ProQuad Refrigerator Stable Formulation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Measles virus; Mumps Virus; Rubella Virus; Varicella Virus

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

J07BD54

Dosage:

3.00 log TCID 50/ dose

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Measles virus 3.00 log TCID 50/ dose; Mumps Virus 4.30 log TCID 50/ dose; Rubella Virus 3.00 log TCID 50/ dose; Varicella Virus 3.99 log PFU/ dose

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Sharp & Dohme LLC

Authorization status:

ACTIVE

Authorization date:

2008-10-23

Patient Information leaflet

ProQuad 

           SG- V221-I-ref-102013 
 [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus
Vaccine Live]    

1 

PRODUCT CIRCULAR 

PROQUAD
®  
[MEASLES, MUMPS, RUBELLA AND VARICELLA (OKA/MERCK) VIRUS 
VACCINE LIVE] 
REFRIGERATOR-STABLE FORMULATION 

I. THERAPEUTIC 
CLASS

ProQuad is a combined attenuated live virus vaccine containing
measles, mumps, rubella, 
and varicella viruses.  ProQuad is a sterile lyophilized
preparation of (1) the components of 
M-M-RII (Measles, Mumps and Rubella Virus Vaccine Live): Measles
Virus Vaccine Live, a 
more attenuated line of measles virus, derived from Enders'
attenuated Edmonston strain 
and propagated in chick
embryo cell culture; Mumps Virus Vaccine Live, the Jeryl
Lynn™ (B 
level) strain of mumps virus propagated in chick embryo cell
culture; Rubella Virus Vaccine 
Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human 
diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live
(Oka/Merck), the Oka/Merck 
strain of varicella-zoster virus propagated in MRC-5 cells
(hereafter referred to as 
VARIVAX). 

II. CLINICAL 
PHARMACOLOGY
Pharmacotherapeutic group: Viral Vaccine 
ATC code: J07BD54 

Measles, mumps, rubella, and varicella are
4 common childhood diseases caused by 
measles virus, mumps virus, rubella virus, and varicella
virus, respectively. These diseases 
may be associated with serious complications and/or death.
 For example, measles can be 
associated with pneumonia and encephalitis; mumps can be associated
with aseptic 
meningitis, deafness, and orchitis; rubella occurring
du

Summary of Product characteristics

SG-V221-I-ref-082021
PRODUCT CIRCULAR
ProQuad®
[Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine
Live]
Refrigerator-stable formulation
I.
THERAPEUTIC CLASS
ProQuad is a combined attenuated live virus vaccine containing
measles, mumps, rubella,
and varicella viruses. ProQuad is a sterile lyophilized preparation of
(1) the components of
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live): Measles
Virus Vaccine Live, a
more attenuated line of measles virus, derived from Enders' attenuated
Edmonston strain
and propagated in chick embryo cell culture; Mumps Virus Vaccine Live,
the Jeryl Lynn™ (B
level) strain of mumps virus propagated in chick embryo cell culture;
Rubella Virus Vaccine
Live, the Wistar RA 27/3 strain of live attenuated rubella virus
propagated in WI-38 human
diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live
(Oka/Merck), the Oka/Merck
strain
of
varicella-zoster
virus
propagated
in
MRC-5
cells
(hereafter
referred
to
as
VARIVAX).
II.
CLINICAL PHARMACOLOGY
Pharmacotherapeutic group: Viral Vaccine
ATC code: J07BD54
Measles, mumps, rubella, and varicella are 4 common childhood diseases
caused by
measles virus, mumps virus, rubella virus, and varicella virus,
respectively. These diseases
may be associated with serious complications and/or death. For
example, measles can be
associated
with
pneumonia
and
encephalitis;
mumps
can
be
associated
with
aseptic
meningitis, deafness, and orchitis; rubella occurring during pregnancy
can cause congenital
rubella
syndrome
in
the
infants
of
infected
mothers;
and
wild-type
varicella
can
be
associated with bacterial superinfection, pneumonia, encephalitis, and
Reye syndrome.
Pharmacodynamics/Pharmacokinetics
Not Applicable
Efficacy
Formal studies to evaluate the efficacy of ProQuad have not been
performed. However, the
efficacy of M-M-R II and VARIVAX has been demonstrated in numerous
studies.
Efficacy of the measles, mumps, and rubella components of ProQuad was
previously
established in a series of double-blind controlled field trials wi