PILOCARPINE HYDROCHLORIDE TABLETS, USP

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PILOCARPINE HYDROCHLORIDE

Disponible depuis:

STERIMAX INC

Code ATC:

N07AX01

DCI (Dénomination commune internationale):

PILOCARPINE

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

PILOCARPINE HYDROCHLORIDE 5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0107358009; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-02-26

Résumé des caractéristiques du produit

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_Pilocarpine Hydrochloride Tablets, USP Product Monograph _
_Page 1 of 30 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PILOCARPINE HYDROCHLORIDE
TABLETS, USP
5 MG TABLETS
CHOLINOMIMETIC AGENT
SteriMax Inc.
2770 Portland Drive
Oakville, ON L6H 6R4
DATE OF REVISION:
June 23, 2015
Submission Control No: 182910
_Pilocarpine Hydrochloride Tablets, USP Product Monograph _
_ Page 2 of 30_
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
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
..............................................................................