ZAVICEFTA

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

AVIBACTAM SODIUM, CEFTAZIDIME PENTAHYDRATE

Disponible depuis:

PFIZER INDONESIA - Indonesia

DCI (Dénomination commune internationale):

AVIBACTAM SODIUM, CEFTAZIDIME PENTAHYDRATE

Dosage:

543,5 MG /2329,7 MG

forme pharmaceutique:

SERBUK INJEKSI

Unités en paquet:

DUS, 10 VIAL @ 2,5 G

Fabriqué par:

ACS DOBFAR S.P.A - Italy

Date de l'autorisation:

2020-07-29

Résumé des caractéristiques du produit

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