CALCITRIOL-ODAN CAPSULE
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
03-10-2014
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Aktivní složka:
CALCITRIOL
Dostupné s:
ODAN LABORATORIES LTD
ATC kód:
A11CC04
INN (Mezinárodní Name):
CALCITRIOL
Dávkování:
0.5MCG
Léková forma:
CAPSULE
Složení:
CALCITRIOL 0.5MCG
Podání:
ORAL
Jednotky v balení:
30/100
Druh předpisu:
Prescription
Terapeutické oblasti:
VITAMIN D
Přehled produktů:
Active ingredient group (AIG) number: 0113628005; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2014-09-24
Charakteristika produktu
PRODUCT MONOGRAPH
PR CALCITRIOL-ODAN
TM
Calcitriol
Capsules 0.25 mcg and 0.5 mcg
House standard VITAMIN D
3 METABOLITE
ODAN LABORATORIES LTD.
DATE OF PREPARATION:
325 STILLVIEW AVENUE
SEPTEMBER 23, 2014
POINTE-CLAIRE, QC
CANADA H9R 2Y6
Submission Control No: 161455
CALCITRIOL-ODAN
TM
is a trade-mark of Odan Laboratories Limited.
_Page 1 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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