ALFACALCIDOL CAPSULES

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALFACALCIDOL

Available from:

STRIDES PHARMA CANADA INC

ATC code:

A11CC03

INN (International Name):

ALFACALCIDOL

Dosage:

1MCG

Pharmaceutical form:

CAPSULE

Composition:

ALFACALCIDOL 1MCG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0135700002; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-12-06

Summary of Product characteristics

_Alfacalcidol Capsules(alfacalcidol) Product Monograph_
Page 1 of 30
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALFACALCIDOL CAPSULES
Alfacalcidol
Capsules, 0.25 mcg and 1 mcg, oral,
House Standard
Vitamin D Analogue
A11CC03 VITAMIN D AND ANALOGUES
Strides Pharma Canada Inc.
1565 boul. Lionel Boulet,
Varennes, QC J3X 1P7
Date of Initial Authorization:
December 3, 2021
Date of Revision:
April 14, 2023
Submission Control No.: 269242
_Alfacalcidol Capsules(alfacalcidol) Product Monograph_
Page 2 of 30
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
1.
INDICATIONS
......................................................................................................................
4
1.1. Pediatrics
......................................................................................................................
4
2.
CONTRAINDICATIONS
......................................................................................................
4
4.
DOSAGE AND ADMINISTRATION
.....................................................................................
4
4.1 Dosing Considerations
...............................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 7
4.4
Administration………………………………………………………………………………..8
4.5 Missed Dose
...............................................................................................................
8
5.
OVERDOSAGE
...................................................................................................................
8
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND
PACKAGING........................... 10
7.
WARNINGS AND PRECAUTIONS
....................................................................................
11
7.1 Special Population
.........................................................................