ZOLEDRONIC ACID FOR INJECTION SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponível em:

FRESENIUS KABI CANADA LTD

Código ATC:

M05BA08

DCI (Denominação Comum Internacional):

ZOLEDRONIC ACID

Dosagem:

4MG

Forma farmacêutica:

SOLUTION

Composição:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

5ML

Tipo de prescrição:

Prescription

Área terapêutica:

BONE RESORPTION INHIBITORS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2014-11-13

Características técnicas

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