CLINDAMYCIN IV INFUSION SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

J01FF01

Designació comuna internacional (DCI):

CLINDAMYCIN

Dosis:

6MG

formulario farmacéutico:

SOLUTION

Composición:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 6MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

50ML

tipo de receta:

Prescription

Área terapéutica:

LINCOMYCINS

Resumen del producto:

Active ingredient group (AIG) number: 0105830008; AHFS:

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2021-04-21

Fitxa tècnica

_ _
_Clindamycin IV Infusion (clindamycin phosphate) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLINDAMYCIN IV INFUSION
Clindamycin Injection in 5% Dextrose w/v
Minibags, clindamycin 12 mg/mL (600 mg/50 mL) and
18 mg/mL (900 mg/50 mL) (as clindamycin phosphate)
Sterile Solution
Antibiotic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
July 10, 2013
Date of Revision:
July 26, 2023
Submission Control Number: 272119
_ _
_Clindamycin IV Infusion (clindamycin phosphate) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
07/2023
7 WARNINGS AND PRECAUTIONS, Renal
07/2023
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
.................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................