SALAGEN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PILOCARPINE HYDROCHLORIDE

Tersedia dari:

AMDIPHARM LIMITED

Kode ATC:

N07AX01

INN (Nama Internasional):

PILOCARPINE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

PILOCARPINE HYDROCHLORIDE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-09-02

Karakteristik produk

_SALAGEN Product Monograph _
_Page 1 of 33 _
PRODUCT MONOGRAPH
PR
SALAGEN
®
PILOCARPINE HYDROCHLORIDE TABLETS
CHOLINOMIMETIC AGENT
Amdipharm Limited
3 Burlington Road
Dublin 4,
Ireland
DATE OF REVISION:
February
28, 2020
Distributed by:
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario
N3S 7X6
Submission Control No:
235967
® Registered trademark of Mercury Pharma Group Limited, used under
License Amdipharm Limited
_SALAGEN Product Monograph _
_Page 2 of 33 _
Table of Contents
PA RT 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
...............