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MARKETING AUTHORISATION HOLDER
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07 October 2002
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You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
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WHAT VELOSULIN IS AND WHAT IT IS USED FOR
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23 Driving and using machines
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VELOSULIN
HOW TO USE VELOSULIN
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VELOSULIN ве
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EMEA/ H/ C/ 474
EMEA/ H/ C/ 474
VENTAVIS
VENTAVIS
Ventavis представлява разтвор за инхалация чрез пулверизатор.
Ventavis is a solution for inhalation using a nebuliser.
Съдържа активното вещество илопрост.
It contains the active substance iloprost.
Белодробната хипертония е анормално високо кръвно налягане в артериите на дробовете.
Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
„ Първична “ означава, че няма други заболявания на сърцето или дробовете, причиняващи високо кръвно налягане, а класът отразява тежестта на симптомите, причинени от заболяването:
Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs. ‘ Primary ’ means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘ class’ reflects the severity of the symptoms caused by the disease: ‘ class III’ involves marked limitation of physical activity.
Тъй като броят на пациентите с първична белодробна хипертония е малък, заболяването се смята за „ рядко “ и Ventavis е определен за „ лекарство сирак “ (лекарство, използвано при редки заболявания) на 29 декември 2000 г.
Because the number of patients with primary pulmonary hypertension is low, the disease is considered ‘ rare’, and Ventavis was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 29 December 2000.
Как да използвате Ventavis?
How is Ventavis used?
Ventavis се прилага чрез инхалация с пулверизатор (специален механизъм, променящ разтвора в аерозол, който пациентът вдишва).
Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Лечението с Ventavis трябва да се започне и наблюдава от лекар с опит в лечението на белодробна хипертония.
Treatment with Ventavis should be started and monitored by a doctor who has experience in the treatment of pulmonary hypertension.
Препоръчителната доза е 2, 5 или 5, 0 микрограма.
The recommended dose is 2.5 or 5.0 micrograms.
Пациентите трябва да започнат с ниската доза от 2, 5 микрограма при първата инхалация, последвана от 5, 0 микрограма при втората.
Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second.
След това дозата отново може да бъде намалена до 2, 5 микрограма, ако пациентът не може да понесе по- високата доза.
The dose can then be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Лекарството трябва да се дава с пулверизатор, наречен дозиметричен пулверизатор, който автоматично спира, след като правилната доза бъде доставена.
The medicine must be given using a type of nebuliser known as a ‘ dosimetric’ nebuliser, which stops automatically when the correct dose has been delivered.
Приема се шест до девет пъти дневно.
It is taken six to nine times a day.
Дозите са по- малки, ако пациентът има бъбречни увреждания.
Doses are lower if the patient has liver problems.
Как действа Ventavis?
How has Ventavis been studied?
Ventavis е сравнен с плацебо (сляпо лечение) в едно проучване, обхващащо 203 възрастни пациенти със стабилна белодробна хипертония, клас III или IV, която е първична или е причинена от друго състояние.
Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adult patients with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Основната мярка за ефективност е броят пациенти, които са се повлияли от лечението след 12 седмици.
The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks.
„ Повлияването “ е определено като комбинация от подобрението на физическата активност с 10% (определена чрез измерване на разстоянието, което пациентът може да извърви за шест минути) и от подобрението на състоянието на пациента (понижаване сериозността на заболяването с поне един клас), без влошаване на белодробната хипертония или смърт.
A ‘ response’ was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient ’ s condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
Ventavis е значително по- ефективен от плацебо:
Ventavis was significantly more effective than placebo:
17% от пациентите, приемащи Ventavis, се повлияват от лечението (17 от 101) в сравнение с 5% от пациентите, приемащи плацебо (5 от 102).
17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
Най- честите нежелани реакции при Ventavis (наблюдавани при повече от 1 на 10 пациенти) са вазодилация (разширяване на кръвоносните съдове, причиняващо руменина или зачервяване на лицето), хипотония (ниско кръвно налягане) и кашлица.
The most common side effects with Ventavis (seen in more than 1 patient in 10) are vasodilation (blood vessels becoming wider causing flushing or reddening of the face), hypotension (low blood pressure) and cough.
За пълния списък с всички наблюдавани при Ventavis нежелани реакции – вижте листовката.
For the full list of all side effects reported with Ventavis, see the Package Leaflet.
Ventavis е противопоказен за хора, които биха могли да проявят свръхчувствителност (алергични реакции) към илопрост или някоя от другите съставки.
Ventavis should not be used in people who may be hypersensitive (allergic) to iloprost or any of the other ingredients.
Не трябва де се използва при пациенти, изложени на риск от кървене, които имат определени проблеми със сърцето, наскоро са претърпели удар или чиято белодробна хипертония е причинена от запушена или стеснена вена.
It must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein.
Не трябва да се използва при бременни или кърмещи жени.
It must also not be used in women who are pregnant or breast-feeding.
Основания за одобряване на Ventavis?
Why has Ventavis been approved?
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че въпреки ограничената информация ползите от Ventavis са по- големи от рисковете при лечение на пациенти с белодробна хипертония, класифицирана като функционален клас ІІІ съгласно Нюйоркската кардиологична асоциация (NYHA), за подобряване на физическата активност и облекчаване на симптомите.
The Committee for Medicinal Products for Human Use (CHMP) decided that, despite the limited data available, Ventavis’ s benefits are greater than its risks for the treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Комитетът препоръчва на Ventavis да бъде издадено разрешение за употреба.
The Committee recommended that Ventavis be given marketing authorisation.
Ventavis е одобрен при „ извънредни обстоятелства “ поради невъзможност да се получи пълна информация за лекарството, тъй като заболяването е рядко.
Ventavis has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Каква информация все още се очаква за Ventavis?
Which information is still awaited for Ventavis?
Компанията производител на Ventavis ще направи по- нататъшни проучвания, за да събере данни за дългосрочната употреба на лекарството.
The company that makes Ventavis will carry out further studies to collect data on the long-term use of the medicine.
Допълнителна информация за Ventavis:
Other information about Ventavis:
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за Ventavis на Bayer Schering Pharma AG на 16 септември 2003 г.
The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis to Bayer Schering Pharma AG on 16 September 2003.
Разрешението за употреба е подновено на 16 септември 2008 г.
The marketing authorisation was renewed on 16 September 2008.
2/ 3 Протоколът за определянето на Ventavis за лекарство сирак може да се намери тук.
The record of Ventavis’ s designation as an orphan medicine is available here.
Пълният текст на EPAR относно Ventavis може да се намери тук.
The full EPAR for Ventavis can be found here.
10 µg/ ml
EU Number
2 ml (10 µg/ ml)
Invented name
10 µg/ ml
Strength
100 ампули
Pharmaceutical Form
EU/ 1/ 03/ 255/ 003
Route of Administration
Ventavis
Packaging
10 µg/ ml
Content
2 ml (10 µg/ ml)
Package size
EU/ 1/ 03/ 255/ 004
EU/ 1/ 03/ 255/ 001 EU/ 1/ 03/ 255/ 002 EU/ 1/ 03/ 255/ 003 EU/ 1/ 03/ 255/ 004 EU/ 1/ 03/ 255/ 005 EU/ 1/ 03/ 255/ 006 EU/ 1/ 03/ 255/ 007 EU/ 1/ 03/ 255/ 008