GD-ZIPRASIDONE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE)

Disponible depuis:

GENMED A DIVISION OF PFIZER CANADA ULC

Code ATC:

N05AE04

DCI (Dénomination commune internationale):

ZIPRASIDONE

Dosage:

80MG

forme pharmaceutique:

CAPSULE

Composition:

ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE) 80MG

Mode d'administration:

ORAL

Unités en paquet:

7/10/30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ATYPICAL ANTIPSYCHOTICS

Descriptif du produit:

Active ingredient group (AIG) number: 0152272004; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2020-10-13

Résumé des caractéristiques du produit

_GD-Ziprasidone (ziprasidone) - Product Monograph _
_Page 1 of 62_
_ _
_ _
PRODUCT MONOGRAPH
PR
GD
*
-ZIPRASIDONE
ziprasidone capsules
20, 40, 60, and 80 mg
ANTIPSYCHOTIC AGENT
GenMed, a Division of Pfizer Canada Inc.
17 300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 221526
* GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2018
Date of Preparation:
November 1, 2018
_GD-Ziprasidone (ziprasidone) - Product Monograph _
_Page 2 of 62_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
30
DOSAGE AND ADMINISTRATION
.............................................................................
32
OVERDOSAGE................................................................................................................
34
ACTION AND CLINICAL
PHARMACOLOGY............................................................
35
STORAGE AND STABILITY
.........................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
39
PHARMACEUTICAL INFORMATION
.................................................