ZITHROMAX SIRUP KERING 200 MG/5 ML

País: Indonesia

Idioma: indonesio

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

Ingredientes activos:

AZITHROMYCIN DIHYDRATE

Disponible desde:

PFIZER INDONESIA - Indonesia

Designación común internacional (DCI):

AZITHROMYCIN DIHYDRATE

Dosis:

200 MG/5 ML

formulario farmacéutico:

SIRUP KERING

Unidades en paquete:

DUS, BOTOL PLASTIK @ 15 ML

Fabricado por:

PFIZER ITALIA S.R.L - Italy

Fecha de autorización:

2015-02-13

Ficha técnica

PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Azithromycin
Trade Name: ZITHROMAX
CDS Effective Date: May 2, 2018
Supersedes: March 21, 2017
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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.
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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.
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PHARMACOLOGICAL PROPERTIES
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_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Macrolides, ATC code J01FA.
DISETUJUI OLEH BPOM: 11/10/2021
ID REG: EREG10024112000633 - EREG1