Pulmozyme 2500 U/2.5 ml nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dornase alfa

Available from:

PCO Manufacturing Ltd.

ATC code:

R05CB; R05CB13

INN (International Name):

Dornase alfa

Dosage:

2500 U/2.5 millilitre(s)

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Mucolytics; dornase alfa (desoxyribonuclease)

Authorization date:

2018-08-17

Patient Information leaflet

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 section 2).
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 pharm

Summary of Product characteristics

Health Products Regulatory Authority
22 February 2023
CRN00DDW7
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pulmozyme 2500 U/2.5 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 2500 U (corresponding to 2.5 mg) of dornase alfa
per 2.5 ml corresponding to 1000 U/ml or 1 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
_Product imported from Greece and Belgium:_
_ _
Clear, colourless to slightly yellowish solution.
4 CLINICAL PARTICULARS
As per PA2307/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2307/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Chloride
Calcium Chloride Dihydrate
Water for Injections
6.2 INCOMPATIBILITIES
Pulmozyme is an unbuffered aqueous solution and should not be diluted
or mixed with other drugs or solutions in the
nebuliser bowl. Mixing of this solution could lead to adverse
structural and/or functional changes in Pulmozyme or the
admixed compound.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a refrigerator (2 °C - 8 °C).
Keep the ampoule in the outer carton in order to protect from light.
A single brief exposure to elevated temperatures (less than or equal
to 24 hours at up to 30 °C) does not affect product
stability.
Health Products Regulatory Authority
22 February 2023
CRN00DDW7
Page 2 of 3
6.5 NATURE AND CONTENTS OF CONTAINER
2.5 ml of nebuliser solution in a plastic ampoule.
Pack size of 6.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
The contents of one 2.5 mg (2500 U) single-use ampoule of Pulmozyme
sterile solution for inhalation should be inhaled once a
day using a recommended nebuliser.
Pulmozyme should not be mixed with other drugs or solutions in the
nebuliser (see section 6.2).

Pulmozyme may be used in conjunction with a jet nebuliser/compressor
syste