PREVENAR 13

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

POLYSACCHARIDE SEROTYPE 1; POLYSACCHARIDE SEROTYPE 14; POLYSACCHARIDE SEROTYPE 18C; POLYSACCHARIDE SEROTYPE 19A; POLYSACCHARIDE SEROTYPE 19F; POLYSACCHARIDE SEROTYPE 23F; POLYSACCHARIDE SEROTYPE 3; POLYSACCHARIDE SEROTYPE 4; POLYSACCHARIDE SEROTYPE 5; POLYSACCHARIDE SEROTYPE 6A; POLYSACCHARIDE SEROTYPE 6B; POLYSACCHARIDE SEROTYPE 7F; POLYSACCHARIDE SEROTYPE 9V

Tersedia dari:

PFIZER INDONESIA - Indonesia

INN (Nama Internasional):

POLYSACCHARIDE SEROTYPE 1; POLYSACCHARIDE SEROTYPE 14; POLYSACCHARIDE SEROTYPE 18C; POLYSACCHARIDE SEROTYPE 19A; POLYSACCHARIDE SEROTYPE 19F; POLYSACCHARIDE SEROTYPE 23F; POLYSACCHARIDE SEROTYPE 3; POLYSACCHARIDE SEROTYPE 4; POLYSACCHARIDE SEROTYPE 5; POLYSACCHARIDE SEROTYPE 6A; POLYSACCHARIDE SEROTYPE 6B; POLYSACCHARIDE SEROTYPE 7F; POLYSACCHARIDE SEROTYPE 9V

Dosis:

2,2 MCG ; 4,4 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML

Diproduksi oleh:

PFIZER IRELAND PHARMACEUTICALS - Ireland

Tanggal Otorisasi:

2018-10-18

Karakteristik produk

Generic Name: Pneumococcal 13-valent Conjugate Vaccine
Trade
Name: Prevenar 13
TM
CDS Effective Date: July 01, 2019
Supersedes: July 13, 2017
Approved by BPOM:
2019-0052394, 2019-0047912
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PT. PFIZER INDONESIA
Local Product Document
Generic Name: Pneumococcal 13-valent Conjugate Vaccine
Trade Name: Prevenar 13
TM
CDS Effective Date: July 01, 2019
Supersedes: July 13, 2017
1. NAME OF THE MEDICINAL PRODUCT
Prevenar 13 suspension for injection
Pneumococcal polysaccharide conjugated vaccine, (13-valent, adsorbed)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1*
2.2 µg
Pneumococcal polysaccharide serotype 3*
2.2 µg
Pneumococcal polysaccharide serotype 4*
2.2 µg
Pneumococcal polysaccharide serotype 5*
2.2 µg
Pneumococcal polysaccharide serotype 6A*
2.2 µg
Pneumococcal polysaccharide serotype 6B*
4.4 µg
Pneumococcal polysaccharide serotype 7F*
2.2 µg
Pneumococcal polysaccharide serotype 9V*
2.2 µg
Pneumococcal polysaccharide serotype 14*
2.2 µg
Pneumococcal polysaccharide serotype 18C*
2.2 µg
Pneumococcal polysaccharide serotype 19A*
2.2 µg
Pneumococcal polysaccharide serotype 19F*
2.2 µg
Pneumococcal polysaccharide serotype 23F*
2.2 µg
*Conjugated to CRM
197
carrier protein and adsorbed on aluminium phosphate (0.125 mg
aluminium).
3. PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a homogeneous white suspension.
Supplied as a pre-filled syringe, single dose vials and multidose
vials (4 doses per vial).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CHILDREN 6 WEEKS TO 5 YEARS OF AGE
Active immunization for the prevention of invasive disease, pneumonia
and acute otitis
media caused by
_Streptococcus pneumoniae_
in infants and children from 6 weeks to 5
years of age (see sections
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
and
5.1
DISETUJUI BPOM 22 APRIL 2021
ID REG : EREG10024112000575-77
Generic Name: Pneumococcal 13-valent Conjugate Vaccine
Trade
Name: Prevenar 13
TM
CDS Effective Date: July 01, 2019
Supersedes: Jul