ETIDROCAL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ETIDRONATE DISODIUM; CALCIUM (CALCIUM CARBONATE)

Disponible desde:

COBALT PHARMACEUTICALS COMPANY

Código ATC:

M05BB01

Designación común internacional (DCI):

ETIDRONIC ACID AND CALCIUM, SEQUENTIAL

Dosis:

400MG; 500MG

formulario farmacéutico:

TABLET

Composición:

ETIDRONATE DISODIUM 400MG; CALCIUM (CALCIUM CARBONATE) 500MG

Vía de administración:

ORAL

Unidades en paquete:

14 WHITE-76 BLUE TABS

tipo de receta:

Prescription

Área terapéutica:

BONE RESORPTION INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0241781001; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2017-09-01

Ficha técnica

Page 1 of 31
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PRODUCT MONOGRAPH
PR
ETIDROCAL
Etidronate Disodium Tablets USP
400 mg
and
Calcium Carbonate Tablets USP
1,250 mg calcium carbonate per tablet
(equivalent to 500 mg elemental calcium)
BONE METABOLISM REGULATOR
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
CONTROL NO.: 167412
DATE OF REVISION:
SEPTEMBER 30, 2013
Page 2 of 31
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
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
11
ACTIONS AND CLINICAL PHARMACOLOGY
......................................................... 11
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
DETAILED PHARMACOLOGY
...........................................................................