MINIRIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
01-03-2006

有效成分:

DESMOPRESSIN ACETATE

可用日期:

FERRING INC

ATC代码:

H01BA02

INN(国际名称):

DESMOPRESSIN

剂量:

0.1MG

药物剂型:

TABLET

组成:

DESMOPRESSIN ACETATE 0.1MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

PITUITARY

產品總結:

Active ingredient group (AIG) number: 0112050005; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2015-07-22

产品特点

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_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........................................................................................
                                
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