ACTONEL SACHET KIT GRANULES (EFFERVESCENTS)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

RISEDRONATE SODIUM; CALCIUM (CALCIUM CARBONATE); VITAMIN D3

Dostępny od:

WARNER CHILCOTT CANADA CO

Kod ATC:

M05BB04

INN (International Nazwa):

RISEDRONIC ACID, CALCIUM AND CHOLECALCIFEROL, SEQUENTIAL

Dawkowanie:

35MG; 1000MG; 880UNIT

Forma farmaceutyczna:

GRANULES (EFFERVESCENTS)

Skład:

RISEDRONATE SODIUM 35MG; CALCIUM (CALCIUM CARBONATE) 1000MG; VITAMIN D3 880UNIT

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

BONE RESORPTION INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0351668001; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2018-02-16

Charakterystyka produktu

_ _
_ _
PRODUCT MONOGRAPH
Pr
ACTONEL SACHET KIT
TM
Risedronate Sodium (as the hemi-pentahydrate) 35 mg Tablets
Professed Standard
Bone Metabolism Regulator
Plus
Calcium Carbonate 2500 mg and Vitamin D
3
880 IU
Effervescent Granules for Oral Solution
Professed Standard
Vitamin and Mineral Supplement
ATC: M05BA07
Warner Chilcott Canada Co.
PO Box 4367, Station A
Toronto, ON
M5W 3N7
Marketed with sanofi-aventis Canada Inc.
Laval, QC H7L 4A8
Date of Preparation:
February 16, 2010
Submission Control No: 136548
2
TABLE OF CONTENTS
PAGE
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
........................................................................................................9
DOSAGE AND ADMINISTRATION
..................................................................................12
OVERDOSAGE.....................................................................................................................14
ACTION AND CLINICAL
PHARMACOLOGY.................................................................14
STORAGE AND STABILITY
..............................................................................................19
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL
INFORMATION....................