AQUA PRO INJECTIONE MEDIEKOS

Základní informace

  • Název přípravku:
  • AQUA PRO INJECTIONE MEDIEKOS, PAR LQF 5000MLPPVAK
  • Dávkování:
  • 100%
  • Léková forma:
  • Rozpouštědlo pro parenterální použití
  • Podání:
  • Parenterální podání
  • Jednotky v balení:
  • 5000ML PPVA, Vak
  • Druh předpisu:
  • Léčiva na lékařský předpis
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • AQUA PRO INJECTIONE MEDIEKOS, PAR LQF 5000MLPPVAK
    Česká republika
  • Jazyk:
  • čeština

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Stav Autorizace:
  • R - registrovaný léčivý přípravek.
  • Registrační číslo:
  • 76/ 062/96-C
  • Poslední aktualizace:
  • 08-11-2016

Příbalovou informaci pro pacienta

Stránka 1 z 2 

Příloha č. 1 k rozhodnutí o převodu registrace sp.zn. sukls277691/2012 

Příbalová informace: Informace pro uživatele 

AQUA PRO INJECTIONE MEDIEKOS 

Rozpouštědlo pro parenterální použití 

Aqua pro iniectione  

Držitel rozhodnutí o registraci:                      

Biomedica, spol. s r. o., Pekařská 8, 155 00 Praha 5, Česká republika 

Výrobce: 

InMediec, s.r.o. 

Luhačovice 

Česká republika 

Složení:                      

Aqua pro iniectione- 500 ml, 1000 ml, 2000 ml, 5000 ml v závislosti na velikosti vaku 

Indikační skupina:       

Varium, infundibilium. 

Charakteristika:    

Sterilní apyrogenní voda. Pomocná látka k přípravě infúzních směsí, k rozpouštění a ředění 

léčivých látek.  

Farmakokinetické   údaje:                           

Jedná se o roztok k přípravě. Problémy absorpce, distribuce, biotransformace a vylučování 

jsou odvislé od přidaných látek. Distribuce v tělesných kompartmentech je dána aktuálně 

stavem pacienta.     

Indikace:                   

Slouží jako pomocná látka k přípravě infúzních směsí z elektrolytových koncentrátů, 

k rozpouštění a ředění léčivých látek. 

Kontraindikace:        

Voda pro injekce nesmí být použita jako samostatný infúzní nebo injekční roztok. 

Intravenózně může být podána pouze isotonická směs nebo jiná dle klinického stavu a 

individuální indikace. Takto i v jiné formě může být použita pouze jako individuální 

přípravek. Kontraindikace pak vyplývají také z přidaných látek.V případech hyperhydratace 

je nutno dbát zvýšené opatrnosti i při irigaci do tělesných dutin a dutých orgánů („otrava 

volnou vodou“). 

Nežádoucí účinky:  

Při respektování indikací nejsou známy. Při intravenózním podání  hypoosmolárního roztoku 

(pod cca 100 mosmol/l) je nebezpečí intravaskulární osmotické hemolýzy. Podávání vodných 

roztoků je nutné přizpůsobit bilanci vody a iontů, aby nedošlo k možnosti vzniku 

hyperhydratace nebo iontové disbalance (edémy, kardiopulmonální dekompenzace). 

Stránka 2 z 2 

Interakce:                

Platí běžná kritéria pro podání iontových roztoků. Interakce jsou spjaty s fyzikálními 

vlastnostmi připravených infúzních roztoků. 

Dávkování a způsob podávání:                     

Dávkování je přísně individuální.Při přípravě roztoku pro intravenózní aplikaci by se 

výsledná koncentrace měla blížit osmolaritě plazmy.Přípravek je vhodný pro dospělé i děti 

bez omezení věku. 

Uchovávání:   

Uchovávejte při teplotě do 25°C. Chraňte před mrazem. 

Varování:                  

Přípravek nesmí být používán po uplynutí doby vyznačené na obalu. 

Uchovávejte mimo dosah a dohled dětí.  

Balení:        

PVC vak nebo PP vak: 1x 500 ml, 1x1000 ml, 1x2000 ml, 1x5000 ml   

Datum revize textu: 30.1.2013 

15-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

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FDA - U.S. Food and Drug Administration

15-11-2018

Vanpak Limited recalls various Cosmetic products in pressurised containers.

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Health Canada

15-11-2018

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA - U.S. Food and Drug Administration

9-11-2018

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

8-11-2018

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Best Leopard Miracle of Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Leopard Secret Miracle Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared 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 this product.

FDA - U.S. Food and Drug Administration

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

2-11-2018

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

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Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

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Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

25-10-2018

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

24-10-2018

U-Pol Inc. recalls Automotive Repair and Refinish Products

U-Pol Inc. recalls Automotive Repair and Refinish Products

Health Canada has established that these products do not meet the mandatory warning labelling requirements for consumer use, as required under Canadian law. They are correctly labelled for workplace professional users, but the products lack the symbols and warnings required for consumer chemicals.

Health Canada

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA - U.S. Food and Drug Administration

19-10-2018

Centrální úložiště elektronických receptů prošlo bezpečnostním testem

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Centrální úložiště elektronických receptů (CÚeR), které provozuje Státní ústav pro kontrolu léčiv (SÚKL), bylo podrobeno plánovanému bezpečnostnímu testování. Testy proběhly ve spolupráci s Národním úřadem pro kybernetickou a informační bezpečnost (NÚKIB) a ukázaly nejen kvalitní fungování úložiště, ale i zodpovědný přístup vedení SÚKL k povinnosti ověřovat spolehlivost a důvěryhodnost svých informačních systémů.

Český Republich - SUKL - State Institute for Drug Control

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

18-10-2018

Reakce na tvrzení společnosti Rohlík.cz, že „schvalování rozvozu léků bylo zdlouhavé kvůli požadavkům SÚKL“

Reakce na tvrzení společnosti Rohlík.cz, že „schvalování rozvozu léků bylo zdlouhavé kvůli požadavkům SÚKL“

Společnost Rohlík.cz nebyla a ani nemůže být partnerem Státního ústavu pro kontrolu léčiv, neboť není oprávněna k zacházení s léčivými přípravky. Rohlík.cz pouze zajišťuje přepravu léčiv pro jiný oprávněný subjekt. Zásilkový výdej může nabízet pouze provozovatel lékárny, nikdo jiný. 

Český Republich - SUKL - State Institute for Drug Control

16-10-2018

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

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

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Strong Horses, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

Public Notification: Like Slim Coffee contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

25-9-2018

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. 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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

24-9-2018

Reakce na avizovanou žalobu České lékárnické komory v souvislosti s opožděnými dodávkami léků

Reakce na avizovanou žalobu České lékárnické komory v souvislosti s opožděnými dodávkami léků

Za posledních deset měsíců, tedy od prosince 2017, obdržel Státní ústav pro kontrolu léčiv pouze 6 podnětů na prověření dostupnosti konkrétních léčivých přípravků. V žádném z nich nebylo zjištěno porušení zákona, neshledali jsme tedy důvod pro uložení pokuty. Ustanovení v zákoně týkající se povinnosti dodávek je právně nevymahatelné. Nevymahatelnost je způsobena zejména nejistotou při počítání tržních podílů distributorů. Zákon totiž nedefinuje, jak takové tržní podíly počítat.

Český Republich - SUKL - State Institute for Drug Control

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

20-9-2018

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Canadians should not buy or use health products that contain 2,4-dinitrophenol, more commonly known as DNP, because it is toxic and can cause death. Products containing DNP are primarily marketed towards bodybuilders and are promoted online as a "fat burner" or "shredder" and for weight loss.

Health Canada

21-10-2018

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most trea

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most trea

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most treatable stages. pic.twitter.com/aoYjsSEPrC

FDA - U.S. Food and Drug Administration

21-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

14-9-2018

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgDd 

FDA - U.S. Food and Drug Administration