מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
CARBAMAZEPINE
APOTEX INC
N03AF01
CARBAMAZEPINE
400MG
TABLET (EXTENDED-RELEASE)
CARBAMAZEPINE 400MG
ORAL
30/60/100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0108674004; AHFS:
APPROVED
2013-11-18
_APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _ _Page 1 of 52 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-CARBAMAZEPINE Carbamazepine Tablets Tablets, 200 mg, oral USP PR APO-CARBAMAZEPINE CR Carbamazepine Controlled Release Tablets Controlled-Release Tablets, 200 mg and 400 mg, oral Apotex Standard Anticonvulsant For Symptomatic Relief of Trigeminal Neuralgia Antimanic ATC code: N03AF01 APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: June 10, 1980 Date of Revision: May 31, 2022 Submission Control Number: 262869 _APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _ _Page 2 of 52 _ _ _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 05/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................4 1 INDICATIONS .......................................................................................................................4 1.1 Pediatrics ..................................................................................................................... 5 1.2 Geriatrics...................................................................................................................... 5 2 CONTRAINDICATIONS ..........................................................................................................5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX......................................................................6 4 DOSAGE AND ADMINISTRATION ..........................................................................................7 4.1 Dosing Considerations .................................................................................................. 7 4.2 Recommended Dose and Dosage Adjustment........................................... קרא את המסמך השלם