SANDOZ ALENDRONATE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

M05BA04

INN (Algemene Internationale Benaming):

ALENDRONIC ACID

Dosering:

5MG

farmaceutische vorm:

TABLET

Samenstelling:

ALENDRONIC ACID (ALENDRONATE SODIUM) 5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

BONE RESORPTION INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0150323004; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2016-08-03

Productkenmerken

_Sandoz Alendronate _
_ Page 1 of 52 _
PRODUCT MONOGRAPH
PR
SANDOZ ALENDRONATE
Alendronate Sodium Tablets
5 mg, 10 mg, 40 mg, 70 mg Alendronate
Bone Metabolism Regulator
Sandoz Canada Inc.
Date of Revision:
145 Jules-Leger St.
February 6, 2012
Boucherville, QC
J4B 7K8
Control number: 153014
_Sandoz Alendronate _
_ Page 2 of 52 _
_ _
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........................................................................................................
13
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
.................................................................................