VAXNEUVANCE

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

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

थमां उपलब्ध:

ORGANON PHARMA INDONESIA TBK - Indonesia -

डोज़:

2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /2 Mcg /4

फार्मास्यूटिकल फॉर्म:

SUSPENSI INJEKSI

रचना:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATE

पैकेज में यूनिट:

DUS, 1 PRE-FILLED SYRINGE @ 0.5 ML

वर्ग:

Obat

द्वारा बनाया गया:

MSD INTERNATIONAL GMBH T/A MSD IRELAND (CARLOW) - Ireland

प्राधिकरण का दर्जा:

Berlakus/d 26-07-2028

प्राधिकरण की तारीख:

2023-07-26

उत्पाद विशेषताएं

Page 1 of 45
VAXNEUVANCE
(PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE [CRM
197 PROTEIN], ADSORBED)
[SUSPENSION FOR INJECTION]
1.
INDICATIONS AND USAGE
VAXNEUVANCE is a vaccine indicated in infants, children and
adolescents from 6 weeks
through 17 years of age (prior to the 18
th
birthday) for active immunization for the prevention
of pneumococcal disease (including invasive disease, pneumonia and
acute otitis media)
caused by
Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
19F, 22F, 23F and 33F.
VAXNEUVANCE is indicated in adults 18 years of age and older for
active immunization for
the
prevention
of
pneumococcal
disease
(including
invasive
disease
and
pneumonia)
caused by
Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
19F, 22F, 23F and 33F.
VAXNEUVANCE may not prevent disease caused by
S. pneumoniae
serotypes that are not
contained in the vaccine.
2.
DOSAGE AND ADMINISTRATION
2.1
GENERAL
The vaccination schedule for VAXNEUVANCE should be based on official
recommendations.
DOSAGE
Administer a 0.5 mL dose of VAXNEUVANCE intramuscularly.
METHOD OF ADMINISTRATION
For intramuscular use only. Do not inject intravascularly.
DISETUJUI OLEH BPOM 9 JUNI 2023
ID REG: EREG10037312200062
Page 2 of 45
The preferred site for injection is the anterolateral aspect of the
thigh in infants or the deltoid
muscle of the upper arm in children and adults. The vaccine should not
be injected in the
gluteal area or areas where there may be a major nerve trunk and/or
blood vessel.
2.2
PEDIATRICS
ROUTINE VACCINATION SCHEDULE FOR INFANTS 6 WEEKS - 6 MONTHS OF AGE
4-Dose Regimen (Three-Dose Primary Series Followed by a Toddler Dose)
The
recommended
routine
infant
immunization
regimen
consists
of
four
doses
of
VAXNEUVANCE, each of 0.5 mL. The primary infant series consists of
three doses, with the
first dose usually given at 2 months of age and with an interval of at
least 4 weeks between
doses. The first dose may be given as early as six weeks of age. The
fourth (booster) dose
is recomm