Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
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
PFIZER INDONESIA - Indonesia
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
2,2 MCG ; 4,4 MCG
SUSPENSI INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML
PFIZER IRELAND PHARMACEUTICALS - Ireland
2018-10-18
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 Lue koko asiakirja