PMS-CALCITRIOL CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CALCITRIOL

Fáanlegur frá:

PHARMASCIENCE INC

ATC númer:

A11CC04

INN (Alþjóðlegt nafn):

CALCITRIOL

Skammtar:

0.5MCG

Lyfjaform:

CAPSULE

Samsetning:

CALCITRIOL 0.5MCG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

VITAMIN D

Vörulýsing:

Active ingredient group (AIG) number: 0113628004; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-03-14

Vara einkenni

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