NUTROPIN AQ - SC 5MG/ML LIQUID

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

SOMATROPIN

Beschikbaar vanaf:

HOFFMANN-LA ROCHE LIMITED

ATC-code:

H01AC01

INN (Algemene Internationale Benaming):

SOMATROPIN

Dosering:

5MG

farmaceutische vorm:

LIQUID

Samenstelling:

SOMATROPIN 5MG

Toedieningsweg:

SUBCUTANEOUS

Eenheden in pakket:

2 ML

Prescription-type:

Prescription

Therapeutisch gebied:

PITUITARY

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2013-04-16

Productkenmerken

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_Page 1 of 72 _
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PRODUCT MONOGRAPH
PR
NUTROPIN
®
somatropin for injection
lyophilized powder for injection; 10 mg/vial
PR
NUTROPIN
AQ
®
somatropin injection
solution; 10 mg/2 mL vial
PR
NUTROPIN AQ PEN
® CARTRIDGE
somatropin injection
solution; 10 mg/2 mL pen cartridge
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
2455 Meadowpine Boulevard
Mississauga, Ontario
L5N 6L7
www.rochecanada.com
Manufactured by:
Genentech, Inc., USA
Date of Preparation:
October 15, 1996
Date of Authorization:
December 21, 2012
Submission Control No: 155362
®
Registered Trade-Marks of Genentech, Inc, used under license by
Hoffmann-La Roche Ltd.
©
Copyright 1996-2012 of Hoffmann-La Roche Limited
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_Page 2 of 72 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
4
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
.................................