Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
Measles virus; Mumps Virus; Rubella Virus; Varicella Virus
MSD PHARMA (SINGAPORE) PTE. LTD.
J07BD54
3.00 log TCID 50/ dose
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
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
SUBCUTANEOUS
Prescription Only
Merck Sharp & Dohme LLC
ACTIVE
2008-10-23
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 read_full_document
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 read_full_document