País: Canadá
Língua: inglês
Origem: Health Canada
RIVASTIGMINE
PHARMASCIENCE INC
N06DA03
RIVASTIGMINE
13.3MG
PATCH
RIVASTIGMINE 13.3MG
TRANSDERMAL
15G/50G
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521009; AHFS:
APPROVED
2023-11-07
_RIVASTIGMINE PATCH (Rivastigmine Transdermal Patch) _ _Page 1 of 62_ PRODUCT MONOGRAPH PR RIVASTIGMINE PATCH 5 Rivastigmine Transdermal Patch Each patch of 5 cm 2 contains 9 mg rivastigmine, _in vivo_ release rate of 4.6 mg/24 h. PR RIVASTIGMINE PATCH 10 Rivastigmine Transdermal Patch Each patch of 10 cm 2 contains 18 mg rivastigmine, _in vivo_ release rate of 9.5 mg/24 h. PR RIVASTIGMINE PATCH 15 Rivastigmine Transdermal Patch Each patch of 15 cm 2 contains 27 mg rivastigmine, _in vivo_ release rate of 13.3 mg/24 h. Cholinesterase Inhibitor Pharmascience Inc. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com Submission Control No.: 279770 Date of Preparation: NOV 07, 2023 _RIVASTIGMINE PATCH (Rivastigmine Transdermal Patch) _ _Page 2 of 62_ 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 ............................................................................................... 12 DRUG INTERACTIONS ............................................................................................... 23 DOSAGE AND ADMINISTRATION ........................................................................... 25 OVERDOSAGE .............................................................................................................. 28 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 29 STORAGE AND STABILITY ....................................................................................... 34 SPECIAL HANDLING INSTRUCTIONS ............... Leia o documento completo