DOM-AZITHROMYCIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Disponibbli minn:

DOMINION PHARMACAL

Kodiċi ATC:

J01FA10

INN (Isem Internazzjonali):

AZITHROMYCIN

Dożaġġ:

250MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

OTHER MACROLIDES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0126072001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2007-03-27

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
DOM-AZITHROMYCIN
Azithromycin Tablets
250 mg and 600 mg
USP
Azithromycin for Oral Suspension
100 mg / 5 mL and 200 mg / 5 mL
House Standard
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
November 29, 2018
Control number: 222071
_Dom-AZITHROMYCIN Product Monograph _
_Page 2 of 82_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................6
WARNINGS AND PRECAUTIONS
....................................................................................6
ADVERSE REACTIONS
....................................................................................................11
DRUG INTERACTIONS
.....................................................................................................18
DOSAGE AND ADMINISTRATION
................................................................................23
OVERDOSAGE
...................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
...............................................................28
STORAGE AND STABILITY
............................................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
............................................................................34
CLINICAL TRIALS
.....................................................................................