PILOCARPINE HYDROCHLORIDE TABLETS
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
13-10-2020
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Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
PILOCARPINE HYDROCHLORIDE
Inapatikana kutoka:
METHAPHARM INC
ATC kanuni:
N07AX01
INN (Jina la Kimataifa):
PILOCARPINE
Kipimo:
5MG
Dawa fomu:
TABLET
Tungo:
PILOCARPINE HYDROCHLORIDE 5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0107358009; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2020-10-14
Tabia za bidhaa
_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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