CALCITRIOL-ODAN CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CALCITRIOL

Tersedia dari:

ODAN LABORATORIES LTD

Kode ATC:

A11CC04

INN (Nama Internasional):

CALCITRIOL

Dosis:

0.5MCG

Bentuk farmasi:

CAPSULE

Komposisi:

CALCITRIOL 0.5MCG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

VITAMIN D

Ringkasan produk:

Active ingredient group (AIG) number: 0113628005; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-09-24

Karakteristik produk

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