SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG0.5ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Recombinant Varicella Zoster Virus glycoprotein E

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J07BK

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION

Composition:

Recombinant Varicella Zoster Virus glycoprotein E 50mcg/0.5mL

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Biologicals SA

Authorization status:

ACTIVE

Authorization date:

2021-01-12

Summary of Product characteristics

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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.
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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