ZOLEDRONIC ACID INJECTION A SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

M05BA08

INN (Nome Internazionale):

ZOLEDRONIC ACID

Dosaggio:

5MG

Forma farmaceutica:

SOLUTION

Composizione:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100ML

Tipo di ricetta:

Prescription

Area terapeutica:

BONE RESORPTION INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2022-06-01

Scheda tecnica

PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION A
Solution for Intravenous Infusion
5 mg /100 mL zoledronic acid
(as zoledronic acid monohydrate)
(0.05 mg/mL)
Bone Metabolism Regulator
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: July 27, 2018
Control Number: 217662
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
..............................................................................................
11
DRUG INTERACTIONS
..............................................................................................
26
DOSAGE AND ADMINISTRATION
...........................................................................
27
OVERDOSAGE
............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 29
STORAGE AND STABILITY
......................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
....................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 33
PART II: SCIENTIFIC INFORMATION
............................................................................
34
PHARMACEUTICAL
INFORMATION.......................................................................
34
CLINICAL
TRIALS......................................................................................................
35
DET