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Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
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6.3 Shelf life
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30 months when stored between 2°C - 8°C.
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MARKETING AUTHORISATION NUMBER(S)
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DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
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EXP/ During use: use within 6 weeks
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POSSIBLE SIDE EFFECTS
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26
26 6 HOW TO STORE VELOSULIN
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Marketing Authorisation Holder and Manufacturer a
Novo Nordisk A/ S εια
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This leaflet was last approved in ed M
Τι είναι το Ventavis; Το Ventavis είναι ένα διάλυμα για εισπνοή με εκνεφωτή.
Ventavis is a solution for inhalation using a nebuliser.
Περιέχει τη δραστική ουσία ιλοπρόστη.
It contains the active substance iloprost.
Σε ποιες περιπτώσεις χρησιμοποιείται το Ventavis; Το Ventavis χορηγείται ως αγωγή σε ενήλικες ασθενείς με πρωτοπαθή πνευμονική υπέρταση, ταξινομημένη στη λειτουργική κατηγορία ΙΙΙ για να βελτιώσει την ικανότητα για άσκηση (σωματική) και τα συμπτώματα της νόσου.
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.
Πνευμονική υπέρταση είναι η υπερβολικά υψηλή πίεση των πνευμονικών αρτηριών. « Πρωτοπαθής » σημαίνει ότι η υψηλή πίεση δεν προκαλείται από άλλες ασθένειες της καρδιάς ή των πνευμόνων, ενώ η « λειτουργική κατηγορία » αναφέρεται στη σοβαρότητα των συμπτωμάτων της νόσου: η λειτουργική κατηγορία ΙΙΙ χαρακτηρίζεται από έντονο περιορισμό της σωματικής δραστηριότητας.
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.
Δεδομένου του μικρού αριθμού ασθενών με πρωτοπαθή πνευμονική υπέρταση και, συνεπώς, της σπανιότητας της νόσου, το Ventavis χαρακτηρίστηκε « ορφανό φάρμακο » (φάρμακο που χρησιμοποιείται σε σπάνιες ασθένειες) στις 29 Δεκεμβρίου 2000.
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.
Πώς χρησιμοποιείται το Ventavis; Το Ventavis χορηγείται με εισπνοή, με τη χρήση ενός εκνεφωτή (ειδικό μηχάνημα που μετατρέπει το διάλυμα σε εκνέφωμα αερολύματος το οποίο εισπνέει ο ασθενής).
Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Η θεραπεία με Ventavis πρέπει να ξεκινά και να παρακολουθείται από ιατρό με πείρα στη θεραπεία της πνευμονικής υπέρτασης.
The recommended dose is 2.5 or 5.0 micrograms.
Η συνιστώμενη δόση είναι 2, 5 ή 5, 0 μικρογραμμάρια.
Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second.
Οι ασθενείς πρέπει να ξεκινούν λαμβάνοντας τη χαμηλότερη δόση των 2, 5 μικρογραμμαρίων για την πρώτη εισπνοή, ακολουθούμενη από μια δόση 5, 0 μικρογραμμαρίων για τη δεύτερη εισπνοή.
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.
Η δόση μπορεί στη συνέχεια να μειωθεί ξανά στα 2, 5 μικρογραμμάρια, εάν η μεγαλύτερη δόση δεν είναι ανεκτή.
Doses are lower if the patient has liver problems.
Η χορήγηση του φαρμάκου πρέπει να γίνεται με ειδικό εκνεφωτή, τον λεγόμενο « δοσομετρικό », ο οποίος σταματά αυτόματα μόλις χορηγηθεί η σωστή δόση.
Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Λαμβάνεται έξι έως εννέα φορές την ημέρα.
It causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Η δόση πρέπει να μειώνεται σε ασθενείς που εμφανίζουν ηπατική δυσλειτουργία.
Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Πώς δρα το Ventavis; Η πνευμονική υπέρταση είναι μια νόσος που καταβάλλει τον οργανισμό, κατά την οποία παρουσιάζεται σοβαρή σύσφιγξη (στένωση) των αιμοφόρων αγγείων των πνευμόνων.
How has Ventavis been studied?
Ποιες μελέτες εκπονήθηκαν για το Ventavis; Το Ventavis συγκρίθηκε με εικονικό φάρμακο (εικονική θεραπεία) σε μια μελέτη στην οποία συμμετείχαν 203 ενήλικες ασθενείς με σταθερή πνευμονική υπέρταση κατηγορίας ΙΙΙ ή IV, είτε πρωτοπαθή είτε οφειλόμενη σε άλλες ασθένειες.
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.
Ο κύριος δείκτης μέτρησης της αποτελεσματικότητας ήταν ο αριθμός των ασθενών που ανταποκρίθηκαν στην αγωγή μετά από 12 εβδομάδες.
The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks.
Ως « ανταπόκριση » ορίζεται ο συνδυασμός της βελτίωσης κατά 10% της ικανότητας για άσκηση (η οποία υπολογίστηκε βάσει της απόστασης που κάλυψε ο ασθενής βαδίζοντας επί 6 λεπτά) και της βελτίωσης της κατάστασης του ασθενούς (η οποία υπολογίστηκε με την μείωση του βαθμού σοβαρότητας της ασθένειας κατά μία κατηγορία τουλάχιστον), χωρίς να επέλθει επιδείνωση της πνευμονικής υπέρτασης ή θάνατος.
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.
Ποιο είναι το όφελος του Ventavis σύμφωνα με τις μελέτες; Το Ventavis αποδείχθηκε σε σημαντικό βαθμό αποτελεσματικότερο από το εικονικό φάρμακο:
Ventavis was significantly more effective than placebo:
17% των ασθενών που έλαβαν Ventavis ανταποκρίθηκαν στην αγωγή (17 στους 101) σε σύγκριση με το 5% των ασθενών που έλαβαν εικονικό φάρμακο (5 στους 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).
Εξετάζοντας ωστόσο τις διαφορετικές κατηγορίες ασθενών που συμμετείχαν στην μελέτη, διαπιστώνεται ότι σημαντικά για τους ασθενείς οφέλη υπήρξαν μόνο σε ασθενείς με πρωτοπαθή πνευμονική υπέρταση κατηγορίας ΙΙΙ.
However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.