ZOLEDRONIC ACID INJECTION SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponível em:

DR REDDY'S LABORATORIES LTD

Código ATC:

M05BA08

DCI (Denominação Comum Internacional):

ZOLEDRONIC ACID

Dosagem:

5MG

Forma farmacêutica:

SOLUTION

Composição:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

100ML(1 VIAL)

Tipo de prescrição:

Prescription

Área terapêutica:

BONE RESORPTION INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0141761003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2014-03-21

Características técnicas

1
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg / 100 mL zoledronic acid (as zoledronic acid monohydrate)
Solution for intravenous infusion
Bone Metabolism Regulator
Manufacturer:
DR. REDDY’S LABORATORIES LIMITED
Bachupally 500 090 – INDIA
Imported/Distributed By:
DATE OF REVISION:
AUGUST 1, 2019
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1 Canada
Submission Control Number: 228238
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
.............................................................................................................
10
DRUG
INTERACTIONS..............................................................................................................
24
DOSAGE AND ADMINISTRATION
.........................................................................................
25
OVERDOSAGE
............................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
27
STORAGE AND STABILITY
.....................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
...................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 31
PART II: SCIENTIFIC INFORMATION
.........