SANDOZ ALFACALCIDOL CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ALFACALCIDOL

থেকে পাওয়া:

SANDOZ CANADA INCORPORATED

এটিসি কোড:

A11CC03

INN (আন্তর্জাতিক নাম):

ALFACALCIDOL

ডোজ:

0.25MCG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

ALFACALCIDOL 0.25MCG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

15G/50G

প্রেসক্রিপশন টাইপ:

Prescription

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0135700001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2022-12-09

পণ্য বৈশিষ্ট্য

_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
...........................