Lucht, Synthetisch Medicinaal Air Products

Hauptinformation

  • Handelsname:
  • Lucht, Synthetisch Medicinaal Air Products Gas zur medizinischen Anwendung, druckverdichtet 22 % v-v
  • Dosierung:
  • 22 % v-v
  • Darreichungsform:
  • Gas zur medizinischen Anwendung, druckverdichtet
  • 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:
  • Lucht, Synthetisch Medicinaal Air Products Gas zur medizinischen Anwendung, druckverdichtet 22 % v-v
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • medizinische Gase

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE345633
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

packungsbeilage

PACKUNGSBEILAGE

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packungsbeilage

GEBRAUCHSINFORMATION: INFORMATIONEN FÜR DEN ANWENDER:

Synthetische medizinische Luft AIR PRODUCTS, 22 % v/v, medizinisches gas, druckverdichtet

Wirkstoff: Sauerstoff

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, denn sie enthält wichtige Informationen

für Sie.

Dieses Arzneimittel ist ohne Verschreibung erhältlich. Um einen bestmöglichen Behandlungserfolg zu

erzielen, muss die Synthetische medizinische Luft AIR PRODUCTS jedoch vorschriftsgemäß

angewendet werden.

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 sich Ihre Beschwerden verschlimmern oder nach 14 Tagen keine Besserung eintritt,

müssen Sie auf jeden Fall einen Arzt aufsuchen.

Informieren Sie bitte Ihren Arzt oder Apotheker, wenn eine der aufgeführten Nebenwirkungen

Sie erheblich beeinträchtigt oder Sie Nebenwirkungen bemerken, die nicht in dieser

Gebrauchsinformation angegeben sind.

Diese Packungsbeilage beinhaltet:

Was ist Synthetische medizinische Luft AIR PRODUCTS und wofür wird sie angewendet?

Was müssen Sie vor der Anwendung von Synthetischer medizinischer Luft AIR PRODUCTS

beachten?

Wie ist Synthetische medizinische Luft AIR PRODUCTS anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Synthetische medizinische Luft AIR PRODUCTS aufzubewahren?

Weitere Informationen

1.

WAS IST SYNTHETISCHE MEDIZINISCHE LUFT AIR PRODUCTS UND WOFÜR

WIRD SIE ANGEWENDET?

Medizinische Luft ist ein Inhalationsgas und gehört zur Gruppe der medizinischen Gase.

Medizinische Luft wird zur Vorbeugung von Sauerstoffmangel eingesetzt.

2.

WAS MÜSSEN SIE VOR DER ANWENDUNG VON SYNTHETISCHER

MEDIZINISCHER LUFT AIR PRODUCTS BEACHTEN?

Synthetische medizinische Luft AIR PRODUCTS darf nicht angewendet werden

Es sind keine Situationen bekannt, in denen Medizinische Luft nicht angewendet werden darf.

Besondere Vorsicht bei der Anwendung von Synthetischer medizinischer Luft AIR PRODUCTS

ist erforderlich

Vor einer Behandlung mit Medizinischer Luft muss sichergestellt sein, dass die Verabreichung

bei Umgebungsdruck erfolgt.

Die Verabreichung von Medizinischer Luft unter Druck kann die Dekompressionskrankheit oder

Sauerstofftoxizität hervorrufen. Die Dekompressionskrankheit kann während des Übergangs

von Überdruck zu Umgebungsdruck auftreten. Sie kann zu Kopfschmerzen, Schwindel,

Übelkeit und Verwirrtheit führen sowie in einigen Fällen Paralyse und Bewusstlosigkeit (und

sogar den Tod) verursachen.

Wenn Medizinische Luft mit anderen Inhalationsgasen gemischt wird, muss immer genügend

Sauerstoff (mindestens 22 % v/v) in solchen Gasgemischen vorhanden sein. Deswegen muss bei

einer Mischung von Medizinischer Luft mit anderen Gasen immer zusätzlicher Sauerstoff aus

anderen Quellen dabei sein.

Wenn Medizinische Luft mit hohen Durchflussraten verabreicht wird, kann sie sich kalt

anfühlen.

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Bei Anwendung mit anderen Arzneimitteln

Es ist nicht zu erwarten, dass Medizinische Luft einen Einfluss auf andere Arzneimittel hat.

Wechselwirkungen von 100 % v/v Sauerstoff mit anderen Arzneimitteln sind bekannt. Bitte fragen Sie

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

Bitte informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen bzw. vor

kurzem eingenommen haben, auch wenn es sich um nicht verschreibungspflichtige Arzneimittel

handelt.

Schwangerschaft und Stillzeit

Medizinische Luft darf während Schwangerschaft und Stillzeit verwendet werden.

Fragen Sie vor der Einnahme von allen Arzneimitteln Ihren Arzt oder Apotheker um Rat.

Verkehrstüchtigkeit und das Bedienen von Maschinen

Medizinische Luft hat keinen Einfluss auf Ihre Fähigkeit, ein Fahrzeug zu führen oder Maschinen zu

bedienen.

3.

WIE IST SYNTHETISCHE MEDIZINISCHE LUFT AIR PRODUCTS ANZUWENDEN?

Dosierung

Die Dosierung ist abhängig von den Umständen, unter denen Medizinische Luft eingesetzt wird.

Bitte fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht ganz sicher sind.

Wie ist Synthetische medizinische Luft AIR PRODUCTS anzuwenden?

Wenn Sie Medizinische Luft über einen längeren Zeitraum anwenden müssen, ist es empfehlenswert,

die Medizinische Luft zu befeuchten.

Medizinische Luft ist ein Gas zur Inhalation, das mit der eingeatmeten Luft durch spezielles Zubehör

wie einem Nasenkatheter oder einer Gesichtsmaske mit eng anliegender Kopfkappe oder einem Tubus

in der Luftröhre (Tracheotomie) aufgenommen wird. Das Produkt muss wie vom Hersteller

beschrieben betrieben werden. Jeglicher überschüssiger Sauerstoff verlässt den Körper beim Ausatmen

und vermischt sich mit der Umgebungsluft. Während einer Narkose wird eine Spezialausrüstung mit

Rückatmungs- oder Rezirkulations-System eingesetzt, sodass die ausgeatmete Luft auch wieder

eingeatmet wird („Rückatmungs“-System). Wenn Sie nicht selbstständig atmen können, wird Ihnen

Medizinische Luft über ein Beatmungsgerät verabreicht.

Befolgen Sie die Anweisungen des Lieferanten, insbesondere in Bezug auf:

Ein Druckbehältnis kann nicht verwendet werden, wenn er erkennbar beschädigt ist oder wenn

der Verdacht einer Beschädigung besteht oder wenn er extremen Temperaturen ausgesetzt war.

Kontakt mit Öl, Schmiermittel oder anderen Kohlenwasserstoffen ist zu vermeiden.

Es darf nur Zubehör verwendet werden, das für den speziellen Druckbehältnis-Typ und das

Gas geeignet ist.

Um das Risiko einer Beschädigung zu vermeiden, dürfen zum Öffnen oder Schließen des

Ventils am Druckbehältnis keine Zangen oder ähnliche Instrumente benutzt werden.

Die Form des Behältnisses darf nicht verändert werden.

Wenn eine Leckage auftritt, ist das Ventil des Druckbehältnisses sofort zu schließen, wenn

dies gefahrlos möglich ist. Wenn das Ventil nicht geschlossen werden kann, muss der

Druckbehältnis an einen sicheren Ort außerhalb geschlossener Räumlichkeiten gebracht

werden, wo der Sauerstoff abfließen kann.

Das Ventil eines leeren Druckbehältnisses muss geschlossen werden.

Die Anschlüsse für Schläuche etc. müssen sauber und trocken sein. Wenn sie verschmutzt

sind, müssen sie nach Herstelleranweisung gereinigt werden. Hierbei dürfen keine

Lösungsmittel eingesetzt werden. Druckbehältnis und Zubehör mit einem sauberen,

fusselfreien Tuch reinigen und trocknen.

Es darf kein Gas unter Druck mit einem Siphon entnommen werden.

Rauchen oder offene Flammen sind in der Nähe von Druckbehältnissen verboten.

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packungsbeilage

Wenn Sie eine größere Menge Synthetische medizinische Luft AIR PRODUCTS bekommen

haben, als Sie sollten

Es sind keine Risiken durch eine Überdosis Medizinischer Luft bekannt.

Die Verabreichung von Medizinischer Luft unter Druck kann die Dekompressionskrankheit oder

Sauerstofftoxizität hervorrufen. Die Dekompressionskrankheit kann während des Übergangs von

Überdruck zu Umgebungsdruck auftreten. Sie kann zu Kopfschmerzen, Schwindel, Übelkeit und

Verwirrtheit führen sowie in einigen Fällen Paralyse und Bewusstlosigkeit (und sogar den Tod)

verursachen.

Wenn Sie die Anwendung von Synthetischer medizinischer Luft AIR PRODUCTS vergessen

haben

Wenden Sie Medizinische Luft an, sobald Sie wieder daran denken. Wenden Sie nicht die doppelte

Dosis Synthetischer medizinischer Luft an, wenn Sie die vorherige Anwendung vergessen haben.

Wenn Sie weitere Fragen zur Anwendung des Arzneimittels haben, fragen Sie Ihren Arzt oder

Apotheker.

4.

WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Es sind keine Nebenwirkungen bekannt.

5.

WIE IST SYNTHETISCHE MEDIZINISCHE LUFT AIR PRODUCTS

AUFZUBEWAHREN?

Arzneimittel für Kinder unzugänglich aufbewahren.

Sie dürfen Medizinische Luft nach dem auf dem Druckbehältnis angegebenen Verfalldatum nicht mehr

anwenden.

Folgende Sicherheitsvorschriften sind bei der Lagerung von Druckbehältnissen zu beachten:

Bei – 20 °C bis + 65 °C lagern.

Stehend lagern.

In einem gut durchlüfteten Raum lagern.

Von entzündlichen Produkten fernhalten.

Vor Stürzen und anderen Einflüssen schützen.

Druckbehältnisse, die eine andere Art von Gas enthalten, sollten getrennt gelagert werden.

Volle und leere Druckbehältnisse sollten getrennt gelagert werden.

Die Druckbehältnisse sind abgedeckt und gut geschützt gegen Witterungseinflüsse zu lagern.

Ventil des Druckbehältnisses schließen.

Leere Druckbehältnisse an den Lieferanten zurückgeben

6.

WEITERE INFORMATIONEN

Was Synthetische medizinische Luft AIR PRODUCTS enthält

Der Wirkstoff ist Sauerstoff 22 % v/v.

-

Der sonstige Bestandteil ist Stickstoff.

Wie Synthetische medizinische Luft AIR PRODUCTS aussieht und Inhalt der Packung

Darreichungsform und Verpackung:

Synthetische medizinische Luft AIR PRODUCTS ist ein farbloses, geruchloses und

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packungsbeilage

geschmackloses verdichtetes medizinisches Gas.

Synthetische medizinische Luft AIR PRODUCTS wird unter Druck in Druckbehältnissen

gelagert. Die Farbe des Druckbehältniskörpers ist weiß, die Schulter ist weiß mit schwarzem

Streifen.

Druckbehältnisse mit einer Kapazität von x Litern liefern bei 15 °C und 1 bar y

(Volumeneinheit) Synthetische medizinische Luft AIR PRODUCTS.

Druckbehältnis – Fülldruck 200 bar,

Synthetische medizinische Luft AIR PRODUCTS.

Menge (x) in Litern

0,5

1

2

3

4

5

7

10

13

Menge in Litern Luft (y)

97

193

387

580

774

967

1354

1935

2515

Menge (x) in Litern

15

20

25

30

40

50

800

(16 x 50 l)

900

(18 x 50 l)

Menge in Litern Luft (y)

2902

3869

4836

5804

7738

9673

154768

174114

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer

Air Products N.V./S.A.

Leonardo da Vincilaan 19

1831 Diegem

België

Tel: +32 2 674 94 11

Hersteller:

Air Products S.A.S.

Zone Industrielle de l’Epinoy

59175 Templemars

France

Tel : +33 3 206 205 17

Carburos Metálicos – Arrigorriaga

Barrio Chaco n/v

48480 Arrigorriaga (Vizcaya)

Spain

Tel : +34 946 71 92 00

Carburos Metálicos – Alcalá de Guadaira

Carretera de Sevilla a Granada,Km 9.6 – Polígono Industrial La Red

41500 Alcala de Guadaira (Sevilla)

Spain

Tel : +34 955 63 15 90

Carburos Metálicos – Massalfassar

Ildefonso Carrascosa, Parcela 20-21 - Polígono Industrial Mediterráneo

46560 Massalfassar (Valencia)

Spain

Tel : +34 96 140 13 54

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Carburos Metálicos – Marratxi

C/ Calleters, 142

Polígono Industrial Can Rubiol

07141 – Marratxi (Islas Baleares)

Spain

Carburos Metálicos – Telde

C/ El Pescador, 21

Poligono Industrial Salinetas

35219 - Telde (Islas Canarias)

Spain

Gasin II Gases Industriales Unipessoal Lda – Perafita

Rua do Progresso, 53 – Perafita

4451 – 801 Leça da Palmeira

Portugal

Zulassungsnummern : BE345633

Verkaufsabgrenzung : Freie Abgabe

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR)

unter den folgenden Bezeichnungen zugelassen:

Belgien: Lucht, Synthetisch medicinaal AIR PRODUCTS, 22%v/v; medicinaal gas,

samengeperst

Air synthétique médicinal AIR PRODUCTS, 22% v/v, gaz médicinal comprimé

Synthetische medizinische Luft AIR PRODUCTS, 22 % v/v, medizinisches gas,

druckverdichtet

Niederlande: Lucht medicinaal synthetisch AIR PRODUCTS, 22%v/v, medicinaal gas,

samengeperst

Tschechische Republik: Vzduch medicinální syntetický Air Products 22% v/v, medicinální

plyn, stlačený

Deutschland: Künstliche Luft zur medizinischen Anwendung Air Products 22 % v/v Gas zur

medizinischen Anwendung, druckverdichtet

Portugal: Ar medicinal Sintético Gasin, 22%v/v, gás medicinal, comprimido

Spanien: Aire medicinal sintetico Carburos Metálicos, 22%v/v, gas medicinal, comprimido

Vereinigtes Königreich: Air medicinal synthetic Air Products, 22% v/v, medicinal gas,

compressed

Diese Gebrauchsinformation wurde zuletzt genehmigt im 09/2016.

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Pollen allergies and food supplements: ANSES reminds consumers of the precautions to be taken

Pollen allergies and food supplements: ANSES reminds consumers of the precautions to be taken

Cases of allergies associated with the consumption of food supplements are regularly reported to ANSES under its nutrivigilance scheme. Recently, severe allergies following the consumption of food supplements containing hive products (royal jelly, propolis) and pollen have been reported. ANSES reminds consumers that people who are allergic to pollen can potentially be at risk from allergies when consuming foods and food supplements containing products of the beehive.

France - Agence Nationale du Médicament Vétérinaire

25-7-2018

Dringende Sicherheitsinformation zu Monnal T60 von Air Liquide Medical Systems

Dringende Sicherheitsinformation zu Monnal T60 von Air Liquide Medical Systems

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

24-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

24-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

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

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

20-7-2018

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Health Canada's inspection program found the recalled product does not meet the labelling and child-resistant packaging requirements for consumer chemical products as set out in the Consumer Chemicals and Containers Regulations, 2001.

Health Canada

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

19-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

19-7-2018

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd is voluntarily recalling K9 Natural Frozen Chicken Feast 11lb bags, batch number #150517, that were imported into the Canadian market in July 2017 because they have the potential to be contaminated with Listeria monocytogenes. No other K9 Natural products are affected in Canada.

Health Canada

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

19-7-2018

Dringende Sicherheitsinformation zu Dermatome AN von Zimmer Orthopaedic Surgical Products

Dringende Sicherheitsinformation zu Dermatome AN von Zimmer Orthopaedic Surgical Products

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

19-7-2018

H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment

H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment

H-E-B is voluntarily issuing a recall for two variety packs of Creamy Creations ice cream and sherbets in 3-ounce cups due to broken metal found in processing equipment during routine maintenance. The potentially affected products were distributed only to H-E-B stores in Texas. Please note, the product was not distributed to the Houston area or Mexico.

FDA - U.S. Food and Drug Administration

19-7-2018

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. 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

18-7-2018

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.

FDA - U.S. Food and Drug Administration

18-7-2018

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

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

17-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers

FDA - U.S. Food and Drug Administration

17-7-2018

Dringende Sicherheitsinformation zu Atellica COAG 360 von Siemens Healthcare Diagnostics Products GmbH

Dringende Sicherheitsinformation zu Atellica COAG 360 von Siemens Healthcare Diagnostics Products GmbH

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

17-7-2018

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

FDA - U.S. Food and Drug Administration

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

15-8-2018

Scientific guideline:  Draft guideline on specifications: test procedures and acceptance criteria for herbal  substances, herbal  preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life.

Europe - EMA - European Medicines Agency

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

Europe - EMA - European Medicines Agency

30-7-2018

TGA's compliance review of sunscreens

TGA's compliance review of sunscreens

Information for consumers about the desktop review of 94 listed sunscreen products

Therapeutic Goods Administration - Australia

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Europe - EMA - European Medicines Agency

27-7-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

Sixteen medicines recommended for approval, including two orphans

Europe - EMA - European Medicines Agency

24-7-2018

 Minutes of the HMPC 26-27 March 2018 meeting

Minutes of the HMPC 26-27 March 2018 meeting

Committee on Herbal Medicinal Products (HMPC) minutes for the meeting on 26-27 March 2018

Europe - EMA - European Medicines Agency

20-7-2018

News and press releases:  Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018

News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018

CVMP adopts revised guidance on assessment of the risk to public health from resistance due to use of antimicrobials in food-producing animals

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

18-7-2018

Agenda:  Agenda - CVMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - CVMP agenda of the 17-19 July 2018 meeting

Committee for Medicinal Products for Veterinary Use - Draft agenda of July 2018 meeting

Europe - EMA - European Medicines Agency

18-7-2018

News and press releases:  EU and Japan reinforce their collaboration on inspections of medicine manufacturers

News and press releases: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines

Europe - EMA - European Medicines Agency