PRIVA-RIVASTIGMINE PATCH

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
05-07-2019

Viambatanisho vya kazi:

RIVASTIGMINE

Inapatikana kutoka:

PHARMAPAR INC

ATC kanuni:

N06DA03

INN (Jina la Kimataifa):

RIVASTIGMINE

Kipimo:

4.6MG

Dawa fomu:

PATCH

Tungo:

RIVASTIGMINE 4.6MG

Njia ya uendeshaji:

TRANSDERMAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0140521007; AHFS:

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2021-07-05

Tabia za bidhaa

                                _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
...............................
                                
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