TEVA-ALENDRONATE/CHOLECALCIFEROL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

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

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

M05BB03

INN (mednarodno ime):

ALENDRONIC ACID AND CHOLECALCIFEROL

Odmerek:

70MG; 2800UNIT

Farmacevtska oblika:

TABLET

Sestava:

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

Pot uporabe:

ORAL

Enote v paketu:

4

Tip zastaranja:

Prescription

Terapevtsko območje:

VITAMIN D

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-03-25

Lastnosti izdelka

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
.....................................