CALCITRIOL-ODAN CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CALCITRIOL

Mevcut itibaren:

ODAN LABORATORIES LTD

ATC kodu:

A11CC04

INN (International Adı):

CALCITRIOL

Doz:

0.25MCG

Farmasötik formu:

CAPSULE

Kompozisyon:

CALCITRIOL 0.25MCG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

VITAMIN D

Ürün özeti:

Active ingredient group (AIG) number: 0113628007; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-09-24

Ürün özellikleri

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
.......................