ZMAX SR GRANULES FOR SUSPENSION,EXTENDED RELEASE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

זמין מ:

PFIZER CANADA ULC

קוד ATC:

J01FA10

INN (שם בינלאומי):

AZITHROMYCIN

כמות:

2G

טופס פרצבטיות:

GRANULES FOR SUSPENSION,EXTENDED RELEASE

הרכב:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 2G

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

OTHER MACROLIDES

leaflet_short:

Active ingredient group (AIG) number: 0126072010; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2015-07-31

מאפייני מוצר

PRODUCT MONOGRAPH
PR
ZMAX SR
Azithromycin sustained-release granules for oral suspension
(as azithromycin dihydrate)
2 g azithromycin (on anhydrous basis)
Antibacterial Agent
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Revised date:
June 27, 2014
Submission Control No: 173319
* TM Pfizer Products Inc.
Pfizer Canada Inc., Licensee 2014
Product Licensed from Pliva, Zagreb, Croatia
_ZMAX SR (azithromycin sustained-release granules for oral suspension)
_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
.............................................................