CLINDAMYCIN CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

זמין מ:

SANIS HEALTH INC

קוד ATC:

J01FF01

INN (שם בינלאומי):

CLINDAMYCIN

כמות:

150MG

טופס פרצבטיות:

CAPSULE

הרכב:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

LINCOMYCINS

leaflet_short:

Active ingredient group (AIG) number: 0105830002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-02-11

מאפייני מוצר

CLINDAMYCIN
Page 1 of 33
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLINDAMYCIN
Clindamycin Hydrochloride capsules
Capsules, 150 mg and 300 mg
clindamycin (as clindamycin hydrochloride), Oral
USP
Antibiotic
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
FEB 11, 2013
Date of Revision:
APR 06, 2023
Submission Control Number: 273482
CLINDAMYCIN
Page 2 of 33
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2023
7 WARNINGS AND PRECAUTIONS, Renal
04/2023
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
..................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
...................................................................................................................
4
1.2 Geriatrics
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5
2 CONTRAINDICATIONS
.........................................................................................................
5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4 Administration
........................................................................................