APO-ETIDRONATE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ETIDRONATE DISODIUM

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

M05BA01

INN (আন্তর্জাতিক নাম):

ETIDRONIC ACID

ডোজ:

200MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

ETIDRONATE DISODIUM 200MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

MISCELLANEOUS THERAPEUTIC AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0113205002; AHFS:

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2019-05-04

পণ্য বৈশিষ্ট্য

Page 1 of 26
PRODUCT MONOGRAPH
PR
APO-ETIDRONATE
ETIDRONATE DISODIUM TABLETS USP
200 MG AND 400 MG
BONE METABOLISM REGULATOR, ANTI-PAGETIC AGENT
ANTI-HYPERCALCEMIC AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
DECEMBER 07, 2017
TORONTO, ONTARIO
M9L 1T9
CONTROL NO. 210905
Page 2 of 26
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................. 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
.............................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................
3
ADVERSE REACTIONS
............................................................................................
7
DRUG INTERACTIONS
.............................................................................................
9
DOSAGE AND ADMINISTRATION
...........................................................................
9
OVERDOSAGE
.......................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 11
STORAGE AND STABILITY
....................................................................................
12
SPECIAL HANDLING
INSTRUCTIONS…………………………………………………12
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 12
PART II: SCIENTIFIC INFORMATION
.......................................................................
14
PHARMACEUTICAL INFORMATION
......................................................................
14
CLINICAL TRIALS
...................................................................................................
15
DETAILED PHARMACOLOGY
.............................................