ACT ZOLEDRONIC ACID CONCENTRATE SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

থেকে পাওয়া:

ACTAVIS PHARMA COMPANY

এটিসি কোড:

M05BA08

INN (আন্তর্জাতিক নাম):

ZOLEDRONIC ACID

ডোজ:

4MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

5ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

BONE RESORPTION INHIBITORS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2017-09-01

পণ্য বৈশিষ্ট্য

_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
...................................................