TEVA-ALENDRONATE/CHOLECALCIFEROL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

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

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

M05BB03

INN (Διεθνής Όνομα):

ALENDRONIC ACID AND CHOLECALCIFEROL

Δοσολογία:

70MG; 2800UNIT

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

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

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

VITAMIN D

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-03-25

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
TEVA-ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
PR
TEVA-ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 24, 2017
Toronto, Ontario
M1B 2K9
Canada
Submission Control No: 207329
2
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
..........................................................................
16
OVERDOSAGE
............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 17
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
......................................................................
24
CLINICAL TRIALS
.....................................