Shingrix Powder and Suspension for Suspension for Injection (IM)

Maa: Filippiinit

Kieli: englanti

Lähde: FDA (Food And Drug Administration)

Aktiivinen ainesosa:

Herpes Zoster Vaccine (recombinant, adjuvanted)

Saatavilla:

N/A; Importer: GlaxoSmithKline Philippines, Inc.; Distributor: GlaxoSmithKline Philippines, Inc.

INN (Kansainvälinen yleisnimi):

Herpes Zoster Vaccine (recombinant, adjuvanted)

Annos:

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

Lääkemuoto:

Powder and Suspension for Suspension for Injection (IM)

Kpl paketissa:

3 mL Type I colorless glass vial with bromobutyl rubber stopper and brown flip-off cap (lyophilized vaccine) + 0.5 mL in 3 mL Type I colorless glass vial with chlorobutyl rubber stopper and blue green flip-off cap (adjuvant as suspension), 3 mL Type I colorless glass vial with bromobutyl rubber stopper and brown flip-off cap (lyophilized vaccine) + 0.5 mL in 3 mL Ty

Valmistaja:

GlaxoSmithKline Biologicals S.A., Belgium

Tuoteyhteenveto:

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

Valtuutus päivämäärä:

2023-05-02