ZOLEDRONIC ACID FOR INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Saatavilla:

FRESENIUS KABI CANADA LTD

ATC-koodi:

M05BA08

INN (Kansainvälinen yleisnimi):

ZOLEDRONIC ACID

Annos:

4MG

Lääkemuoto:

SOLUTION

Koostumus:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

BONE RESORPTION INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2014-11-13

Valmisteyhteenveto

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