Инструкция по применению PULMOTSYME
Содержание инструкции
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)

- Страна регистрации
- Форма выпускаSolution for nebulization, 2.5 MG
- Код АТХR05CB13
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги PULMOTSYMEФорма выпуска: Injectable solution, 300 MG/3 MLДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for oral solution, 100 MGДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается без рецептаФорма выпуска: Oral solution powder, 600 MGДействующее вещество: АцетилцистеинПроизводитель: HEXAL A/SОтпускается по рецепту
Аналоги PULMOTSYME в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог PULMOTSYME в Польша
Аналог PULMOTSYME в Украина
Аналог PULMOTSYME в Испания
Врачи онлайн по PULMOTSYME
Обсудите применение PULMOTSYME и возможные следующие шаги — по оценке врача.
Получите рецепт на PULMOTSYME онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
PULMOTSYME требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество PULMOTSYME — Dornase alfa (дезоксирибонуклеаза). Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
PULMOTSYME производится компанией ROCHE S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения PULMOTSYME с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить PULMOTSYME в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Dornase alfa (дезоксирибонуклеаза)) включают AKK FLUIDIFIKANTE E ANTIDOTO, AKK, AKKFLUBUST. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















