Vit. B

Hauptinformation

  • Handelsname:
  • Vit. B6 "Agepha" - Tabletten
  • Einheiten im Paket:
  • 20 Stück, Laufzeit: 36 Monate
  • Verschreibungstyp:
  • Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Vit. B6 "Agepha" - Tabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Pyridoxin (Vitamin-B6)
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 8707
  • Berechtigungsdatum:
  • 17-10-1955
  • Letzte Änderung:
  • 10-08-2017

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR ANWENDER

Vit. B

6  „Agepha“ - Tabletten

Wirkstoff: Pyridoxin (Vitamin B

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

dieses Arzneimittels beginnen.

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 eine der aufgeführten Nebenwirkungen Sie erheblich beeinträchtigt oder Sie 

Nebenwirkungen bemerken, die nicht in dieser Gebrauchsinformation angegeben sind, 

informieren Sie bitte Ihren Arzt oder Apotheker.

Was in dieser Packungsbeilage steht:

Was sind Vit. B

 „Agepha“ - Tabletten und wofür werden sie angewendet?

Was sollten Sie vor der Einnahme von Vit. B

 „Agepha“ - Tabletten beachten?

Wie sind Vit. B

 „Agepha“ - Tabletten einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie sind Vit. B

 „Agepha“ - Tabletten aufzubewahren?

Inhalt der Packung und weitere Informationen

1. WAS SIND VIT. B

6  „AGEPHA“ - TABLETTEN UND WOFÜR WERDEN SIE 

ANGEWENDET?

Vit. B

 „Agepha“ – Tabletten werden zur Behandlung eines Vitamin B

-Mangels eingesetzt. 

Ein reiner Vitamin B

-Mangel ist beim Menschen selten. Die Vitamin B

-Bedarfsdeckung ist 

aber bei verschiedenen Risikogruppen (z. B. Schwangeren, Senioren) nicht immer gesichert. 

Ein Vitamin B

-Mangel ist häufig verbunden mit einer Unterversorgung weiterer Vitamine des 

B-Komplexes. Die klinischen Symptome sind unterschiedlich. Ein schwerer Vitamin B

Mangel äußert sich beim Menschen hauptsächlich in Form von Hautausschlägen und -

entzündungen, im Augen und Nasenbereich, Entzündungen im Mund und an den Lippen, 

Blutarmut-, sowie Nervenerkrankungen. 

Vitamin B

 kann nicht vom Körper selbst produziert werden, sonderm muss von außen 

zugeführt werden, was im Allgemeinen durch eine ausgewogene Ernährung gewährleistet 

ist. Größere Mengen an Vitamin B

 sind u. a. in Hefen, Getreide (v. a. in 

Getreidekeimlingen), Sojabohnen, Leber, Muskelfleisch, Milch, Milchprodukten, grünem 

Gemüse, Kartoffeln, Karotten und Bananen enthalten. 

2. WAS SOLLTEN SIE VOR DER EINNAHME VON VIT. B

6  „AGEPHA“ - TABLETTEN 

BEACHTEN?

Vit. B6 „Agepha“ – Tabletten dürfen nicht eingenommen werden,

wenn Sie allergisch gegen den Wirkstoff Pyridoxinhydrochlorid (Salzform des Vitamin B

oder einen der in Abschnitt 6. genannten sonstigen Bestandteile dieses Arzneimittels sind.

Besondere Vorsicht bei der Einnahmevon Vit. B

6  „Agepha“ - Tabletten ist erforderlich,

Bei einer langfristigen Einnahme von mehr als 50 mg Pyridoxinhydrochlorid  sowie bei 

kurzfristiger Einnahme von Dosen im Grammbereich wurden Erkrankungen des 

Nervensystems mit Empfindungsstörungen (Kribbeln, Ameisenlaufen), Gangstörungen und 

Reflexstörungen beobachtet. Bei Anzeichen dieser Erkrankungen muss die Dosierung vom 

Arzt überprüft und angepaßt, oder das Präparat gegebenenfalls abgesetzt werden. 

Einnahme von Vit. B

6  „Agepha“ - Tabletten zusammen mit anderen Arzneimitteln

Bitte informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen / 

anwenden bzw. vor kurzem eingenommen / angewendet haben, auch wenn es sich um nicht 

verschreibungspflichtige Arzneimittel handelt.

Ab einer Tagesdosis von 5 mg kann Vitamin B

 die Wirkung von Levodopa (Mittel zur 

Behandlung von Parkinson) herabsetzen. 

Der Bedarf an Vitamin B

 ist während einer Behandlung von folgenden Arzneistoffen erhöht:

 Isoniazid (Mittel gegen Tuberkulose)

 Hydralazin (gefäßerweiterndes Mittel zur Blutdrucksenkung)

 Cycloserin (Mittel gegen Tuberkulose)

 D-Penicillamin (Mittel zur Behandlung von Rheuma, Schwermetallvergiftungen, 

Morbus Wilson/Kupferspeicherkrankheit)

Schwangerschaft und Stillzeit

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

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

Ihren Arzt um Rat.

In der Schwangerschaft und Stillzeit beträgt die empfohlene Tagesdosis für Vitamin B

1,9mg.

Es liegen keine Untersuchungen zur Anwendung von Vitamin B

 in Dosierungen oberhalb 

des angegebenen Tagesbedarfs vor. Vitamin B

 geht in die Muttermilch über. Eine 

Anwendung von Vit. B

 „Agepha“ – Tabletten während der Schwangerschaft und Stillzeit 

sollte daher nur nach Nutzen-Risiko-Abwägung durch den Arzt erfolgen. 

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Vit. B

 „Agepha“ – Tabletten haben keinen Einfluss auf die Verkehrstüchtigkeit und das 

Bedienen von Maschinen.

Vit. B

6  „Agepha“ – Tabletten enthalten Lactose. 

Bitte nehmen Sie Vit. B

 „Agepha“ – Tabletten erst nach Rücksprache mit Ihrem Arzt ein, 

wenn Ihnen bekannt ist, dass Sie unter einer Zuckerunverträglichkeit leiden.

3. WIE SIND VIT. B

6  „AGEPHA“ – TABLETTEN EINZUNEHMEN?

Nehmen Sie Vit. B

 „Agepha“ – Tabletten immer genau nach Anweisung des Arztes ein. Bitte 

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

vom Arzt nicht anders verordnet, ist die empfohlene Dosis 1mal täglich 1 Tablette. Die 

Tabletten werden unzerkaut mit etwas Flüssigkeit eingenommen.

Anwendung bei Kindern <und Jugendlichen:

Vit. B

6  „Agepha“-Tabletten werden nicht empfohlen für Kinder und Jugendliche aufgrund des 

Fehlens von Daten zur Unbedenklichkeit und Wirksamkeit.

Wenn Sie eine größere Menge von  Vit. B6 „Agepha“ – Tabletten eingenommen haben, 

als Sie sollten

Hohe Vitamin B

-Dosen können die Milchproduktion hemmen.

Die Langzeiteinnahme (mehrere Monate bis Jahre) von Vitamin B

 in Dosen von über 50 

mg/Tag sowie die kurzfristige Einnahme (2 Monate) von Dosen über 1g/Tag können 

schädliche Wirkungen auf das Nervensystem haben. Es können Empfindungsstörungen (wie 

Kribbeln und Ameisenlaufen), vor allem an Händen und Füßen, und Krämpfe auftreten. 

Außerdem wurden Magen-Darm Störungen, gesteigerte Lichtempfindlichkeit und Fälle von 

Vitamin B

Abhängigkeit nach höheren Einnahmemengen bzw. längeren Einnahmezeiten 

beschrieben.

Informieren Sie bitte sofort Ihren Arzt, wenn Sie versehentlich eine größere Menge von Vit. 

6  „Agepha“-Tabletten eingenommen haben, oder bei Ihnen oben beschriebenen Symptome 

auftreten.

Wenn Sie die Einnahme von Vit. B

6  „Agepha“ – Tabletten vergessen haben

Nehmen Sie nicht die doppelte Dosis ein, wenn Sie die vorherige Einnahme vergessen 

haben.

Wenn Sie die Einnahme von Vit. B6 „Agepha“ – Tabletten abbrechen

Brechen Sie die Einnahme von Vit. B

 „Agepha“ – Tabletten nicht ohne Rücksprache mit 

Ihrem Arzt ab.

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

oder Apotheker.

4. WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel können Vit. B

 „Agepha“ – Tabletten Nebenwirkungen haben, die aber 

nicht bei jedem auftreten müssen.

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.

In der empfohlenen Dosierung sind bisher keine Nebenwirkungen bekannt.

Für Nebenwirkung im Falle von Langzeiteinnahme und Überdosierung siehe: „Besondere 

Vorsicht bei der Einnahmevon Vit. B6 „Agepha“ - Tabletten ist erforderlich“ und „Wenn Sie 

eine größere Menge von  Vit. B6 „Agepha“ – Tabletten eingenommen haben, als Sie sollten.“ 

5. WIE SIND VIT. B

6  „AGEPHA“ - TABLETTEN AUFZUBEWAHREN?

Nicht über 25°C lagern. In der Originalverpackung aufbewahren, um den Inhalt vor Licht zu 

schützen. 

Arzneimittel für Kinder unzugänglich aufbewahren.

Sie dürfen das Arzneimittel nach dem auf dem Blister und dem Umkarton nach dem 

angegebenen Verfalldatum nicht mehr anwenden. 

Das Arzneimittel darf nicht im Abwasser oder Haushaltsabfall entsorgt werden. Fragen Sie 

Ihren Apotheker wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr benötigen. 

Diese Maßnahme hilft die Umwelt zu schützen.

6. INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Vit. B

6  „Agepha“ – Tabletten enthalten

Der Wirkstoff ist: 24,3 mg Pyridoxinhydrochlorid entsprechend 20 mg Pyridoxin (Vitamin 

) pro Tablette.

Die sonstigen Bestandteile sind: Lactose-Monohydrat, Kartoffelstärke, Povidon K 25, 

Magnesiumstearat.

Wie Vit. B

6  „Agepha“ – Tabletten aussehen und Inhalt der Packung

Weiße, biplane, runde Tabletten mit einseitiger Bruchkerbe. 

Die Bruchkerbe dient nur zum Teilen der Tablette für ein erleichtertes Schlucken und nicht 

zum Aufteilen in gleiche Dosen.

1 Faltkarton enthält einen Blister mit 20 Tabletten. 

Pharmazeutischer Unternehmer und Hersteller

Agepha Pharma s.r.o., SK-90301 Senec, Tel: +421 692054 363, Fax: +421 245528069, 

Email: office@agepha.com

Z.Nr.: 8707

Diese Gebrauchsinformation wurde zuletzt überarbeitet im Januar 2015

Die folgenden Informationen sind nur für medizinisches Fachpersonal bestimmt:

Beim ersten Anzeichen einer Überdosierung sind Vit. B

 „Agepha“-Tabletten sofort 

abzusetzen. Bei Einnahme von über 150 mg/kg Körpergewicht werden das sofortige 

Auslösen von Erbrechen und die Gabe von Aktivkohle empfohlen. Gegebenenfalls sind 

intensivmedizinische Maßnahmen erforderlich.

Document Outline

21-9-2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

13-9-2018

Sarap Asian Fusion Recalls Cookies due to Undeclared Allergens

Sarap Asian Fusion Recalls Cookies due to Undeclared Allergens

Sarap Asian Fusion of Garden Grove, CA is recalling Asian Fusion Cookies due to undeclared allergens of wheat, milk and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

11-9-2018

Market of Choice Issues Allergy Alert for Undeclared Egg in Sesame Noodle Salad Vegan

Market of Choice Issues Allergy Alert for Undeclared Egg in Sesame Noodle Salad Vegan

Market of Choice, based in Eugene, Ore., is recalling its Gourmet Take Away Sesame Noodle Salad Vegan, because it contains undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

4-9-2018

H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls

H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls

H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

28-8-2018

Consumer Alert - Undeclared Sulfites in “Lily Bulb”

Consumer Alert - Undeclared Sulfites in “Lily Bulb”

New York State Agriculture Commissioner Richard A. Ball today alerted consumers that the “Lily Bulb” product (photo attached) distributed by Allied Imports Inc. of 267 52nd Street, Brooklyn, NY 11220 was found to contain sulfites, which are not declared on the product label. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. No illnesses have been reported to date to this Department in connection with this product.

FDA - U.S. Food and Drug Administration

16-8-2018

Marsee Baking Issues Allergy Alert On Undeclared Peanuts In Cookies Sold At Café Yumm! Restaurants

Marsee Baking Issues Allergy Alert On Undeclared Peanuts In Cookies Sold At Café Yumm! Restaurants

Marsee Foods, Inc. dba Marsee Baking is voluntarily recalling chocolate chip, ginger spice, and oatmeal raisin cookies sold at Café Yumm! restaurants. The cookies may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

9-8-2018

"Country Favor Inc Issues Alert on Undeclared Sulfites in “Best Taste Brand Snack Ginger Sliced”

"Country Favor Inc Issues Alert on Undeclared Sulfites in “Best Taste Brand Snack Ginger Sliced”

Country Favor Inc. of Maspeth, New York is recalling its 7 ounce packages of “Best Taste Brand Snack Ginger Sliced” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

3-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

27-7-2018

TeaSource Issues Allergy Alert on Undeclared Almonds in Product

TeaSource Issues Allergy Alert on Undeclared Almonds in Product

TeaSource of Roseville, MN is recalling Roasted Chestnut loose leaf tea, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product

FDA - U.S. Food and Drug Administration

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

21-7-2018

GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels "

GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels "

GiftTree, a gift basket company based in Vancouver, WA, is voluntarily recalling 94,000 units of “Sherman Candy Caramels” sold online in the several Gift Baskets because they may contain undeclared pecans, walnuts, almonds and/or peanuts. People who have an allergy or severe sensitivity to these nuts run the risk of serious or life-threatening reaction if they consume this product.

FDA - U.S. Food and Drug Administration

21-7-2018

Allergy Alert for Undeclared Milk in Food Lion Brand Dill Pickle Flavored Potato Chips

Allergy Alert for Undeclared Milk in Food Lion Brand Dill Pickle Flavored Potato Chips

Shearer’s Foods, LLC of Massillon, OH is recalling Food Lion brand 7.75 ounce packages of Dill Pickle Flavored Potato Chips because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Dill Pickle Flavored Potato Chips were distributed to Food Lion stores in NC, SC, GA, PA, KY, VA, TN, DE, MD, and WV between Dec 1st, 2017 and July 19, 2018.

FDA - U.S. Food and Drug Administration

20-7-2018

Liste der aktuell gültigen Monografien für Standardzulassungen – Humanarzneimittel: Stand 18.07.2018

Liste der aktuell gültigen Monografien für Standardzulassungen – Humanarzneimittel: Stand 18.07.2018

In diesem Dokument wurde bei Argininhydrochlorid-Lösung, 1M-L-Form die Menge an Wasser für Injektionszwecke von "zu 100,0 ml" zu "zu 1000,0 ml" geändert.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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

17-7-2018

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

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

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, 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

3-7-2018

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

1-7-2018

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Whole Foods Market is voluntarily recalling Whole Foods Market brand oatmeal raisin cookies from stores in eight states because the products contained soy flour that was not listed on the product label. 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

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

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

23-6-2018

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc., DBA Honey Mama's of Portland, Oregon is recalling 79 Sleeves (948 units) of Oregon Peppermint bars, lot code 112918, because it may contain undeclared Almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

19-6-2018

Golden Star Wholesale  Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

9-7-2018

Vita Gerin®

Rote - Liste

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety