DALACIN C PHOSPHATE SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

J01FF01

INN (International Nazwa):

CLINDAMYCIN

Dawkowanie:

150MG

Forma farmaceutyczna:

SOLUTION

Skład:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

2/4/6/60 ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

LINCOMYCINS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2003-10-06

Charakterystyka produktu

_DALACIN C PHOSPHATE (clindamycin phosphate)- Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DALACIN
® C PHOSPHATE
clindamycin injection USP
150 mg/mL (as clindamycin phosphate)
Sterile Solution
Antibiotic
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
OCT 05, 1972
Date of Revision:
JAN 10, 2022
Submission Control Number: 255973
®
Pfizer Enterprises, SARL
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC 2021
_ _
_DALACIN C PHOSPHATE (clindamycin phosphate)- Product Monograph _
_Page 2 of 38_
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
..........................................................................................................
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...........................................