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:
  • 60ML 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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Health Canada

10-12-2018

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)

The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution.

FDA - U.S. Food and Drug Administration

10-12-2018

Public Notification: On Demand contains hidden drug ingredient

Public Notification: On Demand contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use On Demand, a product promoted and sold for sexual enhancement on various websites, including www.goodlifeondemand.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

10-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

FDA - U.S. Food and Drug Administration

7-12-2018

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp is recalling it’s 12 ounce (340 g) Meiqili Durian Candy in plastic bag with clear window because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life – threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling five over-the-counter strawberry-flavoured acetaminophen oral drops for infants. The products are labeled as Biomedic, Option, Personnelle, Selection, or Laboratoires Trianon Inc. The products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children’s acetaminophen syrups for th...

Health Canada

7-12-2018

Bonify recalls 2 lots of dried cannabis products

Bonify recalls 2 lots of dried cannabis products

The recalled product may not meet some of the microbial and chemical contaminant limits as specified by the Good Production Practices requirements of the Cannabis Regulations.Documentation confirming test results could not be matched to the lot specific numbers.

Health Canada

7-12-2018

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning'

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning'

Accra Super Market of Worcester MA, is recalling 0.53 lbs packages of "Suya Barbecue Seasoning" because it may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

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

Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S’mores Flavor

Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S’mores Flavor

Danone North America is voluntarily recalling 3,521 cases of Light & Fit® Greek Crunch Nonfat Yogurt & Toppings S’Mores Flavor sold in the United States with an expiration date of December 30, 2018 and UPC of 36632 03825. It was discovered that some of the toppers sold on the product contain peanuts and are improperly labeled. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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

6-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products

FDA - U.S. Food and Drug Administration

6-12-2018

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Favor Inc. of Maspeth, New York is recalling its 12 ounce packages of "Best Taste Brand DRIED BAMBOO SHOOT" food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

6-12-2018

Formula Brands Inc. recalls Betty Crocker Single Serve Pod Coffee Maker

Formula Brands Inc. recalls Betty Crocker Single Serve Pod Coffee Maker

The affected product can overheat during use, posing a burn hazard.

Health Canada

5-12-2018

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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

14-12-2018

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for  developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here:  https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

FDA - U.S. Food and Drug Administration

13-12-2018

voriconazole

voriconazole

voriconazole (Active substance: voriconazole) - Centralised - Art 28 - (PSUR - Commission Decision (2018)8915 of Thu, 13 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3127/201802

Europe -DG Health and Food Safety

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

Europe -DG Health and Food Safety

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

7-12-2018

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7622 of Fri, 07 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/961/T/45

Europe -DG Health and Food Safety

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