Nif-Ten

Informazioni principali

  • Nome commerciale:
  • Nif-Ten Kapseln
  • Forma farmaceutica:
  • Kapseln
  • Composizione:
  • nifedipinum 20 mg, atenololum 50 mg, excipiens pro il capsula.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Nif-Ten Kapseln
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Ipertonia

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 48627
  • Data dell'autorizzazione:
  • 30-06-1988
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Nif-Ten®

ASTRAZENECA

Che cos’è Nif-Ten e quando si usa?

Nif-Ten è la combinazione di due sostanze attive sul cuore, nifedipina e atenololo, che si completano

vicendevolmente nei loro effetti.

L’antagonista del calcio nifedipina protegge il cuore da sollecitazioni eccessive e dilata i vasi

sanguigni periferici. La irrorazione sanguigna migliora e la pressione arteriosa elevata diminuisce.

Il betabloccante atenololo calma l’attività cardiaca e diminuisce la pressione arteriosa elevata senza

influenzare la muscolatura delle vie respiratorie. Gli effetti dei farmaci dilatatori delle vie

respiratorie, assunti da pazienti che hanno malattie polmonari ostruttive, restano invariati. Pertanto

anche i pazienti asmatici o con difficoltà respiratoria possono assumere, con la dovuta prudenza, il

Nif-Ten.

Le due sostanze sono associate in forma speciale in un’unica capsula e si liberano in modo continuo

e lento nel tratto gastrointestinale. L’effetto contro la pressione arteriosa elevata dura così più a lungo

consentendo di assumere il farmaco una sola volta o due volte al giorno.

Il medico prescrive Nif-Ten per diminuire la pressione arteriosa elevata (ipertensione) e per

prevenire i dolori cardiaci consentendo all’organismo di sopportare uno sforzo maggiore. Per contro

Nif-Ten non è adatto ad alleviare i dolori cardiaci acuti dell’angina pectoris perché l’effetto non è

sufficientemente rapido.

Nif-Ten si usa solo su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Non si deve, in nessun caso, interrompere bruscamente la cura ma consultare prima il medico e

procedere gradualmente nell’arco di 1-2 settimane.

Quando non si può usare il Nif-Ten?

Non assuma Nif-Ten in caso Lei abbia avuto una reazione allergica al Nif-Ten o ad uno dei suoi

componenti, in caso di blocco cardiaco (polso inferiore a 50 battiti al minuto) o in caso di

insufficienza cardiaca non ancora curata o curata solo parzialmente.

Nif-Ten è controindicato anche nel caso in cui il paziente abbia problemi alle valvole cardiache

(stenosi dell’aorta), in caso di problemi renali o se ha già accusato polso lento o irregolare e in caso

di pressione arteriosa molto bassa o disturbi circolatori. Comunichi al medico l’eventuale esistenza di

tali malattie.

Nif-Ten non deve essere somministrato contemporaneamente alla rifampicina, un medicamento

contro la tubercolosi.

Nif-Ten non è adatto ai bambini o a giovani di meno di 18 anni (mancanza di sufficiente esperienza

in questo ambito).

Quando è richiesta prudenza nella somministrazione di Nif-Ten?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine!

Ai pazienti con insufficienza cardiaca occorre una terapia particolare con l’eventuale associazione di

altri farmaci cardiaci.

Chieda al medico il suo parere per l’assunzione di Nif-Ten in caso di asma, bronchite cronica o altra

malattia polmonare cronica ostruttiva.

Avvisi il medico in caso di diabete e se la glicemia è sovente troppo bassa, perché può essere

necessario adattare la terapia antidiabetica. I sintomi dell’ipoglicemia (specialmente l’aumento del

polso e i brividi) possono essere coperti da Nif-Ten in presenza di terapia antidiabetica.

Informi il medico o il farmacista se presenta problemi riguardanti il cuore, i reni, il fegato o la

tiroide, se soffre di disturbi circolatori, oppure assume disopiramide risp. amiodarone a causa del

battito cardiaco irregolare. Informi il medico o il farmacista anche dell’eventuale assunzione di

farmaci per il trattamento di irregolarità del battito cardiaco, ipertensione arteriosa, angina pectoris,

insufficienza cardiaca, ulcera gastrica, dolori, reumatismi, epilessia o tubercolosi.

Prima di un intervento chirurgico occorre informare il medico anestesista dei farmaci che si sono

assunti.

Avvisi subito il medico se il polso, a riposo, scende al disotto di 50 battiti al minuto durante la terapia

o se la pressione arteriosa è troppo bassa: essa si manifesta con stanchezza o con vertigine alzandosi

in piedi di colpo.

In rari casi è stata segnalata la comparsa di dolori cardiaci all’inizio della cura. In questo caso avvisi

immediatamente il medico.

Se assume clonidina per la terapia di ipertensione o di emicrania, non deve sospendere né la

clonidina né il Nif-Ten senza averne prima parlato con il Suo medico.

Non ingerire insieme a succo di pompelmo, esso può aumentare l’effetto del farmaco.

Informi il suo medico o il suo farmacista nel caso in cui soffra di altre malattie, soffra di allergie

o assuma o applichi altri medicamenti (anche acquistati di sua iniziativa).

Si può somministrare il Nif-Ten durante la gravidanza o l’allattamento?

Evitare di assumere Nif-Ten durante la gravidanza e l’allattamento.

Come usare il Nif-Ten?

Assumere Nif-Ten seguendo scrupolosamente la prescrizione medica.

Ipertensione (pressione arteriosa elevata)

In genere la dose per l’adulto è di 1 capsula di Nif-Ten al giorno per la pressione arteriosa elevata.

Coronaropatia (dolori cardiaci, angina pectoris)

In genere la dose è di 1 capsula di Nif-Ten 2 volte al giorno per l’ angina pectoris.

Anziani di oltre 65 anni: per l’angina pectoris la dose iniziale è di 1 capsula al giorno che può essere

portata a due al giorno solo sotto stretto controllo medico.

Ingerire la capsula preferibilmente sempre alla stessa ora.

Ingerire la capsula con un poco di acqua o succo di frutta (evitare caffè o alcool), senza masticarla.

In caso di dimenticanza si assume la capsula il giorno stesso, appena possibile. La dose giornaliera

prescritta non deve però essere superata.

Non cambiare la dose o rinunciare al farmaco senza il parere del medico. La pressione arteriosa

elevata e non trattata può avere conseguenze gravi. La interruzione del farmaco non deve essere

repentina ma progressiva nell’arco di 1-2 settimane. Talvolta, per rafforzare l’effetto del Nif-Ten, il

medico associa altri farmaci.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l’azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere il Nif-Ten?

Con l’assunzione di Nif-Ten possono manifestarsi i seguenti effetti collaterali:

E’ frequente la possibilità di comparsa di mal di testa, senso di stordimento, arrossamento del viso

con sensazione di calore, accumulo di acqua nei tessuti, disturbi gastrointestinali, senso di

stanchezza, rallentamento delle pulsazioni, freddo alle estremità, batticuore e nausea.

Occasionalmente, vi sono state segnalazioni di disturbi del sonno, nervosismo, prurito alle mani ed ai

piedi, tremori, vertigini, dolori in regione cardiaca (soprattutto sotto sforzo), abbassamento della

pressione arteriosa, affanno respiratorio, stitichezza, diarrea, secchezza della bocca, disturbi digestivi,

vomito, dolori addominali, prurito, eruzioni cutanee, sudorazione, dolori muscolari, dolori articolari,

aumento dell’escrezione di urina e malessere. Vi sono state rare segnalazioni di emorragie in piccole

aree cutanee, confusione mentale, cambiamenti d’umore, incubi, psicosi, allucinazioni, disturbi della

vista, secchezza degli occhi, ittero (colorazione giallastra della pelle e/o degli occhi), caduta di

capelli, impotenza, flatulenza, problemi a carico delle gengive, orticaria, ingrossamento delle

mammelle nell’uomo, e allergie. Raramente, è possibile osservare un aggravamento di situazioni già

esistenti quali disturbi circolatori, psoriasi, e disturbi respiratori negli asmatici.

La maggior parte degli effetti indesiderati scompare nel corso della terapia mentre l’organismo si

abitua al farmaco.

Se osserva effetti collaterali qui non descritti, dovrebbe informare il suo medico o il suo farmacista.

Questi sapranno stabilire se continuare la cura con altre dosi o se conviene rinunciare

progressivamente a Nif-Ten.

Di che altro occorre tener conto?

Conservare ad una temperatura non superiore ai 30 °C, al riparo dalla luce e dall’umidità e fuori dalla

portata dei bambini.

Il medicamento non deve essere utilizzato oltre la data indicata con «EXP» sulla confezione.

Il medico o il farmacista, che sono in possesso di documentazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene il Nif-Ten?

1 capsula contiene 50 mg di atenololo e 20 mg di nifedipina e eccipienti.

Numero dell'omologazione

48627 (Swissmedic).

Dov’è ottenibile Nif-Ten? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Confezioni da 30 e da 100 capsule.

Titolare dell’omologazione

AstraZeneca AG, 6340 Baar.

Questo foglietto illustrativo è stato controllato l’ultima volta nel marzo 2010 dall’autorità competente

in materia di medicamenti (Swissmedic).

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7-1-2019

Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix

Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been repo...

FDA - U.S. Food and Drug Administration

3-1-2019

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Due to a potential manufacturing defect the lights may overheat, posing a burn and fire hazard.

Health Canada

2-1-2019

Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot  #233 Because of Possible Health Risk

Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot #233 Because of Possible Health Risk

Oskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffnes...

FDA - U.S. Food and Drug Administration

24-12-2018

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes

FDA - U.S. Food and Drug Administration

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can...

FDA - U.S. Food and Drug Administration

20-12-2018

Miles Industries Ltd. recalls H5 Series Fireplaces

Miles Industries Ltd. recalls H5 Series Fireplaces

Convective heat (heated air only) can escape from behind the fireplace trim and overheat. While there is no evidence of a fire risk or significant charring, the stream of convective heat could cause possible discoloration of the adjacent wood studs or, over a period of time, charring of the wood behind the trim.

Health Canada

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Grapholita inopinata

Pest categorisation of Grapholita inopinata

Published on: Wed, 19 Dec 2018 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Grapholita inopinata, (Lepidoptera: Tortricidae), the Manchurian fruit moth, for the territory of the EU. G. inopinata is a well‐defined species that is recognised as a major pest of Malus spp. in Far East Russia, Eastern Siberia and northern China. G. inopinata is less common in Japan where it is not a serious pest. G. inopinata is not known to occur in the EU. G. inopinata is listed in Annex IIAI of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

The red palm weevil:  combating the loss of palm trees on the Mediterranean coast

The red palm weevil: combating the loss of palm trees on the Mediterranean coast

The palm weevil is one of the most damaging insect pests of palm trees, and is a threat to plant biodiversity in many countries. This insect has spread rapidly along the Mediterranean coast in the last ten years or more, and is classified as a regulated quarantine pest and a major danger to plant health in France. It is therefore subject to compulsory control measures. In order to curb the spread of the pest, which was introduced into the country in 2006, control strategies are being implemented at local...

France - Agence Nationale du Médicament Vétérinaire

19-12-2018

Pest categorisation of Phyllosticta solitaria

Pest categorisation of Phyllosticta solitaria

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Pest categorisation of Grapholita prunivora

Pest categorisation of Grapholita prunivora

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Pest categorisation of Carposina sasakii

Pest categorisation of Carposina sasakii

Published on: Mon, 17 Dec 2018 The EFSA Panel on Plant Health performed a pest categorisation of the peach fruit moth, Carposina sasakii Matsumura (Lepidoptera: Carposinidae) for the EU. C. sasakii is not currently regulated in the EU although C. niponensis, a valid species of no economic significance that was previously mistakenly synonymised with C. sasakii, is regulated in Annex IIAI of 2000/29 EC. C. sasakii is a well‐defined species that is recognised as a major pest of apples, peaches and pears in...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018

Inspired Organics Issues Voluntary Recall of Organic Almond Butter Due to Potential Health Risk

Inspired Organics Issues Voluntary Recall of Organic Almond Butter Due to Potential Health Risk

Inspired Organics, LLC has issued a voluntary recall of Organic Almond Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages an...

FDA - U.S. Food and Drug Administration

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

Inspired Organics Issues Voluntary Recall of Organic Sunflower Butter Due to Potential Health Risk

Inspired Organics Issues Voluntary Recall of Organic Sunflower Butter Due to Potential Health Risk

Inspired Organics, LLC has issued a voluntary recall of Organic Sunflower Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages...

FDA - U.S. Food and Drug Administration

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., the Kroger Louisville division announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by the supplier. The dog food was sold in one Kroger store located at 2440 Bardstown Road in Louisville, KY. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which ...

FDA - U.S. Food and Drug Administration

6-12-2018

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may caus...

FDA - U.S. Food and Drug Administration

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

5-12-2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-12-2018

Joint project on Benchmark Dose modelling with RIVM

Joint project on Benchmark Dose modelling with RIVM

Published on: Mon, 03 Dec 2018 A web application for PROAST, a software package for BMD modelling, was developed to make the use of the BMD approach significantly easier for toxicologists and risk assessors. In addition, model averaging was included in the software, for the most frequently occurring types of data in toxicological studies. The PROAST web application now allows for applying model averaging for the case of both quantal and continuous data, as well as for combined datasets (dose‐response da...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

FDA - U.S. Food and Drug Administration

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

FDA - U.S. Food and Drug Administration

23-11-2018

Dilart and Dilart HCT (valsartan)

Dilart and Dilart HCT (valsartan)

Recall - potential contamination

Therapeutic Goods Administration - Australia

21-1-2019

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

Recall - potential risk of harm for children who access the button battery

Therapeutic Goods Administration - Australia

15-1-2019

A warning to consumers about the serious health risks relating to e-cigarette liquid

A warning to consumers about the serious health risks relating to e-cigarette liquid

The TGA is alerting consumers to the potential risks of purchasing electronic cigarette liquid

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

19-12-2018

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices:  https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

FDA - U.S. Food and Drug Administration

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

26-11-2018

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

FDA - U.S. Food and Drug Administration

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration