HUMATROPE LIQUID

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DILUENT; SOMATROPIN

Disponibbli minn:

ELI LILLY CANADA INC

Kodiċi ATC:

H01AC01

INN (Isem Internazzjonali):

SOMATROPIN

Dożaġġ:

3.15ML; 12MG

Għamla farmaċewtika:

LIQUID

Kompożizzjoni:

DILUENT 3.15ML; SOMATROPIN 12MG

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

3.5 ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PITUITARY

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0231839005; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

1999-03-04

Karatteristiċi tal-prodott

_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
.