Страна: Канада
Язык: английский
Источник: Health Canada
GABAPENTIN
DOMINION PHARMACAL
N02BF01
GABAPENTIN
100MG
CAPSULE
GABAPENTIN 100MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929001; AHFS:
APPROVED
2001-04-04
PRODUCT MONOGRAPH Pr DOM-GABAPENTIN Gabapentin Capsules, House Standard 100 mg, 300 mg and 400 mg Gabapentin Tablets, USP 600 mg and 800 mg Antiepileptic Agent DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 Date of Revision: August 11, 2017 Submission Control No.: 207318 _ _ _Dom-GABAPENTIN Product Monograph _ _Page 2 of 30_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................14 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 STORAGE AND STABILITY ..........................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................21 PHARMACEUTICAL INFORMATION ..........................................................................21 CLINICAL TRIALS ..........................................................................................................22 DETAILED PHARMACOLOG Прочитать полный документ