LANTUS SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

INSULIN GLARGINE

Pieejams no:

SANOFI-AVENTIS CANADA INC

ATĶ kods:

A10AE04

SNN (starptautisko nepatentēto nosaukumu):

INSULIN GLARGINE

Deva:

100UNIT

Zāļu forma:

SOLUTION

Kompozīcija:

INSULIN GLARGINE 100UNIT

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

100

Receptes veids:

Schedule D

Ārstniecības joma:

INSULINS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2016-04-07

Produkta apraksts

_Page 1 of 78 _
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:
July 10, 2015
Submission Control No: 176776
_Page 2 of 78 _
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
..............