DOM-RISEDRONATE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Mevcut itibaren:

DOMINION PHARMACAL

ATC kodu:

M05BA07

INN (International Adı):

RISEDRONIC ACID

Doz:

35MG

Farmasötik formu:

TABLET

Kompozisyon:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Uygulama yolu:

ORAL

Paketteki üniteler:

4

Reçete türü:

Prescription

Terapötik alanı:

BONE RESORPTION INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0135301003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2010-09-29

Ürün özellikleri

PRODUCT MONOGRAPH
Pr
DOM-RISEDRONATE
Risedronate Sodium Tablets, USP
(as the hemi-pentahydrate)
35 mg
BONE METABOLISM REGULATOR
DOMINION PHARMACAL
DATE OF REVISION:
6111 Ave. Royalmount
February 24, 2017
Montréal, Québec
H4P 2T4
Submission Control No: 193071
_Dom-RISEDRONATE Product Monograph _
_ Page 2 of 35_
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
...................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 13
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
..........................................................................................................
19
DETAILED PHARMACOLOGY
................................