SANDOZ ALENDRONATE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Fáanlegur frá:

SANDOZ CANADA INCORPORATED

ATC númer:

M05BA04

INN (Alþjóðlegt nafn):

ALENDRONIC ACID

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

ALENDRONIC ACID (ALENDRONATE SODIUM) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

BONE RESORPTION INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0150323001; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2016-08-03

Vara einkenni

_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
.................................................................................