CLINDAMYCIN INJECTION, USP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

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SPC SPC (SPC)
24-05-2022

active_ingredient:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

MAH:

FRESENIUS KABI CANADA LTD

ATC_code:

J01FF01

INN:

CLINDAMYCIN

dosage:

150MG

pharmaceutical_form:

SOLUTION

composition:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

administration_route:

INTRAMUSCULAR

units_in_package:

2/6/60ML

prescription_type:

Prescription

therapeutic_area:

LINCOMYCINS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2006-10-05

SPC

                                _CLINDAMYCIN INJECTION, USP (Clindamycin Injection) _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLINDAMYCIN INJECTION, USP
Clindamycin Injection
Sterile Solution, 150 mg / mL clindamycin (as clindamycin phosphate),
Intramuscular, Intravenous
Antibiotic
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
DEC 31, 1995
Date of Revision:
MAY 24, 2022
Submission Control Number: 262504
_CLINDAMYCIN INJECTION, USP (Clindamycin Injection) _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
05/2022
7 WARNINGS AND PRECAUTIONS, Renal
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
4
DOSAGE AND ADMINISTRATION
.......................................................................................5
4.1
Dosing Considerations
............................................................................................5
4.2
Recommended Dose and Dosage Adjustment
............................................................6
4.3
Reconstitution
.
                                
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SPC SPC ֆրանսերեն 24-05-2022