CALCIUM GLUCONATE INJECTION, USP 10% SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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Fachinformation Fachinformation (SPC)
24-02-2020

Wirkstoff:

CALCIUM GLUCONATE

Verfügbar ab:

FRESENIUS KABI CANADA LTD

ATC-Code:

B05XA19

INN (Internationale Bezeichnung):

CALCIUM GLUCONATE

Dosierung:

100MG

Darreichungsform:

SOLUTION

Zusammensetzung:

CALCIUM GLUCONATE 100MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10/50/100/200ML

Verschreibungstyp:

Ethical

Therapiebereich:

REPLACEMENT PREPARATIONS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108566002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

1998-07-02

Fachinformation

                                Calcium Gluconate Injection, USP 10% - Prescribing Information
Page 1 of 9
PRESCRIBING INFORMATION
CALCIUM GLUCONATE INJECTION, USP 10%
Solution, 100 mg / mL (0.465 mEq / mL)
For Intravenous Use
Single use vial: 1 000 mg per 10
Single use vial: 5 000 mg per 50 mL
Pharmacy bulk package: 10 000 mg per 100 mL
ATC Code: B05BB01
Electrolyte Replenisher
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Preparation:
December 12, 2019
Date of Revision:
February 24, 2020 Submission Control No: 229403
Calcium Gluconate Injection, USP 10% - Prescribing Information
Page 2 of 9
TABLE OF CONTENTS
1.
INDICATIONS
....................................................................................................................
3
2.
CONTRAINDICATIONS
...................................................................................................
3
3.
DOSAGE AND ADMINISTRATION
...............................................................................
3
3.1
Recommended Dose and Dosage Adjustment
............................................................ 3
3.2
Administration
.............................................................................................................
4
3.3
Reconstitution
..............................................................................................................
5
4.
OVERDOSAGE
...................................................................................................................
5
5.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................
5
6.
WARNINGS AND PRECAUTIONS
.................................................................................
6
6.1
Special Populations
.....................................................................................................
7
6.1.1
Pregnant Women
.........................................................................................................
7
6.1.2
Breast-feeding
............................................................................................
                                
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