NADIXA

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • NADIXA 1% W/W CREAM
  • Φαρμακολογική κατηγορία (ATC):
  • D10AF
  • Δοσολογία:
  • 1% W/W
  • Φαρμακοτεχνική μορφή:
  • ΚΡΕΜΑ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

Εντοπισμός

  • Διατίθεται σε:
  • NADIXA 1% W/W CREAM
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική ομάδα:
  • Antiinfectives for treatment of acne
  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

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

φύλλο οδηγιών χρήσης

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ: ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟΝ ΧΡΗΣΤΗ

Nadixa 1% Κρέμα

Δραστικό συστατικό: Ναδιφλοξασίνη

Διαβάστε προσεκτικά ολόκληρο το φύλλο οδηγιών χρήσης προτού αρχίσετε να χρησιμοποιείτε 

αυτό το φάρμακο.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης. Ίσως χρειαστεί να το διαβάσετε ξανά.

Εάν έχετε περαιτέρω απορίες, ρωτήστε το γιατρό ή το φαρμακοποιό σας.

Η συνταγή για αυτό το φάρμακο χορηγήθηκε για σας. Δεν πρέπει να δώσετε το φάρμακο σε 

άλλους. Μπορεί να τους προκαλέσει βλάβη, ακόμα και όταν τα συμπτώματά τους είναι ίδια 

με τα δικά σας.

Εάν κάποια ανεπιθύμητη ενέργεια γίνεται σοβαρή, ή αν παρατηρήσετε κάποια ανεπιθύμητη 

ενέργεια που δεν αναφέρεται στο παρόν φύλλο οδηγιών, παρακαλείσθε να ενημερώσετε το 

γιατρό ή φαρμακοποιό σας.

Το παρόν φύλλο οδηγιών περιέχει:

Τι είναι το Nadixa 1% κρέμα και ποια είναι η χρήση του

Τι πρέπει να γνωρίζετε προτού χρησιμοποιήσετε το Nadixa 1% κρέμα  

Πώς να χρησιμοποιήσετε το Nadixa 1% κρέμα  

Πιθανές ανεπιθύμητες ενέργειες

Πώς να φυλάσσεται το Nadixa 1% κρέμα  

Λοιπές πληροφορίες

1. ΤΙ ΕΙΝΑΙ ΤΟ NADIXA ΚΑΙ ΠΟΙΑ ΕΙΝΑΙ Η ΧΡΗΣΗ ΤΟΥ

Το Nadixa είναι ένας αντιλοιμώδης παράγοντας, που ανήκει στην ομάδα των κινολονών. 

Η κρέμα Nadixa χρησιμοποιείται για την τοπική θεραπεία ήπιων έως μέτριων φλεγμονωδών μορφών 

κοινής ακμής (βλατιδοφλυκταινώδης ακμή, βαθμού Ι-ΙΙ).

2. ΤΙ ΠΡΕΠΕΙ ΝΑ ΓΝΩΡΙΖΕΤΕ ΠΡΙΝ ΝΑ ΧΡΗΣΙΜΟΠΟΙΗΣΕΤΕ ΤΟ NADIXA

Μη χρησιμοποιήσετε το Nadixa

Σε περίπτωση αλλεργίας (υπερευαισθησίας) στη ναδιφλοξασίνη ή σε οποιοδήποτε άλλο 

συστατικό του Nadixa.

Προσέξτε ιδιαίτερα με το Nadixa

Πρέπει   να   αποφεύγεται   η   επαφή   με   τα   μάτια   ή   με   άλλους   βλεννογόνους.  Tα   μάτια   ή   οι 

βλεννογόνοι πρέπει να ξεπλένονται άμεσα με ζεστό νερό μετά από ακούσια επαφή με την κρέμα 

Nadixa.

Μετά την εφαρμογή της κρέμας Nadixa, τα χέρια πρέπει να πλένονται με ζεστό νερό και σαπούνι, 

ώστε να αποφεύγεται η ακούσια επαφή της κρέμας Nadixa με άλλες περιοχές του δέρματος.

Κατά   τη   θεραπεία   με   άλλες   κινολόνες   που   χορηγούνται   συστηματικά   έχουν   παρατηρηθεί 

αντιδράσεις φωτοευαισθησίας. Ενώ σε αρκετές μελέτες σε ζώα και σε ανθρώπους η δραστική 

ουσία  ναδιφλοξασίνη  δεν έχει δείξει δυναμικό φωτοτοξικότητας ή φωτοαλλεργίας, η βάση της 

κρέμας   ενδέχεται   να   αυξήσει   την   φωτοευαισθησία.   Επίσης   δεν   υπάρχει   εμπειρία   με   την 

παρατεταμένη έκθεση στο ηλιακό φως ή σε τεχνητό υπεριώδες (UV) φως με παράλληλη χρήση 

της   κρέμας  Nadixa.   Συνεπώς   οι   ασθενείς   που   χρησιμοποιούν   την   κρέμα  Nadixa  πρέπει   να 

αποφεύγουν   κάθε   έκθεση   στην   τεχνητή   ακτινοβολία  UV  (λάμπες  UV,   τεχνητό   μαύρισμα, 

solarium) και όποτε είναι δυνατόν την έκθεση στο ηλιακό φως.

Εάν   παρουσιασθεί   αντίδραση   υπερευαισθησίας   (με   τη   μορφή   κνησμού,   σχηματισμού 

ερυθήματος, βλατίδων, φλυκταινών) ή σοβαρός ερεθισμός του δέρματος, πρέπει να διακοπεί η 

χρήση του κρέμας Nadixa.

Η κρέμα Nadixa δεν πρέπει να χρησιμοποιείται σε τραυματισμένο, σκισμένο ή γδαρμένο δέρμα.

Παιδιά

Η ασφάλεια και αποτελεσματικότητα της κρέμας Nadixa δεν έχει μελετηθεί επαρκώς σε παιδιά 

ηλικίας κάτω των 14 ετών. Συνεπώς η κρέμα Nadixa δεν πρεπει να χρησιμοποιείται σε ασθενείς 

αυτής της ηλικιακής ομάδας.

Λήψη ή Χρήση άλλων φαρμάκων

Παρακαλείσθε να ενημερώσετε το γιατρό ή το φαρμακοποιό σας εάν παίρνετε ή έχετε πάρει 

πρόσφατα άλλα φάρμακα, ακόμα και αυτά που δεν σας έχουν χορηγηθεί με συνταγή.

Η απορρόφηση της ναδιφλοξασίνης μετά την εφαρμογή της κρέμας  Nadixa  στο δέρμα είναι πολύ 

χαμηλή  και συνεπώς  αλληλεπίδραση με άλλα συγχορηγούμενα  από του στόματος φάρμακα είναι 

απίθανη. Δεν υπάρχουν στοιχεία που να υποδεικνύουν ότι η αποτελεσματικότητα των συστηματικώς 

χορηγούμενων φαρμάκων μπορεί να επηρεαστεί από την τοπική χρήση της κρέμας Nadixa.

Η   κρέμα  Nadixa  μπορεί   να   προκαλέσει   δερματικό   ερεθισμό   και   συνεπώς   είναι   πιθανό   ότι   η 

συγχορήγησή   της   με   προϊόντα   απολέπισης,   στυπτικά   καθαριστικά   και   προϊόντα   που   περιέχουν  

ερεθιστικές   ουσίες,   όπως   αρωματικές   και   αλκοολικές   ουσίες,  ενδέχεται   να  προκαλέσει   αυξημένο 

δερματικό ερεθισμό. 

Κύηση και θηλασμός

Δεν υπάρχουν διαθέσιμα κλινικά δεδομένα όσον αφορά στη χρήση της κρέμας ναδιφλοξασίνης κατά 

τη διάρκεια της εγκυμοσύνης.

Μελέτες σε ζώα δεν καταδεικνύουν κάποια τερατογόνο δράση ή αρνητικές επιπλοκές στην ανάπτυξη  

του εμβρύου.

Εντούτοις, η κρέμα Nadixa πρέπει να χρησιμοποιείται κατά τη διάρκεια της εγκυμοσύνης μόνο μετά 

από εκτίμηση του οφέλους και των κινδύνων για τη μητέρα και το αναπτυσσόμενο έμβρυο από ένα 

γιατρό.

Η ναδιφλοξασίνη είναι γνωστό ότι απεκκρίνεται στο μητρικό γάλα και συνεπώς η κρέμα Nadixa δεν 

πρέπει   να   χρησιμοποιείται   κατά   τη   διάρκεια   του   θηλασμού.   Σε   καμία   περίπτωση   δεν   πρέπει   οι 

γυναίκες που θηλάζουν να επαλείφουν την κρέμα Nadixa στην περιοχή του στήθους. 

Οδήγηση και χειρισμός μηχανών

Δεν απαιτείται καμία ιδιαίτερη προφύλαξη.

Σημαντικές πληροφορίες σχετικά με ορισμένα συστατικά του Nadixa

Η στεατυλική αλκοόλη και η κητυλική αλκοόλη μπορεί να προκαλέσουν τοπικό ερεθισμό του 

δέρματος (π.χ. δερματίτιδα εξ’επαφής). Το χλωριούχο βενζαλκόνιο μπορεί να προκαλέσει ερεθισμό 

του δέρματος.

3. ΠΩΣ ΝΑ ΧΡΗΣΙΜΟΠΟΙΗΣΕΤΕ ΤΟ NADIXA

Πάντοτε να χρησιμοποιείτε την κρέμα Nadixa αυστηρά σύμφωνα με τις οδηγίες του γιατρού σας. Εάν 

έχετε αμφιβολίες, ρωτήστε το γιατρό ή το φαρμακοποιό σας.

Ένα λεπτό στρώμα κρέμας Nadixa πρέπει να εφαρμόζεται στις πάσχουσες περιοχές του δέρματος δύο 

φορές   την   ημέρα.   Η   κρέμα  Nadixa  είναι   κατάλληλη   μόνο   για   δερματική   χρήση   και   πρέπει   να 

εφαρμόζεται   ως   ένα   λεπτό   στρώμα   στις   πάσχουσες   περιοχές   το   πρωί   και   το   βράδυ   πριν   την 

κατάκλιση, αφού πρώτα καθαριστεί το δέρμα. Το δέρμα πρέπει να στεγνώνεται καλά πριν τη χρήση. 

Η κρέμα  Nadixa δεν πρέπει να έρθει σε επαφή με τα μάτια και τα χείλη (βλέπε επισης «Προσέξτε 

ιδιαίτερα με το Nadixa»). Για να αποφύγετε τις επιμολύνσεις, η κρέμα Nadixa πρέπει να εφαρμόζεται 

με ένα τολύπιο βάμβακος. Η κρέμα Nadixa δεν πρέπει να χρησιμοποιείται με κλειστή επίδεση (κάτω 

από σφιχτό επίδεσμο). Η διάρκεια της θεραπείας είναι έως και 8 εβδομάδες.

Εάν χρησιμοποιήσετε περισσότερη κρέμα     Nadixa     από την κανονική:    

Μπορεί να εμφανιστεί έντονη ερυθρότητα ή δυσάρεστη αίσθηση στο δέρμα.

Εάν η κρέμα  Naxida  καταποθεί ακούσια, πρέπει να εξετάζεται  κένωση του στομάχου, εκτός εάν η 

ποσότητα που ελήφθη είναι μικρή.

Εάν ξεχάσετε να χρησιμοποιήσετε την κρέμα     Nadixa    :  

Σε περίπτωση που ξεχάσετε να χρησιμοποιήσετε την κρέμα Nadixa, συνεχίστε την εφαρμογή όπως 

περιγράφεται στις οδηγίες, ή από το γιατρό σας.

Εάν σταματήσετε να χρησιμοποιείτε     την κρέμα     Nadixa    :  

Για να επιτύχετε τον επιθυμητό θεραπευτικό στόχο ακολουθήστε προσεκτικά τις οδηγίες για τη 

διάρκεια της χρήσης που περιέχονται στην παράγραφο «Πώς να χρησιμοποιήσετε την κρέμα Nadixa» 

ή αυτές που σας δόθηκαν από το γιατρό. Η θεραπεία δεν πρέπει να διακόπτεται ή να σταματάει χωρίς 

τη συμβουλή γιατρού.

Εάν έχετε περισσότερες ερωτήσεις σχετικά με τη χρήση αυτού του προϊόντος ρωτήστε το γιατρό ή το 

φαρμακοποιό σας.

4. ΠΙΘΑΝΕΣ ΑΝΕΠΙΘΥΜΗΤΕΣ ΕΝΕΡΓΕΙΕΣ

Όπως όλα τα φάρμακα, έτσι και το Nadixa μπορεί να προκαλέσει ανεπιθύμητες ενέργειες αν και δεν 

παρουσιάζονται σε όλους τους ανθρώπους.

Η πιο συχνά αναφερόμενη ανεπιθύμητη ενέργεια σε κλινικές μελέτες ήταν κνησμός (>1,8%).

Οι   ανεπιθύμητες   ενέργειες   που   παρουσιάζονται   πιό   συχνά   με   την   κρέμα   ναδιφλοξασίνης   και 

αναφέρθηκε ότι πιθανά σχετίζονται με το φάρμακο καταγράφονται κατωτέρω.

Οι συχνότητες αντιστοιχούν σε:

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 δέρματος και του υποδόριου ιστού:

Συχνές: κνησμός

Όχι συχνές: βλατίδες, ξηροδερμία, δερματίτιδα εξ΄επαφής, ερεθισμός του δέρματος, καύσος δέρματος

Αγγειακές διαταραχές:

Όχι συχνές: έξαψη

Δεδομένα μετά την κυκλοφορία:

Μεμονωμένες αναφορές: ερύθημα, κνίδωση και υπόχρωση του δέρματος 

Εάν κάποια ανεπιθύμητη ενέργεια γίνεται σοβαρή, ή αν  παρατηρήσετε κάποια ανεπιθύμητη ενέργεια 

που δεν αναφέρεται στο παρόν φύλλο οδηγιών, παρακαλείσθε να ενημερώσετε το γιατρό ή το 

φαρμακοποιό σας.

5. ΠΩΣ ΝΑ ΦΥΛΑΣΣΕΤΑΙ ΤΟ NADIXA

Να φυλάσσεται σε μέρη που δεν το φθάνουν και δεν το βλέπουν τα παιδιά.

Να μη χρησιμοποιείτε το Nadixa μετά την ημερομηνία λήξης που αναφέρεται στο σωληνάριο και στο 

κουτί. Η ημερομηνία λήξης είναι η τελευταία ημέρα του μήνα που αναφέρεται.

Δεν υπάρχουν ειδικές οδηγίες διατήρησης για το προϊόν αυτό.

Τα φάρμακα δεν πρέπει να απορρίπτονται στο νερό της αποχέτευσης ή στα σκουπίδια. Ρωτήστε το 

φαρμακοποιό σας πώς να πετάξετε τα φάρμακα που δε χρειάζονται πια. Αυτά τα μέτρα θα βοηθήσουν 

στην προστασία του περιβάλλοντος.

6. ΛΟΙΠΕΣ ΠΛΗΡΟΦΟΡΙΕΣ

Τι περιέχει το Nadixa

Η δραστική ουσία είναι η ναδιφλοξασίνη (1%). Κάθε γραμμάριο κρέμας περιέχει 10 mg 

ναδιφλοξασίνης.

Τα  άλλα  συστατικά  είναι:  White  soft  paraffin,  light  liquid  paraffin,  stearyl  alcohol,  cetyl 

alcohol, Ceteth 5, Ceteth 20, sodium hydroxide, glycerol, diethanolamine, edetate disodium, 

benzalkonium chloride και purified water.

Εμφάνιση του Nadixa και περιεχόμενο της συσκευασίας

Λευκή έως υπόλευκη κρέμα, χωρίς ιδιάζουσα οσμή.

Σωληνάρια που περιέχουν 10 g, 20 g, 25 g, 30 g και 50 g.

Σωληνάρια που περιέχουν 5 g (μόνο ως δείγματα).

Μπορεί να μην κυκλοφορούν όλες οι συσκευασίες.

Κάτοχος αδείας κυκλοφορίας και παραγωγός

Δικαιούχος σήματος και παραγωγός

FERRER-INTERNACIONAL, S.A.

Gran Via Carlos IIl, 94

08028 Barcelona (Spain)

Yπεύθυνος Κυκλοφορίας

Ferrer-Galenica A.E.

Ελευθερίας 4, 14564, Κηφισιά  

Τηλ. 210 52 81 700

Το παρόν φύλλο οδηγιών χρήσης εγκρίθηκε για τελευταία φορά στις {ημερομηνία} 

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FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA - U.S. Food and Drug Administration

16-11-2018

FDA approves new drug to treat travelers’ diarrhea

FDA approves new drug to treat travelers’ diarrhea

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

FDA - U.S. Food and Drug Administration

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

14-11-2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

FDA - U.S. Food and Drug Administration

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

14-9-2018

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA - U.S. Food and Drug Administration

13-9-2018

FDA approves new kind of treatment for hairy cell leukemia

FDA approves new kind of treatment for hairy cell leukemia

FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

"My Medicines" ... This Brochure Can be a Lifesaver

"My Medicines" ... This Brochure Can be a Lifesaver

"My Medicines" a brochure offered by FDA's Office of Women's Health, can play a vital role in the medical treatment you receive during an emergency.

FDA - U.S. Food and Drug Administration

7-9-2018

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

22-8-2018

FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

FDA - U.S. Food and Drug Administration

22-8-2018

Orphan designation:  Omaveloxolone,  for the: Treatment of Friedreich's ataxia

Orphan designation: Omaveloxolone, for the: Treatment of Friedreich's ataxia

Europe - EMA - European Medicines Agency

22-8-2018

Orphan designation:  Argon,  for the: Treatment of perinatal asphyxia

Orphan designation: Argon, for the: Treatment of perinatal asphyxia

Europe - EMA - European Medicines Agency

17-8-2018

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA - U.S. Food and Drug Administration

16-8-2018

FDA approves first generic version of EpiPen

FDA approves first generic version of EpiPen

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

FDA - U.S. Food and Drug Administration

13-8-2018

Health Canada Warns Canadians of New Safety Information Related to Long-Term Use of Azithromycin Following Stem Cell Transplants in Cancer Treatment

Health Canada Warns Canadians of New Safety Information Related to Long-Term Use of Azithromycin Following Stem Cell Transplants in Cancer Treatment

OTTAWA – Health Canada is warning Canadians of the potential risk of cancer relapse in patients with cancer of the blood and lymph nodes who have undergone stem cell transplant and are taking long-term azithromycin (Zithromax).

Health Canada

10-8-2018

FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

8-8-2018

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

FDA - U.S. Food and Drug Administration

7-8-2018

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

6-8-2018

Orphan designation:  Metreleptin,  for the: Treatment of Lawrence syndrome

Orphan designation: Metreleptin, for the: Treatment of Lawrence syndrome

Europe - EMA - European Medicines Agency

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

3-8-2018

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical ...

FDA - U.S. Food and Drug Administration

2-8-2018

Orphan designation:  Lenalidomide,  for the: Treatment of diffuse large B-cell lymphoma

Orphan designation: Lenalidomide, for the: Treatment of diffuse large B-cell lymphoma

On 13 May 2011, orphan designation (EU/3/11/868) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of diffuse large B-cell lymphoma.

Europe - EMA - European Medicines Agency

2-8-2018

Orphan designation:  Pomalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Pomalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

13-11-2018

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA  encourages patients and caregivers to beware of illegally markets  diabetes treatments. Check out our Consumer Update on this issue  http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

26-10-2018

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options:  https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1

FDA - U.S. Food and Drug Administration

16-10-2018

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults:  https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH . pic.twitter.com/5mo0xuGCcK

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

13-9-2018

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

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

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

Europe - EMA - European Medicines Agency

3-9-2018

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

To provide health professionals with information on how new pathways will contribute to providing treatment for patients with serious and life threatening conditions

Therapeutic Goods Administration - Australia

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency