ONE-ALPHA DROPS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALFACALCIDOL

Available from:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC code:

A11CC03

INN (International Name):

ALFACALCIDOL

Dosage:

2MCG

Pharmaceutical form:

DROPS

Composition:

ALFACALCIDOL 2MCG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

VITAMIN D

Product summary:

Active ingredient group (AIG) number: 0135700005; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-06-16

Summary of Product characteristics

_ONE-ALPHA® (alfacalcidol) Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ONE-ALPHA®
Alfacalcidol
Capsules, 0.25 and 1 mcg, oral
Oral Drops, 2 mcg/mL, oral
Injection, 2 mcg/mL, intravenous
Vitamin D Analogue
A11CC03 VITAMIN D AND ANALOGUES
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
www.cheplapharm.com
Importer / Distributor:
Xediton Pharmaceuticals Inc.
2000 Argentia Rd
Mississauga
Ontario L5N 1W1
Date of Initial Authorization:
December 31, 1980 (Capsules, 0.25 and
1 mcg)
December 04, 2000 (Oral Drops, 2 mcg/mL)
February 20, 2001 (Injection, 2 mcg/mL)
Date of Revision:
26 January 2022
Submission Control Number: 251287
®Registered trademark of
CHEPLAPHARM Arzneimittel GmbH used under license by Xediton
Pharmaceuticals Inc., Mississauga, Ontario L5N 1W1
_ONE-ALPHA® (alfacalcidol) Product Monograph _
_Page 2 of 32 _
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
1.2.
Geriatrics
............................................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................................
4
4.
DOSAGE AND ADMINISTRATION
...............................................................................
4
4.1.
Dosing Considerations
........................................................................................
4
4.2.
Recommended Dose and Dosage Adjustment
.................................................... 7
4.3.
Reconstitution
.....................................................................................................
8
4.4.
Administration
........................................................