RAN-CLARITHROMYCIN POWDER FOR SUSPENSION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CLARITHROMYCIN

Доступно од:

SUN PHARMA CANADA INC

АТЦ код:

J01FA09

INN (Међународно име):

CLARITHROMYCIN

Дозирање:

125MG

Фармацеутски облик:

POWDER FOR SUSPENSION

Састав:

CLARITHROMYCIN 125MG

Пут администрације:

ORAL

Јединице у пакету:

50/100ML

Тип рецептора:

Prescription

Терапеутска област:

OTHER MACROLIDES

Резиме производа:

Active ingredient group (AIG) number: 0123752003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2022-06-02

Карактеристике производа

TARO-CLARITHROMYCIN
(Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin
Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral
Suspension) Page 1 of 117
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-CLARITHROMYCIN
Clarithromycin Tablets
Tablets, 250 mg and 500 mg, Oral
USP
PR
TARO-CLARITHROMYCIN XL
Clarithromycin Extended-Release Tablets
Extended-Release Tablets, 500 mg, Oral
Mfr. Std.
PR
RAN
™
-CLARITHROMYCIN
Clarithromycin for Oral Suspension
Powder for Suspension, 125 mg / 5 mL and 250 mg / 5 mL when
reconstituted, 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.
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
December 04, 2014
Date of Revision:
June 1, 2022
Submission Control Number: 259707
TARO-CLARITHROMYCIN
(Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin
Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral
Suspension) Page 2 of 117
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast-
feeding
06/2022
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
.......................................................................5
1
INDICATIONS.........................................................................................................................5
1.1 Pediatrics
.........................................................................................................................7
1.2 Geriatrics
..