DDAVP MELT TABLET (ORALLY DISINTEGRATING)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DESMOPRESSIN (DESMOPRESSIN ACETATE)

제공처:

FERRING INC

ATC 코드:

H01BA02

INN (International Name):

DESMOPRESSIN

복용량:

60MCG

약제 형태:

TABLET (ORALLY DISINTEGRATING)

구성:

DESMOPRESSIN (DESMOPRESSIN ACETATE) 60MCG

관리 경로:

SUBLINGUAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

PITUITARY

제품 요약:

Active ingredient group (AIG) number: 0151664002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2006-09-08

제품 특성 요약

_DDAVP® MELT (60μg, 120μg, 240μg) _
_Template Date: January 2010 _
_Page 1 of 34 _
_ _
PRODUCT MONOGRAPH
PR
DDAVP
®
MELT
Desmopressin acetate
60 μg, 120 μg and 240 μg
Oral Disintegrating Tablets
Antidiuretic
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, Ontario
M2J 5C1
Date of Revision: DECEMBER 17, 2015.
SUBMISSION CONTROL NO: 187742
_DDAVP® MELT (60μg, 120μg, 240μg) _
_Template Date: January 2010 _
_Page 2 of 34 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
...................................