Physioneal 40 Glucose 2,27% w/v/22,7 mg/ml

Primær information

  • Handelsnavn:
  • Physioneal 40 Glucose 2,27% w/v/22,7 mg/ml 22,7 mg/ml peritonealdialysevæske
  • Dosering:
  • 22,7 mg/ml
  • Lægemiddelform:
  • peritonealdialysevæske
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Physioneal 40 Glucose 2,27% w/v/22,7 mg/ml 22,7 mg/ml peritonealdialysevæske
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 30919
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Physioneal 40 Glucose 1,36 % w/v/13,6 mg/ml, peritonealdialysevæske

Physioneal 40 Glucose 2,27 % w/v/22,7 mg/ml, peritonealdialysevæske

Physioneal 40 Glucose 3,86 % w/v/38,6 mg/ml, peritonealdialysevæske

Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.

Kontakt lægen eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som

ikke er nævnt her. Se afsnit 4.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide om Physioneal 40

Sådan bliver du behandlet med Physioneal 40

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Physioneal 40 er en peritonealdialysevæske. Den fjerner vand og affaldsprodukter fra blodet. Den

korrigerer også unormale niveauer af forskellige blodkomponenter. Physioneal 40 indeholder

forskellige niveauer af glucose (13,6 mg/ml, 22,7 mg/ml eller 38,6 mg/ml). Jo højere koncentration af

glucose der er i opløsningen, desto større mængde vand vil der blive fjernet fra blodet.

Du kan få Physioneal 40 til behandling af:

enten akut eller kronisk nyresvigt

alvorlig vandretention

alvorlige forstyrrelser i syreholdigheden eller alkaliteten (pH) samt saltindholdet i blodet

visse typer af medicinforgiftning, hvor ingen anden behandling er mulig.

Physioneal 40 opløsning har en surhedsgrad (pH) tæt på dit blods. Derfor kan det være specielt

nyttigt, hvis du får indløbssmerter eller ubehag med andre mere syreholdige peritonealdialysevæsker.

2.

Det skal du vide om Physioneal 40

Din læge skal overvåge dig, første gang du bruger dette produkt.

Brug IKKE Physioneal 40

Hvis du er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i Physioneal 40

(angivet i afsnit 6).

Hvis du har en defekt, der påvirker din bugvæg eller bughule, og som ikke kan udbedres eller

som øger risikoen for infektion.

Hvis du har et kendt tab af peritoneal funktion, der skyldes ardannelse på bughinden.

Advarsler og forsigtighedsregler

Kontakt lægen eller sundhedspersonalet, før du bruger Physioneal 40.

Vær særlig forsigtig:

Hvis du har alvorlige problemer med din bugvæg eller bughule. For eksempel hvis du har brok,

eller en kronisk infektion eller en betændelsestilstand, der påvirker dine tarme.

Hvis du har fået en transplantation af hovedpulsåren.

Hvis du lider af åndedrætsbesvær.

Hvis du får mavesmerter, feber eller bemærker uklar udløbsvæske, eller hvis der er partikler i

udløbsvæsken. Dette kan være et tegn på betændelse i bughinden (peritonitis) eller infektion.

Du skal straks kontakte din læge. Notér batchnummeret på poserne du har brugt og tag dem

med til lægen sammen med posen med dræn. Lægen vil afgøre, om behandlingen skal standses,

eller om der skal startes en korrigerende behandling. Hvis du for eksempel har en infektion, kan

lægen tage nogle prøver for at finde ud af, hvilket antibiotikum der er bedst. Indtil din læge ved,

hvilken infektion du har, kan lægen give dig antibiotika, som virker mod en lang række

forskellige bakterier. Dette kaldes bredspektret antibiotika.

Hvis du har et højt indhold af lactat i dit blod. Du har forhøjet risiko for lactatacidose, hvis:

du har meget lavt blodtryk

du har en infektion i dit blod

du har akut nyresvigt

du har en arvelig metabolisk sygdom

du tager metformin (medicin der bruges til at behandle diabetes)

du tager medicin til behanding af HIV, specielt medicin kaldet NRTI’er.

Hvis du har diabetes og bruger denne opløsning, skal dosis af den medicin der regulerer dit blodsukker

(f.eks. insulin) evalueres regelmæssigt. Især når peritonealdialysebehandlingen startes eller ændres,

kan det være nødvendigt at justere dosis af din diabetesmedicin.

Hvis du har allergi over for majsstivelse som kan føre til overfølsomhedsreaktioner, herunder en alvorlig

allergisk reaktion kaldet anafylaksi. Stop straks infusionen og dræn opløsningen fra bughulen.

Hvis du har et højt indhold af parathyreoideahormon i dit blod pga. nyresygdom. Det lave

indhold af calcium i Physioneal 40 kan forværre hyperparathyreoidisme. Din læge vil overvåge

dit blods indhold af parathyreoideahormon.

Du skal – eventuelt sammen med din læge – registrere din væskebalance og din vægt. Din læge

vil måle dine blodparametre regelmæssigt. Særligt salte (f. eks. hydrogencarbonat, kalium,

magnesium, calcium og fosfat), parathyreoideahormon og lipider.

Hvis du har et højt indhold af hydrogencarbonat i dit blod.

Med ikke at bruge mere væske, end din læge har ordineret. Symptomer på overinfusion er

udspiling af maven, følelse af mæthed og åndenød.

Din læge vil regelmæssigt kontrollere mængden af kalium i dit blod. Hvis det bliver for lavt kan

din læge give dig kaliumchlorid.

Forkert kobling eller primingrækkefølge kan resultere i infusion af luft i bughulen, som kan

give mavesmerter og/eller peritonitis.

Hvis du infunderer en ikke blandet opløsning, bør du straks dræne opløsningen og anvende en

ny blandet pose.

En sygdom, kaldet indkapslende peritoneal sklerose (EPS), er en kendt, sjælden komplikation

til peritonealdialysebehandling. Du skal – eventuelt sammen med din læge – være opmærksom

på denne mulige komplikation. EPS giver:

betændelse i din mave

fortykkelse af tarmene, hvilket kan give mavesmerter, udspiling af maven eller

opkastning. EPS kan være dødeligt.

Børn

Din læge vil vurdere ricisi og fordele ved at anvende denne medicin, hvis du er under 18 år.

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg

altid lægens anvisning og oplysningerne på doseringsetiketten.

Brug af anden medicin sammen med Physioneal 40

Fortæl altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det

for nylig.

Hvis du bruger anden medicin, kan det være nødvendigt, at din læge øger dosis af denne

medicin. Dette skyldes, at peritonealdialysebehandling øger udskillelsen af noget medicin.

Vær forsigtig hvis du bruger hjertemedicin kaldet hjerteglykosider (f.eks. digoxin). Du kan:

have brug for tilskud af kalium og calcium

udvikle uregelmæssig hjerterytme (arytmi)

din læge vil overvåge dig omhyggeligt under behandlingen, specielt dit kaliumniveau.

Graviditet og amning

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal

du spørge din læge eller sundhedspersonalet til råds, før du bruger dette lægemiddel. Lægen vil tage

stilling til, om denne behandling er egnet eller ikke egnet for dig.

Trafik og arbejdssikkerhed

Denne behandling kan give træthed, sløret syn eller svimmelhed. Du må ikke køre bil eller betjene

maskiner, hvis du er påvirket.

3.

Sådan bliver du behandlet med Physioneal 40

Physioneal 40 skal indgives i bughulen. Bughulen er hulrummet i din mave mellem din hud og

bughinden. Bughinden er den membran, som omgiver dine indre organer som dine tarme og lever.

Det må ikke indgives i en vene.

Brug altid dette lægemiddel nøjagtigt som anvist af sundhedspersonalet, der er specialiseret i

peritonealdialyse. Spørg lægen, hvis du ikke er sikker.

Hvis posen er beskadiget, skal du kassere den.

Hvor meget og hvor ofte

Din læge vil ordinere den relevante glucosestyrke og antallet af poser, du skal bruge hver dag.

Brug til børn og unge

Hvis du er under 18 år gammel, vil din læge omhyggeligt vurdere brugen af dette lægemiddel.

Hvis du holder op med at bruge Physioneal 40

Peritonealedialyse må kun afbrydes efter aftale med din læge. Hvis du ophører med behandlingen, kan

det have livstruende konsekvenser.

Indgivelsesmåde

Før brug,

Opvarm posen til 37 ºC. Brug den varmeplade, der er specielt beregnet til dette formål. Posen

må aldrig nedsænkes i vand. Der må aldrig bruges mikrobølgeovn til opvarmning af posen.

Brug aseptisk teknik gennem hele indgivelsen, som du har lært i din træning.

Før start på et skift skal du sikre, at du rengør dine hænder og det område hvor skiftet foretages.

Før yderposen åbnes, skal du tjekke, at det er den rigtige opløsning og mængde (volumen) samt

udløbsdatoen. Løft posen for at tjekke om den lækker (overskydende væske i yderposen). Brug

ikke posen, hvis du opdager, at den lækker.

Efter du har fjernet yderposen, skal du inspicere dialyseposen for utætheder ved at trykke på

den. Tjek at brudstiften mellem kamrene ikke er knækket. Hvis brudstiften allerede er knækket,

kasseres posen. Brug ikke posen hvis du opdager, at den lækker.

Kontrollér, at opløsningen er klar. Brug ikke posen, hvis opløsningen er uklar eller indeholder

partikler.

Før start på et skift skal du sikre dig, at alle koblinger er foretaget korrekt.

Bland indholdet i de to kamre grundigt ved at knække brudstiften mellem kamrene. Vent indtil

det øvre kammers indhold er løbet fuldstændigt ned i det nedre kammer. Bland forsigtigt ved at

trykke med begge hænder på det nedre kammers vægge.

Spørg din læge eller sundhedspersonalet, hvis du har spørgsmål eller tvivl omkring dette

produkt eller hvordan det bruges.

Brug kun hver pose én gang. Kassér ubrugt opløsning.

Opløsningen skal infunderes inden for 24 timer efter blanding.

Efter brug skal du kontrollere at den drænede væske ikke er grumset.

Forligelighed med anden medicin

Din læge kan ordinere anden medicin til indsprøjtning, der tilsættes direkte i Physioneal 40 posen. I

denne situation tilsættes medicinen via medicinporten, der befinder sig på det lille kammer, inden

brudstiften mellem kamrene knækkes. Brug produktet straks, efter at medicinen er tilsat. Spørg din

læge, hvis du er i tvivl.

Hvis du bruger flere Physioneal 40 poser, end du skal inden for 24 timer

Hvis du bruger for meget Physioneal 40 kan du opleve:

udspiling af maven

mæthedsfornemmelse og/eller

åndenød.

Kontakt straks din læge. Lægen vil vejlede dig med hensyn til, hvad du skal gøre.

Kontakt lægen eller sundhedspersonalet, hvis du har brugt mere Physioneal 40 end der står i denne

information, eller mere end lægen har foreskrevet (og du føler dig utilpas).

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Fortæl straks din læge eller dialyseafdeling, hvis du oplever en af følgende:

Hypertension (blodtryk der er højere end normalt)

Hævede ankler eller ben, opsvulmede øjne, kortåndethed eller smerter i brystet (hypervolæmi)

Mavesmerter

Kulderystelser (skælven/influenzalignende symptomer), feber

Bughindebetændelse (peritonitis)

Disse er alle alvorlige bivirkninger. Du kan have behov for omgående behandling.

Hvis du oplever bivirkninger, bør du tale med din læge eller dialyseafdeling. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.

Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter )

Ændring i blodprøver:

stigning i calcium (hypercalciæmi)

fald i kalium (hypokaliæmi), som kan forårsage muskelsvaghed, kramper eller unormal

hjerterytme

Svaghed, træthed

Væskeansamling (ødem)

Vægtøgning

Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter )

Nedsat væskeudskillelse ved dialyse

Besvimelse, svimmelhed eller hovedpine

Uklar udløbsvæske fra bughinden, mavesmerte

Peritonealblødning, pus, hævelse eller smerte omkring kateterudgangsstedet, katetertilstopning

Kvalme, tab af appetit, fordøjelsesbesvær, luftafgang fra tarmen, tørst, tør mund

Udspiling eller betændelse i maven, skuldersmerter, brok i bughulen (lyskeknude)

Ændring i blodprøver:

mælkeacidose

forhøjet kuldioxid

øget blodsukker (hyperglykæmi)

øgning i hvide blodlegemer (eosinofili)

Besvær med at sove

Lavt blodtryk (hypotension)

Hoste

Ømhed i muskler og knogler

Hævelse af ansigtet eller halsen

Udslæt

Andre bivirkninger forbundet med peritonealdialyseproceduren

Infektion omkring kateterudgangsstedet, katetertilstopning

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket. Dette gælder også mulige

bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden

af dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Opbevares i den originale emballage.

Må ikke opbevares ved temperaturer under 4 °C.

Brug ikke lægemidlet efter den udløbsdato, der står på kartonetiketten og på posen efter

forkortelsen

EXP

og symbolet

. Udløbsdatoen er den sidste dag i den nævnte måned.

Bortskaf Physioneal 40 på den måde, som du har fået at vide i undervisningen.

6.

Pakningsstørrelser og yderligere oplysninger

Denne indlægsseddel indeholder ikke alle oplysninger om denne medicin. Spørg din læge, hvis du har

spørgsmål eller er i tvivl om noget.

Physioneal 40 indeholder

De aktive stoffer i den

blandede

peritonealdialysevæske er:

13,6 mg/ml

22,7 mg/ml

38,6 mg/ml

Glucosemonohydrat (g/l)

15,0

25,0

42,5

svarende til vandfri glucose (g/l)

13,6

22,7

38,6

Natriumchlorid (g/l)

5,38

Calciumchloriddihydrat (g/l)

0,184

Magnesiumchloridhexahydrat (g/l)

0,051

Natriumhydrogencarbonat (g/l)

2,10

Natrium (S)-lactatopløsning (g/l)

1,68

Øvrige indholdsstoffer er vand til injektionsvæsker og kuldioxid.

Sammensætningen i mmol/l i den

blandede

opløsning er:

13,6 mg/ml

22,7 mg/ml

38,6 mg/ml

Vandfri glucose (mmol/l)

75,5

Natrium (mmol/l)

Calcium (mmol/l)

Magnesium (mmol/l)

Chlorider (mmol/l)

Hydrogencarbonat (mmol/l)

Lactat (mmol/l)

1,25

0,25

Udseende og pakningsstørrelser

Physioneal 40 er en klar, farveløs, steril opløsning til peritonealdialyse.

Physioneal 40 leveres i en tokammer PVC pose. De to kamre er adskilt fra hinanden med en

permanent forsegling. Du må kun infundere Physioneal 40, når opløsningerne fra begge kamre er

fuldstændigt blandet.

Hver pose er pakket i en yderpose og leveres i en kasse.

Indhold

Antal enheder

pr. kasse

Produkttype

Koblingstype

1,5 l

5 / 6

Enkeltpose (APD)

skrue/spydkobling

1,5 l

5 / 6

Duopose (CAPD)

skrue/spyd/Lineo-kobling

2,0 l

4 / 5

Enkeltpose (APD)

skrue/spydkobling

2,0 l

4 / 5

Duopose (CAPD)

skrue/spyd/Lineo-kobling

2,5 l

4 / 5

Enkeltpose (APD)

skrue/spydkobling

2,5 l

4 / 5

Duopose (CAPD)

skrue/spyd/Lineo-kobling

Lineo-koblingen indeholder jod.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant

for indehaveren af markedsføringstilladelsen:

Indehaver af markedsføringstilladelsen

Baxter A/S

Tobaksvejen 2A

2860 Søborg

Fremstillere

Baxter Healthcare S.A.

Moneen Road

Castlebar

County Mayo - Irland

Baxter Healthcare Ltd.

Caxton Way

Thetford, Nordfolk

IP24 3SE

Storbritannien

Denne indlægsseddel blev senest revideret august 2017

Du kan finde produktresuméet (information til fagpersonale) for Physioneal 40 på

www.produktresume.dk.

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Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

23-8-2018

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

24-9-2018

News and press releases:  EMA to launch new corporate website on 27 September 2018

News and press releases: EMA to launch new corporate website on 27 September 2018

Fresh design and improved features to provide better user experience

Europe - EMA - European Medicines Agency

28-8-2018

 Minutes - PDCO minutes of the 24-27 July 2018 meeting

Minutes - PDCO minutes of the 24-27 July 2018 meeting

Paediatric Committee (PDCO) minutes of the meeting on 24-27 July 2018

Europe - EMA - European Medicines Agency

28-8-2018

ACCM meeting statement, Meeting 19, 22 March 2018

ACCM meeting statement, Meeting 19, 22 March 2018

Advisory Committee on Complementary Medicines Meeting 19 meeting statement

Therapeutic Goods Administration - Australia

27-8-2018

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5683 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1142/T/51

Europe -DG Health and Food Safety

27-8-2018

Biktarvy (Gilead Sciences Ireland UC)

Biktarvy (Gilead Sciences Ireland UC)

Biktarvy (Active substance: bictegravir / emtricitabine / tenofovir alafenamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5680 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004449/T/0001

Europe -DG Health and Food Safety

27-8-2018

Somavert (Pfizer Europe MA EEIG)

Somavert (Pfizer Europe MA EEIG)

Somavert (Active substance: Pegvisomant ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5684 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000409/T/0087

Europe -DG Health and Food Safety

27-8-2018

Opsumit (Actelion Registration Ltd)

Opsumit (Actelion Registration Ltd)

Opsumit (Active substance: macitentan) - Centralised - Renewal - Commission Decision (2018)5713 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2697/R/27

Europe -DG Health and Food Safety

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

27-8-2018

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5703 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3854/T/14

Europe -DG Health and Food Safety

27-8-2018

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Active substance: ertugliflozin / sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5698 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4313T/04

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Duzallo (GrUnenthal GmbH)

Duzallo (GrUnenthal GmbH)

Duzallo (Active substance: allopurinol / lesinurad) - Centralised - Authorisation - Commission Decision (2018)5696 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4412

Europe -DG Health and Food Safety

27-8-2018

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Active substance: daunorubicin / cytarabine) - Centralised - Authorisation - Commission Decision (2018)5695 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4282

Europe -DG Health and Food Safety

27-8-2018

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Active substance: human fibrinogen / human thrombin) - Centralised - Renewal - Commission Decision (2018)5689 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/898/R/54

Europe -DG Health and Food Safety

27-8-2018

Aranesp (Amgen Europe B.V.)

Aranesp (Amgen Europe B.V.)

Aranesp (Active substance: darbepoetin alfa) - Centralised - Yearly update - Commission Decision (2018)5707 of Mon, 27 Aug 2018

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

27-8-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5687 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/II/78

Europe -DG Health and Food Safety

23-8-2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in March 2018

Therapeutic Goods Administration - Australia

22-8-2018

Leucogen (Virbac)

Leucogen (Virbac)

Leucogen (Active substance: Feline leukaemia vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)5625 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/144/WS1282/6

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety