SANDOZ ALENDRONATE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

M05BA04

INN (International Nazwa):

ALENDRONIC ACID

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

ALENDRONIC ACID (ALENDRONATE SODIUM) 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30

Typ recepty:

Prescription

Dziedzina terapeutyczna:

BONE RESORPTION INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2016-08-03

Charakterystyka produktu

_Sandoz Alendronate _
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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 _
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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
.................................................................................