Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
COBALT PHARMACEUTICALS COMPANY
N06AB06
SERTRALINE
25MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG
ORAL
30/100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417003; AHFS:
CANCELLED PRE MARKET
2017-09-01
PRODUCT MONOGRAPH P PR _ _SERTRALINE Sertraline as Sertraline Hydrochloride Capsules, 25 mg, 50 mg and 100 mg ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT Manufactured by: Cobalt Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, Ontario Canada L5N 2B8 Control No.: 135927 Date of Preparation: January 25, 2010 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SUMMARY PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 SPECIAL HANDLING INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . . . . . . . . . 28 PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Đọc toàn bộ tài liệu