PMS-PRUCALOPRIDE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
03-06-2020
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:
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Inapatikana kutoka:
PHARMASCIENCE INC
ATC kanuni:
A06AX05
INN (Jina la Kimataifa):
PRUCALOPRIDE
Kipimo:
2MG
Dawa fomu:
TABLET
Tungo:
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 2MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
MISCELLANEOUS GI DRUGS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0153049002; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2020-06-05
Tabia za bidhaa
_pms-PRUCALOPRIDE – Product Monograph_
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PRODUCT MONOGRAPH
PR
PMS-PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg Prucalopride as Prucalopride Succinate
House Standard
Prokinetic agent
PHARMASCIENCE INC.
Date of Approval:
6111 Royalmount Ave., Suite 100
June 3, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 223701
_pms-PRUCALOPRIDE – Product Monograph_
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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
..............................................................................................................
6
DRUG INTERACTIONS
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
13
STORAGE AND STABILITY
....................................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 17
PART II: SCIENTIFIC INFORMATION
......................................
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