PULMOZYME 1MG/ML SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DORNASE ALFA

Beschikbaar vanaf:

HOFFMANN-LA ROCHE LIMITED

ATC-code:

R05CB13

INN (Algemene Internationale Benaming):

DORNASE ALFA (DESOXYRIBONUCLEASE)

Dosering:

1MG

farmaceutische vorm:

SOLUTION

Samenstelling:

DORNASE ALFA 1MG

Toedieningsweg:

INHALATION

Eenheden in pakket:

2.5 ML

Prescription-type:

Prescription

Therapeutisch gebied:

ENZYMES

Product samenvatting:

Active ingredient group (AIG) number: 0124648001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

1996-06-13

Productkenmerken

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PRODUCT MONOGRAPH
PR
PULMOZYME
®
(dornase alfa)
recombinant
For inhalation, 1 mg/mL, 2.5 mg/ampoule
PROFESSED STANDARD
An enzyme that cleaves DNA
(Mucolytic)
Distributed by:
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
DATE OF APPROVAL:
MARCH 12, 2015
Manufactured by:
Genentech Inc., USA
SUBMISSION CONTROL NO: 174409
PULMOZYME
®
is a registered trade-mark of Genentech Inc., used under license.
©
Copyright 1993-2015 Hoffmann-La Roche Limited.
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................4
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
.........................