VITAMIN D3 CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VITAMIN D3

Available from:

OXLEE PHARMACEUTICALS INC

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL

Dosage:

40000UNIT

Pharmaceutical form:

CAPSULE

Composition:

VITAMIN D3 40000UNIT

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

VITAMIN D

Product summary:

Active ingredient group (AIG) number: 0108524015; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-03-11

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VITAMIN D3
Cholecalciferol
Capsules, 20 000 IU; 40 000 IU, Oral
Ph. Eur.
Vitamin D Product
Oxlee Pharmaceuticals, Inc.
55 Town Center Court, Unit 700
Scarborough, ON, M1P 4X4
Date of Initial Approval:
March 9, 2020
Submission Control No: 225462
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
PART I: HEALTH
PROFESSIONAL INFORMATION
............................................................3
1
INDICATIONS
.............................................................................................................3
2
CONTRAINDICATIONS
.............................................................................................3
3
DOSAGE AND ADMINISTRATION
..........................................................................3
3.1
Dosing Considerations
..................................................................................................
3
3.2
Recommended Dose and Dosage
Adjustment..............................................................
3
3.3
Missed Dose
.................................................................................................................
4
4
OVERDOSAGE
............................................................................................................4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................4
6
WARNINGS AND PRECAUTIONS
...........................................................................4
6.1
Special
Populations.......................................................................................................
5
6.1.1
Pregnant Women
...................................................................................................
5
6.1.2
Breast-feeding
.......................................................................................................
5
7
ADVERSE REACTIONS
.............................................................................................5
7.1
Adverse Reaction Overview
...............................................