Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
PREGABALIN
UPJOHN CANADA ULC
N02BF02
PREGABALIN
100MG
CAPSULE
PREGABALIN 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0151121004; AHFS:
CANCELLED PRE MARKET
2021-09-09
PRODUCT MONOGRAPH PR LYRICA ® Pregabalin capsules 25, 50, 75, 100, 150, 200, 225, 300 mg ANALGESIC AGENT Upjohn Canada ULC 17300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Revision: May 11, 2020 Submission Control No.: 237599 ® C.P. Pharmaceuticals International C.V. Upjohn Canada ULC, Licensee © Upjohn Canada ULC, 2020 _LYRICA (pregabalin) – Product Monograph _ _Page 2 of 62_ 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 ..................................................................................................16 DRUG INTERACTIONS ..................................................................................................34 DOSAGE AND ADMINISTRATION ..............................................................................36 OVERDOSAGE ................................................................................................................39 ACTION AND CLINICAL PHARMACOLOGY ............................................................40 STORAGE AND STABILITY ..........................................................................................43 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................43 PART II: SCIENTIFIC INFORMATION ...............................................................................45 PHARMACEUTICAL INFORMATION ..........................................................................45 CLINICAL TRIALS ............................................................................................ Perskaitykite visą dokumentą