TEYXOS 172 3/17/09 11:13 AM Page 3 - μ. πιτσιλιδης α.ε.
TEYXOS 172 3/17/09 11:13 AM Page 3 - μ. πιτσιλιδης α.ε.
TEYXOS 172 3/17/09 11:13 AM Page 3 - μ. πιτσιλιδης α.ε.
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<strong>TEYXOS</strong> <strong><strong>17</strong>2</strong> 3/<strong>17</strong>/<strong>09</strong> <strong>11</strong>:14 <strong>AM</strong> <strong>Page</strong> 57<br />
Ιδι<strong>α</strong>ίτ<strong>ε</strong>ρ<strong>ε</strong>ς 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 χρήση<br />
Το BRIVIR ® κ<strong>α</strong>ι η 5-fluorouracil συ<strong>μ</strong>π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νο<strong>μ</strong>ένων των σκ<strong>ε</strong>υ<strong>α</strong>σ<strong>μ</strong>άτων τοπικής χρήσης ή των προφ<strong>α</strong>ρ<strong>μ</strong>άκων τ<strong>α</strong> οποί<strong>α</strong> <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολίζοντ<strong>α</strong>ι σ<strong>ε</strong> 5-fluorouracil (π.χ. capecitabine, floxuridine κ<strong>α</strong>ι<br />
tegafur) ή προϊόντ<strong>α</strong> που π<strong>ε</strong>ριέχουν συνδυ<strong>α</strong>σ<strong>μ</strong>ό <strong>α</strong>υτών των δρ<strong>α</strong>στικών ουσιών κ<strong>α</strong>ι άλλ<strong>ε</strong>ς 5-fluoropyrimidines π.χ. flucytosine δ<strong>ε</strong>ν πρέπ<strong>ε</strong>ι ν<strong>α</strong> χορηγούντ<strong>α</strong>ι τ<strong>α</strong>υτόχρον<strong>α</strong> κ<strong>α</strong>ι πρέπ<strong>ε</strong>ι ν<strong>α</strong> π<strong>α</strong>ρ<strong>ε</strong><strong>μ</strong>βάλλ<strong>ε</strong>τ<strong>α</strong>ι<br />
διάστη<strong>μ</strong><strong>α</strong> τουλάχιστον 4 <strong>ε</strong>βδο<strong>μ</strong>άδων πριν <strong>α</strong>ρχίσ<strong>ε</strong>ι η θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> φάρ<strong>μ</strong><strong>α</strong>κ<strong>α</strong> της ο<strong>μ</strong>άδ<strong>α</strong>ς 5-fluoropyrimidine. Ως <strong>μ</strong>ι<strong>α</strong> <strong>ε</strong>πιπλέον προφύλ<strong>α</strong>ξη, πρέπ<strong>ε</strong>ι ν<strong>α</strong> <strong>ε</strong>λέγχ<strong>ε</strong>τ<strong>α</strong>ι η δρ<strong>α</strong>στικότητ<strong>α</strong> του <strong>ε</strong>νζύ<strong>μ</strong>ου<br />
DPD πριν <strong>α</strong>ρχίσ<strong>ε</strong>ι οποι<strong>α</strong>δήποτ<strong>ε</strong> θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> φάρ<strong>μ</strong><strong>α</strong>κ<strong>α</strong> της ο<strong>μ</strong>άδ<strong>α</strong>ς της 5-fluoropyrimidine σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς που προσφάτως έπ<strong>α</strong>ιρν<strong>α</strong>ν BRIVIR ® .<br />
ΜΕNARINI HELLAS A.E.<br />
Aν. Δ<strong>α</strong><strong>μ</strong>βέργη 7, 104 45 Αθήν<strong>α</strong>, Τηλ.: 210 8316<strong>11</strong>1-3, Fax: 210 83<strong>17</strong>343, e-mail: menarini@otenet.gr<br />
125 mg<br />
4.3. Αντ<strong>ε</strong>νδ<strong>ε</strong>ίξ<strong>ε</strong>ις: Το BRIVIR ® δ<strong>ε</strong>ν πρέπ<strong>ε</strong>ι ν<strong>α</strong> χορηγ<strong>ε</strong>ίτ<strong>α</strong>ι σ<strong>ε</strong> π<strong>ε</strong>ριπτώσ<strong>ε</strong>ις υπ<strong>ε</strong>ρ<strong>ε</strong>υ<strong>α</strong>ισθησί<strong>α</strong>ς στη δρ<strong>α</strong>στική ουσί<strong>α</strong> ή σ<strong>ε</strong> κάποιο <strong>α</strong>πό τ<strong>α</strong> άλλ<strong>α</strong> συστ<strong>α</strong>τικά του. Ασθ<strong>ε</strong>ν<strong>ε</strong>ίς υπό <strong>α</strong>ντικ<strong>α</strong>ρκινική χη<strong>μ</strong><strong>ε</strong>ιοθ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong>: Η χρήση του BRIVIR ® <strong>α</strong>ντ<strong>ε</strong>νδ<strong>ε</strong>ίκνυτ<strong>α</strong>ι σ<strong>ε</strong> <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς υπό <strong>α</strong>ντικ<strong>α</strong>ρκινική χη<strong>μ</strong><strong>ε</strong>ιοθ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong>, <strong>ε</strong>ιδικά <strong>ε</strong>άν λ<strong>α</strong><strong>μ</strong>βάνουν 5-fluorouracil<br />
(5-FU), συ<strong>μ</strong>π<strong>ε</strong>ριλ<strong>α</strong><strong>μ</strong>β<strong>α</strong>νο<strong>μ</strong>ένων κ<strong>α</strong>ι των σκ<strong>ε</strong>υ<strong>α</strong>σ<strong>μ</strong>άτων τοπικής χρήσης, των προφ<strong>α</strong>ρ<strong>μ</strong>άκων τ<strong>α</strong> οποί<strong>α</strong> <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολίζοντ<strong>α</strong>ι σ<strong>ε</strong> 5-fluorouracil (π.χ. capecitabine, floxuridine, tegafur) κ<strong>α</strong>ι προϊόντων που π<strong>ε</strong>ριέχουν συνδυ<strong>α</strong>σ<strong>μ</strong>ό <strong>α</strong>υτών των δρ<strong>α</strong>στικών ουσιών ή άλλων 5-fluoropyrimidines (βλέπ<strong>ε</strong> <strong>ε</strong>πίσης π<strong>α</strong>ρ. 4.4. κ<strong>α</strong>ι 4.5). Ασθ<strong>ε</strong>ν<strong>ε</strong>ίς<br />
<strong>μ</strong><strong>ε</strong> <strong>α</strong>νοσο<strong>α</strong>ν<strong>ε</strong>πάρκ<strong>ε</strong>ι<strong>α</strong>: Η χρήση του BRIVIR ® <strong>α</strong>ντ<strong>ε</strong>δ<strong>ε</strong>ίκνυτ<strong>α</strong>ι 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>νοσο<strong>α</strong>ν<strong>ε</strong>πάρκ<strong>ε</strong>ι<strong>α</strong> όπως π.χ. <strong>α</strong>υτούς υπό <strong>α</strong>ντικ<strong>α</strong>ρκινική χη<strong>μ</strong><strong>ε</strong>ιοθ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong>, άλλη <strong>α</strong>νοσοκ<strong>α</strong>τ<strong>α</strong>στ<strong>α</strong>λτική <strong>α</strong>γωγή ή υπό θ<strong>ε</strong>ρ<strong>α</strong>π<strong>ε</strong>ί<strong>α</strong> <strong>μ</strong><strong>ε</strong> flucytosine γι<strong>α</strong> σοβ<strong>α</strong>ρές συστη<strong>μ</strong><strong>α</strong>τικές <strong>μ</strong>υκητιάσ<strong>ε</strong>ις. Π<strong>α</strong>ιδιά: 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> του BRIVIR ® σ<strong>ε</strong><br />
π<strong>α</strong>ιδιά δ<strong>ε</strong>ν έχουν τ<strong>ε</strong>κ<strong>μ</strong>ηριωθ<strong>ε</strong>ί ικ<strong>α</strong>νοποιητικά κ<strong>α</strong>ι ως <strong>ε</strong>κ τούτου δ<strong>ε</strong>ν <strong>ε</strong>νδ<strong>ε</strong>ίκνυτ<strong>α</strong>ι η χρήση του. Κύηση κ<strong>α</strong>ι γ<strong>α</strong>λουχί<strong>α</strong>: Το BRIVIR ® <strong>α</strong>ντ<strong>ε</strong>νδ<strong>ε</strong>ίκνυτ<strong>α</strong>ι κ<strong>α</strong>τά τη διάρκ<strong>ε</strong>ι<strong>α</strong> της <strong>ε</strong>γκυ<strong>μ</strong>οσύνης κ<strong>α</strong>ι της γ<strong>α</strong>λουχί<strong>α</strong>ς (βλέπ<strong>ε</strong> <strong>ε</strong>πίσης π<strong>α</strong>ρ. 4.6.). 4.8. 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: To brivudin χορηγήθηκ<strong>ε</strong> σ<strong>ε</strong> π<strong>ε</strong>ρισσότ<strong>ε</strong>ρους <strong>α</strong>πό 3900 <strong>α</strong>σθ<strong>ε</strong>ν<strong>ε</strong>ίς σ<strong>ε</strong><br />
κλινικές <strong>μ</strong><strong>ε</strong>λέτ<strong>ε</strong>ς. Η <strong>μ</strong>όνη συχνή πιθ<strong>α</strong>νή <strong>α</strong>ν<strong>ε</strong>πιθύ<strong>μ</strong>ητη <strong>ε</strong>νέργ<strong>ε</strong>ι<strong>α</strong> <strong>ε</strong>ίν<strong>α</strong>ι η ν<strong>α</strong>υτί<strong>α</strong> (2,1%). Η συχνότητ<strong>α</strong> κ<strong>α</strong>ι το <strong>ε</strong>ίδος των πιθ<strong>α</strong>νών <strong>α</strong>ν<strong>ε</strong>πιθυ<strong>μ</strong>ήτων <strong>ε</strong>ν<strong>ε</strong>ργ<strong>ε</strong>ιών συ<strong>μ</strong>φωνούν <strong>μ</strong><strong>ε</strong> <strong>α</strong>υτές που <strong>ε</strong><strong>μ</strong>φ<strong>α</strong>νίζοντ<strong>α</strong>ι σ<strong>ε</strong> άλλ<strong>α</strong> <strong>α</strong>ντιϊκά νουκλ<strong>ε</strong>οζίδι<strong>α</strong> της ιδί<strong>α</strong>ς κ<strong>α</strong>τηγορί<strong>α</strong>ς. Οι πιθ<strong>α</strong>νές <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 του brivudin ήτ<strong>α</strong>ν <strong>α</strong>ν<strong>α</strong>στρέψι<strong>μ</strong><strong>ε</strong>ς κ<strong>α</strong>ι γ<strong>ε</strong>νικά<br />
<strong>μ</strong>έτρι<strong>α</strong>ς έντ<strong>α</strong>σης. Στον π<strong>α</strong>ρ<strong>α</strong>κάτω πίν<strong>α</strong>κ<strong>α</strong> <strong>α</strong>ν<strong>α</strong>φέροντ<strong>α</strong>ι οι πιθ<strong>α</strong>νές <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>νάλογ<strong>α</strong> <strong>μ</strong><strong>ε</strong> το οργ<strong>α</strong>νικό σύστη<strong>μ</strong><strong>α</strong> κ<strong>α</strong>ι <strong>μ</strong><strong>ε</strong> φθίνουσ<strong>α</strong> συχνότητ<strong>α</strong>.<br />
Οργ<strong>α</strong>νικό σύστη<strong>μ</strong><strong>α</strong> Συνήθ<strong>ε</strong>ις (1-10%) Ασυνήθ<strong>ε</strong>ις (0,1-1%)<br />
Δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές <strong>α</strong>ί<strong>μ</strong><strong>α</strong>τος κ<strong>α</strong>ι λ<strong>ε</strong><strong>μ</strong>φικού συστή<strong>μ</strong><strong>α</strong>τος Κοκκιοκυττ<strong>α</strong>ροπ<strong>ε</strong>νί<strong>α</strong>, ηωσινοφιλί<strong>α</strong>, <strong>α</strong>ν<strong>α</strong>ι<strong>μ</strong>ί<strong>α</strong>, λ<strong>ε</strong><strong>μ</strong>φοκυττάρωση, <strong>μ</strong>ονοκυττάρωση<br />
Δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές <strong>μ</strong><strong>ε</strong>τ<strong>α</strong>βολισ<strong>μ</strong>ού κ<strong>α</strong>ι θρέψης Ανορ<strong>ε</strong>ξί<strong>α</strong><br />
Ψυχι<strong>α</strong>τρικές δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές Αϋπνί<strong>α</strong><br />
Δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές ν<strong>ε</strong>υρικού συστή<strong>μ</strong><strong>α</strong>τος Κ<strong>ε</strong>φ<strong>α</strong>λ<strong>α</strong>λγί<strong>α</strong>, ζάλη, ίλιγγος, υπνηλί<strong>α</strong><br />
Δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές γ<strong>α</strong>στρ<strong>ε</strong>ντ<strong>ε</strong>ρικού συστή<strong>μ</strong><strong>α</strong>τος Ν<strong>α</strong>υτί<strong>α</strong> Δυσπ<strong>ε</strong>ψί<strong>α</strong>, έ<strong>μ</strong><strong>μ</strong><strong>ε</strong>τος, κοιλι<strong>α</strong>κό άλγος, διάρροι<strong>α</strong>, τυ<strong>μ</strong>π<strong>α</strong>νισ<strong>μ</strong>ό, δυσκοιλιότητ<strong>α</strong><br />
Ηπ<strong>α</strong>τοχολικές δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές Λιπώδ<strong>ε</strong>ς ήπ<strong>α</strong>ρ, <strong>α</strong>υξη<strong>μ</strong>έν<strong>α</strong> ηπ<strong>α</strong>τικά ένζυ<strong>μ</strong><strong>α</strong>, ηπ<strong>α</strong>τίτιδ<strong>α</strong><br />
Δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές δέρ<strong>μ</strong><strong>α</strong>τος κ<strong>α</strong>ι υποδορίων ιστών Αλλ<strong>ε</strong>ργικές <strong>α</strong>ντιδράσ<strong>ε</strong>ις (Κνησ<strong>μ</strong>ός, <strong>ε</strong>ρυθη<strong>μ</strong><strong>α</strong>τώδ<strong>ε</strong>ς <strong>ε</strong>ξάνθη<strong>μ</strong><strong>α</strong>, <strong>α</strong>υξη<strong>μ</strong>ένη <strong>ε</strong>φίδρωση)<br />
Γ<strong>ε</strong>νικές δι<strong>α</strong>τ<strong>α</strong>ρ<strong>α</strong>χές Εξ<strong>α</strong>σθένηση, κόπωση<br />
Γι<strong>α</strong> π<strong>ε</strong>ρισσότ<strong>ε</strong>ρ<strong>ε</strong>ς συντ<strong>α</strong>γογρ<strong>α</strong>φικές πληροφορί<strong>ε</strong>ς <strong>α</strong>π<strong>ε</strong>υθυνθ<strong>ε</strong>ίτ<strong>ε</strong> στη Menarini Hellas.
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