M-CLINDAMYCIN CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Commercializzato da:

MANTRA PHARMA INC

Codice ATC:

J01FF01

INN (Nome Internazionale):

CLINDAMYCIN

Dosaggio:

150MG

Forma farmaceutica:

CAPSULE

Composizione:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

LINCOMYCINS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-08-08

Scheda tecnica

_M-CLINDAMYCIN (Clindamycin Hydrochloride Capsules) _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-CLINDAMYCIN
Clindamycin Hydrochloride Capsules
Capsules, 150 mg and 300 mg clindamycin, Oral
USP
Antibiotic
Mantra Pharma Inc.
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3
Date of Initial Authorization:
AUG 08, 2018
Date of Revision:
NOV 17, 2022
Submission Control Number: 268960
_M-CLINDAMYCIN (Clindamycin Hydrochloride Capsules) _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
11/2022
7 WARNING AND PRECAUTIONS, Renal
11/2022
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
........................................................................................................................
4
1.2
Geriatrics
........................................................................................................................
4
2
CONTRAINDICATIONS
..........................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1
Dosing Considerations
....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4
Admi