Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
RIVASTIGMINE
PHARMAPAR INC
N06DA03
RIVASTIGMINE
4.6MG
PATCH
RIVASTIGMINE 4.6MG
TRANSDERMAL
100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521007; AHFS:
CANCELLED PRE MARKET
2021-07-05
_Page 1 of 63_ PRODUCT MONOGRAPH PR PRIVA-RIVASTIGMINE Rivastigmine Transdermal Patch Each patch of 5 cm 2 contains 9 mg rivastigmine, _in vivo _release rate of 4.6 mg/24 h Each patch of 10 cm 2 contains 18 mg rivastigmine, _in vivo _release rate of 9.5 mg/24 h Each patch of 15 cm 2 contains 27 mg rivastigmine, _in vivo _release rate of 13.3 mg/24 h Cholinesterase Inhibitor DATE OF PREPARATION: July 5, 2019 Pharmapar Inc. 1565 Boul. Lionel-Boulet Varennes, Quebec J3X 1P7 www.pharmapar.ca CONTROL NO.: 228274 _Page 2 of 63_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................... 3 SUMMARY PRODUCT INFORMATION ......................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................... 4 ADVERSE REACTIONS ................................................................................................... 12 DRUG INTERACTIONS ................................................................................................... 24 DOSAGE AND ADMINISTRATION ............................................................................... 25 OVERDOSAGE ................................................................................................................. 28 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 28 STORAGE AND STABILITY ........................................................................................... 33 SPECIAL HANDLING INSTRUCTIONS ........................................................................ 33 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 33 PART II: SCIENTIFIC INFORMATION ............................... Soma hati kamili