BIAXIN XL TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CLARITHROMYCIN

Saatavilla:

BGP PHARMA ULC

ATC-koodi:

J01FA09

INN (Kansainvälinen yleisnimi):

CLARITHROMYCIN

Annos:

500MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

CLARITHROMYCIN 500MG

Antoreitti:

ORAL

Kpl paketissa:

60

Prescription tyyppi:

Prescription

Terapeuttinen alue:

OTHER MACROLIDES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123752002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2020-09-16

Valmisteyhteenveto

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PRODUCT MONOGRAPH
Including Patient Medication Information
PR
BIAXIN BID
®
clarithromycin tablets USP, film-coated
250 mg and 500 mg
PR
BIAXIN
® XL
clarithromycin extended-release tablets
500 mg
Manufacturer’s Standard
PR
BIAXIN
®
clarithromycin for oral suspension USP
125 mg/5 mL and 250 mg/5 mL
when reconstituted
Antibiotic
NOTE: WHEN USED IN COMBINATION WITH ACID ANTISECRETORY DRUGS
AND OTHER ANTIMICROBIALS FOR THE ERADICATION OF _HELICOBACTER _
_PYLORI_, THE PRODUCT MONOGRAPH FOR THOSE AGENTS SHOULD BE
CONSULTED.
Date of Preparation:
December 22, 2014
Date of Previous Revision:
October 22, 2018
BGP Pharma ULC
Date of Revision:
85 Advance Road
Etobicoke, Ontario
October 25, 2018
M8Z 2S6
Submission Control No: 218738
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
4
CONTRAINDICATIONS
................................................................................................
6
WARNINGS AND PRECAUTIONS
..............................................................................
8
ADVERSE REACTIONS
...............................................................................................
15
DRUG INTERACTIONS
...............................................................................................
28
DOSAGE AND ADMINISTRATION
..........................................................................
41
OVERDOSAGE
..............................................................................................................
46
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 47
STORAGE AND STABILITY
.......................................................................................
54
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........