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  • Εμπορική ονομασία:
  • NIQUITIN CQ 4mg/LOZ LOZ.COMP
  • Φαρμακολογική κατηγορία (ATC):
  • N07BA
  • Δοσολογία:
  • 4mg/LOZ
  • Φαρμακοτεχνική μορφή:
  • ΣΥΜΠΙΕΣΜΕΝΟΣ ΤΡΟΧΙΣΚΟΣ
  • 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.

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  • NIQUITIN CQ 4mg/LOZ LOZ.COMP
    Ελλάδα
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  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική ομάδα:
  • Antismoking agents
  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

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

Περίληψη των χαρακτηριστικών του προϊόντος

ΗΜ. ΕΓΚΡΙΣΗΣ:22-10-2004

NiQuitin       CQ     ®    Τροχίσκοι 4    mg    

4mg/LOZ

ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 

1.     ΕΜΠΟΡΙΚΗ ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ:

        NiQuitin CQ ®  Τροχίσκος 4mg 

2.      ΠΟΙΟΤΙΚΗ & ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ σε δραστικά συστατικά:

         Κάθε τροχίσκος περιέχει 4mg νικοτίνης (ως 22,2mg nicotine polacrilex).

         Για τα έκδοχα βλέπε κεφάλαιο 6.1

3.       ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ:

Τροχίσκος συμπιεσμένος.

Λευκός,   στρογγυλός   συμπιεσμένος   τροχίσκος   με   κυρτές   επιφάνειες   με   το 

διακριτικό NL4 χαραγμένο στη μία πλευρά. 

4.       ΚΛΙΝΙΚΑ ΣΤΟΙΧΕΙΑ

4.1 Θεραπευτικές ενδείξεις:

Οι τροχίσκοι NiQuitin CQ ®   ενδείκνυνται για την αντιμετώπιση των συμπτωμάτων 

εξάρτησης από τη νικοτίνη, συμπεριλαμβανομένων και κρίσεων σφοδρής επιθυμίας, 

που μπορεί να προέρχονται από τη διακοπή του καπνίσματος. Συνιστάται όπως, οι 

τροχίσκοι  NiQuitin  CQ ®   χρησιμοποιούνται   σε   συνδυασμό   με   ένα   πρόγραμμα 

συμπεριφερολογικής υποστήριξης για τη διακοπή του καπνίσματος.

4.2 Δοσολογία και τρόπος χορήγησης:

Ενήλικες (συμπεριλαμβανομένων των ηλικιωμένων).

Οι τροχίσκοι  NiQuitin  CQ ®   4mg  είναι κατάλληλοι για καπνιστές που καπνίζουν το 

πρώτο   τσιγάρο   της   ημέρας   εντός   χρονικού   διαστήματος   30   λεπτών   μετά   από   το 

ξύπνημα.

Οι χρήστες θα πρέπει να σταματήσουν εντελώς το κάπνισμα κατά τη διάρκεια της 

θεραπείας με τροχίσκους NiQuitin CQ ® .

Οι χρήστες θα πρέπει να ακολουθούν το παρακάτω δοσολογικό σχήμα:

ΣΤΑΔΙΟ 1 ΣΤΑΔΙΟ 2 ΣΤΑΔΙΟ 3 Για να βοηθηθείτε ώστε να 

μην καπνίσετε για τις 

επόμενες 12 εβδομάδες, 

χρησιμοποιείστε 1-2 

τροχίσκους την ημέρα μόνο 

σε περιπτώσεις έντονης 

επιθυμίας για κάπνισμα.

Πρώτες 6 

εβδομάδες Επόμενες 2 

εβδομάδες  Επόμενες 2 

εβδομάδες

Αρχική περίοδος 

θεραπείας Επόμενο στάδιο 

θεραπείας Επόμενο στάδιο 

θεραπείας

1 τροχίσκος κάθε 

1 έως 2 ώρες 1 τροχίσκος κάθε 

2 έως 4 ώρες 1 τροχίσκος κάθε 

4 έως 8 ώρες

Κατά τη διάρκεια των 6 πρώτων εβδομάδων συνιστάται οι χρήστες να παίρνουν το 

λιγότερο 9 τροχίσκους ημερησίως.

Οι χρήστες δεν πρέπει να υπερβαίνουν τους 15 τροχίσκους ημερησίως.

Οι τροχίσκοι δεν  πρέπει να χρησιμοποιούνται για χρονικό διάστημα μεγαλύτερο των 

24 εβδομάδων (6 μήνες). Εάν οι χρήστες εξακολουθούν να νιώθουν ότι έχουν ανάγκη 

τη θεραπεία, θα πρέπει να συμβουλεύονται το γιατρό τους.

Οδηγίες για τη χρήση

Ένας   τροχίσκος   τοποθετείται   στο   στόμα   και   αφήνεται   να   διαλυθεί.   Περιοδικά,   ο 

τροχίσκος πρέπει να μετακινείται από την μια πλευρά του στόματος στην άλλη και η 

διεργασία επαναλαμβάνεται μέχρι να διαλυθεί εντελώς ο τροχίσκος (περίπου 20 - 30 

λεπτά). Ο τροχίσκος δεν πρέπει να μασάται  ή να καταπίνεται  ολόκληρος.

Οι χρήστες δεν πρέπει να τρώνε ή να πίνουν ενώ έχουν το τροχίσκο στο στόμα τους.

Παιδιά και έφηβοι

Η ασφάλεια και αποτελεσματικότητα σε παιδιά και εφήβους που καπνίζουν δεν έχουν 

αξιολογηθεί. Οι τροχίσκοι NiQuitin CQ ®  δεν συνιστώνται για χρήση στα παιδιά και 

σε εφήβους ηλικίας κάτω των 18 ετών.

4.3 Αντενδείξεις:

Οι τροχίσκοι NiQuitin CQ ®  αντενδείκνυνται σε:

ασθενείς με υπερευαισθησία στη νικοτίνη ή σε κάποιο από τα έκδοχα

παιδιά και εφήβους ηλικίας κάτω των 18 ετών και σε μη καπνίζοντες

ασθενείς με φαινυλκετονουρία

ασθενείς με ασταθή ή επιδεινούμενη στηθάγχη, στηθάγχη Prinzmetal ή σοβαρές 

καρδιακές αρρυθμίες

ασθενείς   με   πρόσφατο   (εντός   των   τελευταίων   4   εβδομάδων)   έμφραγμα   του 

μυοκαρδίου ή εγκεφαλικό επεισόδιο.

4.4 Ιδιαίτερες προειδοποιήσεις και ιδιαίτερες προφυλάξεις κατά τη χρήση:

Απαιτείται ιδιαίτερη προσοχή και χρήση μόνο μετά από ιατρική συμβουλή από άτομα 

με:

υπέρταση

πεπτικό έλκος ή σοβαρή νεφρική ή ηπατική ανεπάρκεια

φαιοχρωμοκύτωμα, υπερθυρεοειδισμό ή σακχαρώδη διαβήτη

σταθερή   καρδιαγγειακή   νόσο   (π.χ.   σταθερή   στηθάγχη,   καρδιακή   ανεπάρκεια, 

νόσο των εγκεφαλικών αγγείων, αγγειοσυσπαστικές νόσους, αποφρακτική νόσο 

των περιφερειακών αρτηριών)

Η   κατάποση   νικοτίνης   μπορεί   να   οξύνει   τα   συμπτώματα   σε   άτομα   με   ενεργό 

οισοφαγίτιδα, φλεγμονή του στόματος ή του φάρυγγα, γαστρίτιδα ή πεπτικό έλκος.

Οι τροχίσκοι  NiQuitin  CQ ®   δεν περιέχουν ζάχαρη, αλλά περιέχουν ασπαρτάμη που 

μεταβολίζεται   σε   φαινυλαλανίνη   η   οποία   είναι   επιβλαβής   σε   ασθενείς   με 

φαινυλκετονουρία.

Κάθε τροχίσκος  NiQuitin  CQ ®   4mg  περιέχει 15mg  νατρίου. Άτομα που βρίσκονται 

σε δίαιτα μειωμένου νατρίου θα πρέπει να συνυπολογίζουν την ποσότητα αυτή.

Οδηγία για την ασφάλεια των  παιδιών

Η ποσότητα της νικοτίνης που είναι ανεκτή από τους ενήλικες καπνιστές μπορεί να 

προκαλέσει συμπτώματα δηλητηρίασης και να αποδειχθεί μοιραία εάν οι τροχίσκοι 

NiQuitin  CQ ®   ληφθούν  από παιδιά.  Για  αυτό  το  λόγο, οι  ασθενείς  θα  πρέπει  να 

ενημερώνονται   να   φυλάσσουν   τους   τροχίσκους   μακριά   από   τα   παιδιά   και   να 

απορρίπτουν τους αχρησιμοποίητους τροχίσκους με προσοχή σε μέρος μακριά από τα 

παιδιά.

Κατά τη διάρκεια της προσπάθειας διακοπής του καπνίσματος οι χρήστες δεν πρέπει 

να εναλλάσσουν τους τροχίσκους NiQuitin CQ ®  με άλλες από του στόματος μορφές 

νικοτίνης γιατί τα φαρμακοκινητικά στοιχεία δείχνουν μεγαλύτερη διαθεσιμότητα της 

νικοτίνης από τους τροχίσκους NiQuitin CQ ®  σε σχέση με τις τσίχλες νικοτίνης.

4.5 Αλληλεπιδράσεις με άλλα φάρμακα και άλλες μορφές αλληλεπίδρασης.

Η   διακοπή   του   καπνίσματος   με   ή   χωρίς   υποκατάστατα   νικοτίνης   μπορεί   να 

μεταβάλλει   την   απόκριση   των   ασθενών   πρώην   καπνιστών   κατά   την   ταυτόχρονη 

χορήγηση   φαρμακευτικής   αγωγής.   Κατά   τη   διακοπή   του   καπνίσματος   μπορεί   να 

απαιτηθεί ρύθμιση της δοσολογίας των ακολούθων φαρμάκων.

Kατά τη διακοπή του καπνίσματος μπορεί 

να χρειασθεί μείωση της δόσης των 

παρακάτω φαρμάκων : Πιθανός μηχανισμός δράσης

Καφεΐνη, θεοφυλλίνη, ιμιπραμίνη, 

πενταζοκίνη, φαινακετίνη, 

φαινυλμπουταζόνη, τακρίνη, 

κλομιπραμίνη, ολανζαπίνη, 

φλουβοξαμίνη, κλοζαπίνη και φλεκαϊνίδη Επαγωγή ηπατικών ενζύμων

Ινσουλίνη Αύξηση της υποδόριας απορρόφησης 

ινσουλίνης.

Αδρενεργικοί ανταγωνιστές π.χ. 

πραζοσίνη, προπρανολόλη. Μείωση των κυκλοφορούντων 

κατεχολαμινών.

Kατά τη διακοπή του καπνίσματος μπορεί 

να χρειασθεί αύξηση της δόσης των 

παρακάτω φαρμάκων: Πιθανός μηχανισμός δράσης.

Ανδρενεργικοί ανταγωνιστές π.χ. 

ισοπρεναλίνη, σαλμπουταμόλη Μείωση των κυκλοφορούντων 

κατεχολαμινών.

Επειδή  το κάπνισμα μπορεί να οδηγήσει σε μείωση  της αναλγητικής  δράσης  της 

προποξυφαίνης, σε μειωμένη απόκριση στην διουρητική δράση της φρουσεμίδης και 

να μεταβάλλει το ρυθμό απόκρισης στη θεραπεία του έλκους με Η

-ανταγωνιστές, 

μπορεί να χρειαστεί ρύθμιση των δόσεων αυτών των φαρμάκων.

4.6 Κύηση και γαλουχία.

Τα επιβλαβή αποτελέσματα της νικοτίνης στην υγεία της εγκύου και του εμβρύου 

είναι αποδεδειγμένα. Αυτά περιλαμβάνουν χαμηλό βάρος του νεογέννητου, αυξημένο 

κίνδυνο αυτόματης αποβολής και αυξημένη περιγεννητική θνησιμότητα. Η νικοτίνη 

μπορεί επίσης να προκαλέσει δοσοεξαρτώμενες μεταβολές στην κυκλοφορία και τις 

αναπνευστικές   κινήσεις   του   εμβρύου.   Οι   έγκυες   ή   γυναίκες   που   προσπαθούν   να 

μείνουν έγκυες θα πρέπει να προσπαθήσουν να σταματήσουν το κάπνισμα χωρίς να 

χρησιμοποιήσουν τους τροχίσκους  NiQuitin CQ ® , αλλά εάν η προσπάθεια αποτύχει 

θα πρέπει να εκτιμηθεί ιατρικά ο συντελεστής κινδύνου / οφέλους για την χρήση 

τους.

Η   νικοτίνη   περνάει   ελεύθερα   στο   μητρικό   γάλα   της   γαλουχούσας   μητέρας   σε 

ποσότητες που μπορεί να επηρεάσουν το παιδί ακόμη και με θεραπευτικές δόσεις. Οι 

γαλουχούσες   μητέρες   θα   πρέπει   να   προσπαθήσουν   να   σταματήσουν   το   κάπνισμα 

χωρίς τη χρήση των τροχίσκων NiQuitin CQ ® . Εάν η προσπάθεια αυτή αποτύχει δεν 

θα πρέπει να χρησιμοποιούν τους τροχίσκους κατά τη διάρκεια της περιόδου του 

θηλασμού παρά μόνο κάτω από την επίβλεψη του γιατρού και αφού έχει εκτιμηθεί 

ιατρικά ο συντελεστής κινδύνου / οφέλους.

4.7 Επίδραση στην ικανότητα οδήγησης και χειρισμού μηχανημάτων

Δεν  υπάρχει  γνωστή επίδραση  από τη χρήση  των τροχίσκων  NiQuitin  CQ ®   στην 

ικανότητα   οδήγησης   και   χειρισμού   μηχανημάτων.   Παρ'   όλα   αυτά   οι   χρήστες 

προϊόντων υποκατάστατων της νικοτίνης θα πρέπει να γνωρίζουν ότι η διακοπή του 

καπνίσματος μπορεί να προκαλέσει συμπεριφερολογικές αλλαγές.

4.8  Ανεπιθύμητες ενέργειες:

Oι τροχίσκοι NiQuitin CQ ®   4mg  μπορούν να προκαλέσουν ανεπιθύμητες ενέργειες 

παρόμοιες με αυτές που σχετίζονται με τη νικοτίνη λαμβανόμενη με άλλους τρόπους. 

Αυτές μπορεί να αποδοθούν στις φαρμακολογικές δράσεις της νικοτίνης οι οποίες 

είναι  δοσοεξαρτώμενες.

Όλες   οι   ανεπιθύμητες   ενέργειες   με   μεγαλύτερη   συχνότητα   στην   ομάδα   του 

δραστικού   σε   σχέση   με   την   ομάδα   του   εικονικού   φαρμάκου   (placebo)   στην 

κεντρική μελέτη αποτελεσματικότητας

Αιμοπετάλια, αιμορραγία και διαταραχές  πήξης :

Ασυνήθεις > 1/1000, <1/100:  ουλορραγίες 

Μεταβολικές διαταραχές και διαταραχές θρέψης:

Ασυνήθεις > 1/1000,<1/100: δίψα, υπερβολική δίψα

Ψυχιατρικές διαταραχές:

Συνήθεις > 1/100, <1/10: αϋπνία

Ασυνήθεις   >   1/1000,   <1/100:   άγχος,   κρίση   άγχους,   αγχωτική     αντίδραση,   εφιάλτες, 

έκδηλη  ανησυχία, μειωμένη όρεξη, ανορεξία, λήθαργος

Διαταραχές του κεντρικού και περιφερικού νευρικού συστήματος:

Συνήθεις > 1/100, <1/10: ζάλη, κεφαλαλγία

Ασυνήθεις > 1/1000, <1/100:   ημικρανία, αίσθημα καύσου των βλεννογόνων, αίσθημα 

καύσου,  παραισθησίες στόματος, διαταραχές  των αισθητηρίων οργάνων,   υπερβολική 

εγρήγορση

Διαταραχές του αναπνευστικού συστήματος:

Συνήθεις > 1/100 , <1/10: βήχας, φαρυγγίτιδα,  κυνάγχη

Ασυνήθεις   >   1/1000   ,   <1/100:   δύσπνοια,   δύσπνοια,   έντονος   βήχας,   λοίμωξη   του 

κατώτερου αναπνευστικού συστήματος, αναπνευστικές  διαταραχές, πταρμός.

Διαταραχές του γαστρεντερικού συστήματος:

Πολύ συχνές > 1/10: ναυτία, λύγξ, μετεωρισμός

Συνήθεις   >   1/100,   <1/10:   έμετος,   δυσκοιλιότητα,   διάρροια,   δυσφαγία,   δυσπεψία, 

επιγαστραλγία,  δυσκολία   στην  πέψη, ερυγές,   ερεθισμός  του  στόματος,  εξέλκωση   του 

στόματος, εξέλκωση της γλώσσας, ξηροστομία, τυμπανισμός 

Ασυνήθεις   >   1/1000,   <1/100:   γαστροοισοφαγική   παλινδρόμηση,   έντονη   οισοφαγική 

παλινδρόμηση,   τάση   προς   έμετο,   αναγωγή,   έμετος,   καταρροή,   αυξημένη   σιελόρροια, 

εξέλκωση των χειλέων, διαταραχές του γαστρεντερικού, κοιλιακοί σπασμοί, πόνος των 

χειλών, ξηρότητα φάρυγγος

Διαταραχές των αισθήσεων:

Ασυνήθεις > 1/1000, <1/100: διαταραχή της αίσθησης της γεύσης

Διαταραχές του δέρματος και των εξαρτημάτων:

Ασυνήθεις > 1/1000, <1/100:  κνησμός, εξάνθημα

Γενικές διαταραχές του οργανισμού στο σύνολό του:

Ασυνήθεις > 1/1000 , <1/100: οίδημα του φάρυγγα, θωρακικό άλγος, αίσθημα συσφίξεως 

στο   στήθος,     ανεπιθύμητες   ενέργειες   υπερδοσολογίας,   στερητικό   σύνδρομο,   αίσθημα 

κακουχίας, ερυθρίαση,  δυσοσμία του στόματος

Ορισμένα   συμπτώματα   που   έχουν   αναφερθεί,   όπως   κατάθλιψη,   ευερεθιστότητα, 

άγχος   και   αϋπνία   μπορεί   να   σχετίζονται   με   τα   συμπτώματα   στέρησης   λόγω   της 

διακοπής του καπνίσματος. Τα άτομα   που σταματούν το κάπνισμα με οιοδήποτε 

μέσο   αναμένεται   να   υποφέρουν   από   κεφαλαλγία,   ζάλη,   αυξημένο   βήχα   ή 

κρυολόγημα.

4.9 Υπερδοσολογία:

Μετά από υπερβολική δόση μπορεί να εμφανιστούν συμπτώματα που αντιστοιχούν 

σε αυτά των δεινών καπνιστών.

Η από του στόματος θανατηφόρος δόση νικοτίνης είναι 0,5 - 0,75mg ανά kg βάρους 

σώματος, το οποίο αντιστοιχεί για τους ενήλικες σε 40 - 60mg. Ακόμα και μικρές 

ποσότητες   νικοτίνης   μπορεί   να   είναι   επικίνδυνες   στα   παιδιά   και   μπορεί   να 

αποδειχθούν μοιραίες. Υποψία δηλητηρίασης από νικοτίνη σε κάποιο παιδί,  πρέπει 

να θεωρηθεί επείγον ιατρικό περιστατικό και να αντιμετωπιστεί άμεσα.

Υπερδοσολογία από τους τροχίσκους NiQuitin CQ ®  μπορεί να συμβεί αν καταποθούν 

πολλοί τροχίσκοι, ή εάν αυτοί ληφθούν μαζί με νικοτίνη  προερχόμενη  από άλλες 

πηγές.

Τα σημεία και τα συμπτώματα από λήψη υπερβολικής δόσης αναμένονται να είναι τα 

ίδια  με   εκείνα   της  οξείας   δηλητηρίασης   με   νικοτίνη,  μεταξύ   των  οποίων  είναι  η 

ωχρότης, κρύος ιδρώτας, ναυτία, σιελόρροια, κάψιμο στο λαιμό, έμετος, πόνος στο 

υπογάστριο, διάρροια, πονοκέφαλος, ζάλη, διαταραχές ακοής και όρασης, τρόμος, 

διανοητική σύγχυση και αδυναμία.

Ταχυκαρδία,   καρδιακή   αρρυθμία,   δύσπνοια,   εξάντληση,   υπόταση,   κυκλοφορική 

έκπτωση, κώμα, σπασμοί και αναπνευστική ανεπάρκεια μπορεί να επέλθουν ύστερα 

από αυξημένη υπερδοσολογία. Θανατηφόρες δόσεις προκαλούν άμεσα σπασμούς και 

ο θάνατος ακολουθεί σαν αποτέλεσμα περιφερειακής και κεντρικής αναπνευστικής 

παράλυσης ή, λιγότερο συχνά, καρδιακής ανεπάρκειας. 

Αντιμετώπιση της υπερδοσολογίας

Σε περίπτωση υπερδοσολογίας, πρέπει να προκληθεί έμετος με σιρόπι ιπεκακουάνας, 

ή να γίνει πλύση στομάχου (με σωλήνα μεγάλης διαμέτρου). Στη συνέχεια θα πρέπει 

να χορηγηθεί, διαμέσου του σωλήνα, εναιώρημα ενεργού άνθρακα και να μείνει στο 

στομάχι. Εάν είναι αναγκαίο θα πρέπει να παρασχεθεί τεχνητή αναπνοή με οξυγόνο 

και να συνεχιστεί για όσο είναι απαραίτητο. Άλλη θεραπεία, συμπεριλαμβανομένης 

της αντιμετώπισης της καταπληξίας είναι εντελώς συμπτωματική.

5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ

5.1 Φαρμακοδυναμικές ιδιότητες

Κωδικός ATC : Ν07ΒΑ01

Η  νικοτίνη  είναι   αγωνιστής   των  υποδοχέων  της   νικοτίνης  του   περιφερειακού  και 

κεντρικού νευρικού συστήματος με έντονη δράση στο Κεντρικό Νευρικό Σύστημα 

και   στο   καρδιαγγειακό.   Όταν   λαμβάνεται   με   τη   μορφή   προϊόντων   καπνού   έχει 

αποδειχθεί ότι προκαλεί εθισμό ενώ η αποχή από τη χρήση της συνδέεται με κρίσεις 

και   συμπτώματα   στέρησης.   Αυτές   οι   κρίσεις   και   τα   συμπτώματα   στέρησης 

περιλαμβάνουν   έντονη   επιθυμία   για   τσιγάρο,   μελαγχολική   διάθεση,   αϋπνία, 

ευερεθιστότητα, απογοήτευση ή θυμό, άγχος, δυσκολία στη συγκέντρωση, ανησυχία 

και   αυξημένη   όρεξη   ή   αύξηση   βάρους.   Οι   τροχίσκοι   αντικαθιστούν   μέρος   της 

νικοτίνης  που παρέχεται  από τον καπνό και βοηθά στη μείωση  της  σοβαρότητας 

αυτών των κρίσεων και των συμπτωμάτων στέρησης.

5.2 Φαρμακοκινητικές ιδιότητες

Οι τροχίσκοι NiQuitin CQ ®   διαλύονται πλήρως μέσα στη στοματική κοιλότητα και 

όλη η ποσότητα της περιεχόμενης νικοτίνης είναι διαθέσιμη για απορρόφηση από το 

στόμα  ή  για  κατάποση.  Η  πλήρης   διάλυση   των  τροχίσκων  NiQuitin  CQ ®   τυπικά 

επιτυγχάνεται μέσα σε 20-30 λεπτά. Η μέγιστη συγκέντρωση νικοτίνης στο πλάσμα 

που επιτυγχάνεται με μια μόνο δόση είναι 10,8ng/ml. Όταν λαμβάνεται κάθε 1,5 ώρα 

η μέγιστη και ελάχιστη συγκέντρωση σε σταθεροποιημένη κατάσταση είναι 26,0 και 

19,7ng/ml  αντίστοιχα. Η κατάποση των τροχίσκων  NiQuitin  CQ ®   κατά παράβαση 

των οδηγιών χρήσης (μάσηση, συγκράτηση στο στόμα και κατάποση / μάσηση και 

άμεση κατάποση) δεν έχει σαν αποτέλεσμα ταχύτερη ή μεγαλύτερη απορρόφηση, 

αλλά ένα σημαντικό ποσό της νικοτίνης (80 - 93%) εξακολουθεί να απορροφάται.

Επειδή η σύνδεση της νικοτίνης με τις πρωτεΐνες του πλάσματος είναι μικρή (4,9% - 

20%)  ο όγκος   κατανομής   της   νικοτίνης  είναι   μεγάλος  (2,5l/kg). Η  κατανομή   της 

νικοτίνης   στους   ιστούς   εξαρτάται   από   το  pH,   με   τις   μεγαλύτερες   συγκεντρώσεις 

νικοτίνης να βρίσκονται στον εγκέφαλο, στο στομάχι, στους νεφρούς και στο ήπαρ.

Η   νικοτίνη   μεταβολίζεται   ευρέως   σε   ένα   αριθμό   μεταβολιτών,   οι   οποίοι   είναι 

λιγότερο ενεργοί από το μητρικό συστατικό. Ο μεταβολισμός της νικοτίνης κυρίως 

συμβαίνει   στο   ήπαρ,   αλλά   και   στους   πνεύμονες   και   στους   νεφρούς.   Η   νικοτίνη 

κυρίως μεταβολίζεται σε κοτινίνη αλλά και σε Ν'-οξείδιο της νικοτίνης. Η κοτινίνη 

έχει   χρόνο   ημιζωής   15   -   20   ώρες   και   τα   επίπεδά   της   στο   αίμα   είναι   10   φορές 

υψηλότερα   από   της   νικοτίνης.   Η   κοτινίνη   οξειδώνεται   περαιτέρω   σε  trans-3'-

υδροξυκοτινίνη,   η   οποία   είναι   ο   μεταβολίτης   της   νικοτίνης   με   τη   μεγαλύτερη 

συγκέντρωση στα ούρα. Η νικοτίνη και η κοτινίνη υφίστανται γλυκουρονιδίωση.

Η ημιπερίοδος αποβολής της νικοτίνης είναι περίπου 2 ώρες (εύρος 1 - 4 ώρες). Η 

συνολική κάθαρση της νικοτίνης κυμαίνεται από περίπου 62 έως 89l/hr. Η κάθαρση 

της   νικοτίνης   δια   μέσου   άλλης   οδού   εκτός   της   νεφρικής   υπολογίζεται   ότι   είναι 

περίπου   το   75%   της   συνολικής   κάθαρσης.   Η   νικοτίνη   και   οι   μεταβολίτες   της 

απεκκρίνονται σχεδόν αποκλειστικά στα ούρα. Η απέκκριση δια της νεφρικής οδού 

της αμετάβλητης νικοτίνης εξαρτάται άμεσα από το pH των ούρων, με τη μεγαλύτερη 

απέκκριση να συμβαίνει σε όξινο pH.

5.3 Προκλινικά στοιχεία για την ασφάλεια

Η τοξικότητα της νικοτίνης είναι επαρκώς γνωστή και έχει ληφθεί υπόψη κατά τη 

διαμόρφωση του συνιστώμενου δοσολογικού σχήματος. Σε μελέτες που έχουν γίνει η 

νικοτίνη   δεν   έδειξε   μεταλλαξιογόνο   δράση.   Τα   αποτελέσματα   μελετών   για 

καρκινογένεση δεν παρουσίασαν καθαρές ενδείξεις για το εάν η νικοτίνη προκαλεί ή 

επιταχύνει την εμφάνιση όγκων ή νεοπλασμάτων. Σε μελέτες που έγιναν σε έγκυα 

ζώα η νικοτίνη προκάλεσε τοξικότητα στην μητέρα και επομένως μέτρια τοξικότητα 

στο έμβρυο. Επιπρόσθετα συμπεριλαμβάνεται η πρόκληση καθυστέρησης προ και 

μετά   γεννητικής   ανάπτυξης   καθώς   και   αλλαγές   στην   ανάπτυξη   του   Κεντρικού 

Νευρικού Συστήματος μετά τη γέννηση.

Οι επιδράσεις αυτές παρατηρήθηκαν μετά από έκθεση  σε επίπεδα νικοτίνης πολύ 

υψηλότερα από εκείνα που προκύπτουν από τη συνιστώμενη δόση των τροχίσκων 

NiQuitin CQ ® . Επίδραση στη γονιμότητα δεν έχει τεκμηριωθεί.

6. ΦΑΡΜΑΚΕΥΤΙΚΑ ΣΤΟΙΧΕΙΑ

6.1. Κατάλογος των εκδόχων:

Mannitol

Sodium alginate

Xanthan gum

Potassium hydrogen carbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame

Magnesium stearate

Menthol  mint  flavour (menthol,  peppermint  oil,  maltodextrin,  colloidal  anhydrous 

silica)

6.2   Ασυμβατότητες.

Καμία γνωστή

6.3. Διάρκεια ζωής:

3 χρόνια

6.4. Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος:

Να  μη   φυλάσσεται   σε  θερμοκρασία   άνω  των  25 o C.  Να  φυλάσσεται  στην  αρχική 

συσκευασία του.

6.5. Φύση και συστατικά του περιέκτη:

Διαφανείς ή αδιαφανείς κυψέλες (blisters) από   Polyvinyl Chloride / Polyethylene / 

Polyvinylidene   Chloride   σε   συσκευασίες   των   12,   36   και   72.   Μπορεί   να   μην 

κυκλοφορούν όλες οι συσκευασίες.

6.6. Οδηγίες χρήσης / χειρισμού:

Καμία

6.7. Κάτοχος της άδειας κυκλοφορίας:

GLAXOSMITHKLINE AEBE

Λ. ΚΗΦΙΣΙΑΣ 266

152 32 ΧΑΛΑΝΔΡΙ

7. ΑΡΙΘΜΟΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ:

8. ΗΜΕΡΟΜΗΝΙΑ   ΤΗΣ   ΠΡΩΤΗΣ   ΑΔΕΙΑΣ   /   ΑΝΑΝΕΩΣΗ   ΤΗΣ 

ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

9. ΗΜΕΡΟΜΗΝΙΑ   ΤΗΣ   (ΜΕΡΙΚΗΣ)   ΑΝΑΘΕΩΡΗΣΗΣ   ΤΟΥ  

ΚΕΙΜΕΝΟΥ.

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Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

5-11-2018

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

FDA - U.S. Food and Drug Administration

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

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

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

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

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

FDA - U.S. Food and Drug Administration

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

2-10-2018

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

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

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).

FDA - U.S. Food and Drug Administration

24-9-2018

November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement

November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement

November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

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

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

13-9-2018

Health Canada advises of a second impurity linked to recalled valsartan drugs

Health Canada advises of a second impurity linked to recalled valsartan drugs

OTTAWA - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA) has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.

Health Canada

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

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

Natural Disaster Preparedness and Response (Drugs)

The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures.

FDA - U.S. Food and Drug Administration

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc

FDA - U.S. Food and Drug Administration

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

24-9-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/z8SW2mlb86

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on resistance in ectoparasites, draft: consultation open

Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open

The Committee adopted a new draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for a 11-month period of public consultation. The reflection paper aims to give an overview of the currently known resistance situation in ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.

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

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency