SANDOZ AZITHROMYCIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01FA10

INN (International Name):

AZITHROMYCIN

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG

Administration route:

ORAL

Units in package:

6/30/100

Prescription type:

Prescription

Therapeutic area:

OTHER MACROLIDES

Product summary:

Active ingredient group (AIG) number: 0126072001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-11-02

Summary of Product characteristics

_ _
_Sandoz Azithromycin _
_Page 1 of 90_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ AZITHROMYCIN
azithromycin dihydrate
Azithromycin, 100 mg / 5 mL, 200 mg / 5 mL for oral suspension
Azithromycin tablets, 250 mg for oral use
Manufacturer’s Standard
Antibacterial Agent
Sandoz Canada Inc.
Date of Initial Authorization:
110 rue de Lauzon
November 2, 2005
Boucherville, QC, Canada
J4B 1E6
Date of Revision:
October 25, 2023
Submission Control Number: 276289
_ _
_Sandoz Azithromycin _
_Page 2 of 90_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1
Pregnant Women
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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7
4.2
Recommended Dose and Dosage Adjustment
......................................................... 7
4.3
Reconstitution
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