M-PILOCARPINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PILOCARPINE HYDROCHLORIDE

Pieejams no:

MANTRA PHARMA INC

ATĶ kods:

N07AX01

SNN (starptautisko nepatentēto nosaukumu):

PILOCARPINE

Deva:

5MG

Zāļu forma:

TABLET

Kompozīcija:

PILOCARPINE HYDROCHLORIDE 5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-02-06

Produkta apraksts

_M-Pilocarpine Product Monograph_
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
M-PILOCARPINE
PILOCARPINE HYDROCHLORIDE TABLETS, USP
5 MG
CHOLINOMIMETIC AGENT
Mantra Pharma Inc.
9150 Leduc Blvd, Suite 201
Brossard, QC, Canada
J4Y 0E3
Date of Revision:
May 10, 2021
Submission Control No.: 250828
_M-Pilocarpine 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
................................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
3
ADVERSE REACTIONS
................................................................................................
6
DRUG INTERACTIONS
...............................................................................................
10
DOSAGE AND ADMINISTRATION
...........................................................................
10
OVERDOSAGE
.............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 12
STORAGE AND STABILITY
......................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 16
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
......................................................................
17
CLINICAL TRIALS
.......................................................................................................
18
DETAILED PHARMACOLOGY
.................................................