VITAMIN D3 ORAL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VITAMIN D3

Available from:

GALEPHAR PHARMACEUTICAL RESEARCH INC

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL

Dosage:

25000UNIT

Pharmaceutical form:

SOLUTION

Composition:

VITAMIN D3 25000UNIT

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

VITAMIN D

Product summary:

Active ingredient group (AIG) number: 0108524012; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-02-05

Summary of Product characteristics

_Vitamin D_
_3_
_ Oral Solution (cholecalciferol) _
_January 14, 2021 _
_Page 1 of 16 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VITAMIN D
3 ORAL SOLUTION
Cholecalciferol Solution, USP
625 mcg (25,000 IU)
Vitamin D
Galephar Pharmaceutical Research Inc.
HC-04 BOX 4540
Humacao Puerto Ricco 00791
Imported and distributed by:
Innomar Strategies Inc.
Oakville, ON
L6L 0C4
Date of Initial Approval/Date
of Preparation:
February 5, 2021
Date of Revision:
Submission Control No:
219321
_Vitamin D_
_3_
_ Oral Solution (cholecalciferol) _
_January 14, 2021 _
_Page 2 of 16 _
TABLE OF CONTENTS
TABLE OF
CONTENTS.......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
1
INDICATIONS
...........................................................................................................
3
1.1
Pediatrics (<18 years of age):
.........................................................................
3
1.2
Geriatrics (> 65 years of age):
........................................................................
3
2
CONTRAINDICATIONS
...........................................................................................
3
4
DOSAGE AND ADMINISTRATION
.........................................................................
3
4.1
Dosing Considerations
....................................................................................
3
4.2
Recommended Dose and Dosage Adjustment
.............................................. 3
4.3
Administration
..................................................................................................
4
4.5
Missed Dose
....................................................................................................
4
5
OVERDOSAGE
.........................................................................................................
4
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 5
7
WARNINGS AND
PRECAUTIO