CLINDAMYCIN INJECTION USP LIQUID

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

J01FF01

INN (International Nazwa):

CLINDAMYCIN

Dawkowanie:

150MG

Forma farmaceutyczna:

LIQUID

Skład:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

10X2ML/10X4ML/10X6ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

LINCOMYCINS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2005-08-05

Charakterystyka produktu

_CLINDAMYCIN INJECTION USP (Clindamycin Injection) _
_ Page 1 of 41 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CLINDAMYCIN INJECTION USP
Clindamycin Injection
Sterile Solution, 150 mg / mL clindamycin (as clindamycin phosphate),
Intravenous,
Intramuscular
USP
Antibiotic
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
January 15, 1999
Date of Revision:
June 2, 2022
Submission Control Number: 262482
_CLINDAMYCIN INJECTION USP (Clindamycin Injection) _
_ Page 2 of 41 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
06/2022
7 WARNINGS AND PRECAUTIONS, Renal
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
.........................................................................
4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics.................................................................................................................
5
1.2 Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
.......................................................................................................
5
4
DOSAGE AND
ADMINISTRATION........................................................................................
6
4.1 Dosing Considerations
.............................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 6
4.3