DDAVP TABLETS 0.1MG

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESMOPRESSIN ACETATE

Tersedia dari:

FERRING INC

Kode ATC:

H01BA02

INN (Nama Internasional):

DESMOPRESSIN

Dosis:

0.1MG

Bentuk farmasi:

TABLET

Komposisi:

DESMOPRESSIN ACETATE 0.1MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

PITUITARY

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2022-05-31

Karakteristik produk

_DDAVP Tablets 0.1 mg and 0.2 mg _
_Template Date: January 2010 _
_Page 1 of 29 _
PRODUCT MONOGRAPH
PR
DDAVP
® TABLETS
Desmopressin Acetate
0.1 mg and 0.2 mg Tablets
Antidiuretic
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
DECEMBER 17, 2015.
CONTROL NUMBER: 187744
_DDAVP Tablets 0.1 mg and 0.2 mg _
_Template Date: January 2010 _
_Page 2 of 29 _
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
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
............................................................................................