CALCIJEX SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CALCITRIOL

Disponible depuis:

ABBVIE CORPORATION

Code ATC:

A11CC04

DCI (Dénomination commune internationale):

CALCITRIOL

Dosage:

2MCG

forme pharmaceutique:

SOLUTION

Composition:

CALCITRIOL 2MCG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

10X1ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

VITAMIN D

Descriptif du produit:

Active ingredient group (AIG) number: 0113628003; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-01-13

Résumé des caractéristiques du produit

_CALCIJEX_
_®_
_ Product Monograph _
_Page 1 of 26 _
_Date of Revision: August 15, 2014 and Control No. 174744 _
PRODUCT MONOGRAPH
PR
CALCIJEX
®
calcitriol injection
1 mcg/mL and 2 mcg/mL
Vitamin D
3
metabolite
AbbVie Corporation
Date of Preparation:
8401 Trans-Canada Highway
December 08, 1995
St-Laurent, Qc H4S 1Z1
Date of Previous Revision:
May 29, 2013
Date of Revision:
August 29, 2014
Submission Control No: 174744
_CALCIJEX_
_®_
_ Product Monograph _
_Page 2 of 26 _
_Date of Revision: August 15, 2014 and Control No. 174744 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
.............................................