देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
SILODOSIN
SANDOZ CANADA INCORPORATED
G04CA04
SILODOSIN
4MG
CAPSULE
SILODOSIN 4MG
ORAL
30/100
Prescription
Selective Alfa-1-Adrenergic Blocking Agents
Active ingredient group (AIG) number: 0152869001; AHFS:
APPROVED
2021-01-07
_ _ _Sandoz Silodosin _ _Page 1 of 37_ PRODUCT MONOGRAPH PR SANDOZ ® SILODOSIN Silodosin Capsules 4 mg and 8 mg Selective antagonist for ALPHA 1A adrenoreceptor subtype in the prostate and bladder ATC Code: G04C A04 Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, Québec, Canada J4B 1E6 Date of Revision: May 14, 2021 Control No.: 247975 _ _ _Sandoz Silodosin _ _Page 2 of 37_ _ _ _Sandoz Silodosin _ _Page 3 of 37_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............ Error! Bookmark not defined. SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS................................................................................................... 7 DRUG INTERACTIONS ................................................................................................. 10 DOSAGE AND ADMINISTRATION ............................................................................. 12 OVERDOSAGE ............................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 14 STORAGE AND STABILITY ......................................................................................... 18 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 18 PART II: SCIENTIFIC INFORMATION ............................................................................... 20 PHARMACEUTICAL INFORMATION......................................................................... पूरा दस्तावेज़ पढ़ें