Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
CARBAMAZEPINE
MYLAN PHARMACEUTICALS ULC
N03AF01
CARBAMAZEPINE
200MG
TABLET (EXTENDED-RELEASE)
CARBAMAZEPINE 200MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0108674001; AHFS:
CANCELLED POST MARKET
2017-01-09
_ _ _ _ _Page 1 of 51_ PRODUCT MONOGRAPH PR MYLAN-CARBAMAZEPINE CR (Carbamazepine) Controlled Release Tablets (200 mg & 400 mg) Manufacturer’s Standard Anticonvulsant For Symptomatic Relief of Trigeminal Neuralgia Antimanic Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Revision: February 12, 2015 Submission Control No: 178990 _ _ _ _ _Page 2 of 51_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 4 SUMMARY PRODUCT INFORMATION ....................................................................... 4 INDICATIONS AND CLINICAL USE ............................................................................. 4 CONTRAINDICATIONS .................................................................................................. 6 WARNINGS AND PRECAUTIONS ................................................................................. 6 ADVERSE REACTIONS ................................................................................................. 18 DRUG INTERACTIONS ................................................................................................. 22 DOSAGE AND ADMINISTRATION ............................................................................. 27 OVERDOSAGE ............................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 31 STORAGE AND STABILITY ......................................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION .............................................................................. 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ......................................................................................................... 35 Կարդացեք ամբողջական փաստաթուղթը