Country: Կանադա
language: անգլերեն
source: Health Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
JAMP PHARMA CORPORATION
A06AX05
PRUCALOPRIDE
2MG
TABLET
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 2MG
ORAL
15G/50G
Prescription
MISCELLANEOUS GI DRUGS
Active ingredient group (AIG) number: 0153049002; AHFS:
APPROVED
2019-12-09
_ JAMP PRUCALOPRIDE_ _Page 1 of 37_ PRODUCT MONOGRAPH PR JAMP PRUCALOPRIDE Prucalopride Tablets 1 mg and 2 mg prucalopride as prucalopride succinate Prokinetic agent Jamp Pharma Corporation 1310 rue Nobel, Boucherville, Québec, J4B 5H3 Date of Preparation: October 28, 2019 Submission Control No: 226302 _ JAMP PRUCALOPRIDE_ _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 ...................................................................................................... 10 DOSAGE AND ADMINISTRATION ................................................................................... 11 OVERDOSAGE .................................................................................................................... 12 ACTION AND CLINICAL PHARMACOLOGY .................................................................. 12 STORAGE AND STABILITY .............................................................................................. 15 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 15 DOSAGE FORMS, COMPOSITION AND PACKAGING.................................................... 16 PART II: SCIENTIFIC INFORMATION ............................................................................. 17 PHARMACEUTICAL INFORMATION .................................................................... read_full_document