DDAVP MELT TABLET (ORALLY DISINTEGRATING)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
31-12-2015
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DESMOPRESSIN (DESMOPRESSIN ACETATE)
Fáanlegur frá:
FERRING INC
ATC númer:
H01BA02
INN (Alþjóðlegt nafn):
DESMOPRESSIN
Skammtar:
120MCG
Lyfjaform:
TABLET (ORALLY DISINTEGRATING)
Samsetning:
DESMOPRESSIN (DESMOPRESSIN ACETATE) 120MCG
Stjórnsýsluleið:
SUBLINGUAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
PITUITARY
Vörulýsing:
Active ingredient group (AIG) number: 0151664001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2006-09-08
Vara einkenni
_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
...................................
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