ZOLEDRONIC ACID FOR INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Dostupné s:

FRESENIUS KABI CANADA LTD

ATC kód:

M05BA08

INN (Mezinárodní Name):

ZOLEDRONIC ACID

Dávkování:

4MG

Léková forma:

SOLUTION

Složení:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Podání:

INTRAVENOUS

Jednotky v balení:

5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

BONE RESORPTION INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2014-11-13

Charakteristika produktu

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