Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
SOMATROPIN
HOFFMANN-LA ROCHE LIMITED
H01AC01
SOMATROPIN
10MG
SOLUTION
SOMATROPIN 10MG
SUBCUTANEOUS
2ML
Prescription
PITUITARY
Active ingredient group (AIG) number: 0131827001; AHFS:
CANCELLED POST MARKET
2017-10-31
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 _ _ _Page 2 of 55 _ _ _ _ _ _ _ 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 ............................................................ Prečítajte si celý dokument