AZITHROMYCIN POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

AZITHROMYCIN

Pieejams no:

DOMINION PHARMACAL

ATĶ kods:

J01FA10

SNN (starptautisko nepatentēto nosaukumu):

AZITHROMYCIN

Deva:

200MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

AZITHROMYCIN 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15/22.5ML

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MACROLIDES

Produktu pārskats:

Active ingredient group (AIG) number: 0126072003; AHFS:

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2019-06-17

Produkta apraksts

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
.