PILOCARPINE HYDROCHLORIDE TABLETS
Država: Kanada
Jezik: engleski
Izvor: Health Canada
Svojstava lijeka
(SPC)
13-10-2020
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Pošalji zahtjev.
Aktivni sastojci:
PILOCARPINE HYDROCHLORIDE
Dostupno od:
METHAPHARM INC
ATC koda:
N07AX01
INN (International ime):
PILOCARPINE
Doziranje:
5MG
Farmaceutski oblik:
TABLET
Sastav:
PILOCARPINE HYDROCHLORIDE 5MG
Administracija rute:
ORAL
Jedinice u paketu:
100
Tip recepta:
Prescription
Područje terapije:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Proizvod sažetak:
Active ingredient group (AIG) number: 0107358009; AHFS:
Status autorizacije:
APPROVED
Datum autorizacije:
2020-10-14
Svojstava lijeka
_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
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