AZITHROMYCIN POWDER FOR SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
14-01-2014
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Werkstoffen:
AZITHROMYCIN
Beschikbaar vanaf:
DOMINION PHARMACAL
ATC-code:
J01FA10
INN (Algemene Internationale Benaming):
AZITHROMYCIN
Dosering:
200MG
farmaceutische vorm:
POWDER FOR SOLUTION
Samenstelling:
AZITHROMYCIN 200MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15/22.5ML
Prescription-type:
Prescription
Therapeutisch gebied:
OTHER MACROLIDES
Product samenvatting:
Active ingredient group (AIG) number: 0126072003; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2019-06-17
Productkenmerken
PRODUCT MONOGRAPH
PR
AZITHROMYCIN
Azithromycin dihydrate
(Powder for Oral Suspension 100 mg azithromycin/5 mL and 200 mg
azithromycin/5 mL) USP
Antibacterial Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
1-888-550-6060
Date of Preparation:
December 17, 2013
Submission Control No: 170490
_ _
AZITHROMYCIN_ Product Monograph _
_Page_
_ _
_2 of 69_
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
........................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
26
STORAGE AND STABILITY
.................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.
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