Страна: Канада
Язык: английский
Источник: Health Canada
RIVASTIGMINE
MYLAN PHARMACEUTICALS ULC
N06DA03
RIVASTIGMINE
9.5MG
PATCH
RIVASTIGMINE 9.5MG
TRANSDERMAL
30
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521008; AHFS:
APPROVED
2016-12-02
_ _ _ _ _Page 1 of 61_ PRODUCT MONOGRAPH PR MYLAN-RIVASTIGMINE PATCH 5 Rivastigmine Transdermal Patch Each patch of 5 cm 2 contains 9 mg rivastigmine base, _in vivo _release rate of 4.6 mg/24 h. PR MYLAN-RIVASTIGMINE PATCH 10 Rivastigmine Transdermal Patch Each patch of 10 cm 2 contains 18 mg rivastigmine base, _in vivo _release rate of 9.5 mg/24 h. Cholinesterase Inhibitor Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Preparation: September 30, 2016 Submission Control No: 167242, 184616, 198467 _ _ _ _ _Page 2 of 61_ 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 ................................................................................................. 22 DOSAGE AND ADMINISTRATION ............................................................................. 24 OVERDOSAGE ............................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 28 STORAGE AND STABILITY ......................................................................................... 33 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION .................................... Прочитать полный документ