M-AZITHROMYCIN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
24-07-2020
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Aktiva substanser:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
Tillgänglig från:
MANTRA PHARMA INC
ATC-kod:
J01FA10
INN (International namn):
AZITHROMYCIN
Dos:
250MG
Läkemedelsform:
TABLET
Sammansättning:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
OTHER MACROLIDES
Produktsammanfattning:
Active ingredient group (AIG) number: 0126072001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2020-07-28
Produktens egenskaper
PRODUCT MONOGRAPH
Pr
M-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Mantra Pharma Inc. Date of Revision:
9150 Leduc BLVD, Suite 201, Brossard July 24, 2020
Quebec, Canada
J4Y 0E3
Control Submission #: 240728
Pr
M-Azithromycin (as azithromycin dihydrate) Product Monograph
Page 2 of 62
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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