MAR-AZITHROMYCIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
12-08-2020

Aktivni sastojci:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Dostupno od:

MARCAN PHARMACEUTICALS INC

ATC koda:

J01FA10

INN (International ime):

AZITHROMYCIN

Doziranje:

600MG

Farmaceutski oblik:

TABLET

Sastav:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100/500

Tip recepta:

Prescription

Područje terapije:

OTHER MACROLIDES

Proizvod sažetak:

Active ingredient group (AIG) number: 0126072005; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2016-09-08

Svojstava lijeka

                                Page 1 of 63
PRODUCT MONOGRAPH
Pr
MAR-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Marcan Pharmaceuticals Inc. Date of Revision:
2 Gurdwara Road, Suite #112 August 12, 2020
Ottawa, Ontario
Canada, K2E 1A2
Control Number: 241406
Page 2 of 63
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
.......................................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................................
19
OVERDOSAGE
......................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
20
STORAGE AND STABILITY
...............................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 23
PART II: SCIENTIFIC INFORMATION
..................................................................
                                
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