PNEUMOVAX 23

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 3, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 4, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 8, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYP

제공처:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Name):

PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 3, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 4, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYPE 8, PNEUMOCOCCAL POLYSACCHARIDE DANISH TYP

복용량:

25 MCG/DOSE /25 MCG/DOSE /25 MCG/DOSE /25 MCG/DOSE /25 MCG/DOSE /25 MCG/DOSE /25 MCG/DOSE /25 MCG/DO

약제 형태:

INJEKSI

패키지 단위:

DUS, 10 PRE-FILLED SYRINGE @ 0.5 ML

Manufactured by:

MERCK SHARP & DOHME CORP. - United States of America

승인 날짜:

2021-07-17

제품 특성 요약

_ _
PNEUMOVAX 23
(PNEUMOCOCCAL VACCINE POLYVALENT)
INJECTION
PNEUMOVAX 23 (pneumococcal vaccine polyvalent), is a sterile, liquid
vaccine for
intramuscular or subcutaneous injection. It consists of a mixture of
highly purified
capsular polysaccharides from the 23 most prevalent or invasive
pneumococcal types
of
Streptococcus pneumoniae
, including the six serotypes that most frequently cause
invasive drug-resistant pneumococcal infections among adults in the
United States
(see Table 1). The 23-valent vaccine accounts for at least 90% of
pneumococcal blood
isolates and at least 85% of all pneumococcal isolates from sites
which are generally
sterile as determined by ongoing surveillance of United States data.
PNEUMOVAX 23 is manufactured according to methods developed by the
MERCK
RESEARCH LABORATORIES. Each 0.5 mL dose of vaccine contains 25mcg of
each
polysaccharide type dissolved in isotonic saline solution containing
0.25% phenol as a
preservative.
CLINICAL PHARMACOLOGY
Pneumococcal infection is a major cause of pneumonia, bacteremia,
meningitis, and
otitis
media.
Strains
of
drug-resistant
S.
pneumoniae
have
become
increasingly
common in the United States and in other parts of the world. In some
areas as many as
35% of pneumococcal isolates have been reported to be resistant to
penicillin. Many
penicillin-resistant pneumococci are also resistant to other
antimicrobial drugs (e.g.,
erythromycin, trimethoprim-sulfamethoxazole and extended-spectrum
cephalosporins),
therefore emphasizing the importance of vaccine prophylaxis against
pneumococcal
disease.
Disetujui Oleh BPOM : 07/11/2023
ID : EREG100373VR12300322
_ _
Epidemiology
Pneumococcal infection causes approximately 40,000 deaths annually in
the United
States. At least 500,000 cases of pneumococcal pneumonia are estimated
to occur
annually in the United States;
S. pneumoniae
accounts for approximately 25%-35% of
cases
of
community-acquired
bacterial
pneumonia
in
persons
who
require
hospitalization.
Pneumococcal disease accounts for an estimated 50,000 cases o