APO-PRUCALOPRIDE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
15-08-2019
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:
APOTEX 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:
15G/50G
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:
2019-12-09
Tabia za bidhaa
Page 1 of 37
PRODUCT MONOGRAPH
PR
APO-PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg prucalopride as prucalopride succinate
Prokinetic agent
Apotex. Inc.
Date of Preparation:
150 Signet Drive
August 15, 2019
Toronto Ontario
M9L 1T9
Submission Control No: 223407
Page 2 of 37
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
......................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 16
PART II: SCIENTIFIC INFORMATION
.........................................................................................
18
PHARMACEUTICAL INFORMATION
.................
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