JAMP-ZOLEDRONIC ACID SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Mevcut itibaren:

JAMP PHARMA CORPORATION

ATC kodu:

M05BA08

INN (International Adı):

ZOLEDRONIC ACID

Doz:

4MG

Farmasötik formu:

SOLUTION

Kompozisyon:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

5 ML

Reçete türü:

Prescription

Terapötik alanı:

BONE RESORPTION INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-11-07

Ürün özellikleri

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
_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
DETAILED PHARMACOLOGY
..