ACT ZOLEDRONIC ACID CONCENTRATE SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Commercializzato da:

ACTAVIS PHARMA COMPANY

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:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2017-09-01

Scheda tecnica

_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
PR
ACT_ _ZOLEDRONIC ACID CONCENTRATE
(Zoledronic acid for Injection)
Sterile Liquid Concentrate: 4 mg/5 mL zoledronic acid (as zoledronic
acid monohydrate) for
intravenous infusion
Bone Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date of Revision:
August 18, 2014
Submission Control No: 176793_ _
_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 2 of 51_
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
..................................................................................................
12
DRUG INTERACTIONS
..................................................................................................
20
DOSAGE AND ADMINISTRATION
..............................................................................
21
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 26
STORAGE AND STABILITY
..........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
...................................................