DIDROCAL KIT

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ETIDRONATE DISODIUM; CALCIUM (CALCIUM CARBONATE)

Dostępny od:

WARNER CHILCOTT CANADA CO

Kod ATC:

M05BB01

INN (International Nazwa):

ETIDRONIC ACID AND CALCIUM, SEQUENTIAL

Dawkowanie:

400MG; 500MG

Forma farmaceutyczna:

KIT

Skład:

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

Droga podania:

ORAL

Sztuk w opakowaniu:

14 & 76

Typ recepty:

Prescription

Dziedzina terapeutyczna:

BONE RESORPTION INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2015-11-19

Charakterystyka produktu

PRODUCT MONOGRAPH
PR DIDROCAL

Etidronate Disodium tablets USP
400 mg
and
Calcium Carbonate tablets USP
1,250 mg calcium carbonate per tablet
500 mg elemental calcium
BONE METABOLISM REGULATOR
Warner Chilcott Canada Co.
Toronto, Ontario, M5W 3N7
CONTROL NO. 160241
Date of Preparation:
February 19, 2013
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
.......................................................................................................................
10
ACTIONS AND CLINICAL PHARMACOLOGY
................................................................. 11
STORAGE AND STABILITY
................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.................................................................................
14
CLINICAL TRIALS
......................................................................................