HUMULIN 30/70 CARTRIDGE SUSPENSION

Country: Կանադա

language: անգլերեն

source: Health Canada

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26-03-2021

active_ingredient:

INSULIN INJECTION HUMAN BIOSYNTHETIC; INSULIN ISOPHANE HUMAN BIOSYNTHETIC

MAH:

ELI LILLY CANADA INC

ATC_code:

A10AD01

INN:

INSULIN (HUMAN)

dosage:

30UNIT; 70UNIT

pharmaceutical_form:

SUSPENSION

composition:

INSULIN INJECTION HUMAN BIOSYNTHETIC 30UNIT; INSULIN ISOPHANE HUMAN BIOSYNTHETIC 70UNIT

administration_route:

SUBCUTANEOUS

units_in_package:

3ML

prescription_type:

Schedule D

therapeutic_area:

INSULINS

leaflet_short:

Active ingredient group (AIG) number: 0223312003; AHFS:

authorization_status:

APPROVED

authorization_date:

1997-12-10

SPC

                                _HUMULIN Product Monograph _
_ _
_Page 1 of 54_
PRODUCT MONOGRAPH
HUMULIN
® R
(insulin, human biosynthetic)
Solution for Injection, 100 units/mL
ATC Code: A10AB01
fast-acting
HUMULIN
® N
(insulin isophane, human biosynthetic, rDNA origin)
Suspension for Injection, 100 units/mL
ATC Code: A10AC01
intermediate-acting
HUMULIN
® 30/70
(30% insulin injection, 70% insulin isophane, human biosynthetic, rDNA
origin)
Suspension for Injection, 100 units/mL
ATC Code: A10AD01
intermediate- or long-acting combined with fast-acting
THERAPEUTIC CLASSIFICATION
ANTI-DIABETIC AGENT

Eli Lilly Canada Inc.
Exchange Tower
130 King Street West, Suite 900
P.O. Box 73
Toronto, Ontario
M5X 1B1
Submission Control
№
245812
Date of Initial Approval:
December 31, 1983
Date of Revision:
March 26, 2021
_HUMULIN Product Monograph _
_ _
_Page 2 of 54_
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
...............................................................................................
9
DRUG INTERACTIONS
...............................................................................................
9
DOSAGE AND ADMINISTRATION
..........................................................................
10
OVERDOSAGE
...........................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 12
STORAGE AND STABILITY
.....................................................................................
13
SPEC
                                
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SPC SPC ֆրանսերեն 26-03-2021