ZITHROMAX

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

AZITHROMYCIN DIHYDRATE

Disponible depuis:

PFIZER INDONESIA - Indonesia

DCI (Dénomination commune internationale):

AZITHROMYCIN DIHYDRATE

Dosage:

209.75 MG

forme pharmaceutique:

SIRUP KERING

Unités en paquet:

DUS, 1 BOTOL PLASTIK @ 15 ML

Fabriqué par:

HAUPT PHARMA LATINA S.R.L - Italy

Date de l'autorisation:

2019-07-03

Résumé des caractéristiques du produit

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