PREVENAR 13

Land: Indonesia

Språk: indonesisk

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

Aktiv ingrediens:

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

Tilgjengelig fra:

PFIZER INDONESIA - Indonesia

INN (International Name):

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

Dosering :

2,2 MCG ; 4,4 MCG

Legemiddelform:

SUSPENSI INJEKSI

Enheter i pakken:

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

Produsert av:

PFIZER IRELAND PHARMACEUTICALS - Ireland

Autorisasjon dato:

2018-10-18

Preparatomtale

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:
2020-0066409, 2021-0067341, 2021-0067342
Page 1 of 34
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
Active immunization for the prevention of invasive disease, pneumonia
and acute otitis
media caused by _Streptococcus pneumoniae_ in infants, children and
adolescents from
6 weeks to 17 years of age (see sections 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
DISETUJUI OLEH BPOM 19 APRIL 2022
ID REG: EREG10024112100232-4
Generic Name: Pneumococcal 13-valent Conjugate Vaccine
Trade Name: Prevenar 13
TM
CDS Effective Date: July 01, 2019
Supersedes: July 13, 2017
Appro