国家: 加拿大
语言: 英文
来源: Health Canada
DESMOPRESSIN ACETATE
FERRING INC
H01BA02
DESMOPRESSIN
0.1MG
TABLET
DESMOPRESSIN ACETATE 0.1MG
ORAL
100
Prescription
PITUITARY
Active ingredient group (AIG) number: 0112050005; AHFS:
CANCELLED POST MARKET
2015-07-22
_ _ _ _ _Page 1 of 37 _ _D:\1.3.2. Proposed Minirin Tablet PM (English) January 12, 2006.doc _ _ _ PRODUCT MONOGRAPH Pr MINIRIN ® TABLETS (Desmopressin Acetate) 0.1 mg and 0.2 mg Tablets Antidiuretic Ferring Inc. 200 Yorkland Blvd., Suite # 800 North York, Ontario M2J 5C1 Date of Preparation: July 13, 2001 Date of Revision: March 1, 2006 Submission Control No: 103726 _ _ _ _ _Page 2 of 37 _ _D:\1.3.2. Proposed Minirin Tablet PM (English) January 12, 2006.doc_ Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ................................................... 3 SUMMARY PRODUCT INFORMATION ..........................................................….3 INDICATIONS AND CLINICAL USE .................................................................... 3 CONTRAINDICATIONS ....................................................................................... 3 WARNINGS AND PRECAUTIONS ...................................................................... 3 ADVERSE REACTIONS ...................................................................................... 6 DRUG INTERACTIONS ....................................................................................... 9 DOSAGE AND ADMINISTRATION.................................................................... 10 OVERDOSAGE.................................................................................................. 11 ACTION AND CLINICAL PHARMACOLOGY..................................................... 11 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................... 21 STORAGE AND STABILITY............................................................................... 21 SPECIAL HANDLING INSTRUCTIONS... ………………………………………… 21 PART II: SCIENTIFIC INFORMATION ………………………………………………… 22 PHARMACEUTICAL INFORMATION ................................................................ 22 CLINICAL TRIALS........................................................................................ 阅读完整的文件