PILOCARPINE HYDROCHLORIDE TABLETS, USP

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PILOCARPINE HYDROCHLORIDE

Saatavilla:

STERIMAX INC

ATC-koodi:

N07AX01

INN (Kansainvälinen yleisnimi):

PILOCARPINE

Annos:

5MG

Lääkemuoto:

TABLET

Koostumus:

PILOCARPINE HYDROCHLORIDE 5MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-02-26

Valmisteyhteenveto

_ _
_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
..............................................................................