HUMATROPE POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-06-2020
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Active ingredient:
SOMATROPIN
Available from:
ELI LILLY CANADA INC
ATC code:
H01AC01
INN (International Name):
SOMATROPIN
Dosage:
5MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
SOMATROPIN 5MG
Administration route:
INTRAMUSCULAR
Units in package:
5ML
Prescription type:
Prescription
Therapeutic area:
PITUITARY
Product summary:
Active ingredient group (AIG) number: 0131827001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-01-15
Summary of Product characteristics
_HUMATROPE Product Monograph _
_Page 1 of 58 _
PRODUCT MONOGRAPH
Pr
HUMATROPE
®
(somatropin for injection)
Biosynthetic Human Growth Hormone of
Recombinant DNA Origin
5 mg vial
6, 12, 24 mg cartridges
Sterile Lyophilized Powder
and Diluent
Lilly Standard
Growth Stimulant
©
ELI LILLY CANADA INC.
3650 Danforth Avenue
Exchange Tower
130 King Street West, Suite 900
PO Box 73
Toronto, Ontario
M5X 1B1
1-888-545-5972
www.lilly.ca
Date of Initial Approval:
December 19, 1997
Revision Date:
June 19, 2020
Submission Control No: 236487
_HUMATROPE Product Monograph _
_Page 2 of 58 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 26
STORAGE AND STABILITY
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.
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