NUTROPIN AQ NUSPIN 10 SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

SOMATROPIN

Beschikbaar vanaf:

HOFFMANN-LA ROCHE LIMITED

ATC-code:

H01AC01

INN (Algemene Internationale Benaming):

SOMATROPIN

Dosering:

10MG

farmaceutische vorm:

SOLUTION

Samenstelling:

SOMATROPIN 10MG

Toedieningsweg:

SUBCUTANEOUS

Eenheden in pakket:

1

Prescription-type:

Prescription

Therapeutisch gebied:

SOMATOTROPIN AGONISTS*

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2014-05-01

Productkenmerken

PRODUCT MONOGRAPH
PR
NUTROPIN AQ
® NUSPIN
®
somatropin injection
solution; NuSpin
®
injection device prefilled with cartridge:
NUTROPIN AQ
®
NuSpin
®
5 (5 mg/2 mL)
NUTROPIN AQ
®
NuSpin
®
10 (10 mg/2 mL)
NUTROPIN AQ
®
NuSpin
®
20 (20 mg/2 mL)
Growth Hormone
Distributed by:
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Manufactured by:
Genentech, Inc., USA
Date of Revision:
June 5, 2018
Submission Control No: 216635
®
Registered trade-marks of Genentech, Inc, used under license.
©
Copyright 1996-2018 of Hoffmann-La Roche Limited
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............