Pulmozime

Pulmozyme

1 mg/ml, for nebulization

nebulization

2500 U/2.5 ml

Dornase alfa

• .
• harm
• or pharmacist. See section 4.

Spi

:

• 1. What is Pulmozyme and what is it used for
• 2. Important information before using Pulmozyme
• 3. Pulmozyme
• 4.
• 5. How to store Pulmozyme
• 6. Undesirable effects

1.

Pulmozyme contains
de
1
cut
out
Dornase alfa produced by
genetic engineering.
Pulmozyme
Drug Pul
Drug
in the form of a solution for inhalation with a nebulizer (see section 3. How
.

2.

using Pulmozyme

When not to use Pulmozyme

I
patient has an allergy (
or
to this drug (listed in section 6).
do not use Pulmozyme
.

Children

u
limited.
Pulmozyme in children under the age of
years
, and therapy
conducted

Pulmozyme and other medicines

tell your doctor or pharmacist about all medicines the patient is taking
,
including standard medicines used in cystic fibrosis,
and
,
Before using any medicine, consult your doctor or pharmacist.
N
when using dornase alfa in women.
operating machinery
Drug
on
operating
machinery.

3.

always
In case of
consult your doctor or pharmacist.
The recommended dose is 2500 U (2.5 mg) of dornase alfa in the form of inhalation once
. Inhalations
ml of solution)
using a recommended nebulizer.
in children under the age of
years
when using Pulmozyme
twice a day
.
during regular, daily
use of Pulmozyme. Studies,
,
about the reason
for
Pulmozyme m
So far, no
,
Pulmozyme should not be mixed with other medicines or solutions in the nebulizer chamber. Mixing Pulmozyme with other
medicines.
using
a nebulizer chamber, such as:
Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, Respirgard/Pulmo-Aide or
Acorn II/Pulmo-Aide.
,
such as Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Pari Baby, Aiolos/2 Aiolos, Side
Stream/CR50 or MobilAire or Porta-Neb.
nebulizer Pari eRAPID
.
nebulizer
ies, because
Pulmozyme
Pulmozyme.
Administering the drug
rules:
.
any unused Pulmozyme from the previous inhalation. All unused
according to the information contained in
section 5.
after their
consult your doctor.
.
O
.
.
nebulizer.
drug
.

Using the dose of Pulmozyme

l

Method of administration of Pulmozyme

Discontinuation of Pulmozyme

In case of discontinuation
discontinuation of Pulmozyme.
inform your doctor or pharmacist.

4.

this drug
,
.
clinical trials, as well as after the introduction of Pulmozyme to the market, used in recommended doses.
drug
in less than 1 in
1000
)
z
,
hoarseness,
laryngitis,
nasal congestion (runny nose),
worsening
,
n
,
rash, urticaria,
b
changes in Pulmozyme dosing.
drug
Pulmozyme.
.
5 in 100
allergic to dornase alfa.
Improvement in tests for
dornase alfa.
In a study conducted in children aged
children aged 5 to 10 years.
any of the following
not listed in
inform your doctor or pharmacist.
in
:
Department of
ation
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
to the person responsible.

5. Pulmozyme

.
foil bags, in the original packaging
to protect against
.
Single
drug.
Pulmozyme after
expiration date
stated on the packaging.
after
,

6.

What Pulmozyme contains

• is dornase alfa (phosphorylated and glycosylated, recombinant). It contains 2500 U (2.5 mg) of dornase alfa in 2.5 ml of solution. U/ml (1 mg/ml, 1 Genentech unit/ml = 1 g/ml).
• In addition, the drug contains: sodium chloride, calcium chloride dihydrate, water.

Drug
in the form of a solution for inhalation with a nebulizer.
ach
is clear and colorless
.
Packaging contains

Marketing Authorization Holder and Importer

Marketing Authorization Holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warsaw, Poland
Phone: +48 22 345 1888
Fax: +48 22 345 1874
Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Date of last revision of the leaflet:

Pulmozyme

1 mg/ml, for nebulization

2500 U/2.5 ml

Dornase alfa

• .
• harm
• or pharmacist. See section 4.

Spi

:

• 1. What is Pulmozyme and what is it used for
• 2. Important information before using Pulmozyme
• 3. Pulmozyme
• 4.
• 5. How to store Pulmozyme
• 6. Undesirable effects

1.

Pulmozyme contains
de
1
cut
out
Dornase alfa produced by
genetic engineering.
Pulmozyme
Drug Pul
Drug
in the form of a solution for inhalation with a nebulizer (see section 3. How
.

2.

using Pulmozyme

When not to use Pulmozyme

I
patient has an allergy (
or
to this drug (listed in section 6).
do not use Pulmozyme
.

Children

u
limited.
Pulmozyme in children under the age of
years
, and therapy
conducted

Pulmozyme and other medicines

tell your doctor or pharmacist about all medicines the patient is taking
,
including standard medicines used in cystic fibrosis,
and
,
Before using any medicine, consult your doctor or pharmacist.
N
when using dornase alfa in women.
operating machinery
Drug
on
operating
machinery.

3.

always
In case of
consult your doctor or pharmacist.
The recommended dose is 2500 U (2.5 mg) of dornase alfa in the form of inhalation once
. Inhalations
ml of solution)
using a recommended nebulizer.
in children under the age of
years
when using Pulmozyme
twice a day
.
during regular, daily
use of Pulmozyme. Studies,
,
about the reason
for
Pulmozyme m
So far, no
,
Pulmozyme should not be mixed with other medicines or solutions in the nebulizer chamber. Mixing Pulmozyme with other
medicines.
using
a nebulizer chamber, such as:
Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, Respirgard/Pulmo-Aide or
Acorn II/Pulmo-Aide.
,
such as Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Pari Baby, Aiolos/2 Aiolos, Side
Stream/CR50 or MobilAire or Porta-Neb.
nebulizer Pari eRAPID
.
nebulizer
ies, because
Pulmozyme
Pulmozyme.
Administering the drug
rules:
.
any unused Pulmozyme from the previous inhalation. All unused
according to the information contained in
section 5.
after their
consult your doctor.
.
O
.
.
nebulizer.
drug
.

Using the dose of Pulmozyme

l

Method of administration of Pulmozyme

Discontinuation of Pulmozyme

In case of discontinuation
discontinuation of Pulmozyme.
inform your doctor or pharmacist.

4.

this drug
,
.
clinical trials, as well as after the introduction of Pulmozyme to the market, used in recommended doses.
drug
in less than 1 in
1000
)
z
,
hoarseness,
laryngitis,
nasal congestion (runny nose),
worsening
,
n
,
rash, urticaria,
b
changes in Pulmozyme dosing.
drug
Pulmozyme.
.
5 in 100
allergic to dornase alfa.
Improvement in tests for
dornase alfa.
In a study conducted in children aged
children aged 5 to 10 years.
any of the following
not listed in
inform your doctor or pharmacist.
in
:
Department of
ation
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
to the person responsible.

5. Pulmozyme

.
foil bags, in the original packaging
to protect against
.
Single
drug.
Pulmozyme after
expiration date
stated on the packaging.
after
,

6.

What Pulmozyme contains

• is dornase alfa (phosphorylated and glycosylated, recombinant). It contains 2500 U (2.5 mg) of dornase alfa in 2.5 ml of solution. U/ml (1 mg/ml, 1 Genentech unit/ml = 1 g/ml).
• In addition, the drug contains: sodium chloride, calcium chloride dihydrate, water.

Drug
in the form of a solution for inhalation with a nebulizer.
ach
is clear and colorless
.
Packaging contains

Marketing Authorization Holder and Importer

Marketing Authorization Holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warsaw, Poland
Phone: +48 22 345 1888
Fax: +48 22 345 1874
Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Date of last revision of the leaflet: