CO MYCOPHENOLATE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
22-10-2013
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
MYCOPHENOLATE MOFETIL
Inapatikana kutoka:
COBALT PHARMACEUTICALS COMPANY
ATC kanuni:
L04AA06
INN (Jina la Kimataifa):
MYCOPHENOLIC ACID
Kipimo:
500MG
Dawa fomu:
TABLET
Tungo:
MYCOPHENOLATE MOFETIL 500MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
50/100
Dawa ya aina:
Prescription
Eneo la matibabu:
IMMUNOSUPPRESSIVE AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0128158002; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2018-05-07
Tabia za bidhaa
_ _
_ _
_Page 1 of 55_
PRODUCT MONOGRAPH
PR
_CO_ MYCOPHENOLATE
Mycophenolate Mofetil Tablets USP
500 mg
Immunosuppressive Agent
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
SUBMISSION CONTROL NO: 168316
Date of Revision:
October 16, 2013
_ _
_ _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
.........................................................................................................
29
DETAILED PHARMACOLOGY
.............................................................................
Soma hati kamili
