PILOCARPINE HYDROCHLORIDE TABLETS, USP
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
14-07-2015
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Aktívna zložka:
PILOCARPINE HYDROCHLORIDE
Dostupné z:
STERIMAX INC
ATC kód:
N07AX01
INN (Medzinárodný Name):
PILOCARPINE
Dávkovanie:
5MG
Forma lieku:
TABLET
Zloženie:
PILOCARPINE HYDROCHLORIDE 5MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0107358009; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2013-02-26
Súhrn charakteristických
_ _
_Pilocarpine Hydrochloride Tablets, USP Product Monograph _
_Page 1 of 30 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PILOCARPINE HYDROCHLORIDE
TABLETS, USP
5 MG TABLETS
CHOLINOMIMETIC AGENT
SteriMax Inc.
2770 Portland Drive
Oakville, ON L6H 6R4
DATE OF REVISION:
June 23, 2015
Submission Control No: 182910
_Pilocarpine Hydrochloride Tablets, USP Product Monograph _
_ Page 2 of 30_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
..............................................................................
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