Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
Recombinant Varicella Zoster Virus glycoprotein E
GLAXOSMITHKLINE PTE LTD
J07BK
INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
Recombinant Varicella Zoster Virus glycoprotein E 50mcg/0.5mL
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals SA
ACTIVE
2021-01-12
_ _ _ _ - 1 - SHINGRIX HERPES ZOSTER (HZ, OR SHINGLES) VACCINE (NON-LIVE RECOMBINANT, AS01 B ADJUVANTED) QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen 1 adjuvanted with AS01 B 2 . 1 Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells 2 The GlaxoSmithKline proprietary AS01 B Adjuvant System is composed of the plant extract _Quillaja saponaria_ Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4’- monophosphoryl lipid A (MPL) from _Salmonella minnesota_ (50 micrograms) The powder is white. The suspension is an opalescent, colourless to pale brownish liquid. PHARMACEUTICAL FORM Powder and suspension for suspension for injection. CLINICAL PARTICULARS INDICATIONS _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 due to immunodeficiency or immunosuppression caused by known disease or therapy. The vaccine’s effect on the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. The use of _Shingrix_ should be based on official recommendations. DOSAGE AND ADMINISTRATION The immunisation schedule for _Shingrix_ should be based on official recommendations. POSOLOGY The primary vaccination schedule consists of two doses of 0.5 ml each; an initial dose followed by a second dose 2 to 6 months later. _ _ _ _ - 2 - For subjects who are immunodeficient, immunosuppressed or likely to become immunosuppressed due to known disease or therapy, and whom would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initial dose (see _Pharmacodynamic Effects_). The need for booster doses has not been established. _Shingrix_ can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see _Pharmacodynamic Effects_). _S Lue koko asiakirja