Q-RISEDRONATE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Доступно од:

QD PHARMACEUTICALS ULC

АТЦ код:

M05BA07

INN (Међународно име):

RISEDRONIC ACID

Дозирање:

35MG

Фармацеутски облик:

TABLET

Састав:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Пут администрације:

ORAL

Јединице у пакету:

4/30

Тип рецептора:

Prescription

Терапеутска област:

BONE RESORPTION INHIBITORS

Резиме производа:

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

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2015-08-21

Карактеристике производа

PRODUCT MONOGRAPH
PR
Q-RISEDRONATE
Risedronate Sodium Tablets, USP
35 mg risedronate sodium (as the hemi-pentahydrate)
Bone Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M8Z 2S6
Control No. 169750
Date of Revision:
November 27, 2013
PAGE 2 OF 43
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
...............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
14
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 16
STORAGE AND STABILITY
......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................... 19
PART II: SCIENTIFIC INFORMATION ..............................................................................
21
PHARMACEUTICAL INFORMATION
................................................................... 21
CLINICAL TRIALS
.......................................................................................................
23
DETAILED PHARMACOLOGY
................................................................................
34
TOXICOLOGY
....................................