ROCALTROL CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-01-2021
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Active ingredient:
CALCITRIOL
Available from:
SEARCHLIGHT PHARMA INC
ATC code:
A11CC04
INN (International Name):
CALCITRIOL
Dosage:
0.5MCG
Pharmaceutical form:
CAPSULE
Composition:
CALCITRIOL 0.5MCG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
VITAMIN D
Product summary:
Active ingredient group (AIG) number: 0113628005; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-01-27
Summary of Product characteristics
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_Page 1 of 25_
PRODUCT MONOGRAPH
PR
ROCALTROL
®
Calcitriol Capsules
Capsules 0.25 mcg and 0.5 mcg
Vitamin D3 Metabolite
Searchlight Pharma Inc.
1600 Notre-Dame Street W. Suite 312
Montreal, Quebec
H3J 1M1
Date of Revision:
January 26, 2021
Submission Control No.: 247457
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_Page 2 of 25_
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
............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
...................................................
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