ZOLEDRONIC ACID FOR INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Prieinama:

FRESENIUS KABI CANADA LTD

ATC kodas:

M05BA08

INN (Tarptautinis Pavadinimas):

ZOLEDRONIC ACID

Dozė:

4MG

Vaisto forma:

SOLUTION

Sudėtis:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

5ML

Recepto tipas:

Prescription

Gydymo sritis:

BONE RESORPTION INHIBITORS

Produkto santrauka:

Active ingredient group (AIG) number: 0141761002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2014-11-13

Prekės savybės

_ _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
May 26, 2017
Submission Control No: 205586
_ _
_Zoledronic Acid for Injection-PM-ENG-v6.0 _
_ _
_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.............................................................................................