pharmanews - μ. πιτσιλιδης α.ε.
pharmanews - μ. πιτσιλιδης α.ε.
pharmanews - μ. πιτσιλιδης α.ε.
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[ΣΥΝΤΑΓΟΓΡΑΦΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ<br />
ΔΙΑΦΗΜΙΖΟΜΕΝΩΝ ΦΑΡΜΑΚΩΝ]<br />
INSTANYL<br />
ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. ΟΝΟΜΑΣΙΑ<br />
ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ Instanyl 50 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση<br />
ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>, διάλυ<strong>μ</strong><strong>α</strong>, Instanyl 100 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση ρινικό<br />
<strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>, διάλυ<strong>μ</strong><strong>α</strong>, Instanyl 200 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>,<br />
διάλυ<strong>μ</strong><strong>α</strong> 2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ Instanyl 50 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση<br />
ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>, διάλυ<strong>μ</strong><strong>α</strong> Κάθ<strong>ε</strong> ml δι<strong>α</strong>λύ<strong>μ</strong><strong>α</strong>τος π<strong>ε</strong>ριέχ<strong>ε</strong>ι<br />
φ<strong>α</strong>ιντ<strong>α</strong>νύλη κιτρική ισοδύν<strong>α</strong><strong>μ</strong>η <strong>μ</strong><strong>ε</strong> 500 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong> φ<strong>α</strong>ιντ<strong>α</strong>νύλης.<br />
1 δόση (100 <strong>μ</strong>ικρόλιτρ<strong>α</strong>) π<strong>ε</strong>ριέχ<strong>ε</strong>ι 50 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong> φ<strong>α</strong>ιντ<strong>α</strong>νύλης.Instanyl<br />
100 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>, διάλυ<strong>μ</strong><strong>α</strong> Κάθ<strong>ε</strong> ml δι<strong>α</strong>λύ<strong>μ</strong><strong>α</strong>τος<br />
π<strong>ε</strong>ριέχ<strong>ε</strong>ι φ<strong>α</strong>ιντ<strong>α</strong>νύλη κιτρική ισοδύν<strong>α</strong><strong>μ</strong>η <strong>μ</strong><strong>ε</strong> 1.000 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong><br />
φ<strong>α</strong>ιντ<strong>α</strong>νύλης.1 δόση (100 <strong>μ</strong>ικρόλιτρ<strong>α</strong>) π<strong>ε</strong>ριέχ<strong>ε</strong>ι 100 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong><br />
φ<strong>α</strong>ιντ<strong>α</strong>νύλης.Instanyl 200 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong>/δόση ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>,<br />
διάλυ<strong>μ</strong><strong>α</strong> Κάθ<strong>ε</strong> ml δι<strong>α</strong>λύ<strong>μ</strong><strong>α</strong>τος π<strong>ε</strong>ριέχ<strong>ε</strong>ι φ<strong>α</strong>ιντ<strong>α</strong>νύλη κιτρική ισοδύν<strong>α</strong><strong>μ</strong>η<br />
<strong>μ</strong><strong>ε</strong> 2.000 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong> φ<strong>α</strong>ιντ<strong>α</strong>νύλης.1 δόση (100 <strong>μ</strong>ικρόλιτρ<strong>α</strong>) π<strong>ε</strong>ριέχ<strong>ε</strong>ι<br />
200 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong> φ<strong>α</strong>ιντ<strong>α</strong>νύλης.Γι<strong>α</strong> τον πλήρη κ<strong>α</strong>τάλογο των<br />
<strong>ε</strong>κδόχων, βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 6.1. 3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ Ρινικό<br />
<strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>, διάλυ<strong>μ</strong><strong>α</strong> (ρινικό <strong>ε</strong>κνέφω<strong>μ</strong><strong>α</strong>). Δι<strong>α</strong>υγές, άχρω<strong>μ</strong>ο διάλυ<strong>μ</strong><strong>α</strong>. 4.<br />
ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ 4.1 Θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>υτικές <strong>ε</strong>νδ<strong>ε</strong>ίξ<strong>ε</strong>ις Το Instanyl <strong>ε</strong>νδ<strong>ε</strong>ίκνυτ<strong>α</strong>ι<br />
γι<strong>α</strong> την <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση του π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου σ<strong>ε</strong> <strong>ε</strong>νήλικ<strong>ε</strong>ς που<br />
ήδη υποβάλλοντ<strong>α</strong>ι σ<strong>ε</strong> θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> συντήρησης <strong>μ</strong><strong>ε</strong> οπιο<strong>ε</strong>ιδή γι<strong>α</strong> χρόνιο<br />
κ<strong>α</strong>ρκινικό πόνο. Ο π<strong>α</strong>ροξυσ<strong>μ</strong>ικός πόνος <strong>ε</strong>ίν<strong>α</strong>ι π<strong>α</strong>ροδική π<strong>α</strong>ρόξυνση του<br />
πόνου που <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίζ<strong>ε</strong>τ<strong>α</strong>ι <strong>ε</strong>πί υποστρώ<strong>μ</strong><strong>α</strong>τος <strong>ε</strong>πί<strong>μ</strong>ονου πόνου κ<strong>α</strong>τά τ<strong>α</strong><br />
άλλ<strong>α</strong> <strong>ε</strong>λ<strong>ε</strong>γχό<strong>μ</strong><strong>ε</strong>νου. Οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς που υποβάλλοντ<strong>α</strong>ι σ<strong>ε</strong> θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> συντήρησης<br />
<strong>μ</strong><strong>ε</strong> οπιο<strong>ε</strong>ιδή <strong>ε</strong>ίν<strong>α</strong>ι <strong>ε</strong>κ<strong>ε</strong>ίνοι που λ<strong>α</strong><strong>μ</strong>βάνουν τουλάχιστον 60 mg<br />
<strong>α</strong>πό του στό<strong>μ</strong><strong>α</strong>τος <strong>μ</strong>ορφίνης η<strong>μ</strong><strong>ε</strong>ρησίως, τουλάχιστον 25 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong><br />
δι<strong>α</strong>δ<strong>ε</strong>ρ<strong>μ</strong>ικής φ<strong>α</strong>ιντ<strong>α</strong>νύλης <strong>α</strong>νά ώρ<strong>α</strong>, τουλάχιστον 30 mg οξυκωδόνης<br />
η<strong>μ</strong><strong>ε</strong>ρησίως, τουλάχιστον 8 mg <strong>α</strong>πό του στό<strong>μ</strong><strong>α</strong>τος υδρο<strong>μ</strong>ορφόνης<br />
η<strong>μ</strong><strong>ε</strong>ρησίως ή δόση άλλου οπιο<strong>ε</strong>ιδούς ισοδύν<strong>α</strong><strong>μ</strong>ης <strong>α</strong>ν<strong>α</strong>λγητικής<br />
δρ<strong>α</strong>στικότητ<strong>α</strong>ς γι<strong>α</strong> <strong>μ</strong>ί<strong>α</strong> <strong>ε</strong>βδο<strong>μ</strong>άδ<strong>α</strong> ή π<strong>ε</strong>ρισσότ<strong>ε</strong>ρο. 4.2 Δοσολογί<strong>α</strong> κ<strong>α</strong>ι<br />
τρόπος χορήγησης Η θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> πρέπ<strong>ε</strong>ι ν<strong>α</strong> ξ<strong>ε</strong>κινά κ<strong>α</strong>ι ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong><strong>μ</strong>έν<strong>ε</strong>ι υπό<br />
την <strong>ε</strong>πίβλ<strong>ε</strong>ψη ι<strong>α</strong>τρού έ<strong>μ</strong>π<strong>ε</strong>ιρου στο χ<strong>ε</strong>ιρισ<strong>μ</strong>ό θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong>ς <strong>μ</strong><strong>ε</strong> οπιο<strong>ε</strong>ιδή σ<strong>ε</strong><br />
κ<strong>α</strong>ρκινοπ<strong>α</strong>θ<strong>ε</strong>ίς. Οι ι<strong>α</strong>τροί πρέπ<strong>ε</strong>ι ν<strong>α</strong> λ<strong>α</strong><strong>μ</strong>βάνουν υπόψη το <strong>ε</strong>νδ<strong>ε</strong>χό<strong>μ</strong><strong>ε</strong>νο<br />
κ<strong>α</strong>τάχρησης της φ<strong>α</strong>ιντ<strong>α</strong>νύλης. Πρέπ<strong>ε</strong>ι ν<strong>α</strong> γίν<strong>ε</strong>τ<strong>α</strong>ι <strong>ε</strong>ξ<strong>α</strong>το<strong>μ</strong>ικ<strong>ε</strong>υ<strong>μ</strong>έν<strong>α</strong> στους<br />
<strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς τιτλοποίηση της δόσης που π<strong>α</strong>ρέχ<strong>ε</strong>ι <strong>ε</strong>π<strong>α</strong>ρκή <strong>α</strong>ν<strong>α</strong>λγησί<strong>α</strong> <strong>μ</strong><strong>ε</strong><br />
<strong>α</strong>ν<strong>ε</strong>κτές <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς <strong>α</strong>πό το φάρ<strong>μ</strong><strong>α</strong>κο. Οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς πρέπ<strong>ε</strong>ι<br />
ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>κολουθούντ<strong>α</strong>ι προσ<strong>ε</strong>κτικά κ<strong>α</strong>τά τη διάρκ<strong>ε</strong>ι<strong>α</strong> της δι<strong>α</strong>δικ<strong>α</strong>σί<strong>α</strong>ς<br />
τιτλοποίησης. Τιτλοποίηση σ<strong>ε</strong> υψηλότ<strong>ε</strong>ρη δόση <strong>ε</strong>πιβάλλ<strong>ε</strong>ι <strong>ε</strong>πικοινωνί<strong>α</strong><br />
<strong>μ</strong><strong>ε</strong> τον <strong>ε</strong>π<strong>α</strong>γγ<strong>ε</strong>λ<strong>μ</strong><strong>α</strong>τί<strong>α</strong> του το<strong>μ</strong>έ<strong>α</strong> υγ<strong>ε</strong>ιονο<strong>μ</strong>ικής π<strong>ε</strong>ρίθ<strong>α</strong>λψης. Η<br />
δόση του Instanyl γι<strong>α</strong> την <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση του π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου ήτ<strong>α</strong>ν<br />
<strong>α</strong>ν<strong>ε</strong>ξάρτητη <strong>α</strong>πό την η<strong>μ</strong><strong>ε</strong>ρήσι<strong>α</strong> δόση συντήρησης οπιο<strong>ε</strong>ιδών στις κλινικές<br />
<strong>μ</strong><strong>ε</strong>λέτ<strong>ε</strong>ς (βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 5.1). Μέγιστη η<strong>μ</strong><strong>ε</strong>ρήσι<strong>α</strong> δόση: Αντι<strong>μ</strong><strong>ε</strong>τώπιση<br />
<strong>μ</strong>έχρι τ<strong>ε</strong>σσάρων <strong>ε</strong>π<strong>ε</strong>ισοδίων π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου, κ<strong>α</strong>θ<strong>ε</strong>νός <strong>μ</strong><strong>ε</strong><br />
όχι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>ε</strong>ς <strong>α</strong>πό δύο δόσ<strong>ε</strong>ις χορηγού<strong>μ</strong><strong>ε</strong>ν<strong>ε</strong>ς <strong>μ</strong><strong>ε</strong> δι<strong>α</strong>φορά τουλάχιστον<br />
10 λ<strong>ε</strong>πτών. Ο <strong>α</strong>σθ<strong>ε</strong>νής πρέπ<strong>ε</strong>ι ν<strong>α</strong> π<strong>ε</strong>ρι<strong>μ</strong>έν<strong>ε</strong>ι ν<strong>α</strong> π<strong>α</strong>ρέλθουν τουλάχιστον<br />
4 ώρ<strong>ε</strong>ς πριν την <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση άλλου <strong>ε</strong>π<strong>ε</strong>ισοδίου π<strong>α</strong>ροξυσ<strong>μ</strong>ικού<br />
πόνου <strong>μ</strong><strong>ε</strong> Instanyl κ<strong>α</strong>τά τη διάρκ<strong>ε</strong>ι<strong>α</strong> κ<strong>α</strong>ι της τιτλοποίησης κ<strong>α</strong>ι της<br />
θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong>ς συντήρησης. Τιτλοποίηση της δόσης Πριν ν<strong>α</strong> γίν<strong>ε</strong>ι τιτλοποίηση<br />
του Instanyl στους <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς, <strong>α</strong>ν<strong>α</strong><strong>μ</strong>έν<strong>ε</strong>τ<strong>α</strong>ι ότι το υπόστρω<strong>μ</strong><strong>α</strong> <strong>ε</strong>πί<strong>μ</strong>ονου<br />
πόνου τους <strong>ε</strong>λέγχ<strong>ε</strong>τ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> τη χρήση χρόνι<strong>α</strong>ς <strong>α</strong>γωγής <strong>μ</strong><strong>ε</strong> οπιο<strong>ε</strong>ιδή<br />
κ<strong>α</strong>ι ότι οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίζουν όχι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>α</strong> <strong>α</strong>πό τέσσ<strong>ε</strong>ρ<strong>α</strong><br />
<strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong> π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου την η<strong>μ</strong>έρ<strong>α</strong>. Μέθοδος τιτλοποίησης Η<br />
<strong>α</strong>ρχική π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>ε</strong>ίν<strong>α</strong>ι <strong>μ</strong>ί<strong>α</strong> δόση 50 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong><strong>α</strong>ρίων<br />
σ<strong>ε</strong> έν<strong>α</strong> ρουθούνι, τιτλοποιώντ<strong>α</strong>ς <strong>α</strong>νοδικά <strong>α</strong>νάλογ<strong>α</strong> <strong>μ</strong><strong>ε</strong> τις <strong>α</strong>νάγκ<strong>ε</strong>ς <strong>μ</strong><strong>ε</strong><br />
χρήση των δι<strong>α</strong>θέσι<strong>μ</strong>ων π<strong>ε</strong>ρι<strong>ε</strong>κτικοτήτων (50, 100 κ<strong>α</strong>ι 200 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong><strong>α</strong>ρίων).<br />
Εάν δ<strong>ε</strong>ν <strong>ε</strong>πιτ<strong>ε</strong>υχθ<strong>ε</strong>ί <strong>ε</strong>π<strong>α</strong>ρκής <strong>α</strong>ν<strong>α</strong>λγησί<strong>α</strong>, <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> γίν<strong>ε</strong>ι <strong>ε</strong>π<strong>α</strong>ν<strong>α</strong>χορήγηση<br />
<strong>μ</strong><strong>ε</strong> την ίδι<strong>α</strong> π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> <strong>μ</strong><strong>ε</strong>τά <strong>α</strong>πό 10 λ<strong>ε</strong>πτά το νωρίτ<strong>ε</strong>ρο.<br />
Κάθ<strong>ε</strong> βή<strong>μ</strong><strong>α</strong> τιτλοποίησης (π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> δόσης) πρέπ<strong>ε</strong>ι ν<strong>α</strong><br />
<strong>α</strong>ξιολογ<strong>ε</strong>ίτ<strong>α</strong>ι σ<strong>ε</strong> <strong>α</strong>ρκ<strong>ε</strong>τά <strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong>. Θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> συντήρησης Μόλις έχ<strong>ε</strong>ι<br />
προσδιορισθ<strong>ε</strong>ί η δόση σύ<strong>μ</strong>φων<strong>α</strong> <strong>μ</strong><strong>ε</strong> τ<strong>α</strong> βή<strong>μ</strong><strong>α</strong>τ<strong>α</strong> που π<strong>ε</strong>ριγράφοντ<strong>α</strong>ι π<strong>α</strong>ρ<strong>α</strong>-<br />
Έν<strong>α</strong>ρξη <strong>μ</strong><strong>ε</strong> 50 <strong>μ</strong>ικρογρ<strong>α</strong><strong>μ</strong><strong>μ</strong>άρι<strong>α</strong><br />
- Χρήση <strong>μ</strong>ί<strong>α</strong>ς δόσης Instanyl<br />
- Αν<strong>α</strong><strong>μ</strong>ονή 10 λ<strong>ε</strong>πτών<br />
Επ<strong>α</strong>ρκής <strong>α</strong>ν<strong>α</strong>κούφιση <strong>α</strong>πό τον πόνο <strong>μ</strong><strong>ε</strong> <strong>μ</strong>ί<strong>α</strong> δόση Instanyl<br />
Ν<strong>α</strong>ι Όχι<br />
Επίτ<strong>ε</strong>υξη Επ<strong>α</strong>ν<strong>α</strong>χορήγηση <strong>μ</strong><strong>ε</strong> την<br />
προσδιορισ<strong>μ</strong>ού ίδι<strong>α</strong> π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong>.<br />
δόσης Εξέτ<strong>α</strong>ση της <strong>ε</strong>πό<strong>μ</strong><strong>ε</strong>νης<br />
υψηλότ<strong>ε</strong>ρης<br />
π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong>ς<br />
γι<strong>α</strong> <strong>ε</strong>πό<strong>μ</strong><strong>ε</strong>νο <strong>ε</strong>π<strong>ε</strong>ισόδιο<br />
πάνω, ο <strong>α</strong>σθ<strong>ε</strong>νής πρέπ<strong>ε</strong>ι ν<strong>α</strong> συντηρ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> <strong>α</strong>υτήν την π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong><br />
Instanyl. Εάν ο <strong>α</strong>σθ<strong>ε</strong>νής π<strong>α</strong>ρουσιάζ<strong>ε</strong>ι <strong>α</strong>ν<strong>ε</strong>π<strong>α</strong>ρκή <strong>α</strong>ν<strong>α</strong>κούφιση <strong>α</strong>πό τον<br />
πόνο, <strong>ε</strong>π<strong>α</strong>ν<strong>α</strong>χορήγηση <strong>μ</strong><strong>ε</strong> την ίδι<strong>α</strong> π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> γίν<strong>ε</strong>ι <strong>μ</strong><strong>ε</strong>τά<br />
<strong>α</strong>πό 10 λ<strong>ε</strong>πτά το νωρίτ<strong>ε</strong>ρο. Προσ<strong>α</strong>ρ<strong>μ</strong>ογή της δόσης Γ<strong>ε</strong>νικά, η π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong><br />
του Instanyl γι<strong>α</strong> τη συντήρηση του <strong>α</strong>σθ<strong>ε</strong>νούς πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>α</strong>υξάν<strong>ε</strong>τ<strong>α</strong>ι<br />
ότ<strong>α</strong>ν έν<strong>α</strong>ς <strong>α</strong>σθ<strong>ε</strong>νής χρ<strong>ε</strong>ιάζ<strong>ε</strong>τ<strong>α</strong>ι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>ε</strong>ς <strong>α</strong>πό <strong>μ</strong>ί<strong>α</strong> δόσ<strong>ε</strong>ις <strong>α</strong>νά<br />
<strong>ε</strong>π<strong>ε</strong>ισόδιο π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου γι<strong>α</strong> <strong>α</strong>ρκ<strong>ε</strong>τά δι<strong>α</strong>δοχικά <strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong>. Προσ<strong>α</strong>ρ<strong>μ</strong>ογή<br />
της δόσης της υπάρχουσ<strong>α</strong>ς <strong>α</strong>γωγής <strong>μ</strong><strong>ε</strong> οπιο<strong>ε</strong>ιδή <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong><br />
χρ<strong>ε</strong>ι<strong>α</strong>σθ<strong>ε</strong>ί <strong>ε</strong>άν ο <strong>α</strong>σθ<strong>ε</strong>νής στ<strong>α</strong>θ<strong>ε</strong>ρά π<strong>α</strong>ρουσιάζ<strong>ε</strong>ι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>α</strong> <strong>α</strong>πό τέσσ<strong>ε</strong>ρ<strong>α</strong><br />
<strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong> π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου <strong>α</strong>νά 24 ώρ<strong>ε</strong>ς. Εάν οι <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς<br />
<strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς <strong>ε</strong>ίν<strong>α</strong>ι <strong>μ</strong>η <strong>α</strong>ν<strong>ε</strong>κτές ή <strong>ε</strong>πί<strong>μ</strong>ον<strong>ε</strong>ς, η π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> πρέπ<strong>ε</strong>ι<br />
ν<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιωθ<strong>ε</strong>ί ή η <strong>α</strong>γωγή <strong>μ</strong><strong>ε</strong> Instanyl ν<strong>α</strong> <strong>α</strong>ντικ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>θ<strong>ε</strong>ί <strong>α</strong>πό άλλ<strong>α</strong><br />
<strong>α</strong>ν<strong>α</strong>λγητικά. Δι<strong>α</strong>κοπή της <strong>α</strong>γωγής Το Instanyl πρέπ<strong>ε</strong>ι ν<strong>α</strong> δι<strong>α</strong>κοπ<strong>ε</strong>ί <strong>α</strong><strong>μ</strong>έσως<br />
<strong>ε</strong>άν ο <strong>α</strong>σθ<strong>ε</strong>νής δ<strong>ε</strong>ν <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίζ<strong>ε</strong>ι πλέον <strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong> π<strong>α</strong>ροξυσ<strong>μ</strong>ικού<br />
πόνου. Η <strong>α</strong>γωγή γι<strong>α</strong> το υπόστρω<strong>μ</strong><strong>α</strong> <strong>ε</strong>πί<strong>μ</strong>ονου πόνου πρέπ<strong>ε</strong>ι ν<strong>α</strong> συν<strong>ε</strong>χισθ<strong>ε</strong>ί<br />
όπως συντ<strong>α</strong>γογρ<strong>α</strong>φήθηκ<strong>ε</strong>.Εάν <strong>α</strong>π<strong>α</strong>ιτ<strong>ε</strong>ίτ<strong>α</strong>ι δι<strong>α</strong>κοπή της <strong>α</strong>γωγής<br />
<strong>μ</strong><strong>ε</strong> όλ<strong>α</strong> τ<strong>α</strong> οπιο<strong>ε</strong>ιδή, ο <strong>α</strong>σθ<strong>ε</strong>νής πρέπ<strong>ε</strong>ι ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>κολουθ<strong>ε</strong>ίτ<strong>α</strong>ι στ<strong>ε</strong>νά <strong>α</strong>πό<br />
το γι<strong>α</strong>τρό <strong>ε</strong>π<strong>ε</strong>ιδή η στ<strong>α</strong>δι<strong>α</strong>κή κ<strong>α</strong>θοδική τιτλοποίηση των οπιο<strong>ε</strong>ιδών <strong>ε</strong>ίν<strong>α</strong>ι<br />
<strong>α</strong>π<strong>α</strong>ρ<strong>α</strong>ίτητη, γι<strong>α</strong> ν<strong>α</strong> <strong>α</strong>ποφ<strong>ε</strong>υχθ<strong>ε</strong>ί η πιθ<strong>α</strong>νότητ<strong>α</strong> <strong>ε</strong>πιδράσ<strong>ε</strong>ων στέρησης<br />
λόγω <strong>α</strong>πότο<strong>μ</strong>ης δι<strong>α</strong>κοπής. Τρόπος χορήγησης Το Instanyl προορίζ<strong>ε</strong>τ<strong>α</strong>ι<br />
γι<strong>α</strong> ρινική χρήση. Συνιστάτ<strong>α</strong>ι ο <strong>α</strong>σθ<strong>ε</strong>νής ν<strong>α</strong> κάθ<strong>ε</strong>τ<strong>α</strong>ι ή ν<strong>α</strong> στέκ<strong>ε</strong>τ<strong>α</strong>ι<br />
σ<strong>ε</strong> όρθι<strong>α</strong> θέση ότ<strong>α</strong>ν χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι το Instanyl. Κ<strong>α</strong>θ<strong>α</strong>ρισ<strong>μ</strong>ός του <strong>α</strong>κροφυσίου<br />
του ρινικού <strong>ε</strong>κν<strong>ε</strong>φώ<strong>μ</strong><strong>α</strong>τος <strong>α</strong>π<strong>α</strong>ιτ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong>τά <strong>α</strong>πό κάθ<strong>ε</strong> χρήση. Π<strong>α</strong>ιδιά<br />
κ<strong>α</strong>ι έφηβοι Το Instanyl δ<strong>ε</strong>ν συνιστάτ<strong>α</strong>ι γι<strong>α</strong> χρήση σ<strong>ε</strong> π<strong>α</strong>ιδιά κ<strong>α</strong>ι <strong>ε</strong>φήβους<br />
ηλικί<strong>α</strong>ς κάτω των 18 <strong>ε</strong>τών, λόγω έλλ<strong>ε</strong>ιψης στοιχ<strong>ε</strong>ίων γι<strong>α</strong> την<br />
<strong>α</strong>σφάλ<strong>ε</strong>ι<strong>α</strong> κ<strong>α</strong>ι <strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τικότητ<strong>α</strong>. Ηλικιω<strong>μ</strong>ένοι Π<strong>ε</strong>ριορισ<strong>μ</strong>έν<strong>α</strong> στοιχ<strong>ε</strong>ί<strong>α</strong><br />
φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κοκινητικής, <strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τικότητ<strong>α</strong>ς κ<strong>α</strong>ι <strong>α</strong>σφάλ<strong>ε</strong>ι<strong>α</strong>ς <strong>ε</strong>ίν<strong>α</strong>ι δι<strong>α</strong>θέσι<strong>μ</strong><strong>α</strong><br />
γι<strong>α</strong> τη χρήση του Instanyl σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς ηλικί<strong>α</strong>ς άνω των 65 <strong>ε</strong>τών.<br />
Οι ηλικιω<strong>μ</strong>ένοι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> έχουν <strong>μ</strong><strong>ε</strong>ιω<strong>μ</strong>ένη κάθ<strong>α</strong>ρση, π<strong>α</strong>ρ<strong>α</strong>τ<strong>ε</strong>τ<strong>α</strong><strong>μ</strong>ένο<br />
χρόνο η<strong>μ</strong>ίσ<strong>ε</strong>ι<strong>α</strong>ς ζωής κ<strong>α</strong>ι υψηλότ<strong>ε</strong>ρη <strong>ε</strong>υ<strong>α</strong>ισθησί<strong>α</strong> στη φ<strong>α</strong>ιντ<strong>α</strong>νύλη<br />
<strong>α</strong>π’ ό,τι οι ν<strong>ε</strong>ότ<strong>ε</strong>ροι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς. Γι<strong>α</strong> το λόγο <strong>α</strong>υτό πρέπ<strong>ε</strong>ι ν<strong>α</strong> δίν<strong>ε</strong>τ<strong>α</strong>ι<br />
προσοχή στη θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> ηλικιω<strong>μ</strong>ένων, κ<strong>α</strong>χ<strong>ε</strong>κτικών ή <strong>ε</strong>ξ<strong>α</strong>σθ<strong>ε</strong>νη<strong>μ</strong>ένων<br />
<strong>α</strong>σθ<strong>ε</strong>νών. Σ<strong>ε</strong> κλινικές δοκι<strong>μ</strong>ές η τιτλοποίηση σ<strong>ε</strong> ηλικιω<strong>μ</strong>ένους τ<strong>ε</strong>ίν<strong>ε</strong>ι<br />
ν<strong>α</strong> γίν<strong>ε</strong>τ<strong>α</strong>ι σ<strong>ε</strong> χ<strong>α</strong><strong>μ</strong>ηλότ<strong>ε</strong>ρη <strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τική π<strong>ε</strong>ρι<strong>ε</strong>κτικότητ<strong>α</strong> <strong>α</strong>π’ ό,τι σ<strong>ε</strong><br />
<strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς ηλικί<strong>α</strong>ς κάτω των 65 <strong>ε</strong>τών. Πρέπ<strong>ε</strong>ι ν<strong>α</strong> δίν<strong>ε</strong>τ<strong>α</strong>ι ιδι<strong>α</strong>ίτ<strong>ε</strong>ρη προσοχή<br />
ότ<strong>α</strong>ν το Instanyl τιτλοποι<strong>ε</strong>ίτ<strong>α</strong>ι σ<strong>ε</strong> ηλικιω<strong>μ</strong>ένους <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς. Ηπ<strong>α</strong>τική<br />
δυσλ<strong>ε</strong>ιτουργί<strong>α</strong> Το Instanyl πρέπ<strong>ε</strong>ι ν<strong>α</strong> χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή σ<strong>ε</strong><br />
<strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> <strong>μ</strong>έτρι<strong>α</strong> έως σοβ<strong>α</strong>ρή ηπ<strong>α</strong>τική δυσλ<strong>ε</strong>ιτουργί<strong>α</strong> (βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο<br />
4.4). Ν<strong>ε</strong>φρική δυσλ<strong>ε</strong>ιτουργί<strong>α</strong> Το Instanyl πρέπ<strong>ε</strong>ι ν<strong>α</strong> χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong><br />
προσοχή σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> <strong>μ</strong>έτρι<strong>α</strong> έως σοβ<strong>α</strong>ρή ν<strong>ε</strong>φρική δυσλ<strong>ε</strong>ιτουργί<strong>α</strong><br />
(βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 4.4). 4.3 Αντ<strong>ε</strong>νδ<strong>ε</strong>ίξ<strong>ε</strong>ις Υπ<strong>ε</strong>ρ<strong>ε</strong>υ<strong>α</strong>ισθησί<strong>α</strong> στη δρ<strong>α</strong>στική<br />
ουσί<strong>α</strong> ή σ<strong>ε</strong> κάποιο <strong>α</strong>πό τ<strong>α</strong> έκδοχ<strong>α</strong>. Χρήση σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς που δ<strong>ε</strong>ν έχουν<br />
λάβ<strong>ε</strong>ι οπιο<strong>ε</strong>ιδή στο π<strong>α</strong>ρ<strong>ε</strong>λθόν. Σοβ<strong>α</strong>ρή <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή ή σοβ<strong>α</strong>ρές<br />
<strong>α</strong>ποφρ<strong>α</strong>κτικές κ<strong>α</strong>τ<strong>α</strong>στάσ<strong>ε</strong>ις πν<strong>ε</strong>υ<strong>μ</strong>όνων. Προηγού<strong>μ</strong><strong>ε</strong>νη <strong>α</strong>κτινοθ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong><br />
προσώπου. Υποτροπιάζοντ<strong>α</strong> <strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong> <strong>ε</strong>πίστ<strong>α</strong>ξης (βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο<br />
4.4). 4.4 Ειδικές προ<strong>ε</strong>ιδοποιήσ<strong>ε</strong>ις κ<strong>α</strong>ι προφυλάξ<strong>ε</strong>ις κ<strong>α</strong>τά τη<br />
χρήση Αν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή Όπως <strong>μ</strong><strong>ε</strong> όλ<strong>α</strong> τ<strong>α</strong> ισχυρά οπιο<strong>ε</strong>ιδή, <strong>μ</strong>πορ<strong>ε</strong>ί<br />
ν<strong>α</strong> <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νισθ<strong>ε</strong>ί κλινικά ση<strong>μ</strong><strong>α</strong>ντική <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή <strong>μ</strong><strong>ε</strong> φ<strong>α</strong>ιντ<strong>α</strong>νύλη<br />
κ<strong>α</strong>ι οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς πρέπ<strong>ε</strong>ι ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>κολουθούντ<strong>α</strong>ι γι<strong>α</strong> <strong>α</strong>υτές τις<br />
<strong>ε</strong>πιδράσ<strong>ε</strong>ις. Ασθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> πόνο που υποβάλλοντ<strong>α</strong>ι σ<strong>ε</strong> χρόνι<strong>α</strong> <strong>α</strong>γωγή <strong>μ</strong><strong>ε</strong><br />
οπιο<strong>ε</strong>ιδή <strong>α</strong>ν<strong>α</strong>πτύσσουν <strong>α</strong>νοχή στην <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή κ<strong>α</strong>ι συν<strong>ε</strong>πώς<br />
ο κίνδυνος <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστικής κ<strong>α</strong>τ<strong>α</strong>στολής σ<strong>ε</strong> <strong>α</strong>υτούς τους <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς<br />
<strong>ε</strong>ίν<strong>α</strong>ι <strong>μ</strong><strong>ε</strong>ιω<strong>μ</strong>ένος. Η τ<strong>α</strong>υτόχρονη χρήση κ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτικών του κ<strong>ε</strong>ντρικού<br />
ν<strong>ε</strong>υρικού συστή<strong>μ</strong><strong>α</strong>τος <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>α</strong>υξήσ<strong>ε</strong>ι τον κίνδυνο <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστικής<br />
κ<strong>α</strong>τ<strong>α</strong>στολής (βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 4.5). Χρόνι<strong>α</strong> πν<strong>ε</strong>υ<strong>μ</strong>ονοπάθ<strong>ε</strong>ι<strong>α</strong> Σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς<br />
<strong>μ</strong><strong>ε</strong> χρόνι<strong>ε</strong>ς <strong>α</strong>ποφρ<strong>α</strong>κτικές πν<strong>ε</strong>υ<strong>μ</strong>ονοπάθ<strong>ε</strong>ι<strong>ε</strong>ς, η φ<strong>α</strong>ιντ<strong>α</strong>νύλη <strong>μ</strong>πορ<strong>ε</strong>ί<br />
ν<strong>α</strong> έχ<strong>ε</strong>ι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρο σοβ<strong>α</strong>ρές <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς. Σ<strong>ε</strong> <strong>α</strong>υτούς<br />
τους <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς, τ<strong>α</strong> οπιο<strong>ε</strong>ιδή <strong>μ</strong>πορούν ν<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιώσουν τον <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστικό<br />
ρυθ<strong>μ</strong>ό κ<strong>α</strong>ι ν<strong>α</strong> <strong>α</strong>υξήσουν την <strong>α</strong>ντίστ<strong>α</strong>ση των <strong>α</strong><strong>ε</strong>ρ<strong>α</strong>γωγών. Μ<strong>ε</strong>ιω<strong>μ</strong>ένη ηπ<strong>α</strong>τική<br />
ή ν<strong>ε</strong>φρική λ<strong>ε</strong>ιτουργί<strong>α</strong> Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη πρέπ<strong>ε</strong>ι ν<strong>α</strong> χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή<br />
σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> <strong>μ</strong>έτρι<strong>α</strong> έως σοβ<strong>α</strong>ρή ηπ<strong>α</strong>τική ή ν<strong>ε</strong>φρική δυσλ<strong>ε</strong>ιτουργί<strong>α</strong>.<br />
Η <strong>ε</strong>πίδρ<strong>α</strong>ση της ηπ<strong>α</strong>τικής κ<strong>α</strong>ι ν<strong>ε</strong>φρικής δυσλ<strong>ε</strong>ιτουργί<strong>α</strong>ς στη<br />
φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κοκινητική του Instanyl δ<strong>ε</strong>ν έχ<strong>ε</strong>ι <strong>α</strong>ξιολογηθ<strong>ε</strong>ί. Ωστόσο, ότ<strong>α</strong>ν η<br />
φ<strong>α</strong>ιντ<strong>α</strong>νύλη χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>ε</strong>νδοφλ<strong>ε</strong>βίως, έχ<strong>ε</strong>ι δ<strong>ε</strong>ιχθ<strong>ε</strong>ί ότι η κάθ<strong>α</strong>ρση <strong>α</strong>υτής<br />
<strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βάλλ<strong>ε</strong>τ<strong>α</strong>ι λόγω της ηπ<strong>α</strong>τικής κ<strong>α</strong>ι ν<strong>ε</strong>φρικής δυσλ<strong>ε</strong>ιτουργί<strong>α</strong>ς που<br />
οφ<strong>ε</strong>ίλ<strong>ε</strong>τ<strong>α</strong>ι σ<strong>ε</strong> <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολές <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολικής κάθ<strong>α</strong>ρσης κ<strong>α</strong>ι των πρωτ<strong>ε</strong>ϊνών<br />
του πλάσ<strong>μ</strong><strong>α</strong>τος. Αυξη<strong>μ</strong>ένη <strong>ε</strong>νδοκρ<strong>α</strong>νι<strong>α</strong>κή πί<strong>ε</strong>ση Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη πρέπ<strong>ε</strong>ι<br />
ν<strong>α</strong> χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> <strong>α</strong>ποδ<strong>ε</strong>δ<strong>ε</strong>ιγ<strong>μ</strong>ένη <strong>α</strong>υξη<strong>μ</strong>ένη<br />
<strong>ε</strong>νδοκρ<strong>α</strong>νι<strong>α</strong>κή πί<strong>ε</strong>ση, <strong>μ</strong><strong>ε</strong>ιω<strong>μ</strong>ένο <strong>ε</strong>πίπ<strong>ε</strong>δο συν<strong>ε</strong>ίδησης ή κώ<strong>μ</strong><strong>α</strong>. Το<br />
Instanyl πρέπ<strong>ε</strong>ι ν<strong>α</strong> χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> όγκο<br />
<strong>ε</strong>γκ<strong>ε</strong>φάλου ή κάκωση της κ<strong>ε</strong>φ<strong>α</strong>λής. Κ<strong>α</strong>ρδιοπάθ<strong>ε</strong>ι<strong>α</strong> Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη <strong>μ</strong>πορ<strong>ε</strong>ί<br />
ν<strong>α</strong> προκ<strong>α</strong>λέσ<strong>ε</strong>ι βρ<strong>α</strong>δυκ<strong>α</strong>ρδί<strong>α</strong>. Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη πρέπ<strong>ε</strong>ι γι<strong>α</strong> το λόγο <strong>α</strong>υτό<br />
ν<strong>α</strong> χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> βρ<strong>α</strong>δυ<strong>α</strong>ρρυθ<strong>μ</strong>ί<strong>ε</strong>ς. Τ<strong>α</strong> οπιο<strong>ε</strong>ιδή<br />
<strong>μ</strong>πορούν ν<strong>α</strong> προκ<strong>α</strong>λέσουν υποτονί<strong>α</strong>, ιδι<strong>α</strong>ίτ<strong>ε</strong>ρ<strong>α</strong> σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong><br />
υποογκ<strong>α</strong>ι<strong>μ</strong>ί<strong>α</strong>. Το Instanyl πρέπ<strong>ε</strong>ι γι<strong>α</strong> το λόγο <strong>α</strong>υτό ν<strong>α</strong> χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι<br />
<strong>μ</strong><strong>ε</strong> προσοχή σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> υποτονί<strong>α</strong> κ<strong>α</strong>ι/ή υποογκ<strong>α</strong>ι<strong>μ</strong>ί<strong>α</strong>. Ρινικές κ<strong>α</strong>τ<strong>α</strong>στάσ<strong>ε</strong>ις<br />
Εάν ο <strong>α</strong>σθ<strong>ε</strong>νής <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίζ<strong>ε</strong>ι υποτροπιάζοντ<strong>α</strong> <strong>ε</strong>π<strong>ε</strong>ισόδι<strong>α</strong> <strong>ε</strong>πίστ<strong>α</strong>ξης<br />
ή ρινικής δυσφορί<strong>α</strong>ς <strong>ε</strong>νώ λ<strong>α</strong><strong>μ</strong>βάν<strong>ε</strong>ι Instanyl, πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>ε</strong>ξ<strong>ε</strong>τ<strong>α</strong>σθ<strong>ε</strong>ί<br />
<strong>ε</strong>ν<strong>α</strong>λλ<strong>α</strong>κτική <strong>μ</strong>ορφή χορήγησης γι<strong>α</strong> την <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση του π<strong>α</strong>ροξυσ<strong>μ</strong>ικού<br />
πόνου. Κοινό κρυολόγη<strong>μ</strong><strong>α</strong> Ο συνολικός β<strong>α</strong>θ<strong>μ</strong>ός έκθ<strong>ε</strong>σης στη φ<strong>α</strong>ιντ<strong>α</strong>νύλη<br />
των υποκ<strong>ε</strong>ι<strong>μ</strong>ένων <strong>μ</strong><strong>ε</strong> κοινό κρυολόγη<strong>μ</strong><strong>α</strong> χωρίς προηγού<strong>μ</strong><strong>ε</strong>νη<br />
θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> ρινικό <strong>α</strong>γγ<strong>ε</strong>ιοσυστ<strong>α</strong>λτικό <strong>ε</strong>ίν<strong>α</strong>ι συγκρίσι<strong>μ</strong>ος <strong>μ</strong><strong>ε</strong> <strong>α</strong>υτόν των<br />
υγιών υποκ<strong>ε</strong>ι<strong>μ</strong>ένων. Γι<strong>α</strong> τ<strong>α</strong>υτόχρονη χρήση ρινικού <strong>α</strong>γγ<strong>ε</strong>ιοσυστ<strong>α</strong>λτικού<br />
βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 4.5. Πιθ<strong>α</strong>νότητ<strong>α</strong> κ<strong>α</strong>τάχρησης κ<strong>α</strong>ι <strong>ε</strong>ξάρτηση Ανοχή κ<strong>α</strong>ι<br />
σω<strong>μ</strong><strong>α</strong>τική κ<strong>α</strong>ι/ή ψυχολογική <strong>ε</strong>ξάρτηση <strong>μ</strong>πορούν ν<strong>α</strong> <strong>α</strong>ν<strong>α</strong>πτυχθούν σ<strong>ε</strong><br />
<strong>ε</strong>π<strong>α</strong>ν<strong>α</strong>λ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νό<strong>μ</strong><strong>ε</strong>νη χορήγηση οπιο<strong>ε</strong>ιδών όπως η φ<strong>α</strong>ιντ<strong>α</strong>νύλη. Ωστόσο,<br />
ι<strong>α</strong>τρογ<strong>ε</strong>νής <strong>ε</strong>θισ<strong>μ</strong>ός <strong>μ</strong><strong>ε</strong>τά <strong>α</strong>πό θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>υτική χρήση οπιο<strong>ε</strong>ιδών <strong>ε</strong>ίν<strong>α</strong>ι<br />
σπάνιος στην <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση του πόνου που σχ<strong>ε</strong>τίζ<strong>ε</strong>τ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> κ<strong>α</strong>ρκίνο.<br />
Συ<strong>μ</strong>πτώ<strong>μ</strong><strong>α</strong>τ<strong>α</strong> στέρησης Τ<strong>α</strong> συ<strong>μ</strong>πτώ<strong>μ</strong><strong>α</strong>τ<strong>α</strong> στέρησης <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>ε</strong>πιτ<strong>α</strong>χύνοντ<strong>α</strong>ι<br />
<strong>μ</strong><strong>ε</strong> τη χορήγηση ουσιών <strong>μ</strong><strong>ε</strong> δράση <strong>α</strong>ντ<strong>α</strong>γωνιστών οπιο<strong>ε</strong>ιδών, π.χ.<br />
ν<strong>α</strong>λοξόνης ή <strong>α</strong>ν<strong>α</strong>λγητικού <strong>μ</strong>ικτής <strong>α</strong>γωνιστικής/<strong>α</strong>ντ<strong>α</strong>γωνιστικής δράσης<br />
(π.χ. π<strong>ε</strong>ντ<strong>α</strong>ζοκίνης, βουτορφ<strong>α</strong>νόλης, βουπρ<strong>ε</strong>νορφίνης, ν<strong>α</strong>λβουφίνης).<br />
Θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> άλλ<strong>α</strong> ρινικώς χορηγού<strong>μ</strong><strong>ε</strong>ν<strong>α</strong> φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κ<strong>ε</strong>υτικά προϊόντ<strong>α</strong> Ότ<strong>α</strong>ν<br />
ξ<strong>ε</strong>κινά η θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> Instanyl, πρέπ<strong>ε</strong>ι ν<strong>α</strong> λ<strong>α</strong><strong>μ</strong>βάνοντ<strong>α</strong>ι υπόψη <strong>ε</strong>ν<strong>α</strong>λλ<strong>α</strong>κτικές<br />
<strong>μ</strong>ορφές χορήγησης γι<strong>α</strong> τ<strong>α</strong>υτόχρονη θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> συνυπ<strong>α</strong>ρχουσών<br />
νόσων που <strong>μ</strong>πορούν ν<strong>α</strong> <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τωπιστούν <strong>μ</strong><strong>ε</strong> ρινική χορήγηση. 4.5 Αλληλ<strong>ε</strong>πιδράσ<strong>ε</strong>ις<br />
<strong>μ</strong><strong>ε</strong> άλλ<strong>α</strong> φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κ<strong>ε</strong>υτικά προϊόντ<strong>α</strong> κ<strong>α</strong>ι άλλ<strong>ε</strong>ς <strong>μ</strong>ορφές <strong>α</strong>λληλ<strong>ε</strong>πίδρ<strong>α</strong>σης<br />
Το Instanyl δ<strong>ε</strong>ν συνιστάτ<strong>α</strong>ι γι<strong>α</strong> χρήση σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς που<br />
έχουν λάβ<strong>ε</strong>ι <strong>α</strong>ν<strong>α</strong>στολ<strong>ε</strong>ίς <strong>μ</strong>ονο<strong>α</strong><strong>μ</strong>ινοξ<strong>ε</strong>ιδάσης (ΜΑΟ) <strong>ε</strong>ντός 14 η<strong>μ</strong><strong>ε</strong>ρών<br />
<strong>ε</strong>π<strong>ε</strong>ιδή έχ<strong>ε</strong>ι <strong>α</strong>ν<strong>α</strong>φ<strong>ε</strong>ρθ<strong>ε</strong>ί σοβ<strong>α</strong>ρή κ<strong>α</strong>ι <strong>α</strong>πρόβλ<strong>ε</strong>πτη <strong>ε</strong>νίσχυση της δράσης<br />
των οπιο<strong>ε</strong>ιδών <strong>α</strong>ν<strong>α</strong>λγητικών <strong>α</strong>πό <strong>α</strong>ν<strong>α</strong>στολ<strong>ε</strong>ίς ΜΑΟ. Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολίζ<strong>ε</strong>τ<strong>α</strong>ι<br />
κυρίως <strong>μ</strong>έσω του ισο<strong>ε</strong>νζυ<strong>μ</strong>ικού συστή<strong>μ</strong><strong>α</strong>τος του <strong>α</strong>νθρώπινου<br />
κυτοχρώ<strong>μ</strong><strong>α</strong>τος P450 3A4 (CYP3A4), <strong>ε</strong>πο<strong>μ</strong>ένως <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νισθούν<br />
πιθ<strong>α</strong>νές <strong>α</strong>λληλ<strong>ε</strong>πιδράσ<strong>ε</strong>ις ότ<strong>α</strong>ν το Instanyl χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι τ<strong>α</strong>υτοχρόνως <strong>μ</strong><strong>ε</strong><br />
π<strong>α</strong>ράγοντ<strong>ε</strong>ς που <strong>ε</strong>πηρ<strong>ε</strong>άζουν τη δράση του CYP3Α4. Η συγχορήγηση<br />
<strong>μ</strong><strong>ε</strong> π<strong>α</strong>ράγοντ<strong>ε</strong>ς που <strong>ε</strong>πάγουν τη δράση του 3Α4 <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιώσ<strong>ε</strong>ι την<br />
<strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τικότητ<strong>α</strong> του Instanyl. H τ<strong>α</strong>υτόχρονη χρήση του Instanyl <strong>μ</strong><strong>ε</strong><br />
ισχυρούς <strong>α</strong>ν<strong>α</strong>στολ<strong>ε</strong>ίς του CYP3A4 (π.χ. ριτον<strong>α</strong>βίρη, κ<strong>ε</strong>τοκον<strong>α</strong>ζόλη,<br />
ιτρ<strong>α</strong>κον<strong>α</strong>ζόλη, τρολ<strong>ε</strong><strong>α</strong>νδο<strong>μ</strong>υκίνη, κλ<strong>α</strong>ριθρο<strong>μ</strong>υκίνη κ<strong>α</strong>ι ν<strong>ε</strong>λφιν<strong>α</strong>βίρη) ή<br />
<strong>μ</strong><strong>ε</strong> <strong>μ</strong>έτριους <strong>α</strong>ν<strong>α</strong>στολ<strong>ε</strong>ίς του CYP3A4 (π.χ. <strong>α</strong><strong>μ</strong>πρ<strong>ε</strong>ν<strong>α</strong>βίρη, <strong>α</strong>πρ<strong>ε</strong>πιτάντη,<br />
διλτι<strong>α</strong>ζέ<strong>μ</strong>η, <strong>ε</strong>ρυθρο<strong>μ</strong>υκίνη, φλουκον<strong>α</strong>ζόλη, φοσ<strong>α</strong><strong>μ</strong>πρ<strong>ε</strong>ν<strong>α</strong>βίρη κ<strong>α</strong>ι β<strong>ε</strong>ρ<strong>α</strong>π<strong>α</strong><strong>μ</strong>ίλη)<br />
<strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> έχ<strong>ε</strong>ι ως <strong>α</strong>ποτέλ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong> <strong>α</strong>υξη<strong>μ</strong>έν<strong>ε</strong>ς συγκ<strong>ε</strong>ντρώσ<strong>ε</strong>ις<br />
φ<strong>α</strong>ιντ<strong>α</strong>νύλης στο πλάσ<strong>μ</strong><strong>α</strong>, <strong>ε</strong>νδ<strong>ε</strong>χο<strong>μ</strong>ένως προκ<strong>α</strong>λώντ<strong>α</strong>ς σοβ<strong>α</strong>ρές <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς<br />
<strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς του φ<strong>α</strong>ρ<strong>μ</strong>άκου συ<strong>μ</strong>π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νο<strong>μ</strong>ένης της θ<strong>α</strong>ν<strong>α</strong>τηφόρου<br />
<strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστικής κ<strong>α</strong>τ<strong>α</strong>στολής. Ασθ<strong>ε</strong>ν<strong>ε</strong>ίς που λ<strong>α</strong><strong>μ</strong>βάνουν Instanyl<br />
τ<strong>α</strong>υτοχρόνως <strong>μ</strong><strong>ε</strong> <strong>μ</strong>έτριους ή ισχυρούς <strong>α</strong>ν<strong>α</strong>στολ<strong>ε</strong>ίς του CYP3A4 πρέπ<strong>ε</strong>ι<br />
ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>κολουθούντ<strong>α</strong>ι προσ<strong>ε</strong>κτικά γι<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>τ<strong>ε</strong>τ<strong>α</strong><strong>μ</strong>ένη χρονική π<strong>ε</strong>ρίοδο.<br />
Αύξηση της δοσολογί<strong>α</strong>ς πρέπ<strong>ε</strong>ι ν<strong>α</strong> γίν<strong>ε</strong>τ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> προσοχή. Σ<strong>ε</strong> φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κοκινητική<br />
<strong>μ</strong><strong>ε</strong>λέτη <strong>α</strong>λληλ<strong>ε</strong>πίδρ<strong>α</strong>σης βρέθηκ<strong>ε</strong> ότι η <strong>μ</strong>έγιστη συγκέντρωση<br />
στο πλάσ<strong>μ</strong><strong>α</strong> της ρινικώς <strong>ε</strong>φ<strong>α</strong>ρ<strong>μ</strong>οζό<strong>μ</strong><strong>ε</strong>νης φ<strong>α</strong>ιντ<strong>α</strong>νύλης <strong>μ</strong><strong>ε</strong>ιώθηκ<strong>ε</strong> κ<strong>α</strong>τά<br />
π<strong>ε</strong>ρίπου 50% <strong>μ</strong><strong>ε</strong> την τ<strong>α</strong>υτόχρονη χρήση οξυ<strong>μ</strong><strong>ε</strong>τ<strong>α</strong>ζολίνης, <strong>ε</strong>νώ ο χρόνος<br />
<strong>ε</strong>πίτ<strong>ε</strong>υξης της Cmax (Tmax) διπλ<strong>α</strong>σιάστηκ<strong>ε</strong>. Αυτό <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιώσ<strong>ε</strong>ι<br />
την <strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τικότητ<strong>α</strong> του Instanyl. Συνιστάτ<strong>α</strong>ι ν<strong>α</strong> <strong>α</strong>ποφ<strong>ε</strong>ύγ<strong>ε</strong>τ<strong>α</strong>ι<br />
η τ<strong>α</strong>υτόχρονη χρήση ρινικών <strong>α</strong>ποσυ<strong>μ</strong>φορητικών (βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο<br />
5.2). Η τ<strong>α</strong>υτόχρονη χρήση άλλων κ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτικών του κ<strong>ε</strong>ντρικού ν<strong>ε</strong>υρικού<br />
συστή<strong>μ</strong><strong>α</strong>τος, π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νο<strong>μ</strong>ένων άλλων οπιο<strong>ε</strong>ιδών, κ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτικών<br />
ή υπνωτικών, γ<strong>ε</strong>νικών <strong>α</strong>ν<strong>α</strong>ισθητικών, φ<strong>α</strong>ινοθ<strong>ε</strong>ι<strong>α</strong>ζινών, ηρ<strong>ε</strong><strong>μ</strong>ιστικών,<br />
χ<strong>α</strong>λ<strong>α</strong>ρωτικών των σκ<strong>ε</strong>λ<strong>ε</strong>τικών <strong>μ</strong>υών, κ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτικών <strong>α</strong>ντιιστ<strong>α</strong><strong>μ</strong>ινικών<br />
κ<strong>α</strong>ι οινοπν<strong>ε</strong>ύ<strong>μ</strong><strong>α</strong>τος <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> προκ<strong>α</strong>λέσ<strong>ε</strong>ι <strong>α</strong>θροιστικές κ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτικές<br />
<strong>ε</strong>πιδράσ<strong>ε</strong>ις. Η τ<strong>α</strong>υτόχρονη χρήση οπιο<strong>ε</strong>ιδών που <strong>ε</strong>ίν<strong>α</strong>ι <strong>μ</strong><strong>ε</strong>ρικοί<br />
<strong>α</strong>γωνιστές/<strong>α</strong>ντ<strong>α</strong>γωνιστές (π.χ. βουπρ<strong>ε</strong>νορφίνης, ν<strong>α</strong>λβουφίνης, π<strong>ε</strong>ντ<strong>α</strong>ζοκίνης)<br />
δ<strong>ε</strong>ν συνιστάτ<strong>α</strong>ι. Έχουν υψηλή συγγέν<strong>ε</strong>ι<strong>α</strong> <strong>μ</strong><strong>ε</strong> τους υποδοχ<strong>ε</strong>ίς<br />
των οπιο<strong>ε</strong>ιδών <strong>μ</strong><strong>ε</strong> σχ<strong>ε</strong>τικά χ<strong>α</strong><strong>μ</strong>ηλή <strong>ε</strong>νδογ<strong>ε</strong>νή δρ<strong>α</strong>στικότητ<strong>α</strong> κ<strong>α</strong>ι <strong>ε</strong>πο<strong>μ</strong>ένως<br />
<strong>α</strong>ντ<strong>α</strong>γωνίζοντ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong>ρικώς την <strong>α</strong>ν<strong>α</strong>λγητική δράση της φ<strong>α</strong>ιντ<strong>α</strong>νύλης<br />
κ<strong>α</strong>ι <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> <strong>ε</strong>πάγουν συ<strong>μ</strong>πτώ<strong>μ</strong><strong>α</strong>τ<strong>α</strong> στέρησης σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>μ</strong><strong>ε</strong> <strong>ε</strong>ξάρτηση<br />
<strong>α</strong>πό οπιο<strong>ε</strong>ιδή. Η τ<strong>α</strong>υτόχρονη χρήση του Instanyl κ<strong>α</strong>ι άλλων φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κ<strong>ε</strong>υτικών<br />
προϊόντων (<strong>ε</strong>κτός <strong>α</strong>πό την οξυ<strong>μ</strong><strong>ε</strong>τ<strong>α</strong>ζολίνη) που χορηγούντ<strong>α</strong>ι<br />
<strong>μ</strong>έσω της ρινός δ<strong>ε</strong>ν έχ<strong>ε</strong>ι <strong>α</strong>ξιολογηθ<strong>ε</strong>ί στις κλινικές δοκι<strong>μ</strong>ές.<br />
Συνιστάτ<strong>α</strong>ι ν<strong>α</strong> <strong>ε</strong>ξ<strong>ε</strong>τάζοντ<strong>α</strong>ι <strong>ε</strong>ν<strong>α</strong>λλ<strong>α</strong>κτικές <strong>μ</strong>ορφές χορήγησης γι<strong>α</strong> τ<strong>α</strong>υτόχρονη<br />
θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> συνυπ<strong>α</strong>ρχουσών νόσων που <strong>μ</strong>πορούν ν<strong>α</strong> <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τωπιστούν<br />
<strong>μ</strong>έσω ρινικής χορήγησης. 4.6 Kύηση κ<strong>α</strong>ι γ<strong>α</strong>λουχί<strong>α</strong> Δ<strong>ε</strong>ν υπάρχουν<br />
<strong>ε</strong>π<strong>α</strong>ρκή στοιχ<strong>ε</strong>ί<strong>α</strong> <strong>α</strong>πό τη χρήση της φ<strong>α</strong>ιντ<strong>α</strong>νύλης σ<strong>ε</strong> έγκυ<strong>ε</strong>ς γυν<strong>α</strong>ίκ<strong>ε</strong>ς.<br />
Μ<strong>ε</strong>λέτ<strong>ε</strong>ς σ<strong>ε</strong> ζώ<strong>α</strong> κ<strong>α</strong>τέδ<strong>ε</strong>ιξ<strong>α</strong>ν τοξικότητ<strong>α</strong> στην <strong>α</strong>ν<strong>α</strong>π<strong>α</strong>ρ<strong>α</strong>γωγική ικ<strong>α</strong>νότητ<strong>α</strong><br />
(βλ. π<strong>α</strong>ράγρ<strong>α</strong>φο 5.3). Ο <strong>ε</strong>νδ<strong>ε</strong>χό<strong>μ</strong><strong>ε</strong>νος κίνδυνος γι<strong>α</strong> τον άνθρωπο<br />
<strong>ε</strong>ίν<strong>α</strong>ι άγνωστος. Το Instanyl δ<strong>ε</strong>ν πρέπ<strong>ε</strong>ι ν<strong>α</strong> χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι κ<strong>α</strong>τά τη<br />
διάρκ<strong>ε</strong>ι<strong>α</strong> της <strong>ε</strong>γκυ<strong>μ</strong>οσύνης <strong>ε</strong>κτός <strong>ε</strong>άν <strong>ε</strong>ίν<strong>α</strong>ι σ<strong>α</strong>φώς <strong>α</strong>π<strong>α</strong>ρ<strong>α</strong>ίτητο.Έπ<strong>ε</strong>ιτ<strong>α</strong><br />
<strong>α</strong>πό <strong>μ</strong><strong>α</strong>κροπρόθ<strong>ε</strong>σ<strong>μ</strong>η <strong>α</strong>γωγή, η φ<strong>α</strong>ιντ<strong>α</strong>νύλη <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> προκ<strong>α</strong>λέσ<strong>ε</strong>ι<br />
στέρηση στο ν<strong>ε</strong>ογνό. Συνιστάτ<strong>α</strong>ι ν<strong>α</strong> <strong>μ</strong>η χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι φ<strong>α</strong>ιντ<strong>α</strong>νύλη<br />
κ<strong>α</strong>τά τη διάρκ<strong>ε</strong>ι<strong>α</strong> του τοκ<strong>ε</strong>τού (π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νο<strong>μ</strong>ένης της κ<strong>α</strong>ισ<strong>α</strong>ρικής το<strong>μ</strong>ής)<br />
<strong>ε</strong>π<strong>ε</strong>ιδή η φ<strong>α</strong>ιντ<strong>α</strong>νύλη διέρχ<strong>ε</strong>τ<strong>α</strong>ι τον πλ<strong>α</strong>κούντ<strong>α</strong> κ<strong>α</strong>ι <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> προκ<strong>α</strong>λέσ<strong>ε</strong>ι<br />
<strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή στο έ<strong>μ</strong>βρυο. Εάν χορηγηθ<strong>ε</strong>ί το Instanyl,<br />
<strong>α</strong>ντίδοτο γι<strong>α</strong> το π<strong>α</strong>ιδί πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>ε</strong>ίν<strong>α</strong>ι <strong>ε</strong>ύκολ<strong>α</strong> δι<strong>α</strong>θέσι<strong>μ</strong>ο. Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη<br />
<strong>α</strong>π<strong>ε</strong>κκρίν<strong>ε</strong>τ<strong>α</strong>ι στο <strong>α</strong>νθρώπινο <strong>μ</strong>ητρικό γάλ<strong>α</strong> κ<strong>α</strong>ι <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> προκ<strong>α</strong>λέσ<strong>ε</strong>ι<br />
κ<strong>α</strong>τ<strong>ε</strong>υν<strong>α</strong>σ<strong>μ</strong>ό κ<strong>α</strong>ι <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή στο βρέφος που θηλάζ<strong>ε</strong>ι.<br />
Η φ<strong>α</strong>ιντ<strong>α</strong>νύλη πρέπ<strong>ε</strong>ι ν<strong>α</strong> χρησι<strong>μ</strong>οποι<strong>ε</strong>ίτ<strong>α</strong>ι <strong>α</strong>πό γυν<strong>α</strong>ίκ<strong>ε</strong>ς που θηλάζουν<br />
Bοηθήστ<strong>ε</strong> ν<strong>α</strong> γίνουν τ<strong>α</strong> φάρ<strong>μ</strong><strong>α</strong>κ<strong>α</strong> πιο <strong>α</strong>σφ<strong>α</strong>λή:<br />
Συ<strong>μ</strong>πληρώστ<strong>ε</strong> την “ΚΙΤΡΙΝΗ ΚΑΡΤΑ”<br />
Aν<strong>α</strong>φέρ<strong>α</strong>τ<strong>ε</strong>:<br />
• ΟΛΕΣ τις <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς γι<strong>α</strong> τ<strong>α</strong> Nέ<strong>α</strong> φάρ<strong>μ</strong><strong>α</strong>κ<strong>α</strong> N<br />
• Tις ΣOBAPEΣ <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς γι<strong>α</strong> τ<strong>α</strong> Γνωστά φάρ<strong>μ</strong><strong>α</strong>κ<strong>α</strong><br />
<strong>μ</strong>όνο <strong>ε</strong>άν τ<strong>α</strong> οφέλη <strong>α</strong>ντιστ<strong>α</strong>θ<strong>μ</strong>ίζουν τους <strong>ε</strong>νδ<strong>ε</strong>χό<strong>μ</strong><strong>ε</strong>νους κινδύνους κ<strong>α</strong>ι<br />
γι<strong>α</strong> τη <strong>μ</strong>ητέρ<strong>α</strong> κ<strong>α</strong>ι γι<strong>α</strong> το π<strong>α</strong>ιδί. 4.7 Επιδράσ<strong>ε</strong>ις στην ικ<strong>α</strong>νότητ<strong>α</strong> οδήγησης<br />
κ<strong>α</strong>ι χ<strong>ε</strong>ιρισ<strong>μ</strong>ού <strong>μ</strong>ηχ<strong>α</strong>νών Δ<strong>ε</strong>ν πρ<strong>α</strong>γ<strong>μ</strong><strong>α</strong>τοποιήθηκ<strong>α</strong>ν <strong>μ</strong><strong>ε</strong>λέτ<strong>ε</strong>ς σχ<strong>ε</strong>τικά<br />
<strong>μ</strong><strong>ε</strong> τις <strong>ε</strong>πιδράσ<strong>ε</strong>ις στην ικ<strong>α</strong>νότητ<strong>α</strong> οδήγησης κ<strong>α</strong>ι χ<strong>ε</strong>ιρισ<strong>μ</strong>ού <strong>μ</strong>ηχ<strong>α</strong>νών.<br />
Ωστόσο, τ<strong>α</strong> οπιο<strong>ε</strong>ιδή <strong>α</strong>ν<strong>α</strong>λγητικά <strong>ε</strong>ίν<strong>α</strong>ι γνωστό ότι <strong>μ</strong><strong>ε</strong>ιώνουν τη νοητική<br />
κ<strong>α</strong>ι/ή σω<strong>μ</strong><strong>α</strong>τική ικ<strong>α</strong>νότητ<strong>α</strong> που <strong>α</strong>π<strong>α</strong>ιτ<strong>ε</strong>ίτ<strong>α</strong>ι γι<strong>α</strong> οδήγηση ή χ<strong>ε</strong>ιρισ<strong>μ</strong>ό<br />
<strong>μ</strong>ηχ<strong>α</strong>νών. Πρέπ<strong>ε</strong>ι ν<strong>α</strong> γίν<strong>ε</strong>ι σύστ<strong>α</strong>ση στους <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς ν<strong>α</strong> <strong>μ</strong>ην οδηγούν ή<br />
ν<strong>α</strong> <strong>μ</strong>η χρησι<strong>μ</strong>οποιούν <strong>μ</strong>ηχ<strong>α</strong>νές <strong>ε</strong>άν <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίσουν υπνηλί<strong>α</strong>, ζάλη, οπτικές<br />
δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές ή άλλ<strong>ε</strong>ς <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς που <strong>μ</strong>πορούν ν<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιώσουν<br />
την ικ<strong>α</strong>νότητ<strong>α</strong> τους ν<strong>α</strong> οδηγούν κ<strong>α</strong>ι ν<strong>α</strong> χ<strong>ε</strong>ιρίζοντ<strong>α</strong>ι <strong>μ</strong>ηχ<strong>α</strong>νές. 4.8<br />
Αν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς Τυπικές <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς οπιο<strong>ε</strong>ιδών<br />
πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>α</strong>ν<strong>α</strong><strong>μ</strong>ένοντ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> το Instanyl. Συχνά, οι π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>ε</strong>ς <strong>α</strong>πό<br />
<strong>α</strong>υτές θ<strong>α</strong> στ<strong>α</strong><strong>μ</strong><strong>α</strong>τήσουν ή θ<strong>α</strong> <strong>μ</strong><strong>ε</strong>ιωθούν σ<strong>ε</strong> έντ<strong>α</strong>ση <strong>μ</strong><strong>ε</strong> τη συν<strong>ε</strong>χή χρήση<br />
του φ<strong>α</strong>ρ<strong>μ</strong><strong>α</strong>κ<strong>ε</strong>υτικού προϊόντος. Οι πιο σοβ<strong>α</strong>ρές <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς<br />
<strong>ε</strong>ίν<strong>α</strong>ι <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική κ<strong>α</strong>τ<strong>α</strong>στολή (που <strong>μ</strong>πορ<strong>ε</strong>ί ν<strong>α</strong> οδηγήσ<strong>ε</strong>ι σ<strong>ε</strong> άπνοι<strong>α</strong><br />
ή <strong>α</strong>ν<strong>α</strong>πν<strong>ε</strong>υστική <strong>α</strong>ν<strong>α</strong>κοπή), κυκλοφορική κ<strong>α</strong>τ<strong>α</strong>στολή, υπότ<strong>α</strong>ση κ<strong>α</strong>ι κ<strong>α</strong>τ<strong>α</strong>πληξί<strong>α</strong><br />
κ<strong>α</strong>ι όλοι οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς πρέπ<strong>ε</strong>ι ν<strong>α</strong> π<strong>α</strong>ρ<strong>α</strong>κολουθούντ<strong>α</strong>ι στ<strong>ε</strong>νά γι<strong>α</strong><br />
<strong>α</strong>υτές τις <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς. Οι κλινικές δοκι<strong>μ</strong>ές του Instanyl έγιν<strong>α</strong>ν<br />
<strong>μ</strong><strong>ε</strong> σκοπό ν<strong>α</strong> <strong>α</strong>ξιολογηθ<strong>ε</strong>ί η <strong>α</strong>σφάλ<strong>ε</strong>ι<strong>α</strong> κ<strong>α</strong>ι η <strong>α</strong>ποτ<strong>ε</strong>λ<strong>ε</strong>σ<strong>μ</strong><strong>α</strong>τικότητ<strong>α</strong><br />
στην <strong>α</strong>ντι<strong>μ</strong><strong>ε</strong>τώπιση του π<strong>α</strong>ροξυσ<strong>μ</strong>ικού πόνου. Όλοι οι <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς <strong>ε</strong>λά<strong>μ</strong>β<strong>α</strong>ν<strong>α</strong>ν<br />
<strong>ε</strong>πίσης τ<strong>α</strong>υτοχρόνως οπιο<strong>ε</strong>ιδή, όπως <strong>μ</strong>ορφίνη βρ<strong>α</strong>δ<strong>ε</strong>ί<strong>α</strong>ς <strong>α</strong>ποδέσ<strong>μ</strong><strong>ε</strong>υσης<br />
ή δι<strong>α</strong>δ<strong>ε</strong>ρ<strong>μ</strong>ική φ<strong>α</strong>ιντ<strong>α</strong>νύλη, γι<strong>α</strong> τον <strong>ε</strong>πί<strong>μ</strong>ονο πόνο τους. Γι<strong>α</strong> το<br />
λόγο <strong>α</strong>υτό, δ<strong>ε</strong>ν <strong>ε</strong>ίν<strong>α</strong>ι δυν<strong>α</strong>τό ν<strong>α</strong> δι<strong>α</strong>χωρισθούν σ<strong>α</strong>φώς οι <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς<br />
<strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς του Instanyl <strong>μ</strong>όνο. Οι <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητ<strong>ε</strong>ς <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>ε</strong>ς που θ<strong>ε</strong>ωρούντ<strong>α</strong>ι<br />
τουλάχιστον πιθ<strong>α</strong>νώς σχ<strong>ε</strong>τιζό<strong>μ</strong><strong>ε</strong>ν<strong>ε</strong>ς <strong>μ</strong><strong>ε</strong> την <strong>α</strong>γωγή στις κλινικές<br />
δοκι<strong>μ</strong>ές του Instanyl π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>βάνοντ<strong>α</strong>ι στον π<strong>α</strong>ρ<strong>α</strong>κάτω πίν<strong>α</strong>κ<strong>α</strong>. Οι <strong>α</strong>κόλουθ<strong>ε</strong>ς<br />
κ<strong>α</strong>τηγορί<strong>ε</strong>ς χρησι<strong>μ</strong>οποιούντ<strong>α</strong>ι γι<strong>α</strong> την κ<strong>α</strong>τάτ<strong>α</strong>ξη των <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητων<br />
<strong>ε</strong>ν<strong>ε</strong>ργ<strong>ε</strong>ιών ως προς τη συχνότητ<strong>α</strong> <strong>ε</strong><strong>μ</strong>φάνισης: πολύ συχνές<br />
(≥1/10), συχνές (≥1/100 έως
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