LANTUS SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

INSULIN GLARGINE

থেকে পাওয়া:

SANOFI-AVENTIS CANADA INC

এটিসি কোড:

A10AE04

INN (আন্তর্জাতিক নাম):

INSULIN GLARGINE

ডোজ:

100UNIT

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

INSULIN GLARGINE 100UNIT

প্রশাসন রুট:

SUBCUTANEOUS

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Schedule D

থেরাপিউটিক এলাকা:

INSULINS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0147062001; AHFS:

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2017-07-07

পণ্য বৈশিষ্ট্য

_Page 1 of 70 _
PRODUCT MONOGRAPH
LANTUS
®
Insulin glargine (rDNA origin)
Solution for injection 100 U/mL
ATC code: A10AE04
Antidiabetic Agent
_ _
Long-acting Recombinant Human Insulin Analogue
_ _
sanofi-aventis Canada Inc.
2905 Place Louis R.Renaud
Laval, Quebec H7V 0A3
DATE OF APPROVAL:
APRIL 6, 2016
SUBMISSION CONTROL NO: 190627
_Page 2 of 70 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
DESCRIPTION
.........................................................................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
10
DRUG INTERACTIONS
........................................................................................................
16
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 20
STORAGE AND
STABILITY................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 25
PART II: SCIENTIFIC INFORMATION
..............