MYLAN-RIVASTIGMINE CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

N06DA03

INN (আন্তর্জাতিক নাম):

RIVASTIGMINE

ডোজ:

1.5MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

14/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0140521001; AHFS:

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2016-11-02

পণ্য বৈশিষ্ট্য

_Page 1 of 56 _
PRODUCT MONOGRAPH
PR
MYLAN-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules
1.5 mg, 3 mg, 4.5 mg and 6 mg Rivastigmine
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control Number: 184285
_Page 2 of 56 _
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
33
PHARMACEUTICAL INFORMATION
.........................................................................
33
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
................................................