ZOLEDRONIC ACID INJECTION SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponível em:

MARCAN PHARMACEUTICALS INC

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

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:

2018-07-25

Características técnicas

_Page 1 of 68_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Marcan Pharmaceuticals Inc.,
Date of Preparation:
2 Gurdwara Road, Suite #112,
July 24, 2018
Ottawa, ON, K2E 1A2
CONTROL NUMBER: 203800
_Page 2 of 68_
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
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STAB
IL
I
T
Y
..........................................................................................33
SPECIAL HANDLING INSTRUCTIONS
.......................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II: SCIENTIFIC
INFORMATION
...............................................................................35
PHARMACEUTICAL
INFORMATION..........................................................................35
CLINICAL
TR
IA
L
S
..............................................................................................