NRA-AZITHROMYCIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
03-02-2022
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Aktiv bestanddel:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
Tilgængelig fra:
NORA PHARMA INC
ATC-kode:
J01FA10
INN (International Name):
AZITHROMYCIN
Dosering:
600MG
Lægemiddelform:
TABLET
Sammensætning:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG
Indgivelsesvej:
ORAL
Enheder i pakken:
(3X10)/30/100/500
Recept type:
Prescription
Terapeutisk område:
OTHER MACROLIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0126072005; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2018-08-02
Produktets egenskaber
PRODUCT MONOGRAPH
Pr
NRA-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Control #: 260531
Nora Pharma Inc.
40 rue Prince-Arthur, Suite 310
Saint-Lambert, Québec, J4P 1X2
Date of Revision:
February 3, 2022
NRA-AZITHROMYCIN Product Monograph
Page 2 of 64
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................................
3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................................
5
ADVERSE REACTIONS
..................................................................................................................
9
DRUG INTERACTIONS
................................................................................................................
15
DOSAGE AND ADMINISTRATION
............................................................................................
19
OVERDOSAGE
...............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
21
DETAILED PHARMACOLOGY).
.................................................................................................
22
STORAGE AND STABILITY
........................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 23
PART II: SCIENTIFIC INFORMATION
.................
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