HUMATROPE LIQUID

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DILUENT; SOMATROPIN

Commercializzato da:

ELI LILLY CANADA INC

Codice ATC:

H01AC01

INN (Nome Internazionale):

SOMATROPIN

Dosaggio:

3.15ML; 6MG

Forma farmaceutica:

LIQUID

Composizione:

DILUENT 3.15ML; SOMATROPIN 6MG

Via di somministrazione:

INTRAMUSCULAR

Confezione:

3.5 ML

Tipo di ricetta:

Prescription

Area terapeutica:

PITUITARY

Dettagli prodotto:

Active ingredient group (AIG) number: 0231839004; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1999-03-04

Scheda tecnica

_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
.