Caverject Dual

Primær information

  • Handelsnavn:
  • Caverject Dual 20 mikrog pulver og solvens til injektionsvæske, opløsning
  • Dosering:
  • 20 mikrog
  • Lægemiddelform:
  • pulver og solvens til injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Caverject Dual 20 mikrog pulver og solvens til injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 48572
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

CAVERJECT

®

DUAL

10 mikrogram og 20 mikrogram pulver og solvens til injektionsvæske, opløsning

Alprostadil

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 apotekspersonalet, hvis der er mere du vil vide. Lægen har

ordineret Caverject Dual til dig personligt. Lad derfor være med at give medicinen til andre. Det kan være skadeligt for andre, selvom de

har de samme symptomer, som du har. Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er

nævnt her. Se punkt 4. Se den nyeste indlægsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at bruge Caverject Dual.

Sådan skal du bruge Caverject Dual.

Bivirkninger.

Opbevaring.

Pakningsstørrelser og yderligere oplysninger.

1. Virkning og anvendelse

Caverject Dual indeholder alprostadil. Det ligner et stof, der hedder prostaglandin E1, som er naturligt forekommende i kroppen.

Caverject Dual virker ved at udvide blodkarrene, hvorved blodet bedre kan flyde ind i penis. Herved opnår du lettere rejsning.

Du kan bruge Caverject Dual til behandling af rejsningsproblemer herunder svag rejsning og impotens. Din læge kan også anvende

Caverject Dual sammen med andre undersøgelser for at finde årsagen til dit rejningsproblem.

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid lægens anvisning og

oplysningerne på doseringsetiketten.

2. Det skal du vide, før du begynder at bruge Caverject Dual

Brug ikke Caverject Dual

hvis du er allergisk over for alprostadil, eller et af de øvrige indholdsstoffer i Caverject Dual (angivet i punkt 6).

hvis du har en abnormitet af de røde blodlegemer (seglcelleanæmi), kræft i blodet (leukæmi), knoglemarvskræft (multipelt

myelom) eller andre lidelser, der kan påvirke, at du kan få for langvarig rejsning (priaprisme). Det vil sige, når rejsningen varer

ved i mere end 4 timer. Kontakt omgående læge eller skadestue.

hvis du har implantater i penis.

hvis du er blevet frarådet seksuel aktivitet, f.eks. på grund af problemer med hjertet.

hvis du har en arret eller krum penis eller lider af Peyronies sygdom.

hvis du har forhudsforsnævring.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du bruger Caverject Dual

hvis du har eller har haft dårligt hjerte, psykiske lidelser, misbrugsproblemer, problemer med blodomløbet eller hvis du har

nedsat lungefunktion.

hvis du har haft et mindre slagtilfælde (forbigående iskæmisk tilfælde)

hvis du har en anatomisk deformitet af penis, som f. eks. vinkling, kavernøs fibrose, fibrøse knuder eller krumning af penis ved

rejsning (Peyronies sygdom) eller udvikler dette under behandlingen med Caverject Dual. Ved langvarig brug øges risikoen for

udvikling af disse tilstande og behandlingen bør stoppes.

Kontakt omgående læge eller skadestue, hvis rejsningen varer mere end 4 timer, da behandlingen bør startes inden for 6

timer.

Ved brug af Caverject Dual anvendes en meget tynd nål, som kan knække. Derfor er det meget vigtigt, at du er blevet instrueret

i at bruge Caverject korrekt. Hvis nålen er bøjet, skal den smides ud og udskiftes med en ny ren nål.

Seksuelt overførte sygdomme:

Caverject Dual beskytter hverken din partner eller dig mod seksuelt overførte sygdomme, f.eks. AIDS, herpes eller gonorré. Når du bruger

Caverject Dual kan der forekomme en lille blødning på injektionsstedet. Denne lille blødning kan øge risikoen for, at du kan smitte din

partner med en seksuelt overførbar sygdom. Der bør i disse tilfælde anvendes kondom.

Brug af anden medicin sammen med Caverject Dual

Tal med din læge, hvis du tager:

andre former for medicin mod rejsningsproblemer (sildefanil, papaverin).

blodfortyndende medicin, da det kan øge risikoen for blødning på injektionsstedet (trombocytaggregationshæmmere,

antikoagulantia f.eks. warfarin, heparin).

medicin mod forhøjet blodtryk (antihypertensiva).

karudvidende medicin (vasodilatorer f.eks. nitroglycerin).

sympatomimetika (adrenalin, dopamin).

Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.

Graviditet og amning

Caverject Dual er kun til behandling af mænd.

Caverject Dual kan både anvendes af par, der ønsker at få børn og af par, hvor kvinden er gravid eller ammer. Caverject Dual beskytter

ikke din partner mod graviditet, så der bør anvendes sikker prævention, hvis graviditet er uønsket.

Trafik- og arbejdssikkerhed

Caverject Dual påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.

Vigtig information om nogle af de øvrige indholdsstoffer i Caverject Dual

Denne medicin indeholder lactose. Hvis din læge har fortalt dig at du ikke tåler visse sukkerarter, så kontakt lægen inden du

tager Caverject Dual.

Caverject Dual indeholder benzylalkohol, der kan give overfølsomhedsreaktioner.

3. Sådan skal du bruge Caverject Dual

Brug altid Caverject Dual nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg lægen eller apotekspersonalet.

Lægen eller sygeplejersken vil vise dig, hvordan du foretager indsprøjtningen i hvert fald den første gang. Forsøg ikke selv at foretage

indsprøjtningerne, før du har lært den rigtige metode. Hvis du ikke kan huske, hvad du skal gøre, skal du kontakte lægen igen. Den

nedenstående instruktion er kun en vejledning.

Den sædvanlige dosis er

Voksne:

Doseringen er individuel og fastsættes af lægen. Lægen vil rådgive dig om den dosis, der passer til dig, og kontrollere dig jævnligt for at

se, hvordan det virker. De fleste bruger 5-20 mikrogram, men nogle kan have behov for større doser.

En dosis større end 40 mikrogram anbefales normalt ikke.

Hvis Caverject Dual anvendes af lægen, til at finde årsagen til dit rejsningsproblem, er dosis 5-20 mikrogram.

Hvis den dosis, du har fået ordineret, ikke fungerer godt nok, skal du fortælle det til lægen. Du må ikke selv ændre din dosis, medmindre

lægen anviser det. Hvis du glemmer, hvor meget du skal bruge, kan du se på etiketten på pakningen eller spørge lægen.

Ældre:

Caverject Dual anbefales ikke til ældre over 75 år.

Brug til børn og unge:

Caverject Dual anbefales ikke til unge under 18 år.

Hvordan bruger du Caverject Dual?

Denne instruktion er kun en vejledning. Du bør følge lægens anvisning, hvis den er forskellig fra denne indlægsseddel.

Du og din partner

Ønsker du, at din partner skal være med til at forberede og/eller foretage indsprøjtningen, så tal med din læge eller sygeplejerske, så din

partner kan deltage i vejledningen.

Forberedelse af indsprøjtningen

Vask dine hænder med vand og sæbe og tør dem i et rent håndklæde. Hvis din partner ønsker at være med til at

forberede eller foretage indsprøjtningen, skal vedkommende også vaske hænder.

Tag 1 engangssprøjte og 1 nål fra æsken. Fjern folien fra nålen.

Sæt nålen på sprøjten ved at skubbe nålen på plads på sprøjtespidsen. Drej mod højre til den sidder fast. Tag den ydre

beskyttelseshætte af nålen. Den indre beskyttelseshætte skal blive siddende.

Hold sprøjten med nålen i en lodret position. Stemplet skal være trukket helt ud i yderste position.

Hold sprøjten som vist på tegningen nedenfor og drej stemplet mod højre til det stopper. Nu blandes pulver og solvens. Vend

sprøjten et par gange for at være sikker på, at opløsningen er blandet jævnt. Opløsningen skal være klar. Brug ikke

opløsningen, hvis den er uklar eller indeholder partikler.

Hold sprøjten med nålen opad. Fjern forsigtigt den indre beskyttelseshætte fra nålen. Kontrollér, at nålen ikke er bøjet. Hvis den

er bøjet, må den ikke bruges. Smid den væk. Forsøg ikke at rette den ud.

For at fjerne eventuelle større luftbobler fra opløsningen bankes der med fingeren på ampullen indtil boblerne forsvinder. Hold

derefter sprøjten med nålen opad, og kontrollér, at stemplet er drejet helt ud ved at skrue det mod højre (med uret). Tryk så

stemplet ind, indtil det møder modstand. NB. Stemplet må ikke trykkes helt i bund. Der vil komme nogle få dråber fra

nålespidsen. Det er normalt, at der er små bobler på siden af glasampullen.

Drej langsomt stemplet mod højre (som vist på tegningen nedenfor). Der findes 4 doseringsintervaller. Hvert interval svarer til

en fjerdedel af den fulde dosis i sprøjten. Indstil den dosis din læge har ordineret. Tallet i det lille vindue viser den valgte dosis.

Hvis du får indstillet en forkert dosis, så fortsæt blot at dreje mod højre, indtil du når den korrekte dosis.

Du kan forberede injektionen op til 24 timer, før du skal bruge den, blot den ikke opbevares over 25ºC.

Sådan foretages injektionen

Tag tøjet af og gør dig det behageligt. Tag dig god tid, så du og din partner slapper af. Hvis lægen har anbefalet, at du bruger

en renseserviet, kan du åbne én nu.

Sørg for at nålen ikke er bøjet. Hvis nålen er bøjet må den må den ikke bruges. Smid den væk. Forsøg ikke at rette en bøjet

nål ud, da den kan være tilbøjelig til at knække. Sæt en ny, ubrugt steril nål på sprøjten. Der er set tilfælde af knækkede nåle,

hvor en del af nålen sad tilbage i penis. Nogle tilfælde krævede hospitalsindlæggelse og nålen skulle fjernes ved en operation.

Hvis nålen er bøjet, må den ikke bruges og skal smides væk.

Hold om penis med pege- og langefinger på undersiden tæt ved testiklerne og tommelfingeren på oversiden. Klem penis

forsigtigt, så injektionsstedet buler ud. Hvis der er forhud, så stræk den ud. Indsprøjtningen skal udføres i det område af penis

der er skraveret på figur A.

Figur A

Rengør injektionsstedet med en af de vedlagte renseservietter. Kontroller dosis, og hvis nødvendigt juster den, så at den

korrekte dosis vises i doseringsvinduet.

Hold penis med et fast greb, tag sprøjten med den frie hånd, og stik nålen vinkelret ind i penis. Vinklen fremgår af figur B og C.

Undgå at stikke synlige blodårer. Tryk stemplet ned med en fast bevægelse. Hvis opløsningen ikke bliver indsprøjtet forholdsvis

hurtigt, så bevæg nålen en smule og prøv igen. Opløsningen må ikke tvinges ud af sprøjten.

Figur B

Figur C

Når opløsningen er indsprøjtet trækkes nålen ud. Tryk forsigtigt på injektionsstedet med renseservietten og massér penis, så

den indsprøjtede opløsning bliver fordelt.

Hvis der er opløsning tilbage i sprøjten, skal det kasseres. Den må ikke gemmes til senere brug. Nålen skal smides væk

således, at ingen kan komme til at stikke sig på den.

Rejsning efter indsprøjtning af Caverject Dual

Efter indsprøjtningen vil der gå lidt tid, før du får rejsning. Med den rette dosering vil rejsningen være tilstrækkelig til, at du kan

gennemføre et samleje. Rejsningen bør ikke vare mere end 1 time. Hvis du ønsker, at rejsningen skal holde længere, skal du tale med din

læge. Kontakt omgående læge eller skadestue, hvis rejsningen varer mere end 4 timer.

Hvor ofte må du bruge Caverject Dual?

Du må højst bruge Caverject Dual 1 gang om dagen og ikke mere end 3 gange i løbet af en uge. Du skal skifte injektionsstedet fra gang til

gang.

Hvis du har brugt for meget Caverject Dual

Kontakt lægen, skadestuen eller på apoteket, hvis du har brugt mere Caverject Dual, end der står i denne information, eller mere end

lægen har foreskrevet, og du føler dig utilpas.

Kontakt omgående læge eller skadestue, hvis rejsningen varer mere end 4 timer.

Hvis du holder op med at bruge Caverject Dual

Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.

4. Bivirkninger

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

Alvorlige bivirkninger

Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter):

Krumning af penis ved rejsning (forsvinder ikke, efter at du er stoppet med behandling). Kontakt lægen.

Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter):

Vedvarende, smertefuld rejsning af penis. Kontakt læge eller skadestue.

Ikke alvorlige bivirkninger

Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter):

Smerter i penis.

Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter):

Forlænget varighed af rejsning. Kontakt omgående læge eller skadestude, hvis rejsningen varer mere end 4 timer.

Dannelse af arvæv i penis, som kan føre til små hårde knuder eller krum penis.

Små blødninger i huden og blå mærker på injektionsstedet. Når du er vant til at bruge Caverject Dual Chamber forekommer de

blå mærker sjældnere.

Muskelkramper.

Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter):

Svampeinfektion.

Forkølelse.

Nedsat eller øget følsomhed ved berøring

Store pupiller.

Uregelmæssig puls på grund af ekstraslag. Kan være eller blive alvorligt. Tal med lægen.

Svimmelhed, evt. besvimelse pga. lavt blodtryk.

Kolde hænder og fødder pga. åreproblemer.

Blødning fra vener.

Kvalme.

Mundtørhed, som kan øge risikoen for huller i tænderne.

Udslæt. Kraftig sveden. Kløe. Rødmen af huden.

Blødning fra urinrøret eller blod i urinen, særligt hvis Caverject Dual ved en fejl indsprøjtes i urinrøret, der leder urin gennem

penis. Kontakt lægen.

Smerter og svien ved vandladningen. Hyppig vandladning og forstærket vandladningstrang.

Bækkensmerter. Knude i testiklerne. Sædbrok med væskefyldte udposninger ïndeholdende sæd på testiklerne (spermatocele).

Hævede testikler. Testikel- eller pungsygdomme. Rød opsvulmet eller øm penis, testikler eller pung. Smertefuld rejsning.

Betændelse i huden på penishovedet. Forhudsforsnævring. Impotens. Anderledes sædudtømmelse end normalt.

Reaktioner på injektionsstedet f.eks. irritation, betændelse, hævelse, småblødninger, følelsesløshed, varmefornemmelse,

smerter eller kløe i penis.

Kraftesløshed og svaghed.

Hævede fødder, ankler og hænder.

Hurtig puls. Kan blive alvorligt. Hvis du får meget hurtig og uregelmæssig puls eller bliver utilpas eller besvimer, skal du

kontakte læge eller skadestue. Ring evt. 112.

Caverject Dual kan herudover give bivirkninger, som du normalt ikke mærker noget til. Det drejer sig om ændringer i visse

laboratorieprøver, f.eks. blodprøver, som igen bliver normale, når behandlingen ophører.

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 Caverject Dual utilgængeligt for børn.

Brug ikke Caverject Dual efter den udløbsdato, der står på pakningen. Hvis pakningen er mærket med EXP betyder det at

udløbsdatoen er den sidste dag i den nævnte måned.

Du kan opbevare Caverject Dual ved almindelig temperatur.

Den færdigblandede opløsning er holdbar i 24 timer, ved højst 25 ºC. Caverject Dual er beregnet til engangsbrug. Gem ikke

eventuelle rester til senere brug.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller

skraldespanden.

6. Pakningsstørreler og yderligere oplysninger

Caverject Dual indeholder:

Aktivt stof:

Alprostadil 10 mikrogram eller 20 mikrogram

Øvrige indholdsstoffer:

Lactosemonohydrat, natriumcitratdihydrat, alfadex, saltsyre, natriumhydroxid.

Solvens består af: Benzylalkohol og vand til injektionsvæsker.

Renseservietterne er vædet med isopropylalkohol.

Udseende og pakningsstørrelser:

Caverject Dual er en tokammer-glascylinderampul, der er samlet i én enhed i en engangssprøjte. Ampullen indeholder pulver i det forreste

kammer og solvens i det bageste kammer.

Caverject Dual fås i:

Caverject Dual 10 mikrogram i pakninger med 2 engangssprøjter, 2 injektionsnåle (Becton Dickinson, 29G 12mm) samt 4 renseservietter.

Caverject Dual 20 mikrogram i pakninger med 2 engangssprøjter, 2 injektionsnåle (Becton Dickinson, 29G 12mm) samt 4 renseservietter.

Alle styrker og pakningsstørrelser er ikke nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Orifarm A/S, Energivej 15, 5260 Odense S

Mail: info@orifarm.com

Fremstiller:

Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, CZ

For yderligere oplysninger om denne medicin og ved reklamationer kan du henvende dig til Orifarm A/S.

Denne indlægsseddel blev senest ændret 07/2017

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Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA - U.S. Food and Drug Administration

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

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

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

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

21-8-2018

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...

FDA - U.S. Food and Drug Administration

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

13-7-2018

FDA warns of imposters sending consumers fake warning letters

FDA warns of imposters sending consumers fake warning letters

FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

FDA - U.S. Food and Drug Administration

12-7-2018

Saje Natural Wellness Inc. recalls Saje Natural Wellness Splish Splash Gentle Baby Wash

Saje Natural Wellness Inc. recalls Saje Natural Wellness Splish Splash Gentle Baby Wash

The affected products are contaminated with the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa can pose a risk of infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

Health Canada

6-7-2018

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

FDA - U.S. Food and Drug Administration

3-7-2018

DKMA Update June 2018

DKMA Update June 2018

In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

28-6-2018

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

FDA - U.S. Food and Drug Administration

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

29-5-2018

X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination

X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination

The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.

FDA - U.S. Food and Drug Administration

19-5-2018

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens and this is not declared on the package. Individuals who have an allergy or severe sensitivity to milk, soy, wheat or cashews run the risk of serious or life-threatening allergic reaction if they consume these products

FDA - U.S. Food and Drug Administration

19-5-2018

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarr...

FDA - U.S. Food and Drug Administration

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

26-6-2015

Guide to individual case safety reporting

Guide to individual case safety reporting

We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority.

Danish Medicines Agency

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

26-6-2018

Electronic submission of individual case safety reports

Electronic submission of individual case safety reports

Electronic data interchange for ICSR submission using the E2B R2 format

Therapeutic Goods Administration - Australia