Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AVIBACTAM SODIUM, CEFTAZIDIME PENTAHYDRATE
PFIZER INDONESIA - Indonesia
AVIBACTAM SODIUM, CEFTAZIDIME PENTAHYDRATE
543,5 MG /2329,7 MG
SERBUK INJEKSI
DUS, 10 VIAL @ 2,5 G
ACS DOBFAR S.P.A - Italy
2020-07-29
Generic Name: Ceftazidime Pentahydrate, Avibactam Sodium Trade Name: Zavicefta ® CDS Effective Date: January 15, 2017 Supersedes: N/A Approved by BPOM: July 29, 2020 2020-0064366 Page 1 of 20 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Ceftazidime Pentahydrate, Avibactam Sodium Trade Name: Zavicefta ® CDS Effective Date: January 15, 2017 Supersedes: NA 1. NAME OF THE MEDICINAL PRODUCT 1.1. PRODUCT NAME Zavicefta ® 1.2. STRENGTH 2 g/0.5 g 1.3. PHARMACEUTICAL DOSAGE FORM Powder for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. QUALITATIVE DECLARATION Each vial contains ceftazidime (as pentahydrate) equivalent to 2 g and avibactam (as sodium salt) equivalent to 0.5 g. After reconstitution, 1 ml of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam (See section 6.6). 2.2. QUANTITATIVE DECLARATION For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. A white to yellow sterile powder. DISETUJUI OLEH BPOM: 29/07/2020 ID: EREG10024111900017 Generic Name: Ceftazidime Pentahydrate, Avibactam Sodium Trade Name: Zavicefta ® CDS Effective Date: January 15, 2017 Supersedes: N/A Approved by BPOM: July 29, 2020 2020-0064366 Page 2 of 20 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zavicefta ® is indicated in adults for the treatment of the following infections of ESBL (Extended Spectrum Beta Lactamase) producing bacteria and Pseudomonas aeruginosa resistance to ceftazidime as follow: • Complicated Intra-Abdominal Infection (cIAI): require surgical intervention and extend beyond the hollow viscus of the intestinal tract into the peritoneal space (laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery). For treatment of cIAI use in combination with metronidazole. • Complicated Urinary Tract Infection, including Pyelonephritis (cUTI): acute pyelonephritis indicated by flank pain or costovertebral angle tenderness on examination and at least one of the following: fever, nausea, vomiting; or c Leggi il documento completo