoprotein e antigen, quantity: 50 microgram - injection, powder for - excipient ingredients: sucrose; monobasic sodium phosphate dihydrate; dibasic potassium phosphate; polysorbate 80 - shingrix is indicated for the prevention of herpes zoster (hz) and post-herpetic neuralgia in: - adults 50 years of age or older; - adults 18 years of age or older at increased risk of hz.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - live attenuated oka/merck strain of varicella-zoster virus - powder and solvent for suspension for injection - live attenuated oka/merck strain of varicella-zoster virus 19400 pfu / 0.65 ml - zoster, live attenuated - zoster, live attenuated - zostavax is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.

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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - recombinant varicella zoster virus glycoprotein e 50ug - suspension for injection - 50 mcg - active: recombinant varicella zoster virus glycoprotein e 50ug excipient: dibasic potassium phosphate monobasic sodium phosphate as dihydrate polysorbate 80 sucrose cholesterol dibasic sodium phosphate dioleoylphosphatidylcholine monobasic potassium phosphate monophosphoryl lipid a quillaja saponaria sodium chloride water for injection - shingrix is indicated for the 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.

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.

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

aptevo biotherapeutics llc - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 125 [iu] - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

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

cangene biopharma - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 1.25 [iu] in 1 ml - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. pregnancy category c. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 adverse reactions and 14 clinical studies]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing moth

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

diasorin australia pty ltd - ct756 - varicella zoster virus (human herpesvirus 3) ivds - for in vitro diagnostic use in testing to provide information about infection with or exposure to the varicella zoster virus.