MYLAN-RISEDRONATE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

M05BA07

INN (Nome Internazionale):

RISEDRONIC ACID

Dosaggio:

35MG

Forma farmaceutica:

TABLET

Composizione:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Via di somministrazione:

ORAL

Confezione:

4/30

Tipo di ricetta:

Prescription

Area terapeutica:

BONE RESORPTION INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2017-11-14

Scheda tecnica

PRODUCT MONOGRAPH
PR
MYLAN-RISEDRONATE
Risedronate Sodium
Tablets, USP
35 mg and 150 mg risedronate sodium (as the hemi-pentahydrate)
Bisphosphonates
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M8Z 2S6
Control No.: 194897
Date of Revision:
July 14, 2016
PAGE 2 OF 48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMAR Y PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE
REACTIONS...............................................................................................
7
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
.......................................................................
14
OVERDOSAGE
.............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................... 16
STORAGE AND STABILITY
....................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................. 20
PART II: SCIENTIFIC INFORMATION
............................................................................
22
PHARMACEUTICAL INFORMATION
................................................................. 22
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
..............................................................................
36
TOXICOLOGY
..............................................................