Elmex Medical Gel

Hauptinformation

  • Handelsname:
  • Elmex Medical Gel Dentalgel 1,25%
  • Dosierung:
  • 1,25%
  • Darreichungsform:
  • Dentalgel
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Elmex Medical Gel Dentalgel 1,25%
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE121037
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Gebrauchsinformation

GEBRAUCHSINFORMATION: INFORMATION FÜR ANWENDER

elmex Medical Gel, 1,25%, Dentalgel

Fluorid (Olaflur - Dectaflur - Natriumfluorid)

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw. genau

nach Anweisung Ihres Arztes oder Apothekers an.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Fragen Sie Ihren Apotheker, wenn Sie weitere Informationen oder einen Rat benötigen.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt

auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

Was ist elmex Medical Gel und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von elmex Medical Gel beachten?

Wie ist elmex Medical Gel anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist elmex Medical Gel aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

WAS IST ELMEX MEDICAL GEL UND WOFÜR WIRD ES ANGEWENDET?

Kategorie, wozu das Arzneimittel gehört

Gel gegen Karies mit zwei Bestandteilen aus der Klasse der fluoridhaltigen Amine (Olaflur und

Dectaflur) und Natriumfluorid.

Anwendungsgebiete

elmex Medical Gel ist zur Kariesprophylaxe angezeigt.

elmex Medical Gel kann von Personen mit Zahnspangen angewendet werden. Das Gel kann ebenfalls

auf Zahnflächen aufgetragen werden, die mit Teilprothesen oder herausnehmbaren Drahtschienen in

Kontakt kommen, und kann zur Behandlung von überempfindlichen Zahnhälse angewendet werden

(Zahnteilen die das Zahnfleisch berühren).

2.

WAS SOLLTEN SIE VOR DER ANWENDUNG VON ELMEX MEDICAL GEL

BEACHTEN?

elmex Medical Gel darf nicht angewendet werden,

bei Kindern unter 6 Jahren.

wenn Sie allergisch gegen die Wirkstoffe oder einen der

in Abschnitt 6. genannten

sonstigen

Bestandteile dieses Arzneimittels sind.

wenn Sie an einer Erkrankung der Mundschleimhaut leiden.

bei Patienten mit einer Knochen- und/oder Zahnschmelzfluorose (hellweiße Flecken auf dem Zahn

durch eine Änderung des Zahnschmelzes, die durch zu hohe Fluoridzufuhr während der

Zahnentwicklung entsteht).

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker bevor Sie elmex Medical Gel anwenden.

elmex Medical Gel nicht verschlucken.

Nicht unnötig anwenden. Die übermäßige Anwendung von Zubereitungen auf Fluoridbasis kann

eine Entfärbung von Zähnen hervorrufen, die die Sprödigkeit des Zahnschmelzes fördert.

Am Tag des Zähneputzens mit elmex Medical Gel wird empfohlen, eine Mundspülung, Zahnpasta,

ein anderes Gel oder Tabletten mit Fluorid nicht anzuwenden. Wenn möglich, auch Nahrungsmittel

oder Getränke vermeiden, die viel Calcium (Milchprodukte) oder Magnesium (Kakao, Getreide,

Gemüse, Trockenfrüchte, ölhaltige Früchte) enthalten. Solche Bestandteile vermindern die

Wirksamkeit von elmex Medical Gel. (Siehe auch die Rubrik „Anwendung von elmex Medical Gel

zusammen mit Nahrungsmitteln und Getränken“).

Wenn Sie noch andere Arzneimittel anwenden. Lesen Sie bitte auch die Rubrik “Anwendung von

elmex Medical Gel zusammen mit anderen Arzneimitteln”.

Konsultieren Sie Ihren Arzt, wenn einer der oben genannten Warnhinweise auf Sie zutrifft, oder in der

Vergangenheit auf Sie zutraf.

Anwendung von elmex Medical Gel zusammen mit anderen Arzneimitteln

elmex Medical Gel bildet mit Calcium, Magnesium und Aluminium unauflösliche Verbindungen.

Jeder Kontakt mit diesen Produkten ist vor und nach dem Zähneputzen zu vermeiden.

Informieren Sie Ihren Arzt oder Apotheker wenn Sie andere Arzneimittel anwenden, kürzlich

andere Arzneimittel angewendet haben oder beabsichtigen andere Arzneimittel anzuwenden.

Anwendung von elmex Medical Gel zusammen mit Nahrungsmitteln und Getränken

elmex Medical Gel bildet mit Calcium, Magnesium und Aluminium unauflösliche Verbindungen.

Jeder Kontakt mit diesen Produkten ist vor und nach dem Zähneputzen zu vermeiden. (Sie auch die

Rubrik „Warnhinweise und Vorsichtsmaßnahmen“).

Eventuell mit dem Apotheker oder dem Hausarzt Kontakt aufnehmen.

Schwangerschaft, Stillzeit und Zeugungs-/Gebärfähigkeit

elmex Medical Gel darf während der Schwangerschaft angewendet werden.

Fluoride gehen in die Muttermilch über. Darum muss elmex Medical Gel während der Stillzeit mit

Vorsicht angewendet werden.

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Anwendung dieses Arzneimittels

Ihren Arzt oder Apotheker um Rat.

elmex Medical Gel enthält Propylenglykol das Hautreizungen kann hervorrufen.

3.

WIE IST ELMEX MEDICAL GEL ANZUWENDEN?

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw.

genau nach der mit Ihrem Arzt oder Apotheker getroffenen Absprache an. Fragen Sie bei

Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Das Arzneimittel ist für die dentale Anwendung bestimmt und darf nicht verschluckt werden.

1. Anwendung zu Hause

Einmal pro Woche vor dem Schlafengehen nach dem Zähneputzen.

Vorab die Zähne mit einer Zahnbürste putzen und den Mund mit Wasser spülen.

Ungefähr 1 Zentimeter Gel auf die Zahnbürste auftragen und alle Oberflächen gründlich putzen. Zwei

bis drei Minuten einwirken lassen und vermeiden, das Gel zu verschlucken.

Der Überschuss an Gel und Speichel ausspucken.

Kurz mit Wasser spülen.

Anwendung bei Kindern

Eltern wird empfohlen, dass Sie kontrollieren ob Ihre Kinder das Gel korrekt anwenden, vor allem bei

Kindern unter 8 Jahren.

Empfehlung zur optimalen Anwendung: nach Anwendung die Tube auf den Schnappdeckel stellen; so

verwenden Sie den vollständigen Inhalt der Tube.

2. Schuldienste zur Zahnversorgung, Polikliniken und Zahnarztpraxen

Die Anwendung ist den Zahnärzten vorbehalten. (Siehe Ende der Gebrauchsinformation – “Die

folgenden Informationen sind für medizinisches Fachpersonal bestimmt”)

Wenn Sie eine größere Menge von elmex Medical Gel angewendet haben, als Sie sollten:

a) Symptome einer Überdosierung

Akute Überdosierung:

Eine lokale Reizung der Schleimhäute ist im Falle einer akuten Überdosierung möglich.

In extremen Fällen (z. B. bei Anwendung eines Löffels) von mehr als 100 mg Fluorid (entspricht

8 g elmex Medical Gel) kann, je nach Dosis und Anwendungsweise, elmex Medical Gel in die

Mundhöhle gelangen.

Das Verschlucken einer solchen Menge kann zu Erbrechen, Übelkeit und Durchfall führen.

In den meisten Fällen treten diese Symptome in der ersten Stunde nach Einnahme auf und

verschwinden nach 3 bis 6 Stunden.

Chronische Überdosierung:

Bis zum Alter von ± 8 Jahren (während der Bildung von Zähnen) kann die regelmäßige

Anwendung von einer täglichen Dosis Fluorid von 2 mg zu Störungen der Mineralisation des

Zahnschmelzes führen.

Dieser Zustand, bekannt als Fluorosis dentalis, tritt nach diesem Alter nicht mehr auf, selbst bei

hohen täglichen Mengen. Es können noch Flecken auf dem Zahnschmelz auftreten.

b) Behandlung bei Überdosierung

Akute Überdosierung:

Bei leichten Symptomen einer Intoxikation (weniger als 100 mg Fluorid, entsprechend weniger als

8 g elmex Medical Gel), müssen calciumhaltige Getränke (Milch, trinkbare Calciumtabletten)

verabreicht werden, um Fluorid zu binden.

Bei schweren Symptomen einer Intoxikation (mehr als 100 mg Fluorid, entsprechend mehr als 8 g

elmex Medical Gel) wird eine zusätzliche Verabreichung von Aktivkohle empfohlen. Falls

erforderlich, kann Calcium intravenös verabreicht werden, oder mit der Förderung von Diurese

durch das Alkalinisieren des Urins begonnen werden.

Der Herzschlag, die Blutgerinnung, die Elektrolyte und das Säure-Basen-Gleichgewicht müssen

sorgfältig kontrolliert werden.

Wenn Sie zuviel von elmex Medical Gel angewendet oder eingenommen haben, nehmen Sie sofort

Kontakt mit Ihrem Arzt, Apotheker oder der Giftnotrufzentrale auf (070/245.245).

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie sich an

Ihren Arzt oder Apotheker.

4.

MÖGLICHE NEBENWIRKUNGEN

Wie alle Arzneimittel kann

auch dieses Arzneimittel

Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Erkrankungen der Haut und des Unterhautzellgewebes

In individuellen Fällen:

Mundschleimhaut

Abschilferung

Oberflächige Erosionen und Blasenbildung nach Anwendung mit einem Löffel im Falle einer

häufigen Anwendung

Überempfindlichkeit, Intoleranz, allergische Reaktionen

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt Apotheker. Dies gilt auch für

Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt anzeigen über:

Föderalagentur für Arzneimittel und Gesundheitsprodukte, Abteilung Vigilanz,

EUROSTATION II, Victor Hortaplein, 40/40, B-1060 Brussel

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen

über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

WIE IST ELMEX MEDICAL GEL AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Bei Raumtemperatur (15 °C - 25 °C) aufbewahren.

Die Tube aufrecht auf den Schnappdeckel lagern.

Verfalldatum

Sie dürfen

elmex Medical Gel

nach dem auf dem Umkarton/der Tube nach EXP angegebenen

Verfalldatum nicht mehr

verwenden

. Das Verfalldatum bezieht sich auf den letzten Tag des

angegebenen

Monats.

6.

INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was elmex Medical Gel enthält

Die Wirkstoffe sind Olaflur, Dectaflur und Natriumfluorid. Diese sind in Form von Olaflur 30,32

mg (= 0,231 %F

) - Dectaflur 2,87 mg (= 0,019%F

) - Natriumfluorid 22,1 mg (=1,0%F

vorhanden, entsprechend 12,5 mg Fluorid (1,25%F

) per Gramm.

Die sonstigen Bestandteile sind Hydroxyethylcellulose, Propylenglykol, Saccharin,

Pfefferminzaroma, Grüne Minze Öl, Menthonaroma, synthetisches Apfel- und Bananenaroma,

gereinigtes Wasser.

Wie elmex Medical Gel aussieht und Inhalt der Packung

elmex Medical Gel ist ein farbloses bis leicht gelbliches Gel für den Dentalgebrauch mit Apfel- und

Pfefferminzgeschmack. elmex Medical Gel ist in Tuben von 25 g und 38 g und in Tuben von 215 g

(Anstaltspackung) verpackt.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer

CP GABA GmbH, Beim Strohhause 17, 20097 Hamburg, Deutschland

Hersteller

Thépenier Pharma Industrie, Route d’Alencon, Saint-Langis-Les-Mortagne, Mortagne, 61400,

Frankreich

Örtlicher Vertreter

Colgate-Palmolive Belgium sa/nv

Vorstlaan 165

1160 Brussel

tel: 00800/321 321 32

Zulassungsnummer

BE121037

Abgabe

Freie Abgabe

Diese

Packungsbeilage

wurde zuletzt

genehmigt

in

09/2015

Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt:

Schuldienste zur Zahnversorgung, Polikliniken und Zahnarztpraxen

Die Anwendung ist den Zahnärzten vorbehalten.

Das Auftragen von elmex Medical Gel kann mit einem speziellen Gelträger (zum Beispiel mit einem

Abdruckapplikator, der das Gebiss des Oberkiefers und/oder des Unterkiefers vollständig umschließt).

Das Gelbad vorzugsweise 4 Minuten lang auf die vorab geputzten und getrockneten Zähne auftragen.

Danach reinigen und spülen.

Ihren Patienten empfehlen, den Überschuss an Gel nicht zu verschlucken.

Die Behandlung alle 6 Monate wiederholen.

Empfehlung zur optimalen Anwendung: nach Anwendung die Tube auf den Schnappdeckel stellen; so

verwenden Sie den vollständigen Inhalt der Tube.

12-12-2018

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December 4, 2018: Medical Device Maker ev3 Agrees to Plead Guilty and Pay $17.9 Million for Distributing Adulterated Device

December 4, 2018: Medical Device Maker ev3 Agrees to Plead Guilty and Pay $17.9 Million for Distributing Adulterated Device

FDA - U.S. Food and Drug Administration

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

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FDA - U.S. Food and Drug Administration

10-12-2018

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

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28-11-2018

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22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

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14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here:  https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological  Health, released a statement on updated safety  communication about  rates of duodenoscope contamination from  preliminary postmarket data.  Read the statement here:  https://go.usa.g

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.g

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for  developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here:  https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

FDA - U.S. Food and Drug Administration

11-12-2018

Regulation of Software as a Medical Device

Regulation of Software as a Medical Device

Updated information on the regulation of Software as a Medical Device

Therapeutic Goods Administration - Australia

10-12-2018

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more:  https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

. @US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDA pic.twitter.com/HiJbgPnsPt

FDA - U.S. Food and Drug Administration

2-12-2018

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt

FDA - U.S. Food and Drug Administration

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall:  https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

FDA - U.S. Food and Drug Administration

28-11-2018

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Clarification of ISO 13485 certificates for IVD medical devices

Therapeutic Goods Administration - Australia

27-11-2018

Reclassification of surgical mesh medical devices

Reclassification of surgical mesh medical devices

New guidance to assist sponsors with the reclassification of surgical mesh devices

Therapeutic Goods Administration - Australia

26-11-2018

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do:  https://go.usa.gov/xPHtk   #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

26-11-2018

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Actio

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Actio

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018

FDA - U.S. Food and Drug Administration

26-11-2018

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

24-11-2018

Pan-Ophtal® Gel

Rote - Liste

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/18/2096 (Hansa Medical AB)

EU/3/18/2096 (Hansa Medical AB)

EU/3/18/2096 (Active substance: Imlifidase) - Orphan designation - Commission Decision (2018)7806 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/093/18

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more:  https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

. @US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevice pic.twitter.com/pv0k2yaNfj

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more:  https://go.usa.gov/xPAzD  #MedicalDevice

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

. @US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

12-11-2018

Tostran 2% Gel

Rote - Liste

9-11-2018

Micotar® Mundgel

Rote - Liste

7-11-2018

ACMD meeting statement, Meeting 43, 11 October 2018

ACMD meeting statement, Meeting 43, 11 October 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

2-11-2018

.@US_FDA  issues a class I recall: Roche Diagnostics recalls CoaguChek  XS PT Test  Strips due to inaccurate INR test results. Find out more:  https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc

FDA - U.S. Food and Drug Administration

2-11-2018

Check out @US_FDA's information on Direct-to-Consumer Tests:  https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

2-11-2018

How to determine if your product should be included in the ARTG

How to determine if your product should be included in the ARTG

Assistance for sponsors with products included in the ARTG as Class I medical devices to decide if their products are included correctly

Therapeutic Goods Administration - Australia

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

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

30-10-2018

#DYK: Mammograms are still the best tool for breast cancer screening.  Check out @US_FDA’s information on the importance of choosing a certified mammography facility:  https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH

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

26-10-2018

Thilo-Tears Gel

Rote - Liste

24-10-2018

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute:  https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

FDA - U.S. Food and Drug Administration

23-10-2018

Metrogel® 0,75%

Rote - Liste

23-10-2018

Benzaknen® 5 %/10 % Gel

Rote - Liste

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

19-10-2018

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

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

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

FDA - U.S. Food and Drug Administration