SANDOZ ALENDRONATE/CHOLECALCIFEROL TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
28-07-2017
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Werkstoffen:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)
Beschikbaar vanaf:
SANDOZ CANADA INCORPORATED
ATC-code:
M05BB03
INN (Algemene Internationale Benaming):
ALENDRONIC ACID AND CHOLECALCIFEROL
Dosering:
70MG; 5600UNIT
farmaceutische vorm:
TABLET
Samenstelling:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 5600UNIT
Toedieningsweg:
ORAL
Eenheden in pakket:
4
Prescription-type:
Prescription
Therapeutisch gebied:
VITAMIN D
Product samenvatting:
Active ingredient group (AIG) number: 0251575002; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2023-07-28
Productkenmerken
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_Sandoz Alendronate/Cholecalciferol _
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PRODUCT MONOGRAPH
Pr
SANDOZ ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 mg alendronate (as alendronate sodium) + 140 mcg cholecalciferol
(5600 IU vitamin D
3
)
Bone Metabolism Regulator and Vitamin D
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Québec
J4B 7K8
Date of Revision:
July 18, 2017
Submission Control No: 206959
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_Sandoz Alendronate/Cholecalciferol. _
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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
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........
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