ZOSTAVAX [ ZOSTER VACCINE LIVE (OKA/MERCK), MSD]

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ZOSTER VACCINE LIVE OKA/MERCK

Available from:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Name):

ZOSTER VACCINE LIVE OKA/MERCK

Units in package:

1Units Units; 10Units Units

Manufactured by:

MERCK SHARP & DOHME CORP.

Summary of Product characteristics

ZOSTAVAX ® S-LPC -V211 -ZST -R-I-052018
Zoster Vaccine Live (Oka/Merck) , MSD
COPYRIGHT © 201 8 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, U.S.A.
All rights reserved. 1
LOCAL PRODUCT CIRCULAR
ZOSTAVAX ®
Zoster Vaccine Live (Oka/Merck) , MSD
Refrigerator stable
I. THERAPEUTIC CLASS
ZOSTAVAX is a lyophilized preparation of the Oka/M erck strain of live, attenuated varicella -
zoster virus (VZV ) for reconstitution containing not less than 19,400 plaque -forming units [PFU]
per 0.65mL dose supplied as single dose vials .
II. CLINICAL PHARMACOLOGY
Herpes Zoster
Herpes zoster (HZ), commonly known as shingles or simply “ zoster,” is a manifestation of the
reactivation of VZV, which, as a primary infection, produces chickenpox (varicella). Following
initial infection, the virus remains latent in the dorsal root or cranial sensory ganglia until it
reactivates, producing zoster. Zoster is usually characterized by a unilateral, painful, ves icular
cutaneous eruption with a dermatomal distribution.
Although the blistering rash is the most distinctive feature of zoster, the most frequently
debilitating symptom is pain, which may occur during the prodrome, the acute eruptive phase,
and the post herpetic phase of the infection. During the acute eruptive phase, local pain has
been reported to occur in up to 90% of immunocompetent individuals.
Anyone who has been infected with VZV, including those without a clinical history of varicella, is
at ris k for developing zoster, which is considered to be due to waning immunity to VZV. Nearly
all adults (~98%) in the U.S. are susceptible to zoster, where an estimated 1 million cases occur
annually. This number is expected to rise as the mean age of the pop ulation increases. The