NOVASALIC

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • NOVASALIC 0,1%+5% OINTMENT
  • Φαρμακολογική κατηγορία (ATC):
  • D07XC
  • Δοσολογία:
  • 0,1%+5%
  • Φαρμακοτεχνική μορφή:
  • ΑΛΟΙΦΗ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

  • για το ευρύ κοινό:
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    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

Εντοπισμός

  • Διατίθεται σε:
  • NOVASALIC 0,1%+5% OINTMENT
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική ομάδα:
  • Corticosteroids, potent, other combinations
  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • τελευταία ενημέρωση:
  • 09-08-2016

Περίληψη των χαρακτηριστικών του προϊόντος

                            ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΙΟΝΤΟΣ

     1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΙΟΝΤΟΣ

 Novasalic   

2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΣΤΙΚΗ ΣΥΝΘΕΣΗ 

Κάθε γραμμάριο αλοιφής Novasalic περιέχει 1mg  φουροϊκή μομεταζόνη αι 50mg σαλικυλικό oξύ 

(φουροϊκή μομεταζόνη 0.1% και σαλικυλικό οξύ5%)

3. ΦΑΡΜΑΚΕΥΤΙΚΗ ΜΟΡΦΗ

Αλοιφή για τοπική χορήγηση.

4. ΚΛΙΝΙΚΑ ΧΑΡΑΚΤΗΡΙΣΤΙΚΑ

4.1 Θεραπευτικές ενδείξεις

Η   αλοιφή  Novasalic    ενδείκνυται   για   την   αντιμετώπιση   των   δερματικών   εκδηλώσεων   της     μέσης 

βαρύτητας έως βαριάς ψωριάσεως.

4.2 Δοσολογία και μέθοδος χορήγησης

Ενα λεπτό στρώμα αλοιφής  Novasalic      θα πρέπει να απλώνεται  στις προσβεβλημένες περιοχές του 

δέρματος δυο φορές την ημέρα, το πρωί και το βράδυ. Η μέγιστη ημερήσια δόση είναι 15  g αλοιφής 

(περίπου το ήμισυ του σωληναρίου).

Μέγιστη διάρκεια θεραπείας 3 εβδομάδες.

4.3 Αντενδείξεις

Η   αλοιφή  Novasalic    αντενδείκνυται   σε   ασθενείς   με   ιστορικό   αντιδράσεων   υπερευαισθησίας   στη 

φουροϊκή   μομεταζόνη,  το   σαλικυλικό   οξύ   ή   σε   οποιοδήποτε   από   τα   συστατικά   αυτού   του 

ιδιοσκευάσματος.

Αντενδείκνυται σε περιπτώσεις φλεγμονώδους ή φλυκταινώδους ψωρίασης.

Όπως με άλλα τοπικά γλυκοκορτικοειδή, η αλοιφή Novasalic    αντενδείκνυται σε ασθενείς με δερματικές 

λοιμώξεις   από   μικρόβια,   ιούς   (απλός   έρπης,   ανεμοευλογιά,  έρπης   ζωστήρας)   ή  μύκητες.  Η   αλοιφή 

Novasalic    δεν πρέπει  να  χρησιμοποιείται  στην αγωγή της ροδοχρόου ακμής,  ή της  περιστοματικής 

δερματίτιδας, επί του προσώπου και επί των πτυχών του δέρματος. Η αλοιφή Novasalic    αντενδείκνυται 

επίσης σε αντιδράσεις μετά από εμβολιασμούς, σε φυματίωση και σύφιλη.

4.4 Ειδικές προειδοποιήσεις και ειδικές προφυλάξεις κατά την χρήση.

Όπως με όλα τα τοπικά γλυκοκορτικοειδή ιδιοσκευάσματα, θα πρέπει να λαμβάνονται οι κατάλληλες 

προφυλάξεις όταν υποβάλλονται σε αγωγή εκτεταμένες επιφάνειες σώματος, ή όταν προορίζεται για 

μακροχρόνια   χρήση.   Αυτό   είναι   ιδιαίτερα   σημαντικό   στους   παιδιατρικούς   ασθενείς.   Λόγω   της 

μεγαλύτερης   αναλογίας   επιφάνειας   δέρματος   ως   προς   το   βάρος   σώματος,   οι   παιδιατρικοί   ασθενείς 

μπορεί να είναι πιο ευαίσθητοι από τους ενήλικους ασθενείς στην καταστολή του άξονα υποθαλάμου- 

υποφύσεως-φλοιού   των   επινεφριδίων   και   στο   σύνδρομο  Cushing,   που   προκαλούνται   από   τα 

γλυκοκορτικοειδή.

Δεν συνιστάται η χρήση της αλοιφής Novasalic     υπό στεγανή επίδεση, περιλαμβανομένων των πανών 

και των πλαστικών πανταλονιών. Η αλοιφή  Novasalic      δεν προορίζεται για χρήση σε περιοχές του 

προσώπου και των πτυχών του δέρματος (μασχάλες ,μηροβουβωνικές περιοχές ).Η αλοιφή  Novasalic  

δεν προορίζεται για οφθαλμική χρήση.

Τα   παιδιά   (δείτε   παρακάτω   την   Παιδιατρική   χρήση)   θα   πρέπει   να λαμβάνουν την μικρότερη 

ποσότητα γλυκοκορτικοειδών που απαιτείται για να υπάρχει αποτελεσματικότητα. Η χρόνια θεραπεία με 

γλυκοκορτικοειδές μπορεί να παρέμβει στην αύξηση και ανάπτυξη των παιδιών.

Αν  αναπτυχθεί   ερεθισμός,  περιλαμβανομένης   της   υπερβολικής  ξηρότητας,   θα  πρέπει  να   διακοπεί  η 

χρήση της αλοιφής Novasalic     και να αρχίσει η κατάλληλη θεραπεία.

Αν  αναπτυχθεί   ταυτόχρονα   μια  δερματική  λοίμωξη,  θα πρέπει   να  χρησιμοποιηθεί  ένας   κατάλληλος 

αντιμυκητιασικός   ή   αντιμικροβιακός   παράγοντας.   Αν   δεν   εμφανιστεί   σύντομα   μια   ικανοποιητική 

ανταπόκριση, η χρήση της αλοιφής  Novasalic     θα πρέπει να διακοπεί μέχρι να ελεγχθεί κατάλληλα η 

λοίμωξη.

Ο κίνδυνος και το όφελος από τη χρήση της αλοιφής  Novasalic    πρέπει να ληφθούν υπ’ όψη όταν 

συνυπάρχουν οι παρακάτω ιατρικές καταστάσεις: σακχαρώδης διαβήτης, περιφερική αγγειακή νόσος ή 

φλεγμονή, ερεθισμός ή λοίμωξη του δέρματος.

Τα γλυκοκορτικοειδή μπορούν να αλλάξουν την εμφάνιση μερικών αλλοιώσεων, καθιστώντας δυσχερή 

την τεκμηρίωση της ορθής διάγνωσης καθώς επίσης  να προκαλέσουν καθυστέρηση της ιάσεως.

Παιδιατρική χρήση

Η ασφάλεια και η αποτελεσματικότητα της αλοιφής Novasalic     δεν έχει τεκμηριωθεί σε παιδιά ηλικίας 

κάτω των 12 χρόνων.

4.5 Αλληλεπιδράσεις με άλλα φαρμακευτικά προϊόντα και άλλες μορφές αλληλεπίδρασης

Μετά   από   τοπική   χρήση   της   αλοιφής  Novasalic      έχει   παρατηρηθεί   απορρόφηση   πολύ   μικρών 

ποσοτήτων σαλικυλικών στο πλάσμα. Η ανασκόπηση της δημοσιευμένης βιβλιογραφίας σχετικά με τις 

αλληλεπιδράσεις φαρμάκων με τα σαλικυλικά μετά από χορήγηση από το στόμα και τοπικά δείχνει ότι η 

δράση   των   παρακάτω   φαρμάκων   μπορεί   να   επηρεαστεί:   τολβουταμίδη,   μεθοτρεξάτη,   ηπαρίνη, 

πυραζιναμίδη,   ουροαπεκκριτικά   φάρμακα   και   φάρμακα   του   τύπου   της   κουμαρίνης.  ´Aλλα 

κορτικοστεροειδή και το θειικό αμμώνιο μπορεί να επηρεάσουν τα επίπεδα σαλικυλικού οξέος. Αυτές οι 

αλληλεπιδράσεις θα πρέπει να λαμβάνονται υπ’ όψη όταν χρησιμοποιείται η αλοιφή Novasalic     με τους 

παραπάνω παράγοντες.

4.6 Χρήση κατά την κύηση και τον θηλασμό

Δεν υπάρχουν επαρκείς και καλά ελεγχόμενες μελέτες σε εγκύους γυναίκες. Η αλοιφή Novasalic      θα 

πρέπει να χρησιμοποιείται κατά την κύηση μόνον αν το πιθανό όφελος δικαιολογεί τον δυνητικό κίνδυνο 

για το έμβρυο και όχι σε μεγάλες ποσότητες ή για παρατεταμένη περίοδο.

Δεν είναι γνωστό αν η τοπική χορήγηση κορτικοστεροειδών ή σαλικυλικού οξέος θα μπορούσε να έχει 

ως   αποτέλεσμα   επαρκή   συστηματική   απορρόφηση   για   να   προκαλέσει   ανιχνεύσιμες   ποσότητες   στο 

ανθρώπινο γάλα. Επειδή πολλά φάρμακα εκκρίνονται στο ανθρώπινο γάλα, θα πρέπει να χορηγείται σε 

θηλάζουσες γυναίκες μόνο αν το πιθανό όφελος δικαιολογεί τον δυνητικό κίνδυνο για το βρέφος.

4.7 Επιδράσεις στην ικανότητα οδήγησης και την χρήση μηχανημάτων.

Δεν εφαρμόζεται.

4.8 Ανεπιθύμητες αντιδράσεις

Γενικά, η αλοιφή  Novasalic  , χορηγούμενη δυο φορές την ημέρα, ήταν καλά ανεκτή από ασθενείς με 

μέσης βαρύτητας έως βαριά ψωρίαση. Η πιο συχνά εμφανιζόμενη ανεπιθύμητη ενέργεια  ήταν ήπιο έως 

μέσης   βαρύτητας   αίσθημα   καύσου   στο   σημείο   της   εφαρμογής   στο   4%   των   ασθενών.   Κνησμός 

εμφανίστηκε στο 2% των ασθενών. Σπανίως, αναφέρθηκαν ήπια έως μέσης βαρύτητας σαφής ατροφία 

του δέρματος ή απολέπιση.

Στις   ανεπιθύμητες   ενέργειες     που   έχουν   αναφερθεί   με   την   χρήση   των   τοπικών   κορτικοστεροειδών 

περιλαμβάνονται: ερεθισμός, εφύγρανση  του δέρματος, ξηρότητα, θυλακίτις, εξανθήματα που μοιάζουν 

με   της   ακμής,   υπομελάχρωση,   περιστοματική   δερματίτιδα,   αλλεργική   δερματίτιδα   εξ   επαφής, 

γραμμοειδείς ραβδώσεις, ιδρώα, δευτεροπαθής λοίμωξη και υπερτρίχωση.

4.9 Υπερδοσολογία

Η   υπερβολική   και   παρατεταμένη   χρήση   τοπικών   κορτικοστεροειδών   μπορεί   να   καταστείλει   τη 

λειτουργία του άξονα υποθάλαμος- υπόφυση-φλοιός των επινεφριδίων με αποτέλεσμα ανεπάρκεια των 

επινεφριδίων. Αν παρατηρηθεί καταστολή του άξονα υποθάλαμος-υπόφυση-φλοιός των επινεφριδίων, 

θα   πρέπει   να   γίνει   κάποια   προσπάθεια   να   σταματήσει   η   χορήγηση   του   φαρμάκου   ή   να   μειωθεί   η 

συχνότητα της χορήγησης.

Σε περίπτωση τοξικότητας από σαλικυλικό οξύ, η χρήση της αλοιφής Novasalic      θα πρέπει να διακοπεί. 

Θα πρέπει να χορηγούνται υγρά για να βοηθηθεί η απέκκριση από τα ούρα. Ανάλογα με τις ανάγκες θα 

πρέπει να αρχίζει η αγωγή με διττανθρακικό νάτριο και κάλιο (από το στόμα ή ενδοφλεβίως).

5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ

5.1 Φαρμακοδυναμικές ιδιότητες

Η   φαρμακοδυναμική   δραστικότητα   της   Αλοιφής  Novasalic      σχετίζεται   άμεσα   με   τα   δραστικά   της 

συστατικά, τη φουροϊκή μομεταζόνη, το σαλικυλικό οξύ και το έκδοχό της.Η φουροϊκή μομεταζόνη 

είναι ένα ισχυρό γλυκοκορτικοειδές που ανήκει στην κατηγορία ΙΙΙ της ΕΕ.

Οπως   με   άλλα   τοπικά   κορτικοστεροειδή,   η   φουροϊκή   μομεταζόνη   έχει   αντιφλεγμονώδεις, 

αντικνησμώδεις  και  αγγειοσυσπαστικές  ιδιότητες. Ο μηχανισμός  της αντιφλεγμονώδους δράσης των 

τοπικών στεροειδών γενικά  είναι  ασαφής. Τα κορτικοστεροειδή όμως  πιστεύεται  ότι δρούν διά της 

αναστολής   των   Α

  ανασταλτικών   πρωτεϊνών   της   φωσφολιπάσης,   που   ονομάζονται   συνολικά 

λιποκορτίνες. Υποτίθεται ότι αυτές οι πρωτεϊνες ελέγχουν την βιοσύνθεση των ισχυρών μεσολαβητών 

της φλεγμονής, όπως οι προσταγλανδίνες και οι λευκοτριένες, μέσω της αναστολής της εκλύσεως της 

κοινής   πρόδρομής   τους     ουσίας   του   αραχιδονικού   οξέος.   Το   αραχιδονικό   οξύ   εκλύεται   από   τα 

φωσφολιπίδια της μεμβράνης από την Α

 φωσφολιπάση.

Η φουροϊκή μομεταζόνη  είναι ένας ισχυρός αναστολέας της παραγωγής  in vivo  τριών κυτοκινών που 

προκαλούν   φλεγμονή   οι   οποίες   εμπλέκονται   στην   έναρξη   και   την   διατήρηση   της   φλεγμονώδους 

καταστάσεως: της ιντερλευκίνης 1 (IL-1), της ιντερλευκίνης 6 (IL-6) και του παράγοντα  νεκρώσεως των 

όγκων α (TNF-α).

Το σαλικυλικό οξύ έχει δειχθεί ότι απολεπίζει την επιδερμίδα ενώ δεν προκαλεί ποιοτικές ή ποσοτικές 

μεταβολές της δομής της ζώσης επιδερμίδας. Αυτός ο  μηχανισμός δράσεως έχει αποδοθεί στην διάλυση 

της μεσοκυτταρίου συνδετικής ουσίας που μοιάζει με τσιμέντο.

5.2 Φαρμακοκινητικές ιδιότητες

Απορρόφηση : Μετά μια απλή τοπική εφαρμογή ενός συνδυασμού   3 Η-φουροϊκής μομεταζόνης 0,1 % 

και   σαλικυλικού   οξέος   5%   σε   αλοιφή   για   12   ώρες   χωρίς   επίδεση   των   ψωριασικών   αλλοιώσεων, 

απορροφήθηκε  συστηματικά  το 1,5%  περίπου  της  εφαρμοσθείσης  δόσης. Τα  μέσα  μέγιστα  επίπεδα 

σαλικυλικού   οξέος   στο   πλάσμα   ήταν   0,0908  mg/dl.  Οι   συστηματικές   τοξικές   αντιδράσεις   στο 

σαλικυλικό οξύ συνήθως σχετίζονται με πολύ υψηλότερα επίπεδα (30-40 mg/dl).

´Oπως δείχτηκε με την δοκιμασία διέγερσης της κοσυντροπίνης, η αλοιφή  Novasalic    δεν προκάλεσε 

καταστολή του άξονα υποθάλαμος - υπόφυση - φλοιός των επινεφριδίων στο τέλος θεραπείας τριών 

εβδομάδων   με   χορήγηση   δύο   φορές   την   ημέρα   χωρίς   επίδεση.   Ελάχιστες   δράσεις   στον   άξονα 

υποθάλαμος - υπόφυση- φλοιός των επινεφριδίων παρατηρήθηκαν όταν εφαρμόστηκαν δυο φορές την 

ημέρα μέχρι 7,5 g της αλοιφής Novasalic    (συνολική ημερήσια δόση 15 g επί επτά μέρες) στο 30% της 

επιφάνειας σώματος, όπως υπάρχουν ενδείξεις από την εμφάνιση ενός μόνο επιπέδου κορτιζόλης στο 

πλάσμα που ήταν κάτω από το φυσιολογικό σε ένα ασθενή, το οποίο επανήλθε στα φυσιολογικά κατά 

την συνέχιση της θεραπείας.

Μετά  από  εφαρμογή  της αλοιφής Novasalic      δυο φορές την ημέρα χωρίς στεγανή επίδεση επί τρεις 

βδομάδες, τα επίπεδα σαλικυλικού ήταν <5mg/dl,  τα οποία είναι το κατώτατο όριο ανιχνεύσεως και 

χαμηλότερα από το εύρος της εργαστηριακής φυσιολογικής συγκεντρώσεως σαλικυλικών στο πλάσμα 

(15-30 mg/dl).

Κατανομή : Λόγω της αμελητέας απορροφήσεως της φουροϊκής μομεταζόνης μετά από χορήγηση από 

το δέρμα, η φαρμακοκινητική του φαρμάκου προσδιορίστηκε από μια μελέτη στην οποία η φουροϊκή 

μομεταζόνη χορηγήθηκε ως ενδοφλέβια ένεση διαλύματος 1 mg/ml. Ο φαινομενικός όγκος κατανομής 

ήταν 917 λίτρα, που δείχνει ότι η τυχόν απορροφούμενη φουροϊκή μομεταζόνη κατανέμεται εκτενώς. 

Στο πλάσμα του ανθρώπου η φουροϊκή μομεταζόνη είναι δεσμευμένη άνω του 99%.

Μεταβολισμός  : Η φουροϊκή μομεταζόνη που έχει  απορροφηθεί υπόκειται  σε ταχύ  και εκτεταμένο 

μεταβολισμό προς πολλαπλούς μεταβολίτες, οι οποίοι είναι πιο πολικοί από τη φουροϊκή μομεταζόνη. 

Λόγω της πολικότητάς τους, οι μεταβολίτες αυτοί δεν θεωρούνται ότι έχουν φαρμακολογική δράση. Δεν 

σχηματίζεται κανένας κύριος μεταβολίτης. Μετά από ενδοφλέβια χορήγηση, η συνολική κάθαρση της 

φουροϊκής μομεταζόνης από τον οργανισμό ήταν 976ml /  λεπτό, γεγονός που επιβεβαιώνει τον ταχύ 

μεταβολισμό.

Οι κύριοι μεταβολίτες του σαλικυλικού οξέος που αναλύονται ποσοτικά στο πλάσμα μετά από τοπική 

χορήγηση Αλοιφής  Novasalic      ήταν διϋδροξυβενζοϊκό οξύ (C

  = 0,00127 mg/dl  στις 24 ώρες) και 

σαλικυλουρικό οξύ (C

 = 0,0171 mg/dl στις 3,3 ώρες).

Αποβολή  :   Μετά   από   μια   μόνο   τοπική   εφαρμογή   (12   ωρών)   ενός   συνδυασμού   3Η-  φουροϊκής 

μομεταζόνης 0,1% και σαλικυλικού οξέος 5% σε μορφή αλοιφής σε ασθενείς με ψωρίαση, το 0,36% και 

το 1.11% περίπου της ραδιενέργειας ανακτήθηκε από τα ούρα και τα κόπρανα αντίστοιχα, κατά την 

διάρκεια μιας περιόδου συλλογής 5-ημερών. Μετά από την ίδια εφαρμογή, η αποτελεσματική διάρκεια 

ημίσειας ζωής του σαλικυλικού οξέος είναι 2.8 ώρες.

5.3 Προκλινικά δεδομένα για την ασφάλεια

Οι ενδείξεις  από  μια  σειρά  δέκα δοκιμασιών γενοτοξικότητας δείχνει ότι η φουροϊκή μομεταζόνη δεν 

έχει μεταλλαξιογόνο δυνατότητα. Το σαλικυλικό οξύ δεν θεωρείται γενικά ότι είναι γενοτοξικό.

´Oταν  τα κορτικοστεροειδή χορηγούνται  συστηματικά  σε  σχετικά χαμηλά  δοσολογικά επίπεδα,  έχει 

δειχτεί   ότι   είναι   τερατογόνα   στα   πειραματόζωα.   Έχει   δειχτεί   ότι   μερικά   κορτικοστεροειδή   είναι 

τερατογόνα μετά από εφαρμογή στο δέρμα στα πειραματόζωα. Το σαλικυλικό οξύ, καθώς και άλλα 

σαλικυλικά περιλαμβανομένης της ασπιρίνης έχουν δειχτεί ότι είναι τερατογόνα και εμβρυοτοξικά στον 

αρουραίο.

Το καρκινογόνο δυναμικό των κορτικοστεροειδών μετά από έκθεση του δέρματος, περιλαμβανομένης 

της φουροϊκής μομεταζόνης καθώς επίσης και εκείνης του σαλικυλικού οξέος δεν έχει δοκιμαστεί σε 

μακροχρόνιες  μελέτες  σε ζώα.  Σύμφωνα  με  τις  μελέτες  καρκινογενέσεως  με  ενδορρινική χορήγηση 

φουροϊκής μομεταζόνης τόσο σε ποντίκια όσο και σε αρουραίους δεν έδειξε καμιά σημαντική σχέση 

δόσης-ανταπόκρισης για οποιοδήποτε τύπο όγκων στους αρουραίους ή τα ποντίκια. 

Στην   γονιμότητα,   τη   γενική   αναπαραγωγή,   τις   περι-   και   μεταγεννητικές   τοξικολογικές     μελέτες   σε 

αρουραίους,   η   φουροϊκή   μομεταζόνη  ήταν   καλά   ανεκτή   σε   δόσεις   7,5  mcg/kg.  Στα   15  mcg/kg 

παρουσιάστηκαν παράταση της κυήσεως και παράταση και δυσκολία κατά τον τοκετό με πτώση της 

επιβιώσεως των νεογέννητων και του σωματικού βάρους ή αύξηση του σωματικού βάρους. Δεν υπήρξε 

βλάβη της γονιμότητας. Δεν έχουν γίνει μελέτες για να αξιολογηθεί η επίδραση του σαλικυλικού οξέος, 

όταν εφαρμόζεται τοπικά, στην γονιμότητα.

6. ΦΑΡΜΑΚΕΥΤΙΚΑ ΧΑΡΑΚΤΗΡΙΣΤΙΚΑ

6.1 Κατάλογος εκδόχων

Μαλακτική βάση αλοιφής με εξυλενο γλυκόλη, απεσταγμένο νερό, στεατική προπυλενο-γλυκόλη, λευκό 

κερί και λευκή παραφίνη.

6.2 Ασυμβατότητες

Δεν υπάρχουν μελέτες συμβατότητας με την Αλοιφή Novasalic  .

6.3 Διάρκεια ζωής

24 μήνες .

6.4 Ειδικές προφυλάξεις για την φύλαξη.

Να φυλάσσεται σε θερμοκρασία  2 0 C -30 0 C.

6.5 Φύση και περιεχόμενο του περιέκτη

Σωληνάριο αλουμινίου των 25 g.

6.6 Οδηγίες για την χρήση

          Καμιά

7. ΚΑΤΟΧΟΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

Schering-Plough Α.Φ.Β.Ε.Ε.

Αγίου Δημητρίου 63 Φιαλίδια μιας δόσης: 

΄Ένα έως δύο φιαλίδια ημερησίως χορηγούμενα κατά προτίμηση πριν τα γεύματα 

174 55 Αλιμος

8. ΑΡΙΘΜΟΣ/ΟΙ ΤΟΥ ΑΡΧΕΙΟΥ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ ΤΗΣ ΚΟΙΝΟΤΗΤΑΣ

9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΕΩΣ / ΑΝΑΝΕΩΣΕΩΣ ΤΗΣ ΕΓΚΡΙΣΗΣ

10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ

  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.

    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.



  • Έγγραφα σε άλλες γλώσσες διατίθενται εδώ

17-11-2018

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

FDA - U.S. Food and Drug Administration

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The Pictsweet Company Recalls 8-ounce Steam’ables Asparagus Spears due to Potential for <em>Listeria Monocytogenes</em>

The Pictsweet Company Recalls 8-ounce Steam’ables Asparagus Spears due to Potential for <em>Listeria Monocytogenes</em>

The Pictsweet Company has recalled 1,872 cases of Pictsweet Farms 8-ounce Steam’ables Asparagus Spears because they have the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

13-11-2018

Registration Reminder: FDA Center for Veterinary Medicine Public Webinar about Genome Editing in Animals on Dec. 3

Registration Reminder: FDA Center for Veterinary Medicine Public Webinar about Genome Editing in Animals on Dec. 3

On Dec. 3, 2018, FDA’s Center for Veterinary Medicine (CVM) will hold a public webinar about genome editing in animals, focusing mainly on current scientific evidence, promising uses of this technology in animals, the potential risks & CVM’s flexible, risk-based approach to regulation.

FDA - U.S. Food and Drug Administration

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

6-11-2018

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

The FDA is investigating the manufacturing facility that made recalled Duncan Hines cake mixes.

FDA - U.S. Food and Drug Administration

6-11-2018

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other ...

FDA - U.S. Food and Drug Administration

5-11-2018

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

The platform on the ladder does not lock securely in place posing a potential fall hazard.

Health Canada

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

2-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids

FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids

FDA warns website networks as part of global crack down for selling illegal pharmaceuticals

FDA - U.S. Food and Drug Administration

23-10-2018

Zeagle recalls Sport Buoyancy Control Device Inflators

Zeagle recalls Sport Buoyancy Control Device Inflators

There exists a possibility that buttons on the Zeagle Sport BCD inflators may break or fracture leading to a rapid loss of air or auto inflation of the BCD, posing a potential drowning hazard.

Health Canada

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

18-10-2018

Hydrolevel Company recalls HydroStat 3000

Hydrolevel Company recalls HydroStat 3000

The controller may not shut down the boiler when it reaches the high temperature limit, potentially allowing it to overheat and posing a fire hazard.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA has issued warning letters to two feed mills that mixed horse feed containing monensin, an animal drug that is toxic and potentially lethal to horses. This should be a reminder to all feed manufacturers making medicated feeds that they must remain vigilant about adhering to CGMP requirements.

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

9-10-2018

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

20-9-2018

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Canadians should not buy or use health products that contain 2,4-dinitrophenol, more commonly known as DNP, because it is toxic and can cause death. Products containing DNP are primarily marketed towards bodybuilders and are promoted online as a "fat burner" or "shredder" and for weight loss.

Health Canada

20-9-2018

Cybex International Inc. Recalls Cybex Smith Press

Cybex International Inc. Recalls Cybex Smith Press

A fall hazard has been identified when a user has not fully engaged the weight bar hooks over the pins and has not set the safety stops, permitting the bar to fall near a user. Potential injuries range from minor to significant including paralysis, spinal fracture and injuries to the head and neck.

Health Canada

18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.

France - Agence Nationale du Médicament Vétérinaire

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

9-10-2018

#FDA is closely tracking #Michael and has activated its Emergency Operations Center to support federal and state efforts in GA, FL, and AL. Additionally, we are taking steps to prevent any potential drug shortages and will share more over the coming days

#FDA is closely tracking #Michael and has activated its Emergency Operations Center to support federal and state efforts in GA, FL, and AL. Additionally, we are taking steps to prevent any potential drug shortages and will share more over the coming days

#FDA is closely tracking #Michael and has activated its Emergency Operations Center to support federal and state efforts in GA, FL, and AL. Additionally, we are taking steps to prevent any potential drug shortages and will share more over the coming days #HurricaneMichael

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

18-9-2018

As part of FDA’s ongoing efforts to reduce the enormous public health burden of tobacco use, the agency is unveiling a new e-cigarette prevention campaign aimed at educating youth about the potential dangers and health impacts caused by e-cigarette use. h

As part of FDA’s ongoing efforts to reduce the enormous public health burden of tobacco use, the agency is unveiling a new e-cigarette prevention campaign aimed at educating youth about the potential dangers and health impacts caused by e-cigarette use. h

As part of FDA’s ongoing efforts to reduce the enormous public health burden of tobacco use, the agency is unveiling a new e-cigarette prevention campaign aimed at educating youth about the potential dangers and health impacts caused by e-cigarette use. https://cards.twitter.com/cards/2m2m96/68507 …

FDA - U.S. Food and Drug Administration

17-9-2018

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording:  https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

FDA - U.S. Food and Drug Administration

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency