JAMP-ZOLEDRONIC ACID SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

M05BA08

SNN (starptautisko nepatentēto nosaukumu):

ZOLEDRONIC ACID

Deva:

4MG

Zāļu forma:

SOLUTION

Kompozīcija:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

5 ML

Receptes veids:

Prescription

Ārstniecības joma:

BONE RESORPTION INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-11-07

Produkta apraksts

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
..