País: Canadá
Língua: inglês
Origem: Health Canada
GABAPENTIN
RANBAXY PHARMACEUTICALS CANADA INC.
N02BF01
GABAPENTIN
100MG
CAPSULE
GABAPENTIN 100MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929001; AHFS:
CANCELLED POST MARKET
2023-02-06
Page 1 of 33 PRODUCT MONOGRAPH PR RAN™-GABAPENTIN Gabapentin Capsules, Mfr. Std 100 mg, 300 mg, and 400 mg Antiepileptic Agent Ranbaxy Pharmaceuticals Canada Inc. Date of Revision 126 East Drive June 17, 2020 Brampton, Ontario L6T 1C1 Submission Control No.: 239409 RAN trademark owned by Sun Pharmaceutical Industries Ltd. Page 2 of 33 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 ........................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................... 13 DOSAGE AND ADMINISTRATION ..................................................................................... 15 OVERDOSAGE ........................................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 17 STORAGE AND STABILITY ................................................................................................. 20 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 22 PHARMACEUTICAL INFORMATION ................................... Leia o documento completo