VARIVAX (Refrigerated)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Varicella Virus Vaccine Live (Oka/Merck)

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

J07BK01

Dosage:

2700 PFU/mL

Pharmaceutical form:

INJECTION

Composition:

Varicella Virus Vaccine Live (Oka/Merck) 2700 PFU/mL

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Sharp & Dohme LLC

Authorization status:

ACTIVE

Authorization date:

2005-04-14

Patient Information leaflet

SG-WPC-V210-I-ref-062013

VARIVAX
®

[VARICELLA VIRUS VACCINE LIVE]  

Refrigerator-stable formulation  
DESCRIPTION  
VARIVAX [Varicella Virus Vaccine Live] is a preparation of
the Oka/Merck strain of live, attenuated varicella 
virus. The virus was initially obtained from a child with wild-type
varicella, then introduced into human embryonic 
lung cell cultures, adapted to and propagated in embryonic guinea
pig cell cultures and finally propagated in 
human diploid cell cultures (WI-38). Further passage of the
virus for varicella vaccine was performed at Merck 
Research Laboratories (MRL) in human diploid cell cultures (MRC-5)
that were free of adventitious agents. This 
live, attenuated varicella vaccine is a lyophilized preparation
containing sucrose, phosphate, glutamate, processed 
gelatin, and urea as stabilizers.  
Refrigerator-stable VARIVAX, when reconstituted as directed, is a
sterile preparation for subcutaneous 
administration. Each 0.5 mL dose contains the following: a minimum
of 1350 plaque forming units (PFU) of 
Oka/Merck varicella virus when reconstituted and stored at room
temperature for 30 minutes, approximately 18 mg 
of sucrose, 8.9 mg hydrolyzed gelatin, 3.6 mg of urea, 2.3 mg of
sodium chloride, 0.36 mg of monosodium L-
glutamate, 0.33 mg of sodium phosphate dibasic, 57 mcg of potassium
phosphate monobasic, 57 mcg of 
potassium chloride. The product also contains residual components
of MRC-5 cells including DNA and protein and 
trace quantities of neomycin and bovine
calf serum from MRC-5 culture media. The product contains no 
preservative.  

VACCINE VIAL  
During shipment, to ensure that there is no loss of potency, the
vaccine must be maintained at a temperature of 
2 to 8°C or colder (36 to 46°F or colder).  
Before reconstitution, refrigerator-stable VARIVAX has a shelf-life of
24 months when refrigerated at 2 to 8°C or 
colder (36 to

Summary of Product characteristics

S-SG-WPC-V210-I-ref-032023
VARIVAX® (Refrigerated)
[Varicella Virus Vaccine Live (Oka/Merck)]
Refrigerator-stable formulation
DESCRIPTION
VARIVAX [Varicella Virus Vaccine Live] is a preparation of the
Oka/Merck strain of live, attenuated varicella virus.
The virus was initially obtained from a child with wild-type
varicella, then introduced into human embryonic lung
cell cultures, adapted to and propagated in embryonic guinea pig cell
cultures and finally propagated in human
diploid cell cultures (WI-38). Further passage of the virus for
varicella vaccine was performed at Research
Laboratories of Merck Sharp & Dohme, LLC, Rahway, NJ, USA in human
diploid cell cultures (MRC-5) that were
free of adventitious agents. This live, attenuated varicella vaccine
is a lyophilized preparation containing sucrose,
phosphate, glutamate, processed gelatin, and urea as stabilizers.
Refrigerator-stable
VARIVAX,
when
reconstituted
as
directed,
is
a
sterile
preparation
for
subcutaneous
administration. Each 0.5 mL dose contains the following: a minimum of
1350 plaque forming units (PFU) of
Oka/Merck varicella virus when reconstituted and stored at room
temperature for 30 minutes, approximately 17 mg
of sucrose, 8.3 mg of hydrolyzed gelatin, 3.5 mg of urea, 2.1 mg of
sodium chloride, 0.33 mg of monosodium
L-glutamate, 0.30 mg of sodium phosphate dibasic, 53 mcg of potassium
phosphate monobasic, 53 mcg of
potassium chloride. The product also contains residual components of
MRC-5 cells including DNA and protein and
trace quantities of neomycin and bovine calf serum from MRC-5 culture
media. The product contains no
preservative.
Vaccine Vial
During shipment, to ensure that there is no loss of potency, the
vaccine must be maintained at a temperature of 2
to 8°C or colder (36 to 46°F or colder), but not exceed temperatures
lower than -50°C (-58°F). Use of dry ice may
subject VARIVAX to temperatures colder than -50°C (-58°F).
Before reconstitution, refrigerator-stable VARIVAX has a shelf-life of
24 months when refrigerated at 2 to 8