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PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION

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About the medicine

How to use PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Pulmozyme 2,500 U/2.5 ml Solution for Inhalation by Nebulizer

Dornase alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

  • Keep this leaflet, as 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 symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Pulmozyme and what is it used for
  2. What you need to know before you start using Pulmozyme
  3. How to use Pulmozyme
  4. Possible side effects
  5. Storage of Pulmozyme
  6. Package Contents and Further Information

1. What is Pulmozyme and what is it used for

Pulmozyme is a medicine that contains dornase alfa, which is a humanized version of the protein found in our body called "DNase".

Pulmozyme is indicated for the treatment of cystic fibrosis to help dissolve the viscous secretions produced in the lungs in adults and children over 5 years of age. Pulmozyme is inhaled using a nebulizer (see section 3: How to use Pulmozyme). During treatment with Pulmozyme, you can usually continue with other medications you are using for the treatment of cystic fibrosis (see "Using Pulmozyme with other medications" in section 2).

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2. What you need to know before you start using Pulmozyme

Do not use Pulmozyme:

  • If you are allergic to dornase alfa or to any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before you start using Pulmozyme.

Children

Pulmozyme is not recommended for use in children under 5 years of age. Before using Pulmozyme, confirm with your doctor or pharmacist if it has been prescribed for a child under 5 years of age.

Using Pulmozyme with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications. This includes medications you buy without a prescription and herbal medicines. Pulmozyme may affect the way other medications work, and other medications may affect how Pulmozyme works.

Usual treatments for cystic fibrosis (such as antibiotics, pancreatic enzymes, bronchodilators, and pain relievers) can be continued with Pulmozyme. If you are unsure, talk to your doctor or pharmacist before using Pulmozyme.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and Using Machines

Pulmozyme is unlikely to affect your ability to drive or use machines.

3. How to use Pulmozyme

Follow exactly the administration instructions of this medicine as indicated by your doctor. Pulmozyme is inhaled using a nebulizer (see section "Which Nebulizer to Use"). If you are unsure, consult your doctor again.

Continue with your chest physiotherapy treatment while using Pulmozyme.

Adults and Children Over 5 Years

  • Use Pulmozyme once a day.
  • The recommended dose is one ampoule per day, for inhalation using the nebulizer.
  • If you are over 21 years of age, your doctor may instruct you to use one ampoule twice a day.

Children Under 5 Years

Pulmozyme is not recommended for children under 5 years of age.

Which Nebulizer to Use:

  • Use a nebulizer such as:
  • The Hudson T Up-draft II/Pulmo-Aide, the Airlife Misty/Pulmo-Aide, the Respirgard/Pulmo-Aide customized, or the AcornII/Pulmo-Aide.
  • Pulmozyme can also be used with a reusable nebulizer system, such as the Pari LL/Inhalierboy, the Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, the Side Stream/CR50, or MobilAire or Porta-Neb.
  • The Pari eFlow Rapid nebulizer, a general-purpose electronic nebulizer using vibrating membrane technology, can be used. The Pari eFlow Rapid nebulizer should be cleaned according to the manufacturer's instructions. Additionally, it is recommended to use the Pari EasyCare cleaning accessory after every seven uses.
  • Ultrasonic nebulizers cannot be usedwith Pulmozyme because they may cause Pulmozyme not to work properly.

Read carefully and follow the manufacturer's instructions for the use of each nebulizer.

Talk to your doctor, as they may instruct you on which nebulizers can be used with Pulmozyme.

How to Use Pulmozyme with a Nebulizer:

When you have the nebulizer ready to be used with Pulmozyme, please note the following points:

  • Do not mix Pulmozyme with other liquids or medications in the nebulizer.
  • Do not use any leftover portions; these should always be discarded.
  • If your nebulizer is reusable, remember to clean it after use. Follow the manufacturer's instructions for the compressor and nebulizer for the use and maintenance of these devices.
  • If someone uses Pulmozyme by mistake, contact your doctor immediately.

To Use the Nebulizer

  • Make sure the nebulizer is clean before using it.
  • Break the top of a Pulmozyme ampoule.
  • Pour the complete contents of the ampoule into the nebulizer chamber.
  • Follow the nebulizer's instructions for use and inhale Pulmozyme immediately.

If You Use More Pulmozyme Than You Should

If you use more Pulmozyme than you should, inform your doctor immediately.

If You Forget to Use Pulmozyme

  • If you forget to take a dose, take it as soon as you remember.
  • If it is almost time for your next dose, skip the missed dose.
  • Do not take a double dose to make up for missed doses.

If You Stop Using Pulmozyme

If you stop using Pulmozyme, your chest symptoms may worsen. Contact your doctor if you want to stop using Pulmozyme.

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

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4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Pulmozyme are rare. They affect less than 1 in 1,000 people.

These side effects include:

  • Chest pain.
  • Fever.
  • Digestive disorders (indigestion).
  • Voice disorders, including hoarseness or loss of voice.
  • Sore throat.
  • Difficulty breathing.
  • Runny nose or stuffy nose and sneezing (rhinitis).
  • Eye irritation (conjunctivitis). These signs include redness, itching, and discharge.
  • Skin rash that may have nodules and cause itching (hives).
  • At the start of treatment with dornase alfa, lung function may decrease, as well as an increase in mucous secretions. This usually improves over time.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pulmozyme

  • Pulmozyme ampoules should be stored in the refrigerator (between 2°C and 8°C), in the original packaging, to protect it from light.
  • The ampoule can be used even if it has been out of the refrigerator for a short period and exposed to high temperatures (provided it is the first time the ampoule is left out of the refrigerator and for a maximum of 24 hours at temperatures up to 30°C).
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the packaging after (EXP). The expiry date is the last day of the month stated. Do not throw away any leftover ampoules; take them to your pharmacist for disposal. Only keep leftover liquid if your doctor tells you to.
  • Medicines should not be disposed of via wastewater or household waste. Take the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Further Information

Composition of Pulmozyme

  • The active ingredient is dornase alfa. It is also known as deoxyribonuclease 1 or rhDnase. Each 2.5 ml (milliliters) of solution contains 2,500 Units (or 2.5 milligrams) of dornase alfa.
  • The other ingredients are sodium chloride, calcium chloride dihydrate, and water for injection.

Appearance of the Product and Package Contents

Pulmozyme solution for inhalation by nebulizer is presented in transparent plastic ampoules. The ampoules contain 2.5 ml of solution. The solution is clear, colorless to slightly yellowish.

Pulmozyme is available in cardboard packages containing 6 or 30 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder

Roche Farma, S.A.

C/ Ribera del Loira, nº 50,

28042 Madrid

Manufacturer

Roche Pharma AG

Emil-Barell-St. 1

D-79639 Grenzach-Wyhlen

This leaflet was approved in November 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
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  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
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General internal medicine and preventive care:
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
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  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

  • Preventive consultations and check-up planning.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Frequently Asked Questions

Is a prescription required for PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
The active ingredient in PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION is dornase alfa (desoxyribonuclease). This information helps identify medicines with the same composition but different brand names.
Who manufactures PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION is manufactured by Roche Farma S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
Other medicines with the same active substance (dornase alfa (desoxyribonuclease)) include ACETYLCYSTEINE ABEX 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE ALTER 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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