MYLAN-AZITHROMYCIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
08-02-2018
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Aktiv bestanddel:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
J01FA10
INN (International Name):
AZITHROMYCIN
Dosering:
250MG
Lægemiddelform:
TABLET
Sammensætning:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG
Indgivelsesvej:
ORAL
Enheder i pakken:
6/30
Recept type:
Prescription
Terapeutisk område:
OTHER MACROLIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0126072001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2018-03-09
Produktets egenskaber
PRODUCT MONOGRAPH
PR
MYLAN-AZITHROMYCIN
Azithromycin Tablets
250 mg
USP
ANTIBACTERIAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
February 8, 2018
Control number: 213343
_ _
_MYLAN-AZITHROMYCIN 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
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................................................................................27
DETAILED PHARMACOLOGY
..............................................................................
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