NEOSTESIN

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • NEOSTESIN 100 IU/DOSE M.D.NAS.SP
  • Φαρμακολογική κατηγορία (ATC):
  • H05BA01
  • Δοσολογία:
  • 100 IU/DOSE
  • Φαρμακοτεχνική μορφή:
  • ΕΚΝΕΦΩΜΑ ΡΙΝΙΚΟ ΣΤΑΘΕΡΩΝ ΔΟΣΕΩΝ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

Εντοπισμός

  • Διατίθεται σε:
  • NEOSTESIN 100 IU/DOSE M.D.NAS.SP
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

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

φύλλο οδηγιών χρήσης

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ

1. ΠΡΟΣΔΙΟΡΙΣΜΟΣ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ

1.1 Ονομασία προϊόντος 

Neostesin ® , 100 I.U./δόση, Εκνέφωμα ρινικό σταθερών δόσεων.

1.2 Σύνθεση

Δραστική ουσία: Calcitonin, Salmon (καλσιτονίνη σολομού). 

            Έκδοχα    :   Citric acid, Sodium citrate dihydrate, Ammonium tartrate, Sodium 

chloride, Methyl-p-hydroxybenzoate, Propyl-p-hydroxybenzoate, 

Water purified.

1.3 Φαρμακοτεχνική μορφή

Εκνέφωμα ρινικό σταθερών δόσεων.

1.4 Περιεκτικότητα σε δραστική ουσία

1 δόση (1 ψεκασμός) περιέχει 100  I.U.  Calcitonin,  Salmon  (καλσιτονίνης  

σολομού).

1.5 Περιγραφή - Συσκευασία

Το ρινικό εκνέφωμα  Neostesin    περιέχεται σε γυάλινο άχρωμο φιαλίδιο με 

δοσιμετρική   αντλία   με   ψεκαστήρα.   Είναι   διαυγές,   άχρωμο   διάλυμα. 

Διατίθεται   σε   συσκευασία   των   4  ml  που   περιέχει   τουλάχιστον   28   δόσεις 

(ψεκασμούς). 

1.6 Φαρμακοθεραπευτική κατηγορία

Αντιπαραθυρεοειδής   ορμόνη,   κωδικός  ATC:   H05BA01   (καλσιτονίνη  

σολομού).

1.7 Υπεύθυνος άδειας κυκλοφορίας

Nycomed Hellas S.A.,

            Λεωφ. Κηφισίας 196, 152 31 Χαλάνδρι, Αθήνα. 

Τηλ.: 210. 6729570, Fax: 210. 6729571.

1.8 Παρασκευαστής - Συσκευαστής

Φαρμακευτική Βιομηχανία

PROEL ΕΠΑΜ. Γ. ΚΟΡΩΝΗΣ Α.Ε.

Δήλου 9, Περιστέρι

121 34 Αθήνα.

1.10 Δικαιούχος  

PH&T

Via Ariosto 34, 20 145 Milano, Ιταλία.

2. ΤΙ   ΠΡΕΠΕΙ   ΝΑ   ΓΝΩΡΙΖΕΤΕ   ΓΙΑ   ΤΟ   ΦΑΡΜΑΚΟ   ΠΟΥ   ΣΑΣ  

ΧΟΡΗΓΗΣΕ Ο ΓΙΑΤΡΟΣ ΣΑΣ.

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2.1 Γενικές πληροφορίες 

Το   ρινικό   εκνέφωμα  Neostesin ®   είναι   συνθετική   καλσιτονίνη   σολομού   η  

οποία   μοιάζει   με   τη   φυσική   ορμόνη   καλσιτονίνη   που   βρίσκεται   στον  

ανθρώπινο οργανισμό.

Η καλσιτονίνη ρυθμίζει τα επίπεδα του ασβεστίου στο αίμα, αναστρέφει την 

απώλεια οστού και βοηθά στο σχηματισμό νέου οστού.

Ο ακριβής μηχανισμός δράσης του Neostesin ®  δεν έχει πλήρως διευκρινισθεί.

Το πλεονέκτημά του σε σχέση με την ανθρώπινη καλσιτονίνη είναι ότι το  

αποτέλεσμα της δράσης του διαρκεί πολύ περισσότερο.

2.2 Θεραπευτικές ενδείξεις

Θεραπεία της εγκατεστημένης  μετεμμηνοπαυσιακής  οστεοπόρωσης  για τη  

μείωση των σπονδυλικών καταγμάτων. Δεν έχει αποδειχθεί η μείωση των  

καταγμάτων του ισχίου.

2.3 Αντενδείξεις

Τα   φάρμακα   μπορούν   να   βοηθήσουν   τους   ασθενείς,   μπορούν   όμως   να  

δημιουργήσουν και προβλήματα όταν αυτά δεν λαμβάνονται σύμφωνα με τις 

οδηγίες. Για το συγκεκριμένο φάρμακο, θα πρέπει πριν το πάρετε, να έχετε  

ενημερώσει το γιατρό σας για τις ακόλουθες περιπτώσεις:

Αν είχατε ποτέ αλλεργική αντίδραση ή κάποια ασυνήθιστη αντίδραση στο 

φάρμακο αυτό ή σε κάποια από τις ουσίες που περιέχονται στο φάρμακο.

Η   καλσιτονίνη   αντενδείκνυται   επίσης   σε   ασθενείς   με   υπασβεστιαιμία.

2.4 Ειδικές προφυλάξεις και προειδοποιήσεις κατά τη χρήση

2.4.1  Γενικά

Πριν από την έναρξη της αγωγής και στην περίπτωση ρινικών ενοχλήσεων, 

πρέπει   να   πραγματοποιηθεί   εξέταση   της   ρινός.   Σε   περίπτωση   σοβαρής 

εξέλκωσης   του   ρινικού   βλεννογόνου   (π.χ.   διείσδυση   κάτω   από   τον 

βλεννογόνο   ή   συσχετισμός   με   βαριά   αιμορραγία),   το   ρινικό   εκνέφωμα 

Neostesin ®   πρέπει   να   διακοπεί.   Στην   περίπτωση   ήπιας   εξέλκωσης,   η 

θεραπευτική αγωγή πρέπει να  διακόπτεται προσωρινά μέχρι την ίαση.

Επειδή η καλσιτονίνη είναι πεπτίδιο, υπάρχει η πιθανότητα συστηματικών  

αλλεργικών   αντιδράσεων   και   σε   ασθενείς   που   ελάμβαναν   ενδορινική  

καλσιτονίνη,   έχουν   αναφερθεί   αλλεργικού   τύπου   αντιδράσεις  

συμπεριλαμβανομένων   μεμονωμένων   περιπτώσεων   αναφυλακτικής  

καταπληξίας. Σε ασθενείς για τους οποίους υπάρχει υποψία ευαισθησίας στην 

καλσιτονίνη θα πρέπει να εξετάζεται η διενέργεια δερματικής δοκιμασίας πριν 

την αγωγή τους με καλσιτονίνη.

2.4.2  Ηλικιωμένοι

Εκτεταμένη   εμπειρία   με   τη   χρήση   της   ενδορινικής   καλσιτονίνης   σε  

ηλικιωμένους   δεν   έδειξε   μειωμένη   ανοχή   ή  ανάγκη   για  τροποποίηση   της  

δοσολογίας.

2.4.3  Ασθενείς με ηπατική ή νεφρική ανεπάρκεια

Η   εμπειρία   με   τη   χρήση   της   ενδορινικής   καλσιτονίνης   σε   ασθενείς   με  

διαταραγμένη νεφρική ή ηπατική λειτουργία δεν έδειξε μειωμένη ανοχή ή  

ανάγκη για τροποποίηση της δοσολογίας. 

2.4.4  Κύηση

Επειδή το ρινικό εκνέφωμα  Neostesin ®  ενδείκνυται σε μετεμμηνοπαυσιακές  

γυναίκες,   δεν   έχουν   διεξαχθεί   μελέτες   σε   έγκυες   γυναίκες   ή   θηλάζουσες  

μητέρες. Γι’ αυτόν το λόγο, το ρινικό εκνέφωμα  Neostesin ®   δεν πρέπει να 

χορηγείται σε αυτές τις ασθενείς.

2.4.5  Γαλουχία

Δεν είναι γνωστό εάν η ουσία απεκκρίνεται στο μητρικό γάλα στον άνθρωπο. 

Στα ζώα, η καλσιτονίνη σολομού έχει δειχθεί ότι μειώνει τη γαλουχία και ότι 

απεκκρίνεται στο γάλα. Γι’ αυτόν το λόγο, το ρινικό εκνέφωμα Neostesin ®  δεν 

πρέπει να χορηγείται σε αυτές τις ασθενείς.

2.4.6  Παιδιά

Δεν συνιστάται η χρήση της καλσιτονίνης σολομού σε παιδιά.

2.4.7  Επίδραση στην ικανότητα οδήγησης και χειρισμού μηχανών

Δεν υπάρχουν δεδομένα για την επίδραση της ενδορινικής καλσιτονίνης στην 

ικανότητα οδήγησης και στον χειρισμό μηχανών. Η ενδορινική καλσιτονίνη 

μπορεί να προκαλέσει παροδική ζάλη που μπορεί να μειώσει τις αντιδράσεις 

του ασθενούς. Οι ασθενείς πρέπει για αυτόν τον λόγο να προειδοποιούνται ότι 

μπορεί να παρουσιασθεί  παροδική ζάλη, ώστε να μην οδηγούν ή να μην  

χειρίζονται μηχανές.

2.5 Αλληλεπιδράσεις   με   άλλα   φαρμακευτικά   προϊόντα   και   άλλες   μορφές  

αλληλεπίδρασης

Δεν έχουν αναφερθεί αλληλεπιδράσεις της ενδορινικής καλσιτονίνης σολομού 

με άλλα φάρμακα.

2.6 Δοσολογία και τρόπος χορήγησης

Η συνιστώμενη δόση του ρινικού εκνεφώματος  Neostesin ®   για τη θεραπεία 

της εγκατεστημένης μετεμμηνοπαυσιακής οστεοπόρωσης είναι 200  I.U. μία 

φορά   την   ημέρα.   Η   χρήση   της   ενδορινικής   καλσιτονίνης   συνιστάται   σε 

συνδυασμό   με   επαρκή   λήψη   ασβεστίου   και   βιταμίνης  D.  H  θεραπευτική 

αγωγή θα πρέπει να χορηγείται μακροχρόνια.

Χρήση σε ηλικιωμένους, σε ασθενείς με ηπατική και νεφρική ανεπάρκεια

Εκτεταμένη   εμπειρία   με   τη   χρήση   της   ενδορινικής   καλσιτονίνης   σε  

ηλικιωμένους   δεν  έδειξε   μειωμένη   ανοχή  ή   ανάγκη   για   τροποποίηση  της  

δοσολογίας. Το ίδιο ισχύει σε ασθενείς με διαταραγμένη νεφρική ή ηπατική 

λειτουργία.

Χρήση σε παιδιά

Δεν   υπάρχουν   επαρκή   στοιχεία   που   να   υποστηρίζουν   τη   χρήση   της 

καλσιτονίνης   σολομού   σε   καταστάσεις   που   σχετίζονται   με   παιδιατρική 

οστεοπόρωση. Επομένως, δεν συνιστάται η χρήση της καλσιτονίνης σολομού 

σε παιδιά ηλικίας 0 έως 18 ετών.

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ΟΔΗΓΙΕΣ ΓΙΑ ΤΟΝ ΣΩΣΤΟ ΧΕΙΡΙΣΜΟ ΚΑΙ ΕΦΑΡΜΟΓΗ ΤΟΥ ΡΙΝΙΚΟΥ 

ΕΚΝΕΦΩΜΑΤΟΣ:

Αφαιρέστε το προστατευτικό κάλυμμα από το φιαλίδιο.

Πριν τη χρησιμοποίηση του φιαλιδίου του ρινικού εκνεφώματος για 

πρώτη φορά, πιέστε την αντλία και  ψεκάστε στον αέρα πολλές φορές 

διαδοχικά (περίπου 6 φορές), μέχρι να εξέλθει ένα νέφος από το υγρό 

(βλέπετε Εικόνα 1). Προσοχή! Αυτό απαιτείται για να ενεργοποιηθεί η 

αντλία και πρέπει να γίνεται μόνο πριν τη χρησιμοποίηση του φιαλιδίου 

για πρώτη φορά και όχι κατά τις επόμενες χρήσεις αυτού.

Με το κεφάλι σας σε όρθια θέση, εισάγετε το ρύγχος του φιαλιδίου μέσα 

στο ένα ρουθούνι (βλέπετε Εικόνα 2).

Κρατείστε την αναπνοή σας (ΜΗΝ ΕΙΣΠΝΕΕΤΕ) και πιέστε την αντλία 

μία φορά.

Επαναλάβατε αυτή τη διαδικασία, στα ρουθούνια εναλλάξ, μέχρι να 

λάβετε τη δόση που σας έχει ορίσει ο γιατρός.

Μετά τη χρήση, κλείστε το φιαλίδιο με το προστατευτικό κάλυμμα.

Διατηρείστε το φιαλίδιο σε όρθια θέση.

Όταν το φιαλίδιο ανοιχθεί για πρώτη φορά, μπορεί να φυλάσσεται και 

εκτός ψυγείου, σε θερμοκρασία 25 ο  C ή χαμηλότερη των 25 ο  C. Μετά το 

άνοιγμα του φιαλιδίου για πρώτη φορά, το περιεχόμενο του φιαλιδίου 

πρέπει να χρησιμοποιείται μέσα σε 1 μήνα από την ημερομηνία που το 

φιαλίδιο ανοίχθηκε για πρώτη φορά, είτε το φιαλίδιο φυλάσσεται εντός 

ψυγείου είτε το φιαλίδιο φυλάσσεται εκτός ψυγείου.

Eικόνα 1  Εικόνα  2   

Βεβαιωθείτε ότι η αντλία είναι μέσα στο υγρό, όταν χρησιμοποιείτε το ρινικό 

εκνέφωμα Neostesin  .

2.7 Υπερδοσολογία - αντιμετώπιση

Ναυτία, έμετος, εξάψεις και ζάλη είναι γνωστό ότι είναι δοσοεξαρτώμενα  

συμπτώματα όταν η καλσιτονίνη χορηγείται παρεντερικά. Έχουν χορηγηθεί  

εφάπαξ δόσεις (μέχρι 10.000 IU) της ενέσιμης καλσιτονίνης σολομού χωρίς 

ανεπιθύμητες αντιδράσεις άλλες από τη ναυτία και τον έμετο, καθώς και την 

επίταση των φαρμακολογικών δράσεων. Τέτοια συμβάμματα επομένως θα  

πρέπει   να   είναι   αναμενόμενο   να   εμφανισθούν   με   την   υπέρβαση   της  

δοσολογίας της ενδορινικής καλσιτονίνης.

Εντούτοις, η ενδορινική καλσιτονίνη χορηγούμενη ως άπαξ δόση έως και  

1600 I.U. αλλά και έως 800 I.U. ημερησίως επί τρεις ημέρες δεν προκάλεσε 

καμία σοβαρή ανεπιθύμητη ενέργεια. 

Η   αντιμετώπιση   πρέπει   να   είναι   συμπτωματική   όταν   εμφανισθούν  

συμπτώματα υπερδοσολογίας.

   

Τηλ. Κέντρου Δηλητηριάσεων: 210. 7793777.

2.8 Ανεπιθύμητες ενέργειες 

Κατηγορίες βάσει συχνότητας:

Πολύ   συχνές   (>1/10),   συχνές   (>1/100,  <1/10),   όχι   συχνές   (>1/1.000,  

<1/100),   σπάνιες   (>1/10.000,  <1/1.000),   πολύ   σπάνιες   (<1/10.000),  

συμπεριλαμβανομένων μεμονωμένων αναφορών.

Διαταραχές του γαστρεντερικού

Συχνές: ναυτία, διάρροια, κοιλιακός πόνος

Όχι συχνές: έμετος

Αγγειακές διαταραχές

Συχνές: ερυθρίαση

Όχι συχνές: υπέρταση

Διαταραχές του αναπνευστικού

Πολύ   συχνές:  ρινίτιδα,   (συμπεριλαμβανομένης   ξηράς   μύτης,   ρινικού  

οιδήματος,   ρινικής   συμφόρησης,   πταρμού,   αλλεργικής   ρινίτιδας),   μη  

εξειδικευμένα συμπτώματα από τη μύτη (π.χ. ερεθισμός της ρινικής διόδου, 

βλατιδώδες εξάνθημα, παρωσμία, ερύθημα, εκδορά)

Συχνές: ελκωτική ρινίτιδα, παραρρινοκολπίτιδα, επίσταξη, φαρυγγίτιδα

Όχι συχνές: βήχας

Αυτά τα συμβάμματα είναι γενικά ήπια (στο 80% περίπου των αναφορών) και 

απαιτούν διακοπή της αγωγής σε λιγότερο από το 5% των περιπτώσεων

Διαταραχές του νευρικού συστήματος

Συχνές: ζάλη, πονοκέφαλος, δυσγευσία

Οφθαλμικές διαταραχές

Όχι συχνές: διαταραχή της όρασης

Διαταραχές του δέρματος και του υποδόριου ιστού

Όχι συχνές: οίδημα (οίδημα προσώπου, περιφερικό οίδημα και ανά σάρκα)

Διαταραχές του μυοσκελετικού συστήματος

Συχνές: μυοσκελετικός πόνος

Όχι συχνές: αρθραλγία

Διαταραχές του ανοσοποιητικού συστήματος

Όχι   συχνές:  αντιδράσεις   υπερευαισθησίας   όπως   γενικευμένες   δερματικές  

αντιδράσεις, εξάψεις, οίδημα (οίδημα προσώπου, περιφερικό οίδημα και ανά 

σάρκα), υπέρταση, αρθραλγία και κνησμός

Πολύ   σπάνιες:  αλλεργικές   και   αναφυλακτικού   τύπου   αντιδράσεις   όπως  

ταχυκαρδία, υπόταση, κυκλοφορική καταπληξία και αναφυλακτικό σοκ

Έρευνες

Σπάνιες:  ανάπτυξη   αντισωμάτων   που   αδρανοποιούν   την   καλσιτονίνη.   Η  

ανάπτυξη αυτών των αντισωμάτων δεν σχετίζεται συνήθως με την απώλεια 

της κλινικής αποτελεσματικότητας, αν και η παρουσία τους σε μικρό ποσοστό 

ασθενών μετά από μακροχρόνια θεραπεία με υψηλές δόσεις καλσιτονίνης  

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μπορεί   να   έχει   ως   αποτέλεσμα   τη   μειωμένη   ανταπόκριση   στο   προϊόν.   Η  

παρουσία   αντισωμάτων   φαίνεται   να   μη   συσχετίζεται   με   αλλεργικές  

αντιδράσεις οι οποίες είναι σπάνιες. Η ρύθμιση προς τα κάτω των υποδοχέων 

της   καλσιτονίνης   μπορεί   να   έχει   ως   αποτέλεσμα   μειωμένη   κλινική  

ανταπόκριση σε μικρό ποσοστό ασθενών μετά από μακροχρόνια θεραπεία με 

υψηλές δόσεις.

Γενικές διαταραχές

Συχνές: κόπωση

Όχι συχνές: νόσος παρόμοια της γρίπης

Αν εμφανίσετε κάποια από αυτές τις ανεπιθύμητες ενέργειες ή κάποια άλλη που 

δεν αναφέρεται στο φύλλο οδηγιών, ενημερώστε τον γιατρό σας.

2.9 Τι πρέπει να γνωρίζετε στην περίπτωση που παραλείψατε μία δόση

Πάρτε τη δόση που παραλείψατε μόλις το θυμηθείτε, εκτός αν πλησιάζει η  

ώρα να πάρετε την επόμενη δόση. Σε αυτή τη περίπτωση πάρτε την επόμενη 

δόση στην κανονική ώρα.

Μην διπλασιάζετε τη δόση.

2.10 Ημερομηνία λήξης του προϊόντος

Πριν το φιαλίδιο να ανοιχθεί για πρώτη φορά, το προϊόν διατηρείται στο

            ψυγείο και μπορεί να χρησιμοποιηθεί μέχρι την ημερομηνία λήξης που

            αναγράφεται στο φιαλίδιο και στο κουτί. Σε περίπτωση που η ημερομηνία

            αυτή έχει παρέλθει, μην χρησιμοποιήσετε το προϊόν.

Μετά το άνοιγμα του φιαλιδίου για πρώτη φορά, το προϊόν μπορεί να 

φυλάσσεται και εκτός ψυγείου, σε θερμοκρασία 25  ο C ή χαμηλότερη των 

25   ο C. Μετά το άνοιγμα του φιαλιδίου για πρώτη φορά, το περιεχόμενο του 

φιαλιδίου πρέπει να χρησιμοποιείται μέσα σε 1 μήνα από την ημερομηνία που 

το φιαλίδιο ανοίχθηκε για πρώτη φορά, είτε το φιαλίδιο φυλάσσεται εντός 

ψυγείου είτε το φιαλίδιο φυλάσσεται εκτός ψυγείου.

2.11 Ιδιαίτερες προφυλάξεις για τη φύλαξη του προϊόντος

Διατηρήστε το προϊόν στο ψυγείο. Όταν το φιαλίδιο ανοιχθεί για πρώτη φορά, 

μπορεί   να   φυλάσσεται   και   εκτός   ψυγείου,   σε   θερμοκρασία   25   ο C  ή 

χαμηλότερη   των   25   ο C  και   το   περιεχόμενο   του   φιαλιδίου   πρέπει   να 

χρησιμοποιείται σε διάστημα 1 μηνός.

2.12 Ημερομηνία τελευταίας αναθεώρησης του φύλλου οδηγιών χρήσης

29-3-2011

3. ΠΛΗΡΟΦΟΡΙΕΣ   ΓΙΑ   ΤΗΝ   ΟΡΘΟΛΟΓΙΚΗ   ΧΡΗΣΗ   ΤΩΝ  

ΦΑΡΜΑΚΩΝ

Το φάρμακο αυτό σας το έγραψε ο γιατρός σας μόνο για το συγκεκριμένο  

ιατρικό σας πρόβλημα. Δεν θα πρέπει να το δίνετε σε άλλα άτομα ή να το  

χρησιμοποιείτε   για   κάποια   άλλη   πάθηση,   χωρίς   προηγουμένως   να   έχετε  

συμβουλευθεί τον γιατρό σας. 

Εάν κατά την διάρκεια της θεραπείας εμφανισθεί κάποιο πρόβλημα με το  

φάρμακο, ενημερώστε αμέσως τον γιατρό σας ή τον φαρμακοποιό σας.

Εάν   έχετε   οποιαδήποτε   ερωτηματικά   γύρω   από   τις   πληροφορίες   που  

αφορούν το φάρμακο που λαμβάνετε ή χρειάζεσθε καλύτερη ενημέρωση 

για το ιατρικό σας πρόβλημα, μην διστάσετε να ζητήσετε τις πληροφορίες 

            αυτές από το γιατρό σας ή το φαρμακοποιό σας.

Για να είναι αποτελεσματικό και ασφαλές το φάρμακο που σας χορηγήθηκε, 

θα πρέπει να λαμβάνεται σύμφωνα με τις οδηγίες που σας δόθηκαν.

Για την ασφάλειά σας και την υγεία σας, είναι απαραίτητο να διαβάσετε με

            προσοχή κάθε πληροφορία που αφορά το φάρμακο που σας χορηγήθηκε.

Να μην διατηρείτε τα φάρμακα σε ερμάρια του λουτρού, διότι η ζέστη και η 

υγρασία   μπορεί   να   αλλοιώσουν   το   φάρμακο   και   να   το   καταστήσουν  

επιβλαβές για την υγεία σας.

Να μην κρατάτε φάρμακα που δεν τα χρειάζεσθε πλέον ή που ήδη έχουν  

λήξει.

Για μεγαλύτερη ασφάλεια κρατάτε όλα τα φάρμακα σε ασφαλές μέρος 

μακριά από τα παιδιά.

4. ΤΡΟΠΟΣ ΔΙΑΘΕΣΗΣ

Το φάρμακο αυτό χορηγείται με ιατρική συνταγή.

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Document Outline

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

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

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

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

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

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

25-10-2018

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

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

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

9-10-2018

Notice of call for expressions of interest - Salmonella molecular serotyping

Notice of call for expressions of interest - Salmonella molecular serotyping

France - Agence Nationale du Médicament Vétérinaire

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

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

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

10-9-2018

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Outbreak of Salmonella Enteritidis Linked to Shell Eggs

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

8-9-2018

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

FDA - U.S. Food and Drug Administration

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

26-7-2018

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

24-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

23-7-2018

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

FDA - U.S. Food and Drug Administration

19-7-2018

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which 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 b...

FDA - U.S. Food and Drug Administration

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

15-6-2018

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which 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, diarrhe...

FDA - U.S. Food and Drug Administration

23-5-2018

Golden International Corporation  Issues Public Safety Warning For Stolen Tilapia Because  of Possible Health Risk

Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, an organism which 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. In rare circumstances, infection wi...

FDA - U.S. Food and Drug Administration

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which 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, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

4-5-2018

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, 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

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.

Health Canada

20-4-2018

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk.

FDA - U.S. Food and Drug Administration

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which 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. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

1-6-2018

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA) - Transfer of orphan designation - Commission Decision (2018)3398 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety