Pulmozyme
Poland
Table of Contents
Pulmozyme
1 mg/ml, solution for nebulization
2500 U/2.5 ml
Dornase alfa
- .
- or pharmacist. See section 4.
Summary of Product Characteristics:
- What Pulmozyme is and what it is used for
- Important information before using Pulmozyme
- How to use Pulmozyme
- Possible side effects
- How to store Pulmozyme
- Contents of the pack
1. What Pulmozyme is and what it is used for
Pulmozyme contains the active substance dornase alfa, a recombinant human deoxyribonuclease I produced by genetic engineering.
Pulmozyme is a solution for inhalation via a nebulizer (see section 3. How to use Pulmozyme).
Pulmozyme is used in the treatment of cystic fibrosis in patients with respiratory tract complications. It helps to improve lung function by reducing the viscosity of mucus in the airways through the cleavage of DNA in sputum.
2. Pulmozyme medicinal product use
When not to use Pulmozyme
Do not use this medicine if the patient is allergic (hypersensitive) to dornase alfa or any of the other components of this medicine (listed in section 6).
Use in children
The use of Pulmozyme in children under 5 years of age is not recommended. The safety and efficacy of Pulmozyme in children aged 5 years and older have been established, and therapy may be initiated based on clinical need.
Pulmozyme with other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. This includes medicines taken together with standard therapies used in cystic fibrosis, as well as herbal products and supplements.
Before taking any new medicine, consult your doctor or pharmacist.
There are no data on the use of dornase alfa in pregnant women.
Driving and operating machinery
Pulmozyme has no or negligible influence on the ability to drive and operate machinery.
3.
Always consult your doctor or pharmacist.
The recommended dose is 2500 U (2.5 mg) of dornase alfa administered once daily by inhalation (using 2.5 ml of solution) via a recommended nebulizer.
For children under the age of 5 years, administration twice daily is recommended during treatment with the medicinal product.
Inhalations should be performed during regular, daily use of Pulmozyme. Studies have shown that efficacy is maintained with daily use of Pulmozyme.
No evidence has been found to support the need for dose adjustment.
Pulmozyme must not be diluted or mixed with other medicines or solutions in the nebulizer chamber. Mixing Pulmozyme with other medicinal products in the nebulizer chamber is not recommended.
Pulmozyme should be used with a nebulizer system that delivers an aerosol with appropriate particle size, such as:
Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, Respirgard/Pulmo-Aide or Acorn II/Pulmo-Aide.
Other suitable nebulizers include:
Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Pari Baby, Aiolos/2 Aiolos, Side Stream/CR50 or MobilAire or Porta-Neb.
The Pari eRAPID nebulizer is also suitable.
Nebulizers must be used according to manufacturer's instructions, as performance may vary depending on the device used.
Administration of Pulmozyme should follow these principles:
Do not mix Pulmozyme with other medications in the nebulizer chamber.
Discard any unused residue from a previous inhalation of Pulmozyme. Dispose of unused medication according to the instructions provided in section 5.
Do not change your dosing schedule without consulting your doctor.
O.
.
Clean the nebulizer after each use according to the manufacturer's instructions.
Store the medication as directed.
Administration of Pulmozyme dose
l
P recautions for use of Pulmozyme
Discontinuation of Pulmozyme treatment
If treatment is interrupted, consult your doctor or pharmacist before resuming therapy.
In case of any doubts, contact your doctor or pharmacist.
4.
This medicinal product, both in clinical trials and after the introduction of the drug Pulmozyme into circulation, used at recommended doses.
Less than 1 in 1000 patients experienced:
hoarseness,
laryngitis,
nasal symptoms (rhinitis),
worsening of,
n,
rash, urticaria,
b
changes in the dosage of Pulmozyme.
drug
Pulmozyme.
5 in 100
against dornase alfa.
Improvement in tests or
dornase alfa.
In a conducted study, in children aged
children aged 5 to 10 years.
If any side effects occur which are not listed here, inform your doctor or pharmacist.
In case of
:
Department of Health and Food Safety
Al. Jerozolimskie 181C
02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
responsible person.
5. Pulmozyme
.
in foil pouches, in the original packaging to protect
.
Single-use
medicinal product.
Do not use Pulmozyme after the expiry date stated on the packaging.
after
,
6.
What Pulmozyme contains
- The active substance is dornase alfa (recombinant, phosphorylated and glycosylated). Each vial contains 2500 U (2.5 mg) of dornase alfa in 2.5 ml of solution, i.e. 1000 U/ml (1 mg/ml; 1 Genentech unit/ml = 1 μg/ml).
- Other ingredients: sodium chloride, calcium chloride dihydrate, water for injections.
Pulmozyme is a solution for inhalation using a nebulizer.
The solution is clear and colourless.
Packaging contains:
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warszawa, Poland
Tel. +48 22 345 1888
Fax +48 22 345 1874
Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Pulmozyme
1 mg/ml, solution for nebulization
2500 U/2.5 ml
Dornase alfa
- .
- harm or pharmacist. See section 4.
Contents:
- What Pulmozyme is and what it is used for
- Important information before using Pulmozyme
- How to use Pulmozyme
- Possible side effects
- How to store Pulmozyme
- Contents of the pack
1.
Pulmozyme contains
dez 1
cleaves extracellular DNA. Dornase alfa produced
by genetic engineering.
Pulmozyme
Pulmozyme
Medicinal product in the form of a solution for inhalation via nebulizer (see section 3. How to
.
2. Pulmozyme usage
When not to use Pulmozyme
Do not use this medicine if the patient is allergic (hypersensitive) to dornase alfa or any of the other ingredients of this medicine (listed in section 6).
Contraindications for the use of Pulmozyme.
Children
The use of Pulmozyme is not recommended in children under 5 years of age, and therapy should be undertaken with caution.
Pulmozyme and other medicines
Tell your doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Pulmozyme has been used concomitantly with standard medications used in cystic fibrosis, including antibiotics, bronchodilators, and other therapies administered by inhalation.
Before using any medicine, consult your doctor or pharmacist.
No interactions were observed during the use of dornase alfa in women.
Driving and operating machinery
Pulmozyme has no or negligible influence on the ability to drive and operate machinery.
3.
Always consult your
doctor or pharmacist.
The recommended dose is 2500 U (2.5 mg) of dornase alfa administered once daily by inhalation. Inhalations
(1 mL of solution)
should be performed using the recommended nebulizer.
In children under 5 years of age, during treatment with the medicine,
the dose should be administered twice daily.
This applies during regular, daily
use of Pulmozyme. Studies have shown
no evidence of loss of efficacy
over time.
Pulmozyme must not be diluted or mixed with other medicines or solutions in the
nebulizer chamber. Mixing Pulmozyme
with other medicinal products is not recommended.
The solution should be used with a nebulizer chamber such as:
Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, Respirgard/Pulmo-Aide, or
Acorn II/Pulmo-Aide.
Alternatively, nebulizers such as:
Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Pari Baby, Aiolos/2 Aiolos, Side
Stream/CR50, MobilAire, or Porta-Neb may be used.
The Pari eRAPID nebulizer
is also suitable.
Nebulizers must be used according to manufacturer's instructions, as
the performance of
Pulmozyme depends on the type of nebulizer used.
Administration of Pulmozyme must follow these
general principles:
.
Do not use leftover Pulmozyme from previous inhalations. Any
unused portions must be discarded according to the instructions provided
in section 5.
Dispose of them properly, following your
doctor’s instructions.
.
O .
.
components of the nebulizer.
medicinal product.
Administration of the dose of Pulmozyme
l
P recautions for use of Pulmozyme
Discontinuation of Pulmozyme treatment
If treatment is interrupted,
consult your doctor or pharmacist regarding the need to adjust or resume
treatment.
In case of any doubts,
contact your doctor or pharmacist.
4.
this medicine, both in clinical trials and after the introduction of the medicine Pulmozyme into circulation, used at recommended doses.
medicine in less than 1 in
1,000 patients)
such as:
hoarseness,
laryngitis,
nasal symptoms (nasal congestion),
worsening of
n,
rash, urticaria,
b
dose adjustments of the medicine Pulmozyme.
medicine
Pulmozyme.
.
5 in 100
against dornase alfa.
Improvement in lung function tests or
dornase alfa.
In a completed study, in children aged
children aged 5 to 10 years.
however, any
not listed in this leaflet to your doctor or pharmacist.
in case of
:
Department of Health
Al. Jerozolimskie 181C
02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
responsible person.
5. Pulmozyme
.
in foil pouches, in the original packaging to protect
.
Single-use
medicinal product.
Do not use Pulmozyme after the expiry date stated on the packaging.
after
,
6.
What the Pulmozyme medicine contains
- dornase alfa (recombinant, phosphorylated and glycosylated), containing 2500 U (2.5 mg) of dornase alfa in 2.5 ml of solution. U/ml (1 mg/ml, 1 Genentech unit/ml = 1 \μg/ml).
- Other ingredients: sodium chloride, calcium chloride dihydrate, water.
The medicine is in the form of a solution for inhalation via a nebulizer.
The solution is clear and colourless.
Packaging contains
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warszawa, Poland
Tel. +48 22 345 1888
Fax +48 22 345 1874
Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany