ZMAX SR GRANULES FOR SUSPENSION,EXTENDED RELEASE

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Հասանելի է:

PFIZER CANADA ULC

ATC կոդը:

J01FA10

INN (Միջազգային անվանումը):

AZITHROMYCIN

Դոզան:

2G

Դեղագործական ձեւ:

GRANULES FOR SUSPENSION,EXTENDED RELEASE

Կազմը:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 2G

Կառավարման երթուղին:

ORAL

Միավորները փաթեթում:

100

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ տարածք:

OTHER MACROLIDES

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

CANCELLED POST MARKET

Հաստատման ամսաթիվը:

2015-07-31

Ապրանքի հատկությունները

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
.............................................................