Dextromethorphan Certa

Hauptinformation

  • Handelsname:
  • Dextromethorphan Certa Sirup 1 mg-ml
  • Dosierung:
  • 1 mg-ml
  • Darreichungsform:
  • Sirup
  • 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:
  • Dextromethorphan Certa Sirup 1 mg-ml
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE190224
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage

Packungsbeilage

PACKUNGSBEILAGE

Seite 1 von 7

Packungsbeilage

PACKUNGSBEILAGE: INFORMATION FÜR DEN ANWENDER

Dextromethorphan Certa, 1 mg/ml Sirup

Dextromethorphanhydrobromid

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

Arzneimittels beginnen, denn Sie enthält wichtige Informationen.

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

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter. Es

kann anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

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 DEXTROMETHORPHAN CERTA und wofür wird es angewendet?

Was sollten Sie vor der Einnahme von DEXTROMETHORPHAN CERTA beachten?

Wie ist DEXTROMETHORPHAN CERTA einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist DEXTROMETHORPHAN CERTA aufzubewahren?

Inhalt der Packung und weitere Informationen

1. WAS IST DEXTROMETHORPHAN CERTA UND WOFÜR WIRD ES ANGEWENDET?

Arzneimittelgruppe: Sirup gegen Husten. Zentral wirkendes Antitussivum

Indikationen: symptomatische Behandlung von trockenem Husten und Reizhusten

Vorgefertigtes Arzneimittel für die Verwendung durch Apotheker für Magistralrezepturen und

Zubereitungen, das als solches nicht für die Öffentlichkeit bestimmt ist.

Bitte sprechen Sie mit Ihrem Arzt, wenn Sie sich nach 5 Tagen nicht besser oder gar schlechter

fühlen.

2. WAS SOLLTEN SIE VOR DER EINNAHME VON DEXTROMETHORPHAN CERTA

BEACHTEN?

DEXTROMETHORPHAN CERTA darf nicht eingenommen werden,

wenn Sie allergisch gegen Dextromethorphan oder einen der in Abschnitt 6 genannten

sonstigen Bestandteile dieses Arzneimittels

sind

wenn Sie an einer respiratorischen Insuffizienz leiden

wenn Sie mit Monoaminoxidase-Inhibitoren (MAO-Hemmern) behandelt werden

im Falle von asthmatischem Husten

wenn Sie stillen

bei Kindern unter 6 Jahren.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie DEXTROMETHORPHAN CERTA

einnehmen.

Seite 2 von 7

Packungsbeilage

Das Abhusten von gestautem Schleim ist ein wesentliches Element des Abwehrsystems der Bronchien

und der Lunge. Dieser Faktor muss berücksichtigt werden.

Wenn der Husten länger als 4 bis 5 Tage dauert, und/oder Fieber auftritt, ist es ratsam, einen Arzt

aufzusuchen.

Bei wesentlichen Leberfunktionsstörungen und bei älteren Patienten muss die erste Dosis um die

Hälfte reduziert werden und kann anschließend, je nach den Bedürfnissen des Patienten und der

Verträglichkeit des Arzneimittels, um ein Viertel erhöht werden.

Der Konsum von alkoholischen Getränken wird während der Behandlung nicht empfohlen, weil der

Alkohol die dämpfende Wirkung von Dextromethorphan auf das zentrale Nervensystem erhöht.

Bei Diabetes-Patienten muss der Gehalt von Zucker im Sirup berücksichtigt werden: 1 Teelöffel

enthält ± 3,92 g Zucker und ein Esslöffel enthält ± 11,76 g Zucker.

Bitte konsultieren Sie Ihren Arzt, wenn eine der oben genannten Einschränkungen für Sie gilt, oder in der

Vergangenheit gegolten hat.

Kinder

Darf nicht bei Kindern unter

Jahren angewendet werden.

Andere Arzneimittel und DEXTROMETHORPHAN CERTA

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

Arzneimittel eingenommen haben oder beabsichtigen, andere Arzneimittel einzunehmen.

Die gleichzeitige Anwendung von MAO-Hemmern und Dextromethorphan kann Muskelsteifheit,

deutliche Erhöhung der Körpertemperatur, erhebliche Aufregung, Atemstillstand sowie Kontraktionen

der Kehlkopfmuskulatur verursachen, die zum Tod führen können. Es ist daher notwendig, 14 Tage

nach Beendigung der Behandlung mit MAO-Inhibitoren zu warten, bevor die Behandlung mit

Dextromethorphan begonnen wird.

Wegen der Gefahr einer Atemdepression wird nicht empfohlen, den Dextromethorphan-Sirup

zusammen mit Morphin-Derivaten gegen Schmerzen einzunehmen.

Wegen der Gefahr einer Atemdepression wird ebenfalls nicht empfohlen, den Dextromethorphan-

Sirup zusammen mit Sedativa, Beruhigungsmitteln, Antidepressiva oder bestimmten Antihistaminika

(H1) einzunehmen.

DEXTROMETHORPHAN CERTA mit Nahrungsmitteln, Getränken und Alkohol.

Die gleichzeitige Einnahme von Alkohol wird nicht empfohlen, da diese Kombination die sedierende

Wirkung von DEXTROMETHORPHAN CERTA erhöhen kann.

Schwangerschaft, Stillzeit und Fruchtbarkeit

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

schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittels Ihren Arzt oder Apotheker

um Rat.

In am Menschen durchgeführten Studien wurde die sichere Verwendung von Dextromethorphan-Sirup

während der Schwangerschaft nicht nachgewiesen. Die Verwendung des Sirups muss also vor allem

während der ersten drei Schwangerschaftsmonate und auch gegen Ende der Schwangerschaft vermieden

werden (Risiko einer Atemdepression beim Neugeborenen).

Da keine genauen Daten zur Übertragung durch die Muttermilch vorliegen, ist der Dextromethorphan-

Sirup während der Stillzeit kontraindiziert.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

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Packungsbeilage

Menschen, deren Wachsamkeit konstant sein muss (z. B. zum Führen von Fahrzeugen oder Maschinen),

sollten sich darüber bewusst sein, dass die Einnahme dieses Sirups in großen Mengen, Schläfrigkeit und

Benommenheit verursachen kann. Dieser Effekt kann bei empfindlichen Personen auch bei üblichen

Dosen beobachtet werden. Die gleichzeitige Einnahme von Alkohol und Arzneimitteln mit beruhigender

Wirkung auf das zentrale Nervensystem kann auch diese unerwünschte Wirkung erhöhen.

DEXTROMETHORPHAN CERTA enthält

Ethanol

einer

Konzentration

16,67 mg/ml

flüssigen

Mohnextrakt

flüssigen

Tolubalsamextrakt für Sirup - einfachen Sirup

Dieses Arzneimittel enthält 2,1 vol % Ethanol (Alkohol), d.h. bis zu 500 mg pro Dosis, entsprechend

12,4 ml Bier, 5,2 ml Wein pro Dosis.

Gesundheitliches Risiko für Patienten, die unter Alkoholismus leiden.

Ist bei Schwangeren bzw. Stillenden sowie bei Kindern und Patienten mit erhöhtem Risiko auf Grund

einer Lebererkrankung oder Epilepsie zu berücksichtigen.

Dieses Arzneimittel enthält 23,52 g Zucker pro Dosis. Dies ist bei Patienten mit Diabetes mellitus zu

berücksichtigen. Bitte nehmen Sie erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt ist,

dass Sie unter einer Zuckerungverträglichkeit leiden.

3. WIE IST DEXTROMETHORPHAN CERTA EINZUNEHMEN?

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt oder Apotheker ein.

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

Die empfohlene Dosis beträgt:

BEI ERWACHSENEN

1 bis 2 Esslöffel (1 Esslöffel = 15 ml) 3-4 mal am Tag, alle 6 Stunden, bis zu 8 Esslöffel pro Tag.

Der Sirup sollte so kurz wie möglich eingesetzt werden. Wenn der Husten länger als 4 bis 5 Tage

andauert, ist es ratsam, einen Arzt aufzusuchen.

Anwendung bei Kindern

Nicht bei Kindern unter 6 Jahren anwenden.

BEI KINDERN UNTER 6 JAHREN

Die übliche Dosis beträgt 1 mg Dextromethorphanhydrobromid pro kg pro Tag in 2 bis 4 Dosen im

Abstand von mindestens 4 Stunden; dies entspricht 10 bis 20 mg Dextromethorphanhydrobromid (2-4 mal

einen Teelöffel) pro Tag, mit einem Maximum von 30 mg pro Tag (6 Teelöffel).

BEI KINDERN VON 7 BIS 12 JAHREN

Die übliche Dosis beträgt 1 mg Dextromethorphanhydrobromid pro kg pro Tag in 2 bis 4 Dosen im

Abstand von mindestens 4 Stunden; dies entspricht 20 bis 50 mg Dextromethorphanhydrobromid (2-5 mal

2 Teelöffel) pro Tag, mit einem Maximum von 60 mg pro Tag (6 Mal 2 Teelöffel).

Wenn Sie eine größere Menge von DEXTROMETHORPHAN CERTA eingenommen haben, als Sie

sollten

Wenn Sie eine größere Menge von DEXTROMETHORPHAN CERTA eingenommen haben, wenden Sie

sich unverzüglich an Ihren Arzt, Apotheker oder an die Giftnotrufzentrale (070/245 245)

Seite 4 von 7

Packungsbeilage

Symptome, die auftreten können, wenn zu hohe Dosen eingenommen wurden:

Übelkeit, Erbrechen, Verwirrtheit, Schläfrigkeit, Sehstörungen, zitternde Augen, Unruhe und

Hautausschlag.

Die Absorption von hohen Dosen kann Krämpfe, Atemdepression und Bewusstlosigkeit verursachen.

Zu ergreifende Maßnahmen, wenn zu hohe Dosen eingenommen wurden:

Wenn höhere als die normalen Dosen eingenommen wurden, ist eine Einweisung ins Krankenhaus

erforderlich.

Magenspülung

In einigen Fällen kann eine künstliche Beatmung erforderlich sein. Als Gegenmittel ist Naloxon zu

verabreichen. Die Initialdosis von Naloxon beträgt (Erwachsene und Kinder): 0,4-2 mg i. v.,

Wiederholung nach 2-3 Minuten.

Im Fall von Krämpfen können z. B. Benzodiazepine verabreicht werden, etwa Diazepam: 5 bis 10 mg

i. v. bei Erwachsenen und älteren Kindern, 0,1 bis 0,2 mg rektal bei jungen Kindern.

Wenn Sie die Einnahme von DEXTROMETHORPHAN CERTA vergessen haben

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen haben.

Wenn Sie die Einnahme von DEXTROMETHORPHAN CERTA abbrechen

Nur im Falle von trockenem sowie Reizhusten zu verwenden.

Wenn Sie weitere Fragen zur Einnahme dieses Arzneimittels haben, wenden Sie sich an Ihren Arzt

oder Apotheker.

4.

WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

Ausdrücklich genannt sind gastrointestinale Symptome (Übelkeit, Erbrechen, Verstopfung), Schläfrigkeit,

Schwindel, Unruhe, Verwirrtheit, Atembeschwerden und Überempfindlichkeitsreaktionen an der Haut.

Bei den empfohlenen Dosen hat dieser Sirup keinen Einfluss auf die Atmung, aber eine Atemdepression

kann auftreten, wenn sehr hohen Dosen eingenommen werden.

Meldung von Nebenwirkungen

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

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Sie können

Nebenwirkungen auch direkt melden über:

L’agence fédérale des médicaments et des produits de santé

Division Vigilance

EUROSTATION II

Place Victor Horta, 40/40

B-1060 Brüssel

www.afmps.be

patientinfo@fagg-afmps.be

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

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

Seite 5 von 7

Packungsbeilage

5.

WIE IST DEXTROMETHORPHAN CERTA AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Lagern Sie es in der Originalverpackung bei Raumtemperatur (15-25 °C) und lichtgeschützt.

Sie dürfen dieses Arzneimittel nach dem auf dem Etikett nach der Abkürzung für Verfalltag

angegebenen Datum nicht mehr verwenden. Das Verfalldatum bezieht sich auf den letzten Tag des

betreffenden Monats.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker, wie

das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen damit zum Schutz

der Umwelt bei.

6.

INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Dextromethorphan Certa enthält

Der Wirkstoff ist

Dextromethorphanhydrobromid

Die sonstigen Bestandteile sind

Ethanol, Flüssigextrakt aus rotem Mohn, Flüssigextrakt aus

Tolubalsam, einfacher Sirup 1 ml

Wie DEXTROMETHORPHAN CERTA aussieht und Inhalt der Packung

Sirups in Bulkflaschen von 1 und 5 Litern

Inhaber der Genehmigung für das Inverkehrbringen und Hersteller

Inhaber der Genehmigung für das Inverkehrbringen

Certa NV

Avenue du Commerce, 23

1420 Braine I’AIIeud

Tel: 056/628900

Fax: 056/628820

info@acapharma.be

Hersteller

Conforma NV

Zenderstraat 10,

9070 Destelbergen

Belgien

Tel: + 32 (0)9 228 20 00

Fax: +32 (09) 228 22 62

E-Mail: info@conforma.be

Weitere Informationen zu diesem Arzneimittel erhalten Sie vom lokalen Vertreter des Inhabers der

Genehmigung für das Inverkehrbringen:

Certa AG

Avenue du Commerce, 23

1420 Braine I’AIIeud

Tel: 056/628900

Seite 6 von 7

Packungsbeilage

Fax: 056/628820

info@acapharma.be

Arzneimittelzulassungsnummer: BE190224

Ausgabeart: Ärztliche Verschreibung

Dies ist ein vorgefertigtes Arzneimittel für die Verwendung durch Apotheker für Magistralrezepturen

und Zubereitungen, das als solches nicht für die Öffentlichkeit bestimmt ist.

Diese Packungsbeilage wurde zuletzt überarbeitet am

Das Datum der Genehmigung dieser Packungsbeilage ist 08/2013

Seite 7 von 7

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Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

26-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

FDA - U.S. Food and Drug Administration

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Health Canada

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of 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

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

17-8-2018

Seabreeze International Corp. recalls certain Smart ThermafloTM Heaters

Seabreeze International Corp. recalls certain Smart ThermafloTM Heaters

In the event of a fault, the safety cut-offs may not operate and allow the heater to rapidly overheat, posing a fire hazard.

Health Canada

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

7-8-2018

Dollarama recalls the Skip Ball toy

Dollarama recalls the Skip Ball toy

The Skip Ball toy may contain levels of phthalates that exceed the allowable limit. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

3-8-2018

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.

FDA - U.S. Food and Drug Administration

2-8-2018

The 2017 ANSES Annual Report is now available !

The 2017 ANSES Annual Report is now available !

At a time when its responsibilities are being extended, ANSES is consolidating its position as a protector of public health. With a field of action that covers all the risks to which the population may be exposed on a daily basis, the Agency confirms its scientific expertise capability and its mission to assess risks in situations of uncertainty.

France - Agence Nationale du Médicament Vétérinaire

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

24-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

24-7-2018

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA - U.S. Food and Drug Administration

23-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

20-7-2018

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

16-7-2018

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz® Quality Foods, LLC., is voluntarily recalling select expiration dates of Utz® Carolina Style Barbeque Potato Chips due to undeclared soy allergen. This recall was initiated after learning a certain number of packages were mislabeled. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

12-7-2018

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

FDA - U.S. Food and Drug Administration

10-7-2018

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

FDA - U.S. Food and Drug Administration

6-7-2018

Revocation of S-classification status for certain
medicinal products: lists

Revocation of S-classification status for certain medicinal products: lists

The Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status of medicinal products that have also been used outside the hospital  environment as well as for products which are now not considered to be limited to hospital use.

IMA - Icelandic Medicines Agency

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

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

FDA - U.S. Food and Drug Administration

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

12-6-2018

FLIR Lorex, Inc. recalls certain Lorex Video Monitors

FLIR Lorex, Inc. recalls certain Lorex Video Monitors

Batteries in the affected monitors can overheat and expand, posing a potential burn hazard to consumers.

Health Canada

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

31-5-2018

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store recall for certain flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets for broken metal in processing equipment found during routine maintenance. The affected products were distributed to stores in Texas and Mexico.

FDA - U.S. Food and Drug Administration

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication  - Risk of Serious and Potentially Fatal Blood Disorder

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder

Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.

FDA - U.S. Food and Drug Administration

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

19-5-2018

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens and this is not declared on the package. Individuals who have an allergy or severe sensitivity to milk, soy, wheat or cashews run the risk of serious or life-threatening allergic reaction if they consume these products

FDA - U.S. Food and Drug Administration

19-5-2018

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarr...

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

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

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments:  h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT  pic.twitter.com/hAuLWaIYiK

FDA - U.S. Food and Drug Administration

20-8-2018

Application requirements for medical devices - preliminary assessment

Application requirements for medical devices - preliminary assessment

Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment

Therapeutic Goods Administration - Australia

15-8-2018

Concerta® 27 mg Retardtabletten

Rote - Liste