CALCIUM CHLORIDE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CALCIUM CHLORIDE

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

B05XA07

INN (Διεθνής Όνομα):

CALCIUM CHLORIDE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

CALCIUM CHLORIDE 100MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

REPLACEMENT PREPARATIONS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-09-01

Αρχείο Π.Χ.Π.

_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
..................