Pulmozyme 2500 U/ 2.5ml, nebuliser solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Dornase alfa

Tilgængelig fra:

Roche Products (Ireland) Ltd

ATC-kode:

R05CB; R05CB13

INN (International Name):

Dornase alfa

Dosering:

2500 U/ 2.5 millilitre(s)

Lægemiddelform:

Nebuliser solution

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Mucolytics; dornase alfa (desoxyribonuclease)

Autorisation status:

Marketed

Autorisation dato:

1994-03-14

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PULMOZYME® 2500 U/2.5 ML
NEBULISER SOLUTION
Dornase alfa
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If any of the side effects become serious or troublesome, or if you
notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Pulmozyme is and what it is used for
2.
What you need to know before you use Pulmozyme
3.
How to use Pulmozyme
4.
Possible side effects
5.
How to store Pulmozyme
6.
Contents of the pack and other information
1.
WHAT PULMOZYME IS AND WHAT IT IS USED FOR
Pulmozyme contains a medicine called dornase alfa. It is a man-made
version of a protein found in
your body called ‘DNase’.
Pulmozyme is used for people with cystic fibrosis. It helps by
breaking down the thick mucus found
in lungs. This helps lungs of people with cystic fibrosis to work
better.
Pulmozyme is breathed in (inhaled) using something called a
nebuliser’ (see Section 3: How to use
Pulmozyme). As well as using Pulmozyme you will normally keep taking
the other medicines you use
for cystic fibrosis (see ‘Other medicines and Pulmozyme in section2)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PULMOZYME
DO NOT USE PULMOZYME:

if you are allergic (hypersensitive) to dornase alfa or any of the
other ingredients in Pulmozyme
(listed in section 6) .
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Pulmozyme.
CHILDREN
Pulmozyme is not recommended for use by children under 5 years of age.
Check with your doctor or
pharmacist

Produktets egenskaber

Health Products Regulatory Authority
15 July 2021
CRN00CGX4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pulmozyme 2500 U/ 2.5ml, nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 2500 U (corresponding to 2.5mg) of dornase alfa*
per 2.5ml corresponding to 1000 U/ml or 1mg/ml**.
*phosphorylated glycosylated protein human deoxyribonuclease 1
produced in in Chinese Hamster Ovary Cell Line CHO
A14.16-1 MSB #757 by recombinant DNA technology
**1 Genentech unit/ml = 1 microg/ml)
For a full list of excipients, seesection 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution
Clear, colourless to slightly yellowish solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of cystic fibrosis patients with a forced vital capacity
(FVC) of greater than 40% of predicted and over 5 years of
age to improve pulmonary function.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2.5 mg (corresponding to 2500 U) deoxyribonuclease l by inhalation
once daily.
Some patients over the age of 21 years may benefit from twice daily
dosage.
Most patients gain optimal benefit from regular daily use of
Pulmozyme. In studies in which Pulmozyme was given in an
intermittent regimen, improvement in pulmonary function was lost on
cessation of therapy. Patients should therefore be
advised to take their medication every day without a break.
Patients should continue their regular medical care, including their
standard regimen of chest physiotherapy.
Administration can be safely continued in patients who experience
exacerbation of respiratory tract infection.
Safety and efficacy have not yet been established in patients with
forced vital capacity less than 40% of predicted.
_Paediatric population_
Safety and efficacy have not yet been established in patients under
the age of 5 years.
Method of administration
Inhale the content of one ampoule (2.5 ml of solution) undiluted using
a recommended nebuliser system (see section 6.6).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active