PANADOL PRO DĚTI

Základní informace

  • Název přípravku:
  • PANADOL PRO DĚTI Perorální suspenze 24MG/ML
  • Dávkování:
  • 24MG/ML
  • Léková forma:
  • Perorální suspenze
  • Podání:
  • Perorální podání
  • Jednotky v balení:
  • 200ML II Lahev
  • Druh předpisu:
  • volně prodejné léčivé přípravky
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • PANADOL PRO DĚTI Perorální suspenze 24MG/ML
    Česká republika
  • Jazyk:
  • čeština

Terapeutická informace

  • Terapeutické oblasti:
  • PARACETAMOL
  • Přehled produktů:
  • PANADOL PRO DĚTI 24 MG/ML JAHODA

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Stav Autorizace:
  • B - přípravek po provedené změně. Smí být uváděn na trh po dobu
  • Registrační číslo:
  • 07/ 261/92-C
  • Poslední aktualizace:
  • 23-06-2017

Příbalovou informaci pro pacienta: složení, indikace, nežádoucí účinky, dávkování, interakce, těhotenství, kojení

Přílohač. 2ak rozhodnutíozměněregistracesp.zn. sukls70513/2011 a přílohake

sp.zn.sukls35935/2012

PŘÍBALOVÁ INFORMACE-INFORMACEPRO UŽIVATELE

PANADOLPRO DĚTIJAHODA24 MG/ML

Perorální suspenze

(paracetamolum)

Přečtětěsipozorněceloupříbalovouinformaci, protože obsahuje provás důležité údaje.

Tento přípravek jedostupnýbezlékařského předpisu.Přesto všakPANADOLPRO

DĚTIJAHODA24 mg/mlmusíte užívat pečlivěpodle návodu, abyVám co nejvíce

prospěl.

Ponechte si příbalovou informaci propřípad, žesi ji budetepotřebovat přečíst

znovu.

Požádejtesvého lékárníka, pokud potřebujetedalšíinformacenebo radu.

Pokudsepříznakyonemocněnízhoršínebosenezlepšído3dnůmusítese

poraditseslékařem.Dětemod3měsícůnepodávejtepřípravekbezporadys

lékařem délenež3 dny.Děti ve věku 2-3 měsícevizbod 3(upozornění).

Pokud sekterýkoliznežádoucích účinků vyskytnev závažnémíře, nebo

pokud sivšimnetejakýchkolinežádoucích účinků, kterénejsou uvedenyvtéto

příbalovéinformaci, sdělteto, prosím, svému lékaři nebo lékárníkovi.

PANADOLPRO DĚTIJAHODA 24 mg/ml jev této příbalovéinformaci

uveden téžjako PANADOLPRO DĚTI.

Vpříbalové informaci naleznete:

1. CojePANADOLPRO DĚTIakčemu sepoužívá

2. Čemu musítevěnovat pozornost, nežzačnetePANADOLPRO DĚTIužívat

3. Jak sePANADOLPRODĚTIužívá

4. Možnénežádoucí účinky

5 JakPANADOLPRO DĚTIuchovávat

6. Dalšíinformace

1.CojePANADOLPRO DĚTI JAHODA24 mg/ml a kčemuse používá

PANADOLPRO DĚTIobsahuje paracetamol–látku protibolesti(analgetikum) ake

snížení horečky(antipyretikum). Májahodovou příchuť a neobsahujealkohol.

PANADOLPRO DĚTInedráždí žaludek asnadno se dětem podává.Paracetamol se

po podání rychle vstřebává, účineksedostavujedo 30 minut, vrcholízhrubaza2

hodinypo podání a odeznívá během 4 hodin.PANADOLPRO DĚTIje určen ke

snížení horečkyabolestiprovázející chřipku, nachlazení, infekční onemocnění

dětského věku ( např. spalničky, zarděnky, planéneštovice,spála, příušnice) a

očkování.PANADOLPRO DĚTIje téžvhodnýk tlumení bolestiprovázející

prořezávání zoubků abolestizubů.

PANADOLPRODĚTIjevhodnýprodětiod3měsícůdo12let.Kesnížení

horečkypo očkování můžebýt podán dětem od 2 měsíců.

2. Čemumusítevěnovat pozornost, nežzačnetePANADOLPRO DĚTIužívat

NeužívejtepřípravekPANADOLPRO DĚTI

-přialergii(přecitlivělosti)naparacetamol nebo nakteroukolisložku přípravku

-při žloutence

-přitěžkém jaternímselhávání

-při těžkéhemolytickéanémii(chudokrevnostzrozpadu červených krvinek)

PANADOLPRO DĚTIobsahuje paracetamolaprotosenesmípodávat současně

sjinýmiléky, kteréobsahujíparacetamolnebokterépoškozujíčinnost jater.

Zvláštníopatrnostipři použití přípravku PANADOLPRO DĚTI je zapotřebí

-podáváte-lipřípravek dítětisonemocněnímjater

-podáváte-lipřípravek dítětisonemocněnímledvin

-při deficituenzymuglukózo-6-fosfátdehydrogenázy

Pokud Vašedítětrpí některým zvýšeuvedených onemocněnímusíte seo vhodnosti

užívání přípravku předem poraditslékařem.

Přípravek není určen dětem do 3 měsíců svýjimkou snížení horečkypo očkování, kde

můžebýt podán dětem od 2 měsíců.

Vzájemnépůsobení s dalšími léčivými přípravky

ÚčinkypřípravkuPANADOLPRO DĚTIaúčinkyjiných současně užívaných léků se

mohou navzájem ovlivňovat.Prosím, informujte svého lékařenebo lékárníkao všech

lécích, kteréVašedítěsoučasně užívánebo je užívalo v nedávnédoběatoi o lécích,

kteréjsoudostupnébezlékařského předpisu.

Závažnélékovéinterakcejsouu paracetamolu vzácné. Současnédlouhodobé užívání

PANADOLu PRO DĚTIsněkterýmilékynaspaní, protiepilepsiianěkterých

antibiotik můževést kpoškození funkcejater. Metoklopramid nebo domperidon může

zvýšitrychlostvstřebávání paracetamolu, cholestyramin jimůžesnížit. Při

pravidelném dlouhodébém užívání paracetamolumůžebýt zvýšen účinek léků

snižujících srážlivostkrve(warfarin nebo jinékumarinové přípravky)snásledným

zvýšenímrizika krvácivých projevů. Občasné užívání nemávýznamnývliv.Současné

dlouhodobé užíváníPANADOLu PRO DĚTIakyselinyacetylsalicylové nebo dalších

nesteroidních protizánětlivých přípravků můževést kpoškození ledvin.

Nenívhodnékombinovatparacetamolslátkamipoškozujícímijátra.Některélátky

zvyšujícíčinnost oxidačních enzymů v játrech (rifampicin, fenobarbital) mohou zvýšit

toxicitu paracetamolu.

Užívání přípravkuPANADOLPRO DĚTIsjídlema pitím

PANADOLPRODĚTI jeurčenproděti,pokudbyvšakpřípravekužívaldospělýnesmí

jej užívat bezdoporučení lékaře, pokud má problémys požíváním alkoholu.

Běhemléčbysenesmíkonzumovatalkohol.Přípraveksemůžepodávatnezávislena

jídle.

Těhotenství a kojení

Přípravekjeurčenproděti.Zbezpečnostníchdůvodůvšakuvádímeiinformace

týkající se těhotenstvíakojení.

Jste-litěhotnánebokojíteporaďtesesvýmlékařemnebolékárníkemdřívenež

začnete užívat jakýkolilék.

Těhotnéženymohoupřípravekužívatpoporaděslékařem.Přikojeníjemožné

přípravek užívat 1 den, dále pouzepo poraděslékařem.

Řízení dopravních prostředkůa obsluhastrojů

Přípravekjeurčenproděti.Pokudbyvšakpřípravekužívaldospělýuvádíme

následující informaci:

PANADOLPRO DĚTInemá žádnývliv naschopnostřídit nebo obsluhovat stroje.

DůležitéinformaceoněkterýchsložkáchpřípravkuPANADOLPRO DĚTI

Přípravekobsahujeparabeny,vdůsledkutohomůžezpůsobitalergickéreakce

(pravděpodobnězpožděné).

Přípravekobsahujesorbitol.PokudVámlékařřekl,žeVašedítěnesnášíněkteré

cukry, poraďte seslékařem, nežzačnete tento léčivýpřípravek dítětipodávat.

3.JaksePANADOLPRO DĚTI JAHODA24mg/mlužívá

VždyužívejtePANADOLPRODĚTIpřesněpodlepokynůtétopříbalovéinformace.

Pokud sinejstejistý(á), poraďte sese svým lékařem nebolékárníkem.

Přípravek je určen properorálnípodání.

Před použitímlahev protřepejte.

Doporučenédávkování:

Hmotnost dítěte věk dávka(ml)

6-8 kg 3–6 měsíců 4,0

8-10 kg 6–12 měsíců 5,0

10-13 kg 1-2 roky 7,0

13-15 kg 2–3 roky 9,0

15-21 kg 3–6 let 10,0

21-29kg 6–9 let 14,0

29-42 kg 9–12 let 20,0

Pokud lékař nedoporučí jinak určete správnou dávku přípravku pomocí uvedené

tabulkypodle hmotnostidítěte. Pokud sinejstejistiváhou dítěte určete dávku podle

věku dítěte.Přiloženýdávkovacíaplikátorvložte do lahve, otočtednem vzhůrua

natahujte suspenzi doaplikátorudokud senastupnici namodrém pístu neobjeví

požadovanémnožstvínad hornímokrajem průhledného pláštěaplikátoru.Potom

otočtelahvičku opět dnem dolů avytáhněteaplikátorven (vizobrázek).

Aplikátorvložte dítěti doúst, zatlačte napístapomalu vstříkněte. Je-listanovená

dávkavětšínež10ml, odměření podlepotřebyopakujte.

Po použitíaplikátorpropláchněte teplou vodouanechte vyschnout.

Přípravek můžebýt podáván opakovaněpodle potřeby, dávku lzeopakovatnejdříve

po 6 hodinách. Jednotlivádávkapro dětiod 3 měsíců do 12 let je 10-15 mg/kg.

Celková denní dávkanesmípřesáhnout 60 mg/kgtělesné hmotnosti u dětí do 6 let,

1500 mgu dětíod 6 do 12 let shmotností 21-25 kga2000 mgpři hmotnosti 26-40

kg.

U pacientů sesníženou funkcí ledvin určí dávkování lékař.

Upozornění:Užívání vyšších neždoporučenýchdávek můževést k riziku závažného

poškození jater.

Bezporadys lékařem nepodávejtetento přípravekdítětidéle než3 dny. Jestliže

příznakypřetrvávají, vyhledejtelékaře.

Dětiod 2 do 3 měsíců mohou užívat přípravek pouzekesnížení horečkypo očkování.

Doporučenájednotlivádávkaje2,5 ml.Podávajísemaximálně 2 dávkysodstupem

nejméně6 hodin.Přetrvává-lizvýšenáteplotai po druhédávcePANADOLu PRO

DĚTIje třebavyhledat lékaře, kterýurčí dalšíléčbu.

Jestližese vašedítěnarodilo nedonošené, poraďteseslékařem dřívenežPANADOL

PRO DĚTIzačnete dítětipodávat.

Jestližejsteužil(a)vícepřípravkunežjsteměl(a)

Vevšechpřípadech podezření napředávkování,kterése můžeprojevitpocitem na

zvracení, zvracenímabledostínebopřináhodnémpožití přípravku dítětem

kontaktujteihned svého lékaře nebo nejbližší zdravotnickézařízení. Předložte jim

požitébalení atuto příbalovou informaci.

Jestližejstezapomněl(a) užítpřípravek

Nezdvojujte následující dávku, abyste nahradil(a)vynechanoudávku.Užijte obvyklou

dávkupřípravku,jakmilesivzpomenete,apřípadnoudalšídávkuužijtesčasovým

odstupem uvedeným vbodě3. výše.

4. Možnénežádoucí účinky

Podobnějako všechnyléky, můžemít iPANADOLPRO DĚTInežádoucí účinky,

kteréseale nemusívyskytnout u každého.

Pokud sekterýkoliznežádoucích účinků vyskytnev závažnémíře, nebo pokud si

všimnete jakýchkolinežádoucích účinků, kterénejsou uvedenyv této příbalové

informaci, prosím, sdělteto svému lékaři nebo lékárníkovi.

PřípravekPANADOLPRO DĚTIje při dodržování doporučeného dávkování

poměrnědobřesnášen,ale můžese vyskytnoutkožní vyrážka, vzácnězúžení

průdušek, poruchyjaterních funkcí a krvetvorby.Při případném výskytu těchto nebo

jiných neobvyklých reakcí přestaňtepřípravek dítěti podávat a poraďte seslékařem.

5.JakPANADOLPRODĚTI uchovávat

Uchovávejtev původnímobalu při teplotědo30° C.Chraňte před mrazem.

Po prvnímotevření jedobapoužitelnosti 1 rok.

PANADOLPRO DĚTInepoužívejtepouplynutídobypoužitelnostivyznačenéna

obalu.Dobapoužitelnosti se vztahujekposlednímu dni uvedeného měsíce.

Uchovávejtemimo dosahadohleddětí.

Léčivépřípravkysenesmívyhazovatdoodpadníchvodnebodomácíhoodpadu.Tato

opatření pomáhajíchránit životní prostředí.

6. Dalšíinformace

CoPANADOLPRO DĚTI JAHODA24mg/mlobsahuje

-Léčivá látka:paracetamolum24mgv1mlsuspenze

-Pomocnélátkyjsou:kyselinajablečnáL-forma, xanthanováklovatina,jahodové

aroma,nekrystalizujícísorbitol 70%,roztok maltitolu,směs sodných solí parabenů,

karbomer 974P, dinatrium-edetát, hydroxid sodný,sukralosa, draselná sůl

acesulfamu, čištěnávoda

JakPANADOLPRO DĚTIvypadáa co obsahujebalení

PANADOLPRODĚTIje bezbarváažbílánebonahnědláprůsvitnásuspenze

sjahodovoupříchutí.

Druh obalu:

HnědáPET lahvičkasbílýmPPdětským bezpečnostním a pojistným uzávěrem

sHDPE vložkou aPE vložkou vhrdle lahvičkypro použití dávkovacího aplikátoru,

10 mlpístovýdávkovacíaplikátor (bílýPE pístabezbarváprůhlednáPPpipeta

dělenámodřepo 0,5 ml),krabička.Velikostbalení 60 ml, 100 ml a 200 ml.

Natrhu nemusíbýt všechnyvelikosti balení.

VýrobcempřípravkujeFarmaclair, 440 avenueduGénéral deGaulle,

Hérouville-Saint Clair, Francie

Držitelemrozhodnutíoregistracije GlaxoSmithKlineConsumerHealthcare,

GlaxoSmithKlineExportLtd.,Brentford, TW8 9GS,Velká Británie

Tato příbalová informacebyla naposledy schválena: 4.4.2012

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FDA - U.S. Food and Drug Administration

5-12-2018

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk

Hiland Dairy is announcing a voluntary recall of half-gallon premium whole milk chocolate that is produced at the Kansas City, Missouri facility, over concerns the products may contain eggnog that could affect those individuals that have sensitivity to egg allergens. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

1-12-2018

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: MOB Candy contains hidden drug ingredients

Public Notification: MOB Candy contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use MOB Candy, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: Willy Go Wild contains hidden drug ingredients

Public Notification: Willy Go Wild contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Willy Go Wild, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Státní ústav pro kontrolu léčiv informuje o stahování přípravku IBALGIN JUNIOR č. š. 8K0151 od pacientů

Státní ústav pro kontrolu léčiv informuje o stahování přípravku IBALGIN JUNIOR č. š. 8K0151 od pacientů

Věnujte pozornost informaci Státního ústavu pro kontrolu léčiv o stahování přípravku IBALGIN JUNIOR šarže č. 8K0151 od pacientů z důvodu podezření na závadu v jakosti. 

Český Republich - SUKL - State Institute for Drug Control

30-11-2018

RedeCan recalls one lot of B.E.C. dried cannabis

RedeCan recalls one lot of B.E.C. dried cannabis

The affected product may contain mould. In certain individuals, exposure to mould can result in allergic symptoms such as sneezing, coughing, wheezing, runny nose or nasal congestion, and watery eyes or itchy eyes.

Health Canada

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Published on: Thu, 29 Nov 2018 The study described in this report was conducted with the aim of developing an unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. The main sources of data were the information submitted in the context of approval of active substances and authorization of products and and additional information retrieved through a systematic literature review. The data were screened and organised in thr...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

ELM Pet Foods, Inc is issuing a voluntary recall of Elm Chicken and Chickpea Recipe dog food because the products could contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

29-11-2018

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

FDA - U.S. Food and Drug Administration

29-11-2018

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

The recalled products were not destined for the Canadian marketplace and do not have mandatory 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

28-11-2018

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

ANF, Inc. is issuing a voluntary recall of select products of ANF Pet Lamb and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

28-11-2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 12. 11. – 25. 11. 2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 12. 11. – 25. 11. 2018

Státní ústav pro kontrolu léčiv informuje o přípravcích, u kterých držitel rozhodnutí o registraci oznámil přerušení nebo ukončení dodávek na český trh, včetně informace o nahrazujícím léčivém přípravku, pokud byl léčivý přípravek vyhodnocen jako nahraditelný.

Český Republich - SUKL - State Institute for Drug Control

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella

Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

27-11-2018

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

27-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA - U.S. Food and Drug Administration

27-11-2018

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

FDA - U.S. Food and Drug Administration

27-11-2018

Human placenta products for consumption not authorized in Canada, may pose serious health risks

Human placenta products for consumption not authorized in Canada, may pose serious health risks

November 27, 2018 For immediate release

Health Canada

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

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

5-12-2018

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Authorisation - Commission Decision (2018)7970 of Wed, 05 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451

Europe -DG Health and Food Safety

2-12-2018

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more:  https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4

FDA - U.S. Food and Drug Administration

29-11-2018

alli (GlaxoSmithKline Dungarvan Limited)

alli (GlaxoSmithKline Dungarvan Limited)

alli (Active substance: Orlistat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8041 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/854/T/59

Europe -DG Health and Food Safety

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

28-11-2018

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8039 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/808/T/56

Europe -DG Health and Food Safety

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

28-11-2018

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Active substance: darunavir) - Centralised - 2-Monthly update - Commission Decision (2018)8046 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4891/IB/2/G

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

27-11-2018

Pifeltro (Merck Sharp and Dohme B.V.)

Pifeltro (Merck Sharp and Dohme B.V.)

Pifeltro (Active substance: doravirine) - Centralised - Authorisation - Commission Decision (2018)7983 of Tue, 27 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4747

Europe -DG Health and Food Safety

26-11-2018

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.

FDA - U.S. Food and Drug Administration

26-11-2018

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety and performance.

FDA - U.S. Food and Drug Administration

26-11-2018

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Ziextenzo (Sandoz GmbH)

Ziextenzo (Sandoz GmbH)

Ziextenzo (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7961 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4802

Europe -DG Health and Food Safety

26-11-2018

Delstrigo (Merck Sharp and Dohme B.V.)

Delstrigo (Merck Sharp and Dohme B.V.)

Delstrigo (Active substance: doravirine / lamivudine / tenofovir disoproxil) - Centralised - Authorisation - Commission Decision (2018)7960 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004746

Europe -DG Health and Food Safety

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

Europe -DG Health and Food Safety

26-11-2018

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Active substance: naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7966 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4325/T/04

Europe -DG Health and Food Safety

26-11-2018

Kentera (Teva B.V.)

Kentera (Teva B.V.)

Kentera (Active substance: Oxybutynin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7967 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/532/T/49

Europe -DG Health and Food Safety

26-11-2018

Jivi (Bayer AG)

Jivi (Bayer AG)

Jivi (Active substance: damoctocog alfa pegol) - Centralised - Authorisation - Commission Decision (2018)7987 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004054/0000

Europe -DG Health and Food Safety

26-11-2018

Erivedge (Roche Registration GmbH)

Erivedge (Roche Registration GmbH)

Erivedge (Active substance: vismodegib) - PSUSA - Modification - Commission Decision (2018)7973 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10140/201801

Europe -DG Health and Food Safety