MINT-ALENDRONATE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Dostupné z:

MINT PHARMACEUTICALS INC

ATC kód:

M05BA04

INN (Medzinárodný Name):

ALENDRONIC ACID

Dávkovanie:

10.0MG

Forma lieku:

TABLET

Zloženie:

ALENDRONIC ACID (ALENDRONATE SODIUM) 10.0MG

Spôsob podávania:

ORAL

Počet v balení:

28

Typ predpisu:

Prescription

Terapeutické oblasti:

BONE RESORPTION INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0150323003; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-08-01

Súhrn charakteristických

_Product Monograph – _
MINT-ALENDRONATE
_ _
_ Page 1 of 47 _
PR O D U CT MON OGR A PH
MINT-ALENDRONATE
ALENDRONATE SODIUM TABLETS
5 MG, 10 MG AND 70 MG
Bone Metabolism Regulator
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Date of Revision:
April 19, 2018
SUBMISSION CONTROL NO.: 214834
_Product Monograph – _
MINT-ALENDRONATE
_ _
_ Page 2 of 47 _
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
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
............................................... 22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
.........................................................