DALACIN C 300 MG CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Disponible depuis:

PFIZER CANADA ULC

Code ATC:

J01FF01

DCI (Dénomination commune internationale):

CLINDAMYCIN

Dosage:

300MG

forme pharmaceutique:

CAPSULE

Composition:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 300MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

LINCOMYCINS

Descriptif du produit:

Active ingredient group (AIG) number: 0105830003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2001-04-11

Résumé des caractéristiques du produit

_Dalacin C (clindamycin hydrochloride) – Product Monograph _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DALACIN
® C
Clindamycin hydrochloride capsules USP
(as clindamycin 150 mg, 300 mg)
Antibiotic
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
DEC 29, 1969
Date of Revision:
JAN 10, 2022
Submission Control Number: 255793
®
Pfizer Enterprises, SARL
Pfizer Canada ULC, Licensee
©Pfizer Canada ULC 2021
_ _
_Dalacin C (clindamycin hydrochloride) – Product Monograph _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
[4 DOSAGE AND ADMINISTRATION], [4.2 Recommended Dose and
Dosage Adjustment]
[01/2022]
[7 WARNINGS AND PRECAUTIONS], [Renal]
[01/2022]
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
Administr