국가: 캐나다
언어: 영어
출처: Health Canada
LEFLUNOMIDE
ODAN LABORATORIES LTD
L04AA13
LEFLUNOMIDE
20MG
TABLET
LEFLUNOMIDE 20MG
ORAL
30
Prescription
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Active ingredient group (AIG) number: 0140182002; AHFS:
APPROVED
2017-07-05
_ _ _ _ _PAGE 1 OF 70_ PRODUCT MONOGRAPH Pr ODAN-LEFLUNOMIDE Leflunomide, Mfr. Std. Film-coated Tablets 10, 20 mg Antirheumatic, Immunomodulator Agent ATC Code: L04AA13 ODAN LABORATORIES LTD 325 STILLVIEW AVENUE POINTE-CLAIRE, QUEBEC H9R 2Y6 Date of Revision: July 5, 2017 SUBMISSION CONTROL NO.: 205879 _ _ _ _ _PAGE 2 OF 70_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................... 3 CONTRAINDICATIONS ........................................................................................... 3 WARNINGS AND PRECAUTIONS ......................................................................... 5 ADVERSE REACTIONS ......................................................................................... 15 DRUG INTERACTIONS .......................................................................................... 21 DOSAGE AND ADMINISTRATION ...................................................................... 26 OVERDOSAGE ........................................................................................................ 27 ACTION AND CLINICAL PHARMACOLOGY .................................................... 27 STORAGE AND STABILITY ................................................................................. 30 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................... 31 PART II: SCIENTIFIC INFORMATION ................................................................................ 32 PHARMACEUTICAL INFORMATION ................................................................. 32 CLINICAL TRIALS ................................................................................................. 32 DETAILED PHARMACOLOGY ............................................................................. 40 TOXICOLOGY ............................... 전체 문서 읽기