MYLAN-AZITHROMYCIN TABLET
Maa: Kanada
Kieli: englanti
Lähde: Health Canada
Valmisteyhteenveto
(SPC)
08-02-2018
Jotkut tämän tuotteen asiakirjat eivät ole tällä hetkellä saatavissa. Voit lähettää pyynnön asiakaspalvelumme ja ilmoitamme sinulle heti, kun pystymme hankkimaan ne.
Lähetä pyyntö.
Lähetä pyyntö.
Aktiivinen ainesosa:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)
Saatavilla:
MYLAN PHARMACEUTICALS ULC
ATC-koodi:
J01FA10
INN (Kansainvälinen yleisnimi):
AZITHROMYCIN
Annos:
250MG
Lääkemuoto:
TABLET
Koostumus:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG
Antoreitti:
ORAL
Kpl paketissa:
6/30
Prescription tyyppi:
Prescription
Terapeuttinen alue:
OTHER MACROLIDES
Tuoteyhteenveto:
Active ingredient group (AIG) number: 0126072001; AHFS:
Valtuutuksen tilan:
CANCELLED POST MARKET
Valtuutus päivämäärä:
2018-03-09
Valmisteyhteenveto
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
..............................................................................
Lue koko asiakirja
