Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
PILOCARPINE HYDROCHLORIDE
AMDIPHARM LIMITED
N07AX01
PILOCARPINE
5MG
TABLET
PILOCARPINE HYDROCHLORIDE 5MG
ORAL
15G/50G
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0107358009; AHFS:
APPROVED
2003-09-02
_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 ............... Prečítajte si celý dokument