OMNITROPE KIT

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SOMATROPIN; WATER

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

H01AC01

DCI (Dénomination commune internationale):

SOMATROPIN

Dosage:

5.8MG; 1.14ML

forme pharmaceutique:

KIT

Composition:

SOMATROPIN 5.8MG; WATER 1.14ML

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PITUITARY

Descriptif du produit:

Active ingredient group (AIG) number: 0228557006; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2023-10-30

Résumé des caractéristiques du produit

_OMNITROPE (somatropin for injection) _
_Page 1 of 93_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
OMNITROPE®
Somatropin for injection
produced in _Escherichia coli_ cells by recombinant DNA technology
Lyophilized Powder for solution: 5.8 mg/vial
Solution for Injection: 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL
Pharmaceutical Standard: Ph.Eur./USP
Human Growth Hormone
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Québec
J4B 1E6
Date of Initial Authorization:
April 20, 2009
Date of Revision:
November 1, 2022
Submission Control Number: 256693
_ _
_OMNITROPE (somatropin for injection) _
_Page 2 of 93_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics.........................................................................................................
5
1.2
Geriatrics
.........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing
Considerations......................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................... 6
4.3
Reconstitution
...........................................................................