Land: Kanada
Tungumál: enska
Heimild: Health Canada
GABAPENTIN
TARO PHARMACEUTICALS INC
N02BF01
GABAPENTIN
100MG
CAPSULE
GABAPENTIN 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929001; AHFS:
CANCELLED PRE MARKET
2023-11-08
_ _ _Taro-Gabapentin Product Monograph _ _Page 1 of 30_ PRODUCT MONOGRAPH Pr TARO-GABAPENTIN Gabapentin Capsules 100 mg, 300 mg and 400 mg Antiepileptic Agent Taro Pharmaceuticals Inc. 130 East Drive Brampton, Ontario L6T 1C1 Date of Revision: December 16, 2020 Submission Control No: 245306 _ _ _Taro-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 ................................................................................................. 13 DOSAGE AND ADMINISTRATION ............................................................................. 15 OVERDOSAGE ............................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 18 STORAGE AND STABILITY ......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 20 PART II: SCIENTIFIC INFORMATION .............................................................................. 21 PHARMACEUTICAL INFORMATION ......................................................................... 21 CLINICAL TRIALS ......................................................................................................... 21 DETAILED PHARMACOLOGY ........ Lestu allt skjalið