Інструкція із застосування PULMOTSYME
Зміст інструкції
Pulmozyme 2500 U/2,5 ml
Solution for nebulizer
Dornase alfa
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. See paragraph
- 4.
Contents of 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 IS PULMOZYME AND WHAT IT IS USED FOR
Pulmozyme contains a substance called dornase alfa, the human-made version of a protein
present in the human body called ‘DNase’.
Pulmozyme is used for the treatment of people affected by cystic fibrosis. By helping to dissolve
the thickened mucus present in the bronchi, Pulmozyme helps the lungs of people with cystic fibrosis to
function better.
Pulmozyme must be inhaled using a device called a ‘nebulizer’ (see
section 3: How to use Pulmozyme). During treatment with Pulmozyme, you will normally continue to take any other medicines that have been prescribed for your cystic fibrosis (see
‘Other medicines and Pulmozyme’ in section 2).
2. WHAT YOU NEED TO KNOW BEFORE USING PULMOZYME
Do not use Pulmozyme
- if you are allergic (hypersensitive) to dornase alfa or any of the excipients of Pulmozyme (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Pulmozyme
Children
The use of Pulmozyme is not recommended in children under 5 years of age. Consult your doctor or
pharmacist before using Pulmozyme if the medicine has been prescribed for a child under 5
years of age.
Other medicines and Pulmozyme
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including over-the-counter medicines and herbal remedies. This is because
Pulmozyme may affect the mechanism of action of some medicines and some medicines may
affect the mechanism of action of Pulmozyme.
During treatment with Pulmozyme you can continue the therapies you usually take for
cystic fibrosis (including antibiotics, pancreatic enzymes, bronchodilators and analgesics). If you have any doubts,
consult your doctor or pharmacist before using Pulmozyme.
Pregnancy and breastfeeding
Do not use Pulmozyme if you are pregnant, planning a pregnancy or breastfeeding, unless
your doctor has told you to do so.
Driving and operating machinery
It is unlikely that Pulmozyme will affect your ability to drive or operate tools or
machinery.
3. HOW TO USE Pulmozyme
Always use Pulmozyme exactly as your doctor has instructed. Pulmozyme must be
inhaled (breathed in) using a nebulizer (see ‘Which nebulizer to use’). If you have any doubts,
consult your doctor.
During treatment with Pulmozyme, continue to undergo standard respiratory physiotherapy
as prescribed.
Children 5 years of age and older
- Pulmozyme must be used every day.
- The recommended dose is one vial per day, to be inhaled with an appropriate nebulizer.
- If you are over 21 years of age, your doctor may prescribe the use of one vial twice a day. Children under 5 years of age
- The use of Pulmozyme is not recommended in children under 5 years of age.
Which nebulizer to use:
Use a nebulizer such as:
- Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, Respirgard adapted/Pulmo-Aide or AcornII/Pulmo-Aide.
- Pulmozyme can also be used with a reusable nebulizer system, such as Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Aiolos/2Aiolos, Side Stream/CR50 or MobilAire or Porta-Neb.
- The Pari eFlow Rapid nebulizer can be used, a generic electronic nebulizer that uses vibrating membrane technology. The Pari eFlow Rapid nebulizer must be cleaned as indicated in the manufacturer's instructions. In addition, the use of the Pari EasyCare cleaning device is recommended after every seven uses.
- Ultrasonic nebulizers must not be used, as this type of device may prevent Pulmozyme from functioning properly.
Read and follow the manufacturer's instructions for using each nebulizer carefully.
Consult your doctor to find out which nebulizers can be used with Pulmozyme.
How to use Pulmozyme with the nebulizer
Each time you prepare the nebulizer for use with Pulmozyme, remember these important points:
- Do not mix Pulmozyme with other liquids or medicines in the nebulizer.
- Never use any leftover Pulmozyme, which must always be discarded.
- If you have a “reusable” nebulizer, remember to clean it after use. The nebulizer manufacturers will provide you with all the necessary instructions for cleaning the device components after using Pulmozyme.
- If someone other than you accidentally uses Pulmozyme, inform your doctor immediately.
To use the nebulizer
- Make sure the nebulizer is clean.
- Break the neck of a Pulmozyme vial.
- Pour the contents into the nebulizer chamber.
- Follow the nebulizer’s instructions for use and immediately begin inhaling Pulmozyme.
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 a dose, use the missed dose as soon as you remember.
- If it is almost time for your next scheduled inhalation, skip the missed dose.
- Do not use a double dose to make up for a missed dose.
If you stop using Pulmozyme
If you stop using Pulmozyme, your respiratory symptoms may worsen. Inform your
doctor if you intend to stop using Pulmozyme.
If you have any further questions about using Pulmozyme, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pulmozyme can cause side effects, although not everybody gets them.
Side effects associated with treatment with Pulmozyme are rare and occur in
less than 1 in 1000 people.
Side effects include:
- Chest pain.
- Fever.
- Stomach discomfort (indigestion).
- Changes in voice including hoarseness or loss of voice.
- Sore throat.
- Difficulty breathing.
- Runny or stuffy nose and sneezing (rhinitis).
- Eye irritation (conjunctivitis). Signs include redness and itching of the eyes and increased production of eye secretions.
- Skin rash, which may appear with welts and itching (urticaria).
- At the beginning of treatment, lung function may decrease and mucus production may increase above normal. However, these symptoms usually improve over time.
If any of these side effects gets worse, or if you notice any side effect
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE Pulmozyme
- Pulmozyme vials must be stored in a refrigerator (2°C - 8°C) in the original package to protect them from light.
- If a vial remains outside the refrigerator for a short period of time at temperatures higher than those indicated (only once and for a period not exceeding 24 hours at temperatures up to 30°C), it can still be used.
- Keep this medicine out of the reach and sight of children.
- Do not use Pulmozyme after the expiry date (Exp.) which is stated on the carton. The expiry date refers to the last day of the month.
- Do not dispose of any unused medicine in the drain or with household waste. Instead, return it to the pharmacist for proper disposal. This will help protect the environment. Keep any unused medicine only if your doctor tells you to do so.
6. Contents of the pack and other information
What Pulmozyme contains
- The active substance of Pulmozyme 2500 U/2.5 ml solution for nebulizer is dornase alfa, also known as recombinant human deoxyribonuclease 1 or rhDNase. Each 2.5 ml (milliliters) of liquid medicine contains 2500 units (or 2.5 milligrams) of dornase alfa.
- The excipients are sodium chloride, calcium chloride dihydrate and water for injections.
Description of the appearance of Pulmozyme and contents of the pack
Pulmozyme solution for nebulizer is supplied in transparent plastic vials. The vials contain
2.5 ml of liquid medicine. The medicine is transparent, from colorless to slightly yellowish.
Pulmozyme is supplied in packs of 6 vials.
Marketing Authorisation Holder
Roche S.p.A.
Piazza Durante 11
20131 Milan.
Manufacturer responsible for batch release
Roche Pharma AG,
Emil-Barel Str. 1 D
79639 Grenzach-Wyhlen (Germany)

- Країна реєстрації
- Лікарська формаSolution for nebulization, 2.5 MG
- Код АТХR05CB13
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до PULMOTSYMEЛікарська форма: Injectable solution, 300 MG/3 MLДіюча речовина: АцетилцистеинВиробник: SANDOZ S.P.A.Потрібен рецептЛікарська форма: Powder for oral solution, 100 MGДіюча речовина: АцетилцистеинВиробник: SANDOZ S.P.A.Рецепт не потрібенЛікарська форма: Oral solution powder, 600 MGДіюча речовина: АцетилцистеинВиробник: HEXAL A/SПотрібен рецепт
Аналоги PULMOTSYME в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог PULMOTSYME у Польща
Аналог PULMOTSYME у Україна
Аналог PULMOTSYME у Іспанія
Лікарі онлайн щодо PULMOTSYME
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на PULMOTSYME онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
PULMOTSYME потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у PULMOTSYME — Dornase alfa (дезоксирибонуклеаза). Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
PULMOTSYME виробляється компанією ROCHE S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування PULMOTSYME з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати PULMOTSYME у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Dornase alfa (дезоксирибонуклеаза)) включають AKK FLUIDIFIKANTE E ANTIDOTO, AKK, AKKFLUBUST. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















