NUTROPIN AQ PEN CARTRIDGE SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

SOMATROPIN

Saadav alates:

HOFFMANN-LA ROCHE LIMITED

ATC kood:

H01AC01

INN (Rahvusvaheline Nimetus):

SOMATROPIN

Annus:

10MG

Ravimvorm:

SOLUTION

Koostis:

SOMATROPIN 10MG

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

2ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

PITUITARY

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2017-10-31

Toote omadused

PRODUCT MONOGRAPH
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
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Manufactured by:
Genentech, Inc., USA
Date of Approval:
May 1, 2014
Submission Control No: 172192
®
Registered trade-marks of Genentech, Inc, used under license.
©
Copyright 1996-2014 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
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
............................................................