JAMP-ZOLEDRONIC ACID SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

M05BA08

DCI (Denominação Comum Internacional):

ZOLEDRONIC ACID

Dosagem:

4MG

Forma farmacêutica:

SOLUTION

Composição:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

5 ML

Tipo de prescrição:

Prescription

Área terapêutica:

BONE RESORPTION INHIBITORS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2018-11-07

Características técnicas

PRODUCT MONOGRAPH
Pr
JAMP-ZOLEDRONIC ACID
(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
JAMP Pharma Corporation
Date of Preparation:
1310 Rue Nobel
November 7, 2018
Boucherville, Québec
J4B 5H3
Control # 220781
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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
DETAILED PHARMACOLOGY
..