SANDOZ ALFACALCIDOL CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
08-12-2022
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Werkstoffen:
ALFACALCIDOL
Beschikbaar vanaf:
SANDOZ CANADA INCORPORATED
ATC-code:
A11CC03
INN (Algemene Internationale Benaming):
ALFACALCIDOL
Dosering:
0.25MCG
farmaceutische vorm:
CAPSULE
Samenstelling:
ALFACALCIDOL 0.25MCG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Product samenvatting:
Active ingredient group (AIG) number: 0135700001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2022-12-09
Productkenmerken
_Sandoz Alfacalcidol (Alfacalcidol Capsules) Product Monograph_
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ® ALFACALCIDOL
Alfacalcidol Capsules
Capsules, 1 and 0.25 mcg, oral
House Standard
Vitamin D Analogue
[A11CC VITAMIN D AND ANALOGUES]
Sandoz Canada Inc.
110, Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Approval:
DEC 8, 2022
Submission Control No.: 268441
_Sandoz Alfacalcidol (Alfacalcidol Capsules) Product Monograph_
Page 2 of 25
Table des matières
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................3
1.
INDICATIONS
..................................................................................................................3
1.1. PEDIATRICS
............................................................................................................................3
2.
CONTRAINDICATIONS
.....................................................................................................3
3.
DOSAGE AND ADMINISTRATION
.....................................................................................3
3.1.
Dosing Considerations
............................................................................................................
3
3.2.
Recommended Dose and Dosage Adjustment Pre-Dialysis Patients on Daily
Oral Therapy .. 4
3.3.
Missed Dose
............................................................................................................................
5
4.
OVERDOSAGE
.................................................................................................................5
5.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................................6
6.
WARNINGS AND PRECAUTIONS
......................................................................................7
6.1.
Special Population
...................................................................................................................
9
7.
ADVERSE REACTIONS
...........................
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