HUMATROPE POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SOMATROPIN

Disponible depuis:

ELI LILLY CANADA INC

Code ATC:

H01AC01

DCI (Dénomination commune internationale):

SOMATROPIN

Dosage:

5MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

SOMATROPIN 5MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

5ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PITUITARY

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-01-15

Résumé des caractéristiques du produit

_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
.