FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (ASA).
English: How to take Clopidogrel/Acetylsalicylic acid Zentiva
Danish: Sådan skal du tage Clopidogrel/Acetylsalicylsyre Zentiva
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172) - Polishing agent: carnauba wax
Danish: Øvrige indholdsstoffer: - Tabletkernen: mannitol (E421), macrogol 6000, mikrokrystallinsk cellulose, lavsubstitueret hydroxypropylcellulose, majsstivelse, hydrogeneret ricinusolie (se afsnit 2 ‘Clopidogrel/Acetylsalicylsyre Zentiva indeholder hydrogeneret ricinusolie'), stearinsyre og kolloid vandfri silica.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg
English: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Danish: Samtidig indgift af heparin havde ingen virkning på den hæmning af trombocytaggregationen, som Clopidogrel/Acetylsalicylsyre Zentiva inducerer.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Danish: Da clopidogrel til dels metaboliseres til dets aktive metabolit af CYP2C19, kan anvendelse af medicin,
English: This leaflet was last revised in <Month YYYY>.
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
English: Do not take Clopidogrel/Acetylsalicylic acid Zentiva
Danish: Tag ikke Clopidogrel/Acetylsalicylsyre Zentiva:
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets The active substances are clopidogrel and acetylsalicylic acid (ASA).
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Aktive stoffer: clopidogrel og acetylsalicylsyre (ASA).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Light pink, oval, slightly biconvex, engraved with «C75» on one side and «A100» on the other side.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Lys pink, oval, lettere bikonveks, med "C75" præget på den ene side og ”A100” på den anden side.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow, engraved on one side with ‘C75' and ‘A75'on the other side.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter (tabletter) er ovale, let bikonvekse, gule og er præget på den ene side med "C75" og på den anden side med "A75".
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Yellow, oval, slightly biconvex, engraved with «C75» on one side and «A75» on the other side.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Gul, oval, lettere bikonveks, med "C75" præget på den ene side og ”A75” på den anden side.
English: What Clopidogrel/Acetylsalicylic acid Zentiva is and what it is used for What you need to know before you take Clopidogrel/Acetylsalicylic acid Zentiva How to take Clopidogrel/Acetylsalicylic acid Zentiva Possible side effects
Danish: Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Zentiva Sådan skal du tage Clopidogrel/Acetylsalicylsyre Zentiva Bivirkninger
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: Clopidogrel/Acetylsalicylic acid Zentiva is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Clopidogrel/Acetylsalicylsyre Zentiva tages af voksne for at forebygge dannelse af blodpropper i blodårer, som er blevet stive.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75' and ‘A100'on the other side.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter (tabletter) er ovale, let bikonvekse, lyserøde og er præget på den ene side med "C75" og på den anden side med "A100".
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva should be given as a single daily 75 mg/75 mg dose.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva bør gives som en enkelt daglig dosis på 75 mg/75 mg.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) - Polishing agent: carnauba wax
Danish: - Tablettens overtræk: lactosemonohydrat (se afsnit 2 ‘Clopidogrel/Acetylsalicylsyre Zentiva indeholder lactose'), hypromellose (E464), titandioxid (E171), triacetin (E1518), rød jernoxid (E172) - Polérmiddel: carnaubavoks.
English: Clopidogrel/Acetylsalicylic acid Zentiva fixed-dose combination is used following initiation of therapy with clopidogrel and ASA given separately, and replaces the individual clopidogrel and ASA products.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva bør gives som en enkelt daglig dosis på 75 mg/100 mg. Clopidogrel/Acetylsalicylsyre Zentiva fast dosiskombination anvendes efter indledning af behandling med clopidogrel og ASA givet separat, og erstatter de individuelle clopidogrel og ASA produkter.
English: In any case, you should take it for as long as your doctor continues to prescribe it.
Danish: Under alle omstændigheder skal du fortsætte med at tage Clopidogrel/Acetylsalicylsyre Zentiva, så længe din læge udskriver det til dig.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg tablet clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg tabletter clopidogrel/acetylsalicylsyre
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg tablet clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg tabletter clopidogrel/acetylsalicylsyre
English: 28 March 2019
Danish: 28. marts 2019
English: It began operating in 1995.
Danish: Det indledte sin virksomhed i 1995.
English: The revised policy entered into force on 30 January 2015.
Danish: Den reviderede politik trådte i kraft den 30. januar 2015.
English: About us
Danish: Om os
English: The Agency has separate policies in place for these groups.
Danish: Agenturet har særskilte politikker for disse grupper.
English: EMA/338312/2016 Rev. 2 European Medicines Agency
Danish: EMA/338312/2016 Rev. 2
English: This restriction is reflected in the guidance document.
Danish: Denne begrænsning fremgår af det vejledende dokument.
English: Each EU Member State has its own national authorisation procedures.
Danish: Hver EU-medlemsstat har sine egne nationale godkendelsesprocedurer.
English: It is optional for other medicines:
Danish: Den er fakultativ for andre lægemidler:
English: • the type of activity that the expert will be undertaking.
Danish: • den type aktivitet, som eksperten skal udføre.
English: Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
Danish: Begrænsningen af vedkommendes deltagelse vil blive reduceret over tid, og der skelnes mellem aktuelle interesser og interesser inden for de sidste tre år
English: This supports an exchange of information on a number of issues, including:
Danish: Dette støtter udveksling af oplysninger om en række spørgsmål, herunder:
English: • the Innovation Task Force, a forum for early dialogue with applicants.
Danish: • Innovationstaskforcen, et forum for tidlig dialog med ansøgerne.
English: • Transparency
Danish: • Gennemsigtighed
English: Annual review of policies on independence
Danish: Årlig gennemgang af politikkerne om uafhængighed
English: The Management Board is made up of the following members:
Danish: Bestyrelsen består af følgende medlemmer:
English: For more information, see Section 3.1.
Danish: Yderligere oplysninger findes i afsnit 3.1.
English: • Single evaluation by European experts.
Danish: • En enkelt vurdering foretaget af europæiske eksperter.
English: EMA strives towards being as open and transparent as possible about how it reaches its scientific conclusions.
Danish: EMA tilstræber at være så åbent og gennemsigtigt som muligt om, hvordan det når frem til sine videnskabelige konklusioner.
English: The centralised procedure is compulsory for:
Danish: Den centrale procedure er obligatorisk for:
English: Information about these can normally be found on the websites of the national competent authorities:
Danish: Oplysninger om disse procedurer kan normalt findes på de nationale kompetente myndigheders websteder:
English: EMA is involved in the assessment of certain categories of medical devices.
Danish: EMA er involveret i vurderingen af visse kategorier af medicinsk udstyr.
English: Medical devices are regulated by national competent authorities in Europe.
Danish: Medicinsk udstyr reguleres af nationale kompetente myndigheder i Europa.
English: EMA is governed by an independent Management Board.
Danish: EMA ledes af en uafhængig bestyrelse.
English: • containing new active substances for indications other than those stated above;
Danish: • der indeholder nye aktive stoffer for andre indikationer end dem, der er anført ovenfor
English: EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Danish: EMA er et decentralt agentur i Den Europæiske Union (EU) og ligger i Amsterdam.
English: EMA subsequently updated the policy:
Danish: Efterfølgende opdaterede EMA politikken med henblik på at:
English: They can be nominated by Member States or by the Agency itself and are made available by the national competent authorities.
Danish: De kan udpeges af medlemsstaterne eller af agenturet selv og stilles til rådighed af de nationale kompetente myndigheder.
English: • developing guidelines and setting standards;
Danish: • udarbejde retningslinjer og fastsætte standarder
English: All other DoIs are available on request.
Danish: Alle andre interesseerklæringer kan fås på anmodning.
English: • support for early access;
Danish: • støtte til tidlig adgang
English: • for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.
Danish: • for nogle interessers vedkommende, f.eks. økonomiske interesser, vil nedkølingsperioden bortfalde, når interessen ikke længere er til stede.
English: • Accelerates the exchange of information on important issues, such as the safety of medicines.
Danish: • Fremskynder udvekslingen af oplysninger om vigtige spørgsmål, såsom lægemiddelsikkerheden.
English: Facilitate development and access to medicines
Danish: Fremme udvikling og adgang til lægemidler
English: The report includes results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.
Danish: Rapporten indeholder resultaterne af tillidsbrudprocedurer, eventuelle gennemførte tilsyn, planlagte initiativer for det kommende år og anbefalinger til forbedring.
English: Board members are appointed for a three-year term, which may be renewed.
Danish: Bestyrelsesmedlemmerne udpeges for tre år, og deres mandat kan fornyes.
English: Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.
Danish: På samme vis er kravene til formænd og medlemmer med en ledende rolle, f.eks. rapportører, strengere end kravene til øvrige udvalgsmedlemmer.
English: The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned.
Danish: Repræsentanterne for medlemsstaterne, Europa-Kommissionen og Europa-Parlamentet udpeges direkte af den pågældende medlemsstat og institution.
English: The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Danish: Bestyrelsen består af 35 medlemmer, der er udpeget til at handle i offentlighedens interesse, og som ikke repræsenterer nogen offentlig myndighed, organisation eller sektor.
English: Experts can only be involved once the Agency has assessed their declaration of interests.
Danish: Eksperterne kan først deltage, når agenturet har vurderet deres interesseerklæring.
English: The European medicines regulatory network is the cornerstone of EMA's work and success.
Danish: Det europæiske netværk for regulering af lægemidler er hjørnestenen i EMA's arbejde og succes.
English: Please note that the document contains links to sections of the EMA website, some of which are only available in English.
Danish: Bemærk, at dokumentet indeholder links til sektioner på EMA's websted, hvoraf nogle kun er tilgængelige på engelsk.
English: All medicines must be authorised before they can be marketed and made available to patients.
Danish: Alle lægemidler skal godkendes, inden de kan markedsføres og udleveres til patienterne.
English: The system for regulating medicines in Europe is unique in the world.
Danish: Systemet til regulering af lægemidler i Europa er unikt på verdensplan.
English: Not all aspects of medicine regulation in the EU fall under the remit of the Agency.
Danish: Ikke alle aspekter af lægemiddelregulering i EU er omfattet af agenturets ansvarsområde.
English: • Product information available in all EU languages at the same time.
Danish: • Produktinformation er tilgængelig på alle EU-sprog på samme tid.
English: The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.
Danish: For at nå disse mål anvender agenturet en lang række reguleringsmekanismer, som løbende gennemgås og forbedres.
English: In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
Danish: Foruden medlemmerne har bestyrelsen også en observatør fra henholdsvis Island, Liechtenstein og Norge.
English: This includes public versions of scientific assessment reports and summaries written in lay language.
Danish: Dette omfatter offentlige versioner af videnskabelige vurderingsrapporter og sammendrag skrevet i letforståeligt sprog.
English: • the time since the interest occurred;
Danish: • hvor længe siden interessen opstod
English: − human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
Danish: − human immundefekt virus (HIV) eller erhvervet immundefektsyndrom (AIDS)
English: It includes a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:
Danish: Den omfatter en række foranstaltninger, der tager højde for den oplyste interesses art, før der træffes afgørelse om varigheden af eventuelle begrænsninger:
English: The representatives of the Member States and of the Commission may have alternates.
Danish: Repræsentanterne for medlemsstaterne og Kommissionen kan have suppleanter.
English: The European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt it.
Danish: Europa-Kommissionen udarbejder EUlovgivning vedrørende lægemidler, og Europa-Parlamentet vedtager den sammen med Rådet for Den Europæiske Union.
English: EMA is a networking organisation whose activities involve thousands of experts from across Europe.
Danish: EMA er en netværksorganisation, hvis aktiviteter involverer flere tusinde eksperter fra hele Europa.
English: The revised rules are similar to the principles adopted for committee members and experts.
Danish: De reviderede regler er de samme som de principper, der er vedtaget for udvalgsmedlemmer og eksperter.
English: The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
Danish: Målet er at sikre den bedste ekspertise til vurdering af lægemidler, uanset hvor eksperterne er baseret.
English: New staff must get rid of any interests they have before they can start to work at the Agency.
Danish: Nye medarbejdere skal frigøre sig fra eventuelle modstridende interesser, før de kan begynde at arbejde for agenturet.
English: • Enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively;
Danish: • Gør det muligt for medlemsstaterne at samle ressourcerne og koordinere arbejdet for at regulere lægemidlerne effektivt
English: As of 2015, EMA reviews all of its policies on independence and rules for handling competing interests and their implementation on an annual basis and publishes an annual report.
Danish: Fra og med 2015 gennemgår EMA hvert år alle dets politikker om uafhængighed og regler for håndtering af modstridende interesser og gennemførelsen deraf og offentliggør en årlig rapport.
English: EMA's Management Board adopted the current version of the policy and trust of-breach procedure in December 2015.
Danish: EMA's bestyrelse vedtog den gældende version af politikken og tillidsbrudproceduren i december 2015.
English: They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
Danish: De udvælges således, at der sikres det maksimalt faglige niveau, en bred vifte af relevant ekspertise og den størst mulige geografiske spredning inden for EU.
English: The Agency also seeks to publish clear and up-to-date information on how it operates, including planning and reporting documents and information on funding, financial management and budgetary reporting.
Danish: Agenturet tilstræber også at offentliggøre klare og ajourførte oplysninger om, hvordan det arbejder, herunder planlægnings- og rapporteringsdokumenter og oplysninger om finansiering, økonomisk forvaltning og budgetrapportering.
English: Some of the data are supplied by the Member States and centrally managed by EMA.
Danish: Nogle af dataene stilles til rådighed af medlemsstaterne og forvaltes centralt af EMA.
English: It is consulted on the rules of procedure and the membership of the Agency's committees.
Danish: Den høres om forretningsordenen for og medlemskabet af agenturets udvalg.
English: The Agency also implements policies and procedures to ensure its works independently, openly and transparently and upholds the highest standards in its scientific recommendations.
Danish: Agenturet gennemfører også strategier og procedurer for at sikre, at dets arbejde er uafhængigt, åbent og gennemsigtigt, og opretholder de højeste standarder i sine videnskabelige anbefalinger.
English: If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
Danish: Hvis en virksomhed ønsker at anmode om markedsføringstilladelse i flere EU-medlemslande for et lægemiddel, der ikke er omfattet af den centrale procedure, kan den anvende én af følgende procedurer:
English: The Board also gives its opinion on the Agency's annual accounts.
Danish: Bestyrelsen afgiver også udtalelse om agenturets årsregnskab.
English: The Agency publishes clear and impartial information about medicines and their approved uses.
Danish: Agenturet offentliggør klar og upartisk information om lægemidler og de godkendte anvendelser heraf.
English: This document provides an overview of the main responsibilities of the European Medicines Agency (EMA).
Danish: Dette dokument indeholder en oversigt over Det Europæiske Lægemiddelagenturs (EMA) hovedopgaver.
English: • to restrict involvement of experts in the assessment of medicines if they plan to take up a job in the pharmaceutical industry in May 2015.
Danish: • begrænse deltagelsen af eksperter i vurderingen af lægemidler, hvis de har planer om ansættelse i lægemiddelindustrien (maj 2015).
English: • Reduces the administrative burden through the centralised authorisation procedure, helping medicines to reach patients faster;
Danish: • Mindsker den administrative byrde via den centrale godkendelsesprocedure, hvilket bidrager til, at lægemidlerne når hurtigere ud til patienterne
English: • for the majority of declared interests a three-year cooling-off period is foreseen.
Danish: • størstedelen af de oplyste interesser vil være pålagt en treårig nedkølingsperiode.
English: The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA's creation or they were not in the scope of the centralised procedure.
Danish: De fleste lægemidler, der er tilgængelige i EU, blev godkendt på nationalt plan, enten fordi de blev godkendt inden EMA's oprettelse, eller de ikke var omfattet af den centrale procedure.