DIDROCAL KIT
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
28-02-2013
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Aktivní složka:
ETIDRONATE DISODIUM; CALCIUM (CALCIUM CARBONATE)
Dostupné s:
WARNER CHILCOTT CANADA CO
ATC kód:
M05BB01
INN (Mezinárodní Name):
ETIDRONIC ACID AND CALCIUM, SEQUENTIAL
Dávkování:
400MG; 500MG
Léková forma:
KIT
Složení:
ETIDRONATE DISODIUM 400MG; CALCIUM (CALCIUM CARBONATE) 500MG
Podání:
ORAL
Jednotky v balení:
14 & 76
Druh předpisu:
Prescription
Terapeutické oblasti:
BONE RESORPTION INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0241781001; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2015-11-19
Charakteristika 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
......................................................................................
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