SANDOZ ALFACALCIDOL CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-12-2022
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Active ingredient:
ALFACALCIDOL
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
A11CC03
INN (International Name):
ALFACALCIDOL
Dosage:
1MCG
Pharmaceutical form:
CAPSULE
Composition:
ALFACALCIDOL 1MCG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0135700002; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-12-09
Summary of Product characteristics
_Sandoz Alfacalcidol (Alfacalcidol Capsules) Product Monograph_
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ® ALFACALCIDOL
Alfacalcidol Capsules
Capsules, 1 and 0.25 mcg, oral
House Standard
Vitamin D Analogue
[A11CC VITAMIN D AND ANALOGUES]
Sandoz Canada Inc.
110, Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Approval:
DEC 8, 2022
Submission Control No.: 268441
_Sandoz Alfacalcidol (Alfacalcidol Capsules) Product Monograph_
Page 2 of 25
Table des matières
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................3
1.
INDICATIONS
..................................................................................................................3
1.1. PEDIATRICS
............................................................................................................................3
2.
CONTRAINDICATIONS
.....................................................................................................3
3.
DOSAGE AND ADMINISTRATION
.....................................................................................3
3.1.
Dosing Considerations
............................................................................................................
3
3.2.
Recommended Dose and Dosage Adjustment Pre-Dialysis Patients on Daily
Oral Therapy .. 4
3.3.
Missed Dose
............................................................................................................................
5
4.
OVERDOSAGE
.................................................................................................................5
5.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................................6
6.
WARNINGS AND PRECAUTIONS
......................................................................................7
6.1.
Special Population
...................................................................................................................
9
7.
ADVERSE REACTIONS
...........................
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