PMS-CALCITRIOL CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CALCITRIOL

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

A11CC04

INN (Internationale Bezeichnung):

CALCITRIOL

Dosierung:

0.25MCG

Darreichungsform:

CAPSULE

Zusammensetzung:

CALCITRIOL 0.25MCG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

VITAMIN D

Produktbesonderheiten:

Active ingredient group (AIG) number: 0113628001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-03-14

Fachinformation

_pms-CALCITRIOL Product Monograph _
_ _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
PMS-CALCITRIOL
Calcitriol Capsules
Capsules 0.25 mcg and 0.5 mcg
House Standard
Vitamin D
3
Metabolite
Pharmascience Inc.
Date of Preparation:
6111 Royalmount Ave., Suite 100
MAR 13, 2023
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 272415
_pms-CALCITRIOL Product Monograph _
_ _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................... 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
......................................................................
3
CONTRAINDICATIONS
...........................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
...........................................................................................
5
DRUG INTERACTIONS
............................................................................................
7
DOSAGE AND ADMINISTRATION
........................................................................
8
OVERDOSAGE
........................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
.................................................... 10
STORAGE AND STABILITY
..................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................... 12
PART II: SCIENTIFIC INFORMATION
................................................................ 14
PHARMACEUTICAL INFORMATION
................................................................. 14
CLINICAL TRIALS
..................................................................................................
15
DETAILED PHARMACOLOGY
.............................................................................