DESMOPRESSIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESMOPRESSIN ACETATE TRIHYDRATE

Tersedia dari:

MELIAPHARM INC

Kode ATC:

H01BA02

INN (Nama Internasional):

DESMOPRESSIN

Dosis:

0.1MG

Bentuk farmasi:

TABLET

Komposisi:

DESMOPRESSIN ACETATE TRIHYDRATE 0.1MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

PITUITARY

Ringkasan produk:

Active ingredient group (AIG) number: 0152416001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2014-06-25

Karakteristik produk

PRODUCT MONOGRAPH
PR
DESMOPRESSIN
(Desmopressin Acetate Trihydrate)
0.1 mg and 0.2 mg Tablets
ANTIDIURETIC
MELIAPHARM INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
March 16, 2010
Montreal, Quebec
H4P 2T4
CONTROL NO.: 137032
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY
PRODUCT
INFORMATION
.............................................................................3
INDICATIONS
AND
CLINICAL
USE
....................................................................................3
CONTRAINDICATIONS
.........................................................................................................4
DRUG
INTERACTIONS
..........................................................................................................6
DOSAGE
AND
ADMINISTRATION
......................................................................................7
OVERDOSAGE
.........................................................................................................................8
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................8
STORAGE
AND
STABILITY
................................................................................................16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
..................................................16
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL
INFORMATION
..............................................................................18
CLINICAL
TRIALS
................................................................................................................18
TOXICOLOGY
........................................................................................................................21
REFERENCES
.........................................................................................................................23
PART III: CONSUMER
IN