ZEMPLAR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PARICALCITOL

Beschikbaar vanaf:

ABBVIE CORPORATION

ATC-code:

H05BX02

INN (Algemene Internationale Benaming):

PARICALCITOL

Dosering:

5MCG

farmaceutische vorm:

SOLUTION

Samenstelling:

PARICALCITOL 5MCG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

1ML

Prescription-type:

Prescription

Therapeutisch gebied:

VITAMIN D

Product samenvatting:

Active ingredient group (AIG) number: 0150742001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2012-11-03

Productkenmerken

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_ZEMPLAR_
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_ Product Monograph _
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
ZEMPLAR
®
Paricalcitol Capsules
1 mcg, 2 mcg, 4 mcg
Paricalcitol Injection USP
5 mcg/mL
Vitamin D Analog
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Canada
Date of Preparation:
November 1, 2012
Date of Previous Revision:
Date of Revision:
Submission Control No: 158316
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_ZEMPLAR_
®
_Product Monograph _
_Page 2 of 46_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..................................................