Страна: Канада
мова: англійська
Джерело: Health Canada
PREGABALIN
MINT PHARMACEUTICALS INC
N02BF02
PREGABALIN
50MG
CAPSULE
PREGABALIN 50MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0151121002; AHFS:
APPROVED
2014-05-02
______________________________________________________________________________ _Mint-Pregabalin Product Monograph _ 1 of 64 _ _ PRODUCT MONOGRAPH PR MINT-PREGABALIN Pregabalin Capsules Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg ANALGESIC AGENT Mint Pharmaceuticals Inc. 6575 Davand Dr Mississauga, Ontario, Canada L5T 2M3 SUBMISSION CONTROL NUMBER: 255444 DATE OF PREPARATION: September 22, 2021 ______________________________________________________________________________ _Mint-Pregabalin Product Monograph _ 2 of 64 _ _ 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..................................................................................................15 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....................................... Прочитайте повний документ