PRO-AZITHROMYCINE TABLET
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
28-05-2019
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Aktīvā sastāvdaļa:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)
Pieejams no:
PRO DOC LIMITEE
ATĶ kods:
J01FA10
SNN (starptautisko nepatentēto nosaukumu):
AZITHROMYCIN
Deva:
250MG
Zāļu forma:
TABLET
Kompozīcija:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
30/100
Receptes veids:
Prescription
Ārstniecības joma:
OTHER MACROLIDES
Produktu pārskats:
Active ingredient group (AIG) number: 0126072001; AHFS:
Autorizācija statuss:
APPROVED
Autorizācija datums:
2008-09-25
Produkta apraksts
PRODUCT MONOGRAPH
PR
PRO-AZITHROMYCINE
Azithromycin Tablets
250 mg
USP
ANTIBACTERIAL AGENT
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9 DATE OF REVISION:
May 28, 2019
Control number: 227600
_PRO-AZITHROMYCINE Product Monograph _
_Page 2 of 71_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................6
WARNINGS AND PRECAUTIONS
....................................................................................6
ADVERSE REACTIONS
....................................................................................................11
DRUG INTERACTIONS
.....................................................................................................18
DOSAGE AND
ADMINISTRATION.................................................................................23
OVERDOSAGE
...................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
...............................................................25
STORAGE AND STABILITY
............................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................29
PART II: SCIENTIFIC INFORMATION
................................................................................30
PHARMACEUTICAL INFORMATION
............................................................................30
CLINICAL TRIALS
............................................................................................................31
DETAILED
PHARMACOLOGY.................................................................
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