SALAGEN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-02-2020
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
PILOCARPINE HYDROCHLORIDE
Fáanlegur frá:
AMDIPHARM LIMITED
ATC númer:
N07AX01
INN (Alþjóðlegt nafn):
PILOCARPINE
Skammtar:
5MG
Lyfjaform:
TABLET
Samsetning:
PILOCARPINE HYDROCHLORIDE 5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0107358009; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2003-09-02
Vara einkenni
_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
...............
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