País: Canadá
Língua: inglês
Origem: Health Canada
GABAPENTIN
RANBAXY PHARMACEUTICALS CANADA INC.
N02BF01
GABAPENTIN
400MG
CAPSULE
GABAPENTIN 400MG
ORAL
30/100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929002; AHFS:
CANCELLED PRE MARKET
2023-07-24
_ _ _ _ _Page 1 of 28_ PRODUCT MONOGRAPH PR GABAPENTIN CAPSULES Gabapentin Capsules USP 100 mg, 300 mg, and 400 mg Antiepileptic Agent Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 20, 2009. 2680 Matheson Blvd. E., Suite 200 Mississauga, Ontario L4W 0A5 Submission Control No: 132106 _ _ _ _ _Page 2 of 28_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION..............................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ....…...........................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................3 ADVERSE REACTIONS....................................................................................................5 DRUG INTERACTIONS ..................................................................................................11 DOSAGE AND ADMINISTRATION..............................................................................13 OVERDOSAGE ................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ............................................................15 STORAGE AND STABILITY..........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................18 PART II: SCIENTIFIC INFORMATION ....................................................................20 PHARMACEUTICAL INFORMATION..........................................................................20 CLINICAL TRIALS..........................................................................................................21 DETAILED PHARMACOLOGY.............................................................. Leia o documento completo