NUTROPIN - KIT PWS(5MG) & LIQ(10ML) IM SC

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SOMATROPIN; WATER

Предлага се от:

HOFFMANN-LA ROCHE LIMITED

АТС код:

H01AC01

INN (Международно Name):

SOMATROPIN

дозиране:

5MG; 10ML

Лекарствена форма:

KIT

Композиция:

SOMATROPIN 5MG; WATER 10ML

Начин на приложение:

INTRAMUSCULAR

Броя в опаковка:

6X5MG-6X10ML

Вид предписание :

Prescription

Терапевтична област:

PITUITARY

Каталог на резюме:

Active ingredient group (AIG) number: 0228557001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

1997-12-10

Данни за продукта

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_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
NUTROPIN
®
somatropin for injection
lyophilized powder for injection; 5 mg/vial and 10 mg/vial
PR
NUTROPIN
AQ
®
somatropin injection
solution; 10 mg/2ml vial
PR
NUTROPIN AQ PEN
® CARTRIDGE
somatropin injection
solution; 10 mg/2mL pen cartridge
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 Revision:
August 23, 2006
MECS No.: 06-120001-60
Date of Approval: September 5, 2006
®
Registered Trade-Marks of Genentech, Inc, used under license by
Hoffmann-La Roche Ltd.
©
Copyright 1996-2006 of Hoffmann-La Roche Limited
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_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND
STABILITY....................