PMS-CLARITHROMYCIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CLARITHROMYCIN

Disponible desde:

PHARMASCIENCE INC

Código ATC:

J01FA09

Designación común internacional (DCI):

CLARITHROMYCIN

Dosis:

250MG

formulario farmacéutico:

TABLET

Composición:

CLARITHROMYCIN 250MG

Vía de administración:

ORAL

Unidades en paquete:

100/250

tipo de receta:

Prescription

Área terapéutica:

OTHER MACROLIDES

Resumen del producto:

Active ingredient group (AIG) number: 0123752001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2007-08-10

Ficha técnica

_pms-CLARITHROMYCIN (clarithromycin) _
_Page 1 of 80_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-CLARITHROMYCIN
Clarithromycin Tablets, USP
Film-Coated Tablets, 250 mg and 500 mg, Oral
USP
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.
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite #100
Montréal, Québec, H4P 2T4
www.pharmascience.com
Submission Control Number: 259932
Date of Initial Authorization
AUG 10, 2007
Date of Revision:
May 5, 2022
_pms-CLARITHROMYCIN (clarithromycin) _
_Page 2 of 80_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast-feeding
05/2022
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
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
......................................................................................................................4
1.1
Pediatrics
................................................................................................................5
1.2
Geriatrics.................................................................................................................5
2
CONTRAINDICATIONS
.........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................................................................7
4
DOSAGE AND ADMINISTRATION
........................................................................................7
4.1
Dosing Co