JAMP PILOCARPINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
09-12-2020
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Werkstoffen:
PILOCARPINE HYDROCHLORIDE
Beschikbaar vanaf:
JAMP PHARMA CORPORATION
ATC-code:
N07AX01
INN (Algemene Internationale Benaming):
PILOCARPINE
Dosering:
5MG
farmaceutische vorm:
TABLET
Samenstelling:
PILOCARPINE HYDROCHLORIDE 5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0107358009; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2020-12-10
Productkenmerken
_JAMP Pilocarpine Product Monograph_
_Page 1 of 32_
PRODUCT MONOGRAPH
PR
JAMP PILOCARPINE
PILOCARPINE HYDROCHLORIDE TABLETS, USP
5 MG
CHOLINOMIMETIC AGENT
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Preparation:
December 09, 2020
Submission Control No: 234963
_JAMP Pilocarpine Product Monograph_
_Page 2 of 32_
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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