PILOCARPINE HYDROCHLORIDE TABLETS

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PILOCARPINE HYDROCHLORIDE

Commercializzato da:

METHAPHARM INC

Codice ATC:

N07AX01

INN (Nome Internazionale):

PILOCARPINE

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

PILOCARPINE HYDROCHLORIDE 5MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-10-14

Scheda tecnica

_PILOCARPINE HYDROCHLORIDE TABLETS Product Monograph _
_Page 1 of 33 _
PRODUCT MONOGRAPH
PR
PILOCARPINE HYDROCHLORIDE TABLETS
5 MG
CHOLINOMIMETIC AGENT
Methapharm Inc
81 Sinclair Boulevard
Brantford, Ontario
N3S 7X6, Canada
Date of Revision:
October 13, 2020
Submission Control No.: 241563
_PILOCARPINE HYDROCHLORIDE TABLETS Product Monograph _
_Page 2 of 33 _
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
CLINICAL TRIALS
..........................................................................................................20
DETAILED PHARMAC