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PULMOZYME INHALATION SOLUTION 1MG/ML

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10132924

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Date

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20.09.11

11.08.10

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Signature

1058

97.4.3524

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Signature

TG-MT/5157
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Patient Information Leaflet

10132924 GB 1108.1079

Pulmozyme

®

2500 U/2.5 ml
Nebuliser Solution
Dornase alfa

Please read all of this leaflet carefully
before you start using this medicine.
 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. Do not pass it on to others.
It may harm them even if their
symptoms 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.

Pregnancy and breast-feeding
Do not use Pulmozyme if you are
pregnant, trying to get pregnant or
breast-feeding, unless your doctor
has told you to.
Driving and using machines
Pulmozyme is not likely to affect you
being able to drive or use any tools
or machines.

3. How to use Pulmozyme
Always use Pulmozyme exactly as
your doctor has told you. Pulmozyme
is breathed in (inhaled) using a
‘compressed air-driven (jet) nebuliser’
(See ‘Which nebuliser to use’). You should
check with your doctor if you are not
sure.

In this leaflet:
1. What Pulmozyme is and what
it is used for
2. Before you use Pulmozyme
3. How to use Pulmozyme
4. Possible side effects
5. How to store Pulmozyme
6. Further information

Keep having your standard chest
physiotherapy when you are using
Pulmozyme.

1. What Pulmozyme is
and what it is used for

People under 5 years of age
Pulmozyme is not recommended
in children under 5 years of age.

Pulmozyme contains a medicine called
dornase alfa. It is a man-made version
of a protein found in your body called
‘DNase’.

People 5 years of age and over
 You should use Pulmozyme every
day.
 The usual dose is one ampoule every
day, inhaled using your nebuliser.
 If you are over 21, your doctor may
tell you to use one ampoule twice
a day.
Which nebuliser to use:
 Use a compressed air-driven (jet)
nebuliser.
 Most types of ultrasonic nebulisers
must not be used, as they may
stop Pulmozyme from working
properly.
 Talk to your doctor as they will
be able to tell you which nebulisers
can be used with Pulmozyme.

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 ‘compressed
air-driven (jet) 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 ‘Taking other
medicines’ in Section 2).

2. Before you use Pulmozyme

How to use Pulmozyme
with the nebuliser
When getting your nebuliser ready
for use with Pulmozyme, please
remember these important points:
 Do not mix
Pulmozyme with
any other liquids
or medicines in
the nebuliser.
 Do not use any left
over Pulmozyme,
this should always
be thrown away.
 If you have a ‘re-usable’ nebuliser,
remember to clean it after use.
The makers of the nebuliser will be
able to give you the best advice on how
to clean their equipment after using
Pulmozyme.

Do not use Pulmozyme if:
You are allergic (hypersensitive)
to dornase alfa or any of the other
ingredients in Pulmozyme.
Take special care
with Pulmozyme
Pulmozyme is not
recommended
for use by children
under 5 years of age.
Check with your doctor
or pharmacist before
using Pulmozyme
if it has been prescribed
for a child under 5 years
of age.

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently taken
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines. This
is because Pulmozyme may affect the way
some medicines work. Also some other
medicines may affect the way Pulmozyme
works.

To use your nebuliser:
 Make sure that the nebuliser is clean.
 Snap the top off one Pulmozyme
ampoule.
 Pour the contents into the nebuliser
chamber.
 Follow the nebuliser instructions
and inhale the Pulmozyme straight
away.

You can carry on using your usual
treatments for cystic fibrosis when you
are using Pulmozyme (such as antibiotics,
pancreatic enzymes, bronchodilators
and painkillers). If you are not sure about
this, talk to your doctor or pharmacist
before using Pulmozyme.

If you use more Pulmozyme than
you should
If you use more Pulmozyme than
you should, talk to a doctor straight
away.
1

10132924 NP 9344.indd 1

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21.09.2011 10:01:16

10132924

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

11 pt

Drawing Norm

NP9344

make-up code

GB

Good To Print

Version

Date

2

20.09.11

11.08.10

Date

Genisys-No.

Signature

1058

97.4.3524

Checked and
approved

KAU-Nr.

Signature

TG-MT/5157
TG-MT/3870

Züge

If you forget to use Pulmozyme
 If you forget to take a dose, take it as
soon as you remember.
 If it is nearly time for the next dose,
skip the missed dose.
 Do not take a double dose to make up
for a forgotten dose.

6. Further information
What Pulmozyme contains
The active ingredient in Pulmozyme
2500 U/2.5 ml Nebuliser Solution
is dornase alfa. This is also known as
recombinant human deoxyribonuclease
1 or rhDNase. Each 2.5 ml (millilitres)
of liquid medicine contains 2500 Units
(or 2.5 milligrams) of dornase alfa.

If you stop using Pulmozyme
If you stop using Pulmozyme your
chest symptoms may get worse.
Talk to your doctor if you would like
to stop using Pulmozyme.

Other ingredients are sodium chloride,
calcium chloride dihydrate and water
for injections.

If someone else uses your Pulmozyme
by mistake, they should talk to a doctor
straight away.

What Pulmozyme looks like
and contents of the pack
Pulmozyme Nebuliser Solution
is provided in clear plastic ampoules.
The ampoules contain 2.5 ml of
liquid medicine. The medicine is clear
and colourless to slightly yellowish.

If you have any further questions on
the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects

Pulmozyme is supplied in cartons
containing either 6 or 30 ampoules.
Not all pack sizes may be marketed.

Like all medicines, Pulmozyme can
cause side effects, although not everyone
will get them. Side effects from
Pulmozyme are rare. They affect less
than 1 in 1000 people.

Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

Side effects include:
 Chest pain.
 Fever.
 Upset stomach (indigestion).
 Changes to your voice including
hoarseness or loss of voice.
 Sore throat.
 Difficulty breathing.
 A runny or blocked nose and sneezing
(rhinitis).
 Irritation of your eye (conjunctivitis).
The signs include redness and
itchiness of the eye and a discharge
from the eye.
 Skin rash, which may be lumpy
and itchy (hives).
 When you start your treatment, your
lung function may get worse and you
may produce more mucus than normal.
This usually gets better with time.
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.

Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This leaflet was last approved in
August 2011

5. How to store Pulmozyme
 Pulmozyme ampoules must be stored
in a refrigerator (2°C to 8°C) in the
original carton, to protect them from
light.
 You can still use
an ampoule if it has
been left out of the
refrigerator for only
a short time at a
higher temperature
(only left out once
and for no longer
than 24 hours
at temperatures
up to 30°C).
 Keep out of the reach and sight
of children.
 Do not use Pulmozyme after
the expiry date (EXP) printed
on the pack.
 Do not throw away any left over
ampoules. Instead, return them
to your pharmacist so that they can be
disposed of carefully. Only keep them
if your doctor tells you to.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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