ALENDRONATE-CHOLECALCIFEROL TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)

Fáanlegur frá:

FROSST A DIVISION OF MERCK CANADA INC

ATC númer:

M05BB03

INN (Alþjóðlegt nafn):

ALENDRONIC ACID AND CHOLECALCIFEROL

Skammtar:

70MG; 2800UNIT

Lyfjaform:

TABLET

Samsetning:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 2800UNIT

Stjórnsýsluleið:

ORAL

Einingar í pakka:

4

Gerð lyfseðils:

Prescription

Lækningarsvæði:

VITAMIN D

Vörulýsing:

Active ingredient group (AIG) number: 0251575001; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2016-05-05

Vara einkenni

_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
PRODUCT MONOGRAPH
ALENDRONATE-CHOLECALCIFEROL 70/2800
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
ALENDRONATE-CHOLECALCIFEROL 70/5600
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
FROSST, A DIVISION OF MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
DATE OF REVISION:
APRIL 25, 2016
www.merck.ca
SUBMISSION CONTROL NO:
193513
_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
_Page 2 of 44_
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....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...................