ZOLEDRONIC ACID FOR INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Commercializzato da:

MARCAN PHARMACEUTICALS INC

Codice ATC:

M05BA08

INN (Nome Internazionale):

ZOLEDRONIC ACID

Dosaggio:

4MG

Forma farmaceutica:

SOLUTION

Composizione:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Via di somministrazione:

INTRAVENOUS

Confezione:

5ML

Tipo di ricetta:

Prescription

Area terapeutica:

BONE RESORPTION INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-02-05

Scheda tecnica

PRODUCT MONOGRAPH
ZOLEDRONIC ACID CONCENTRATE FOR
INJECTION (Zoledronic Acid for Injection)
4 mg Zoledronic acid/5 mL incorporated as the monohydrate
Sterile liquid concentrate must be diluted before use
Bone Metabolism Regulator
Marcan Pharmaceuticals Inc.
Date of Preparation: February 5, 2018
77 Auriga Drive, Suite#4,
Ottawa, ON, K2E 7Z7
Control # 198168
_Page 2 of 52_
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..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STAB
IL
I
T
Y
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC
INFORMATION
...............................................................................30
PHARMACEUTICAL
INFORMATION..........................................................................30
CLINICAL
TR
IA
L
S
..........................................................................................................31
D