SANDOZ ALENDRONATE/CHOLECALCIFEROL TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-07-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)
Fáanlegur frá:
SANDOZ CANADA INCORPORATED
ATC númer:
M05BB03
INN (Alþjóðlegt nafn):
ALENDRONIC ACID AND CHOLECALCIFEROL
Skammtar:
70MG; 5600UNIT
Lyfjaform:
TABLET
Samsetning:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 5600UNIT
Stjórnsýsluleið:
ORAL
Einingar í pakka:
4
Gerð lyfseðils:
Prescription
Lækningarsvæði:
VITAMIN D
Vörulýsing:
Active ingredient group (AIG) number: 0251575002; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2023-07-28
Vara einkenni
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_Sandoz Alendronate/Cholecalciferol _
_Page 1 of 46_
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. _
_Page 2 of 46_
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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