NUTROPIN AQ PEN CARTRIDGE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SOMATROPIN

Διαθέσιμο από:

HOFFMANN-LA ROCHE LIMITED

Φαρμακολογική κατηγορία (ATC):

H01AC01

INN (Διεθνής Όνομα):

SOMATROPIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SOMATROPIN 10MG

Οδός χορήγησης:

SUBCUTANEOUS

Μονάδες σε πακέτο:

2ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PITUITARY

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-10-31

Αρχείο Π.Χ.Π.

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
............................................................