PILOCARPINE HYDROCHLORIDE TABLETS, USP

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PILOCARPINE HYDROCHLORIDE

Tersedia dari:

STERIMAX INC

Kode ATC:

N07AX01

INN (Nama Internasional):

PILOCARPINE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

PILOCARPINE HYDROCHLORIDE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-02-26

Karakteristik produk

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