TEVA-DESMOPRESSIN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DESMOPRESSIN ACETATE

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

H01BA02

INN (International Adı):

DESMOPRESSIN

Doz:

0.2MG

Farmasötik formu:

TABLET

Kompozisyon:

DESMOPRESSIN ACETATE 0.2MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

PITUITARY

Ürün özeti:

Active ingredient group (AIG) number: 0112050003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2018-06-15

Ürün özellikleri

PRODUCT MONOGRAPH
PR
TEVA-DESMOPRESSIN
Desmopressin acetate Tablets
0.1 mg and 0.2 mg
Antidiuretic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
March 08, 2016
Toronto, Ontario
M1B 2K9
Control Number: 192433
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
6
DRUG INTERACTIONS
...........................................................................................................
7
DOSAGE AND ADMINISTRATION
.......................................................................................
8
OVERDOSAGE
.........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 10
STORAGE AND STABILITY
.................................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
.................................................................................
13
CLINICAL TRIALS
.................................................................................................................
14
COMPARATIVE BIOAVAILABILITY DATA
..........