PHL-ALENDRONATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Disponible depuis:

PHARMEL INC

Code ATC:

M05BA04

DCI (Dénomination commune internationale):

ALENDRONIC ACID

Dosage:

70MG

forme pharmaceutique:

TABLET

Composition:

ALENDRONIC ACID (ALENDRONATE SODIUM) 70MG

Mode d'administration:

ORAL

Unités en paquet:

4/30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BONE RESORPTION INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0150323002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2016-10-25

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
PHL-ALENDRONATE
Alendronic Acid Tablets, USP
Alendronic Acid 70 mg (as Alendronate Sodium)
Bone Metabolism Regulator
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
October 16, 2012
Submission Control No: 159326
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_phl-ALENDRONATE Product Monograph _
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_Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
.................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 14
STORAGE AND STABILITY
..........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 18
PART II: SCIENTIFIC INFORMATION
................................................................................
19
PHARMACEUTICAL INFORMATION
..........................................................................
19
CLINICAL TRIALS
..........................................................................................................
20
DETAILED PHARMACOLOGY
.