CALCIUM CHLORIDE INJECTION USP SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CALCIUM CHLORIDE

זמין מ:

PFIZER CANADA ULC

קוד ATC:

B05XA07

INN (שם בינלאומי):

CALCIUM CHLORIDE

כמות:

100MG

טופס פרצבטיות:

SOLUTION

הרכב:

CALCIUM CHLORIDE 100MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10ML

סוג מרשם:

Ethical

איזור תרפויטי:

REPLACEMENT PREPARATIONS

leaflet_short:

Active ingredient group (AIG) number: 0108565001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2017-09-01

מאפייני מוצר

_Calcium Chloride Injection USP _
_Page 1 of 16_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CALCIUM CHLORIDE INJECTION USP
100 mg/mL
(27 mg [0.7 mmol or 1.4 mEq] Ca
++
/mL)
10% Hypertonic solution for intravenous injection
Calcium Replenisher
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
December 31, 1981
Date of Revision:
August 25, 2022
Submission Control Number: 262054
_ _
_Calcium Chloride Injection USP _
_Page 2 of 16_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS (2)
08/2022
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
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 4
4.4
Administration...................................................................................................
5
4.5
Missed Dose
......................................................................................................
5
5
OVERDOSAGE
.............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
..................