NU-DESMOPRESSIN SPRAY METERED-DOSE PUMP

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESMOPRESSIN ACETATE

Tersedia dari:

NU-PHARM INC

Kode ATC:

H01BA02

INN (Nama Internasional):

DESMOPRESSIN

Dosis:

0.1G

Bentuk farmasi:

METERED-DOSE PUMP

Komposisi:

DESMOPRESSIN ACETATE 0.1G

Rute administrasi :

NASAL

Unit dalam paket:

2.5ML/5ML

Jenis Resep:

Prescription

Area terapi:

PITUITARY

Ringkasan produk:

Active ingredient group (AIG) number: 0112050008; AHFS:

Status otorisasi:

CANCELLED (UNRETURNED ANNUAL)

Tanggal Otorisasi:

2018-03-28

Karakteristik produk

Page 1 of 20
PRODUCT MONOGRAPH
PR
NU-DESMOPRESSIN SPRAY, 10 ΜG/SPRAY
(DESMOPRESSIN ACETATE NASAL SOLUTION)
ANTIDIURETIC
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
OCTOBER 14, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133359
Page 2 of 20
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL
USE........................................................................................
3
WARNINGS AND
PRECAUTIONS............................................................................................
3
ADVERSE
REACTIONS..............................................................................................................
6
DRUG INTERACTIONS
..............................................................................................................
7
DOSAGE AND
ADMINISTRATION..........................................................................................
7
OVERDOSAGE
............................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
9
STORAGE AND
STABILITY....................................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL
INFORMATION....................................................................................
12
CLINICAL
TRIALS....................................................................................................................
13
TOXICOLOGY
.................................................................................................