Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AZITHROMYCIN DIHYDRATE
PFIZER INDONESIA - Indonesia
AZITHROMYCIN DIHYDRATE
265.96 MG
KAPLET SALUT SELAPUT
DUS, 1 BLISTER @ 6 KAPLET SALUT SELAPUT
PFIZER INDONESIA - Indonesia
2020-05-24
PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Azithromycin Trade Name: ZITHROMAX CDS Effective Date: May 2, 2018 Supersedes: March 21, 2017 0 B FORM AND PRESENTATION FILM-COATED TABLETS: Azithromycin film-coated tablets are capsular shaped and contain azithromycin dihydrate equivalent to 500 mg, of azithromycin. FILM-COATED CAPTABS: Azithromycin film-coated captabs are capsular shaped and contain azithromycin dihydrate equivalent to 250 mg, of azithromycin. POWDER FOR ORAL SUSPENSION: Azithromycin powder for oral suspension is presented as a dry powder which yields, on reconstitution with water, a white to off-white suspension containing the equivalent of 200 mg azithromycin per 5 mL. POWDER FOR INTRAVENOUS (IV) SOLUTION: Azithromycin is supplied in lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg azithromycin for intravenous administration. Upon reconstitution, azithromycin powder yields a solution containing the equivalent of 100 mg azithromycin per 1 mL. 1 B DESCRIPTION POWDER FOR ORAL SUSPENSION – The powder for oral suspension contains sucrose (1.94 g per 100 mg dose), sodium phosphate tribasic anhydrous, hydroxypropyl cellulose, xanthan gum, artificial cherry, crème de vanilla and banana flavors. FILM-COATED TABLETS – The tablets contain pregelatinized starch, calcium phosphate dibasic anhydrous, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate. The film coating contains hydroxypropyl methylcellulose, triacetin and titanium dioxide (E171). FILM-COATED CAPTABS – The tablets contain pregelatinized starch, calcium phosphate dibasic anhydrous, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate, and film coating solution. POWDER FOR INTRAVENOUS (IV) SOLUTION – The IV formulation contains citric acid (anhydrous) 384.6 mg, and sodium hydroxide 198.3 mg. 2 B PHARMACOLOGICAL PROPERTIES 1 1 B _PHARMACODYNAMIC PROPERTIES _ Pharmacotherapeutic group: Macrolides, ATC code J01FA. DISETUJUI OLEH BPOM: 11/10/2021 ID REG: EREG10024112000633 - EREG1 Lees het volledige document