HUMATROPE POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SOMATROPIN

から入手可能:

ELI LILLY CANADA INC

ATCコード:

H01AC01

INN（国際名）:

SOMATROPIN

投薬量:

5MG

医薬品形態:

POWDER FOR SOLUTION

構図:

SOMATROPIN 5MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

5ML

処方タイプ:

Prescription

治療領域:

PITUITARY

製品概要:

Active ingredient group (AIG) number: 0131827001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2021-01-15

製品の特徴

_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
.