NTP-RISEDRONATE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Verfügbar ab:

NT PHARMA CANADA LTD

ATC-Code:

M05BA07

INN (Internationale Bezeichnung):

RISEDRONIC ACID

Dosierung:

35MG

Darreichungsform:

TABLET

Zusammensetzung:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

4/30

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2017-03-16

Fachinformation

PRODUCT MONOGRAPH
PR
NTP-RISEDRONATE
Risedronate sodium (as the monohydrate)
5 mg, 30 mg and 35 mg Tablets
Bone Metabolism Regulator
NT Pharma Canada Ltd.
5691 Main Street
Stouffville, Ontario
Canada, L4A 1H5
Submission Control No: 156479
Date of Revision:
July 26, 2012
2
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
.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 15
STORAGE AND STABILITY
.................................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
.................................................................................................................
22