TARO-CALCITRIOL CAPSULE
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
11-02-2019
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Aktīvā sastāvdaļa:
CALCITRIOL
Pieejams no:
TARO PHARMACEUTICALS INC
ATĶ kods:
A11CC04
SNN (starptautisko nepatentēto nosaukumu):
CALCITRIOL
Deva:
0.25MCG
Zāļu forma:
CAPSULE
Kompozīcija:
CALCITRIOL 0.25MCG
Ievadīšanas:
ORAL
Vienības iepakojumā:
15G/50G
Receptes veids:
Prescription
Ārstniecības joma:
VITAMIN D
Produktu pārskats:
Active ingredient group (AIG) number: 0113628001; AHFS:
Autorizācija statuss:
APPROVED
Autorizācija datums:
2019-02-12
Produkta apraksts
PRODUCT MONOGRAPH
PR
TARO-CALCITRIOL
Calcitriol Capsules
Soft-gelatin capsules; 0.25 mcg and 0.5 mcg
Taro Standard
Vitamin D3 Metabolite
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Preparation:
February 11, 2019
Submission Control No: 208690
_Page 1 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
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
..........................................................
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