ZOSTAVAX Refrigerator Stable Formulation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LIVE ATTENUATED OKA/MERCK STRAIN OF VARICELLA-ZOSTER VIRUS

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

J07BK

Dosage:

19,400 pfu/dose

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Composition:

LIVE ATTENUATED OKA/MERCK STRAIN OF VARICELLA-ZOSTER VIRUS 19,400 pfu/dose

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Sharp & Dohme LLC

Authorization status:

ACTIVE

Authorization date:

2008-10-30

Patient Information leaflet

SG-V211-ZST-R-I-022014 

PRODUCT CIRCULAR 

ZOSTAVAX
p

ZOSTER VACCINE LIVE (OKA/MERCK) 
REFRIGERATOR STABLE 

I. THERAPEUTIC 
CLASS 

ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of
live, attenuated varicella-zoster virus 
(VZV). 

II. INDICATIONS 

ZOSTAVAX is indicated for prevention of herpes zoster (shingles) 

ZOSTAVAX is indicated for immunization of individuals 50 years of age
or older. 

III. 
DOSAGE AND ADMINISTRATION 
_ _
FOR SUBCUTANEOUS ADMINISTRATION. 

Do not inject intravascularly. 

Individuals should receive a single dose.  At present, the duration
of protection after vaccination with 
ZOSTAVAX is unknown.  In the Shingles Prevention Study (SPS),
protection was demonstrated through 
4 years of follow-up.  The need for revaccination has not yet been
defined. 

ZOSTAVAX is not a treatment for zoster or PHN. 

ZOSTAVAX can be administered concomitantly with inactivated
influenza vaccine using separate 
syringes. 

Reconstitute immediately upon removal from the refrigerator. 

To reconstitute the vaccine, use only the diluent supplied, since it
is free of preservatives or other antiviral 
substances which might inactivate the vaccine virus. 

Prefilled syringe of diluent: 
To reconstitute the vaccine, inject all the diluent in the syringe
into the vial of lyophilized vaccine and 
gently agitate to mix thoroughly.  Withdraw the entire contents
into a syringe and inject the total volume of 
reconstituted vaccine subcutaneously, preferably into the upper arm
(preferably in the deltoid region). 

IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY
AFTER 
RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD
RECONSTITUTED VACCINE IF IT 
IS NOT USED WITHIN 30 MINUTES. 

Do not freeze reconstituted vaccine. 

CAUTION: A sterile syringe free of preservatives, antiseptics, and
detergents should be used for each 
injection and/or reconstitution of ZO

Summary of Product characteristics

S-WPC-V211-R-I-052018
PRODUCT CIRCULAR
ZOSTAVAX®
Zoster Vaccine Live (Oka/Merck)
Refrigerator stable
I.
THERAPEUTIC CLASS
ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live,
attenuated varicella-zoster virus
(VZV).
II.
INDICATIONS
ZOSTAVAX is indicated for prevention of herpes zoster (shingles).
ZOSTAVAX is indicated for immunization of individuals 50 years of age
or older.
III.
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION.
Do not inject intravascularly.
Individuals should receive a single dose. At present, the duration of
protection after vaccination with
ZOSTAVAX is unknown. In the Shingles Prevention Study (SPS),
protection was demonstrated through 4
years of follow-up. The need for revaccination has not yet been
defined.
ZOSTAVAX is not a treatment for zoster or PHN.
ZOSTAVAX
can
be
administered
concomitantly
with
inactivated
influenza
vaccine
using
separate
syringes.
Reconstitute immediately upon removal from the refrigerator.
To reconstitute the vaccine, use only the diluent supplied, since it
is free of preservatives or other antiviral
substances which might inactivate the vaccine virus.
Prefilled syringe of diluent:
To reconstitute the vaccine, inject all the diluent in the syringe
into the vial of lyophilized vaccine and
gently agitate to mix thoroughly. Withdraw the entire contents into a
syringe and inject the total volume of
reconstituted vaccine subcutaneously, preferably into the upper arm
(preferably in the deltoid region).
IT
IS
RECOMMENDED
THAT
THE
VACCINE
BE
ADMINISTERED
IMMEDIATELY
AFTER
RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD RECONSTITUTED
VACCINE IF IT
IS NOT USED WITHIN 30 MINUTES.
Do not freeze reconstituted vaccine.
CAUTION: A sterile syringe free of preservatives, antiseptics, and
detergents should be used for each
injection and/or reconstitution of ZOSTAVAX because these substances
may inactivate the vaccine virus.
A separate sterile needle and syringe should be used for
administration of ZOSTAVAX to prevent transfer
of infectious diseases.
N