FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with genotype 1a virus, 93% of patients (483 out of 519 patients) treated with Zepatier tested negative compared with 95% (55 out of 58 patients) on Zepatier with ribavirin.
Danish: For så vidt angår patienterne med genotype 1a-virus, havde 93 % (483 ud af 519) af de patienter, der blev behandlet med Zepatier, en negativ test sammenholdt med 95 % (55 ud af 58) af de patienter, der blev behandlet med Zepatier + ribavirin.
English: Zepatier is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Danish: Zepatier er et lægemiddel mod virus (et antiviralt lægemiddel), og det anvendes til behandling af voksne med kronisk hepatitis C, der er en smitsom leversygdom, som forårsages af hepatitis C-virus.
English: Zepatier is recommended for use in patients infected with hepatitis C virus genotypes 1a, 1b and 4 who may or may not have compensated liver cirrhosis (scarring of the liver but the liver is still able to work adequately).
Danish: Zepatier anbefales til brug hos patienter, der er smittet med hepatitis C-virus genotype 1a, 1b og 4, og som har eller ikke har kompenseret levercirrose (ardannelse på leveren, men hvor leveren stadig fungerer tilstrækkeligt).
English: It must also not be used with the herbal remedy St. John's wort (used for depression and anxiety), or the epilepsy medicines carbamazepine and phenytoin because these medicines may affect the way Zepatier works.
Danish: Det må heller ikke bruges sammen med prikbladet perikum, der anvendes mod depression og angst, eller carbamazepin og phenytoin, der anvendes mod epilepsi, da disse lægemidler kan påvirke den måde, Zepatier virker på.
English: What benefits of Zepatier have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zepatier?
English: How does Zepatier work?
Danish: Hvordan virker Zepatier?
English: How is Zepatier used?
Danish: Hvordan anvendes Zepatier?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zepatier have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Zepatier.
English: The company also provided data from 2 studies in a total of 150 healthy participants.
Danish: Virksomheden fremlagde også data fra 2 undersøgelser af i alt 150 sunde deltagere.
English: These studies examined the medicine's effects on humans and how the medicine was broken down and removed from the body.
Danish: Disse undersøgelser så nærmere på lægemidlets virkning på mennesker, og hvordan lægemidlet blev nedbrudt og fjernet fra kroppen.
English: It was to be available as a solution for injection into a muscle.
Danish: Det var hensigten, at det skulle kunne fås som en opløsning til injektion i en muskel.
English: In addition, there were questions about whether the company had sufficient measures in place to ensure the manufacturing of Entolimod TMC was properly controlled.
Danish: Desuden blev der rejst spørgsmål om, hvorvidt virksomheden havde truffet tilstrækkelige foranstaltninger til at sikre, at fremstillingen af Entolimod TMC blev kontrolleret godt nok.
English: Exposure to high amounts of radiation can result in multiple organ failure and death.
Danish: Eksponering for store mængder stråling kan medføre multiorgansvigt og dødsfald.
English: Entolimod TMC is a medicine that contains the active substance entolimod.
Danish: Entolimod TMC er et lægemiddel, der indeholder det aktive stof entolimod.
English: The CHMP's main concern was that there was insufficient evidence from studies, including the macaque study, to determine the effects of the medicine in humans and how it should be used.
Danish: CHMP's vigtigste betænkeligheder bestod i, at der ikke forelå tilstrækkelig dokumentation fra undersøgelser, herunder studier af makakaber, til at bestemme lægemidlets virkninger på mennesker, og hvordan det bør anvendes.
English: Because dangerous doses of radiation cannot be given to humans, the effects of Entolimod TMC against radiation were evaluated in a main study involving 179 macaque monkeys.
Danish: Da der ikke kan gives farlige strålingsdoser til mennesker, blev virkningerne af Entolimod TMC mod strålingen vurderet i en hovedundersøgelse med 179 makakaber.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that they needed more time to generate the additional data required to address some of the points raised by the CHMP.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den havde brug for mere tid til at fremskaffe de yderligere oplysninger, der kræves for at behandle nogle af de punkter, som CHMP har rejst.
English: The attachment to TLR5 triggers production of substances whose effects are expected to reduce damage to the body caused by radiation.
Danish: Bindingen til TLR5 udløser produktion af stoffer, hvis virkning forventes at mindske kropsskader som følge af stråling.
English: Entolimod TMC works by attaching to a protein on the surface of cells known as toll-like receptor 5 (TLR5).
Danish: Entolimod TMC virker ved at binde sig til et protein på overfladen af celler kendt som Toll-lignende receptor 5 (TLR5).
English: how many of them survived high doses of radiation when given different doses of Entolimod TMC or placebo (a dummy treatment).
Danish: I undersøgelsen blev der set på, hvor mange af dem, der overlevede store doser stråling, når de fik forskellige doser af Entolimod TMC eller placebo (en uvirksom behandling).
English: Entolimod TMC was expected to be used to reduce the risk of death in adults and children from 2 years of age exposed to a high amount of radiation following a disaster such as a nuclear accident.
Danish: Entolimod TMC forventedes anvendt til at mindske risikoen for dødsfald blandt voksne og børn fra 2 år, som udsættes for en stor strålingsmængde efter en ulykke, f.eks. en atomulykke.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Entolimod TMC did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Entolimod TMC ikke opvejede risiciene.
English: What is Entolimod TMC?
Danish: Hvad er Entolimod TMC?
English: On 31 July 2018, TMC Pharma Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Entolimod TMC, intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation.
Danish: Den 31. juli 2018 meddelte TMC Pharma Services Ltd officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for Entolimod TMC, som er beregnet til at mindske risikoen for dødsfald efter eksponering for potentielt dødelig mængder stråling.
English: Entolimod TMC was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 January 2016, for the treatment of acute radiation syndrome.
Danish: Entolimod TMC blev udpeget som "lægemiddel til sjældne sygdomme" den 11. januar 2016 til behandling af akut strålesyndrom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2018 EMA/632431/2018 EMEA/H/C/004656
Danish: september 2018 EMA/632431/2018 EMEA/H/C/004656
English: What was Entolimod TMC expected to be used for?
Danish: Hvad forventedes Entolimod TMC anvendt til?
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with the medicine.
Danish: Virksomheden har til CHMP oplyst, at der i øjeblikket ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for lægemidlet.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Entolimod TMC could not have been approved to reduce the risk of death following exposure to potentially lethal amounts of radiation.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Entolimod TMC ikke kunne være blevet godkendt til at mindske risikoen for dødsfald efter eksponering for potentielt dødelige mængder stråling.
English: How does Entolimod TMC work?
Danish: Hvordan virker Entolimod TMC?
English: Withdrawal of the marketing authorisation application for Entolimod TMC (entolimod) EMA/632431/2018
Danish: EMA/632431/2018
English: Allow the area to dry completely.
Danish: Lad området tørre helt.
English: Thereafter, steady concentrations are maintained for up to 96 hours.
Danish: Derefter opretholdes de stabile koncentrationer i op til 96 timer.
English: Date of first authorisation: 15/06/2004 Date of latest renewal: 30/04/2009
Danish: Dato for første tilladelse: 15/06/2004 Dato for seneste fornyelse af tilladelsen: 30/04/2009
English: Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
Danish: Skift plaster på de to samme ugedage hver uge, for eksempel hver søndag og onsdag eller hver mandag og torsdag.
English: If you forget to change the patch after 3-4 days:
Danish: Hvis du glemmer at skifte plaster efter 3-4 dage:
English: Both patients recovered fully with symptomatic treatment.
Danish: Begge patienter blev helt raske med symptomatisk behandling.
English: Using Kentera with food and drink
Danish: Brug af Kentera sammen med mad og drikke
English: If irritation persists, please contact your doctor.
Danish: Hvis irritationen varer ved, bedes du kontakte din læge.
English: The metered dose should be applied immediately.
Danish: Den afmålte dosis skal appliceres med det samme.
English: Patients should be monitored until symptoms resolve.
Danish: Patienterne skal overvåges, indtil symptomerne er forsvundet.
English: The product should not come in contact with an open flame.
Danish: Produktet bør ikke komme i kontakt med åben ild.
English: - Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
Danish: - Nyligt afvasket, men alligevel tørt og køligt (vent et par minutter efter et varmt kar- eller brusebad).
English: Of these 188 patients (38%) were 65 years of age and older and exhibited no overall differences in safety or effectiveness compared to younger patients.
Danish: Ud af disse var 188 patienter (38 %) i alderen 65 år eller derover, og de udviste ingen samlet forskel i sikkerhed og virkning, sammenlignet med yngre patienter.
English: Do not apply Kentera in an area that is not approved.
Danish: Brug ikke Kentera på et område, der ikke er godkendt.
English: If it does, try putting the same patch back on the same spot.
Danish: Hvis det sker, så prøv at sætte det samme plaster fast igen på samme sted.
English: Do not apply a patch to the same place on your body for at least 1 week.
Danish: Påfør ikke plastre samme sted på kroppen i mindst 1 uge.
English: The pump is now primed and ready for use.
Danish: Pumpen er nu forberedt og klar til brug.
English: These results were evident after the first month of treatment and were maintained throughout double-blind treatment as shown in the table below.
Danish: Disse resultater blev tydelige efter den første måneds behandling og blev fastholdt gennem hele den dobbeltblindede behandling som vist i nedenstående tabel.
English: For transdermal use only.
Danish: Kun til transdermal anvendelse.
English: Social relationships subscale -15.2 (20.07)
Danish: Underskala for sociale forhold -15,2 (20,07)
English: The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients.
Danish: De hyppigst rapporterede bivirkninger var reaktioner på applikationsstedet hos 23,1 % af patienterne.
English: If not, take it off and put a new patch on a new spot.
Danish: Hvis ikke, så tag det af og sæt et nyt plaster fast på et nyt sted.
English: Approximately 75% of patients had no prior pharmacological treatment for incontinence.
Danish: Cirka 75 % af patienterne var ikke tidligere blevet behandlet med lægemidler for inkontinens.
English: Wash your hands with soap and water before applying Kentera.
Danish: Vask hænderne med vand og sæbe, før du påfører Kentera.
English: The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years).
Danish: Størstedelen af patienterne var kaukasere (86,3 %) og kvinder (89,2 %) med en gennemsnitlig alder på 59,4 år (interval: 18 til 88 år).
English: A 14-week, open-label treatment was available for a subset of patients who completed the double-blind period.
Danish: En 14-ugers åben behandling var tilgængelig for en undergruppe af patienter, der fuldførte den dobbeltblindede periode.
English: (N=400) Mean (SD) Median Mean (SD) Median
Danish: (N = 400) Gennemsnit (SD) Median Gennemsnit (SD) Median
English: After use the patch still contains substantial quantities of active ingredients.
Danish: Efter brug indeholder plasteret stadig betydelige mængder aktive stoffer.
English: Kentera contains alcohol and is considered flammable.
Danish: Kentera indeholder alkohol og betragtes som brændbar.
English: Talk to your doctor before using Kentera if you are pregnant, might be pregnant or are planning to become pregnant.
Danish: Tal med lægen, før du bruger Kentera, hvis du er gravid, kan være gravid eller planlægger at blive gravid.
English: Press for at least 10 seconds to make sure the patch will stay in place.
Danish: Tryk i mindst 10 sekunder, så det sikres, at plasteret holdes på plads.
English: - Bend the patch back over itself.
Danish: - Bøj plasteret bag over sig selv.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg din læge til råds, før du bruger nogen form for medicin.
English: Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar.
Danish: Sæt kryds ved den plan, du følger, og husk altid at skifte plaster på de samme to ugedage i den uge, du har valgt i kalenderen.
English: The expression of CYP3A and CYP3A4 may vary by as much as 40 fold due to genetic polymorphism.
Danish: Ekspressionen af CYP3A og CYP3A4 kan variere så meget som 40 gange på grund af genetisk polymorfi.
English: The 12-week double-blind treatment included daily applications of Kentera or matching placebo gel.
Danish: Den 12-uger lange dobbeltblindede behandling omfattede daglig applicering af Kentera eller matchende placebo-gel.
English: The patient should not apply more than one patch at a time.
Danish: Patienten må ikke anvende mere end ét plaster ad gangen.
English: Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule.
Danish: Trykt på indersiden af Kentera-pakningen finder du en Kenterakalendercheckliste, der hjælper dig til at huske doseringsplanen.
English: Drowsiness may be increased by consumption of alcohol.
Danish: Døsigheden kan forværres ved indtagelse af alkohol.
English: - If you have difficulty emptying your bladder.
Danish: - hvis du har problemer med at tømme blæren.
English: It is important you read and follow these directions on how to use the Kentera pump properly.
Danish: Det er vigtigt, at du læser og følger denne vejledning om, hvordan Kentera-pumpen bruges.
English: Kentera must not be taken by mouth.
Danish: Kentera må ikke indtages gennem munden.
English: The results of the study indicate that showering after one hour does not affect the overall systemic exposure to oxybutynin.
Danish: Resultaterne af forsøget tyder på, at et brusebad efter én time ikke påvirker den samlede systemiske eksponering for oxybutynin.
English: Bathing, showering, swimming and exercise:
Danish: Badning, svømning og motion:
English: When changing the patch, remove the old patch slowly.
Danish: Ved skift af plasteret fjernes det gamle plaster langsomt.
English: Consumption of grapefruit juice may also influence metabolism of oxybutynin.
Danish: Indtagelse af grapefrugtjuice kan også påvirke metaboliseringen af oxybutynin.
English: Kentera led to consistent improvements in overactive bladder symptoms compared with placebo.
Danish: Kentera medførte konsekvente forbedringer af symptomerne på overaktiv blære, sammenlignet med placebo.
English: - Free of body powder, lotion, and oil.
Danish: - Fri for kropspudder, lotion og olie.
English: Kentera delivers approximately 0.08 mg/kg/day.
Danish: Kentera leverer ca. 0,08 mg/kg/dag.
English: No cases of overdose have been reported with Kentera.
Danish: Der er ikke indberettet tilfælde af overdosis med Kentera.
English: The effect of fever, exposition to external heat sources, sun bathing and sauna on the absorption characteristics of Kentera have not been investigated.
Danish: Indvirkningen af feber, eksponering for eksterne varmekilder, solbadning og sauna på absorptionskarakteristika for Kentera er ikke blevet undersøgt.
English: Repeat until the sachet is empty.
Danish: Gentag dette, indtil brevet er tomt.
English: However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Danish: Da kendskabet til sammenhængen mellem maternal toksicitet og effekter på fosterudviklingen imidlertid er mangelfuldt, kan den sikkerhedsmæssige betydning for mennesker ikke vurderes.
English: Steady-state conditions are reached after the seventh day of administration.
Danish: Steady state-tilstand nås efter 7 dages administration.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: If the patch comes off:
Danish: Hvis plasteret falder af:
English: A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
Danish: Der skal vælges et nyt påføringssted for hvert nyt plaster, så det undgås, at plasteret påføres det samme sted inden for 7 dage.
English: A small amount of baby oil may also be used to remove any excess residue.
Danish: Der kan også anvendes en lille smule babyolie til at fjerne eventuelle rester af klæbestof.
English: This redness should disappear within several hours after removal of the patch.
Danish: Denne rødmen skulle forsvinde i løbet af nogle timer efter at plasteret er fjernet.
English: Kentera is formulated for daily application and is capable of maintaining therapeutic blood levels of oxybutynin.
Danish: Kentera er formuleret med henblik på daglig applicering og kan fastholde terapeutiske niveauer af oxybutynin i blodet.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge,sygeplejerske eller apoteket.
English: To apply Kentera: Step 1: Choose a spot for the patch that is:
Danish: Sådan påsætter du Kentera: Trin 1: Vælg et område til plasteret, der er:
English: - If you have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily.
Danish: - hvis du lider af en sjælden sygdom, der hedder myasthenia gravis, der får musklerne i kroppen til at blive svage og hurtigt trætte.
English: Gel 30 sachets of 1 gram.
Danish: Gel 30 breve med 1 gram.
English: Studies in animals have shown minor reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist en mindre reproduktionstoksicitet (se pkt.
English: The expiry date refers to the last date of that month.
Danish: Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: Alcohol or other strong solvents may cause skin irritation and should not be used.
Danish: Alkohol og andre stærke opløsningsmidler kan medføre hudirritation og bør ikke anvendes.
English: Very rarely will the patch come off completely.
Danish: I sjældne tilfælde falder plasteret helt af.
English: Kentera should not be used during pregnancy unless clearly necessary.
Danish: Kentera bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: During the double-blind treatment a significant positive effect on quality of life was seen with Kentera based on the Incontinence Impact Questionnaire (IIQ).
Danish: I løbet af den dobbeltblindede behandling sås der en signifikant positiv virkning på livskvaliteten i Kentera-gruppen baseret på IIQ-spørgeskemaet (Incontinence Impact Questionnaire).
English: The efficacy and safety of Kentera were evaluated in patients with urge urinary incontinence in a single Phase 3 study.
Danish: Virkningen af og sikkerheden ved Kentera blev undersøgt hos patienter med urge-inkontinens i et enkelt fase 3-forsøg.
English: In total 496 patients were exposed to Kentera in the randomised, double-blind, placebo-controlled 12week and the 14-week safety extension studies.
Danish: I alt 496 patienter blev eksponeret over for Kentera i det randomiserede, dobbeltblindede, placebokontrollerede studie over 12 uger og det 14-ugers forlængelsesstudie til undersøgelse af sikkerheden.
English: Northern Ireland BT51 3RP
Danish: Nordirland BT51 3RP
English: The patch is designed to re-stick.
Danish: Plasteret er konstrueret til at genklæbe.
English: At a concentration of 0.4 mg/kg/day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
Danish: Ved en koncentration på 0,4 mg/kg/dag, hvor oxybutynin administreres subkutant, er forekomsten af organanomalier signifikant forøget, men observeres dog kun ved forekomst af maternal toksicitet.
English: The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%).
Danish: Den hyppigst rapporterede bivirkning var mundtørhed (Kentera 6,9 %, placebo 2,8 %).
English: Significant positive effects were also noted for each subscale domain of the IIQ and for six of ten quality of life domains, including the incontinence impact domain, of the King's Health Questionnaire (KHQ) as shown in the table below.
Danish: Signifikante positive virkninger blev også registreret for hvert underskalaområde af IIQ-skemaet og for seks ud af ti livskvalitetsområder, herunder området for indvirkningen af inkontinens, i KHQspørgeskemaet (King's Health Questionnaire) som vist i nedenstående tabel.
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Danish: I tilfælde af urinvejsinfektion skal en passende antibiotisk behandling sættes i gang.
English: Avoid contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not approved for the application of Kentera.
Danish: Undgå kontakt med øjne, næse, åbne sår, nybarberet hud og hud med udslæt eller andre områder, der ikke er godkendt til påføring af Kentera.
English: No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
Danish: Uanset hvilken dag dette sker, skal du fortsætte med det samme påføringsskema to gange ugentligt for det næste plaster, også selvom det betyder skift af plaster, før de 3 til 4 dage er forløbet.
English: Each sachet contains 1 g of gel.
Danish: Hvert brev indeholder 1 g gel.
English: Like all medicines, Kentera can cause side effects, although not everybody gets them.
Danish: Kentera kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.