Lamisil Pedisan Once

Hauptinformation

  • Handelsname:
  • Lamisil Pedisan Once Filmbildende Lösung
  • Darreichungsform:
  • Filmbildende Lösung
  • Zusammensetzung:
  • terbinafinum 10 mg zu terbinafini hydrochloridum, excipiens zur Lösung pro 1 g.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Lamisil Pedisan Once Filmbildende Lösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Fusspilz

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 57223
  • Berechtigungsdatum:
  • 23-09-2005
  • Letzte Änderung:
  • 25-10-2018

Packungsbeilage

Patienteninformation

Transferiert von Novartis Consumer Health Schweiz AG

Lamisil Pedisan® Once Filmbildende Lösung

GSK Consumer Healthcare Schweiz AG

Was ist Lamisil Pedisan Once und wann wird es angewendet?

Lamisil Pedisan Once Filmbildende Lösung ist ein Arzneimittel zur einmaligen Anwendung für die

Behandlung von Fusspilz. Das Präparat enthält den Wirkstoff Terbinafin. Nach Anwendung der

filmbildenden Lösung bleibt ein farbloser Film auf den Füssen zurück. Aus diesem Film wird der

Wirkstoff zur Behandlung des Fusspilzes in die Haut abgegeben.

Unter der Behandlung mit Lamisil Pedisan Once klingen die allgemeinen Symptome von Fusspilz

wie Juckreiz, Schuppung und Rötung ab.

Was sollte dazu beachtet werden?

Zur Verhinderung von Fusspilz sollten Sie einige Regeln beachten:

·Strümpfe täglich wechseln.

·Enges Schuhwerk vermeiden.

·Nach dem Waschen Haut sorgfältig trocknen.

·Handtücher täglich wechseln.

·Nicht barfuss gehen, täglich Strümpfe und Schuhe innen mit einem gegen Pilzinfektionen

wirksamen Puder bestreuen oder mit einem Spray besprühen.

·Hände nach der Anwendung und nach Kontakt mit den erkrankten Hautstellen gut waschen. Damit

kann die Weiterverbreitung der Pilzinfektion verhindert werden.

Wann darf Lamisil Pedisan Once nicht angewendet werden?

Lamisil Pedisan Once darf nicht angewendet werden bei Überempfindlichkeit gegenüber dem

Wirkstoff Terbinafin oder einem der enthaltenen Hilfsstoffe.

Bei Kindern unter 15 Jahren: Lamisil Pedisan Once wurde für die Anwendung bei Kindern unter 15

Jahren nicht geprüft. Die Anwendung von Lamisil Pedisan Once wird bei Kindern unter 15 Jahren

deshalb nicht empfohlen.

Wann ist bei der Anwendung von Lamisil Pedisan Once Vorsicht geboten?

Lamisil Pedisan Once ist nur für den äusserlichen Gebrauch bestimmt (nicht im Mund anwenden,

nicht einnehmen).

Lamisil Pedisan Once nicht im Gesicht anwenden; es darf nicht in die Augen gelangen. Falls Lamisil

Pedisan Once trotzdem mit den Augen in Kontakt kommt, sind die Augen sofort unter fliessendem

Wasser gut auszuspülen.

Konsultieren Sie Ihren Arzt bzw. Ihre Ärztin, falls allfällige Beschwerden nicht verschwinden.

Lamisil Pedisan Once sollte auf geschädigter Haut (z.B. nach Sonnenexposition, bei stark

schuppender und/oder rissiger Haut) vorsichtig angewendet werden, da der enthaltene Alkohol zu

Reizungen führen kann.

Bei ausgedehntem Pilzbefall, bei langandauernden Pilzinfektionen oder bei Mitbefall der Nägel ist

der Arzt bzw. die Ärztin aufzusuchen.

Während der Behandlung mit Lamisil Pedisan Once sollten auf die behandelten Hautstellen keine

anderen Arzneimittel aufgetragen werden.

Lamisil Pedisan Once Filmbildende Lösung enthält Alkohol – von offener Flamme fernhalten.

Informieren Sie Ihren Arzt, Apotheker oder Drogisten bzw. Ihre Ärztin, Apothekerin oder Drogistin,

wenn Sie

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbst gekaufte!) einnehmen oder äusserlich anwenden.

Darf Lamisil Pedisan Once während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Schwangerschaft

Während der Schwangerschaft darf Lamisil Pedisan Once nicht angewendet werden, ausser auf

ausdrückliche ärztliche Verschreibung. Wenn Sie vermuten schwanger zu sein oder wenn Sie eine

Schwangerschaft planen, sollten Sie Lamisil Pedisan Once nur nach ärztlicher Rücksprache

anwenden.

Stillzeit

Während der Stillzeit darf Lamisil Pedisan Once nicht angewendet werden. Kleinkinder dürfen mit

den behandelten Hautstellen nicht in Kontakt kommen.

Wie verwenden Sie Lamisil Pedisan Once?

Erwachsene und Jugendliche ab 15 Jahren:

Lamisil Pedisan Once ist für die einmalige Anwendung bestimmt.

·Vor der Anwendung von Lamisil Pedisan Once, die Hände gut waschen und die betroffenen

Hautstellen an den Füssen mit einem Wattebausch und warmem Wasser gründlich reinigen und

sorgfältig abtrocknen.

·Lamisil Pedisan Once soll auf beide Füsse aufgetragen werden, damit die Pilze auch dort behandelt

und beseitigt werden, wo sie nicht sichtbar sind. Verwenden Sie für jeden Fuss je ungefähr den halbe

Tubeninhalt. Beenden Sie die Behandlung des ersten Fusses bevor Sie den zweiten Fuss behandeln.

·Zuerst wird Lamisil Pedisan Once in einer dünnen Schicht zwischen und um alle Zehen herum

aufgetragen.

·Anschliessend Lamisil Pedisan Once auf die ganze Fusssohle und bis ungefähr 1.5 cm am Fuss nach

oben (siehe Bild) auftragen. Nicht einreiben, nicht einmassieren.

·Dann die aufgetragene Lösung während 1–2 Minuten eintrocknen lassen, bevor Sie Socken und

Schuhe anziehen.

·Nach der Anwendung die Hände gut waschen.

·Tragen Sie das Präparat kein zweites Mal auf.

·Nicht verwendetes Arzneimittel ist zu entsorgen.

Um gute Resultate zu erzielen, muss Lamisil Pedisan Once während 24 Stunden auf den Füssen

belassen werden und darf nicht abgewaschen werden. Vorzugsweise sollte deshalb Lamisil Pedisan

Once nach einer Dusche oder einem Bad aufgetragen werden.

Sind nach 1 Woche keine Anzeichen einer Besserung festzustellen, ist ein Arzt oder eine Ärztin zu

konsultieren.

Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt bzw. von der Ärztin

verschriebene Dosierung.

Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt,

Apotheker oder Drogisten bzw. mit Ihrer Ärztin, Apothekerin oder Drogistin.

Welche Nebenwirkungen kann Lamisil Pedisan Once haben?

Folgende Nebenwirkungen können bei der Anwendung von Lamisil Pedisan Once auftreten:

Gelegentlich (bei bis zu 1 von 100 Personen) kann es an der Applikationsstelle zu Rötungen,

Hauttrockenheit, Hautreizungen, Jucken oder einem Brennen auf der Haut kommen.

Sehr selten (bei weniger als 1 von 10'000 Personen) wurden allergische Reaktionen beobachtet.

Informieren Sie sofort Ihren Arzt oder Ihre Ärztin, wenn bei Ihnen eines oder mehrere der folgenden

Symptome auftreten, die Zeichen einer allergischen Reaktion sein können:

·Atem- oder Schluckprobleme,

·Schwellung im Gesicht, an Lippen, Zunge oder Rachen,

·starker Juckreiz der Haut mit rotem Ausschlag oder Blasen.

Beim Auftreten einer allergischen Reaktion oder eines der oben genannten Symptome, sollte der

Film mit Alkohol (in Apotheken erhältlich) entfernt werden und die Füsse mit warmem Wasser und

Seife gewaschen werden

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt,

Apotheker oder Drogisten bzw. Ihre Ärztin, Apothekerin oder Drogistin informieren.

Was ist ferner zu beachten?

Arzneimittel für Kinder unerreichbar aufbewahren.

In der Originalpackung bei 15-30 ºC aufbewahren.

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet

werden.

Weitere Auskünfte erteilt Ihnen Ihr Arzt, Apotheker, oder Drogist bzw. Ihre Ärztin, Apothekerin

oder Drogistin. Diese Personen verfügen über die ausführliche Fachinformation.

Was ist in Lamisil Pedisan Once enthalten?

1 g Lamisil Pedisan Once enthält 10 mg Terbinafin als Terbinafinhydrochlorid (Wirkstoff), Alkohol

und andere Hilfsstoffe.

Zulassungsnummer

57223 (Swissmedic).

Wo erhalten Sie Lamisil Pedisan Once? Welche Packungen sind erhältlich?

In Apotheken und Drogerien ohne ärztliche Verschreibung.

Tube zu 4 g.

Zulassungsinhaberin

GSK Consumer Healthcare Schweiz AG, Risch.

Diese Packungsbeilage wurde im Juni 2015 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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Danish Medicines Agency

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Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

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

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk 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

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the 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 milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

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

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

21-10-2018

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.”  During this Breast Cancer Awareness month, I urge women to check the facts  https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky

FDA - U.S. Food and Drug Administration

21-10-2018

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.

FDA - U.S. Food and Drug Administration

12-9-2018

 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

Europe - EMA - European Medicines Agency

21-8-2018

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months!  https://go.usa.gov/xUskq 
#OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCare pic.twitter.com/VRDkVPvMTR

FDA - U.S. Food and Drug Administration

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

15-8-2018

Concerta® 27 mg Retardtabletten

Rote - Liste

22-7-2018

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns.  https://www.fda.gov/NewsEvents

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm …

FDA - U.S. Food and Drug Administration

22-7-2018

Once on market, #FDA monitors for safety issues by collecting adverse event reports  https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t provide real-time information pic.twitter.com/WJMYVcAyoQ

FDA - U.S. Food and Drug Administration