ALFACALCIDOL CAPSULES

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ALFACALCIDOL

Dostupno od:

STRIDES PHARMA CANADA INC

ATC koda:

A11CC03

INN (International ime):

ALFACALCIDOL

Doziranje:

0.25MCG

Farmaceutski oblik:

CAPSULE

Sastav:

ALFACALCIDOL 0.25MCG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0135700001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2021-12-06

Svojstava lijeka

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