FrancophonIA/ELRC3.0 huggingface dataset:
English: • Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination.
Danish: • På grundlag af analysen af mulige kerneårsager konkluderede CHMP, at alle indehavere af markedsføringstilladelse bør gennemføre en risikovurdering af fremstillingsprocesserne for de aktive stoffer i de færdige produkter for at evaluere risikoen for N-nitrosamin-dannelse ogforurening.
English: 1 June 2018
Danish: 1. juni 2018
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for yderligere information om din behandling, kan du kontakte den læge, der behandler dig.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Restaysis (ciclosporin)
English: What was Restaysis expected to be used for?
Danish: Hvad forventedes Restaysis anvendt til?
English: Restaysis is a medicine that contains the active substance ciclosporin.
Danish: Restaysis er et lægemiddel, der indeholder det aktive stof ciclosporin.
English: What is Restaysis?
Danish: Hvad er Restaysis?
English: The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Danish: Det aktive stof i Restaysis, ciclosporin, reducerer aktiviteten i de celler i immunsystemet (kroppens naturlige forsvarssystem), der indgår i de processer, som forårsager betændelse.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin) EMA/275525/2018
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Restaysis (ciclosporin) EMA/275525/2018
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser?
English: On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Danish: Den 25. april 2018 meddelte Allergan Pharmaceuticals International Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Restaysis til behandling af moderat øjentørhed.
English: Inflammation seems to have an important role in the development of dry eye disease, regardless of the cause of the disease.
Danish: Betændelse lader til at spille en vigtig rolle i udviklingen af øjentørhed, uanset årsagen til sygdommen.
English: Applying it directly to the eye was expected to reduce inflammation and the symptoms of the disease.
Danish: Det forventedes, at applicering direkte på øjet ville reducere betændelsen og symptomerne på sygdommen.
English: The CHMP concluded that the results presented by the company were not robust enough to demonstrate that Restaysis is effective.
Danish: CHMP konkluderede, at de resultater, som virksomheden havde fremlagt, ikke var solide nok til at påvise, at Restaysis er effektivt.
English: The company informed the CHMP that the withdrawal will have no consequences on ongoing clinical trials.
Danish: Virksomheden oplyste til CHMP, at tilbagetrækningen ikke ville have nogen konsekvenser for igangværende kliniske undersøgelser.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter CHMP havde vurderet den dokumentation, som virksomheden havde fremlagt, og udarbejdet lister med spørgsmål.
English: It was to be available as eye drops.
Danish: Det skulle markedsføres som øjendråber.
English: The main measures of effectiveness were the number of patients with damaged eye surface and with blurred vision, after 6 months of treatment.
Danish: De primære mål for virkning var antallet af patienter med skader på øjenoverfladen og sløret syn efter 6 måneders behandling.
English: The company presented an analysis of the results from three studies with ciclosporin conducted in the 1990s in patients with moderate to severe dry eye disease, where Restaysis was compared with placebo (a dummy treatment).
Danish: Virksomheden fremlagde en analyse af resultaterne af tre studier med ciclosporin, der var gennemført i 1990'erne hos patienter med moderat til svær øjentørhed, hvor Restaysis blev sammenlignet med placebo (ikke-aktivt stof).
English: Restaysis was expected to be used in adults with moderate dry eye disease that was inadequately controlled despite treatment with tear substitutes or eye lubricants.
Danish: Restaysis forventedes anvendt til behandling af voksne med moderat øjentørhed, som ikke var tilstrækkeligt kontrolleret på trods af behandling med tåresubstitutter eller smørende øjendråber.
English: In particular, the way the results were analysed in patients with moderate dry eye disease could have introduced a bias in favour of Restaysis.
Danish: Navnlig kunne den måde, hvorpå resultaterne blev analyseret hos patienter med moderat øjentørhed, have introduceret bias til fordel for Restaysis.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Danish: Efter CHMP havde vurderet virksomhedens svar på den sidste spørgsmålsrunde, var der fortsat visse uafklarede punkter.
English: The analysis focused on a subgroup of patients with moderate dry eye disease.
Danish: Analysen fokuserede på en undergruppe af patienter med moderat øjentørhed.
English: How does Restaysis work?
Danish: Hvordan virker Restaysis?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Restaysis could not have been approved for the treatment of moderate dry eye disease.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Restaysis ikke ville kunne være blevet godkendt til behandling af moderat øjentørhed.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew its application because of the CHMP's view that the data provided did not allow concluding on a positive benefit-risk balance in the intended patient population.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak sin ansøgning tilbage på grund af CHMP's udtalelse om, at de fremlagte data ikke gjorde det muligt at konkludere, at benefit/risk-forholdet er positivt i den tilsigtede patientpopulation.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Restaysis did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Restaysis ikke opvejede risiciene, da virkningen ikke var blevet påvist.
English: Allow the area to dry for 10 seconds.
Danish: Lad området tørre i 10 sekunder.
English: However, this difference was not statistically significant.
Danish: Men denne forskel var ikke statistisk signifikant.
English: • If you have severe heart problems.
Danish: • Hvis du har alvorlige hjerteproblemer.
English: Twice daily.
Danish: To gange daglig.
English: Wait 1 to 3 minutes.
Danish: Vent 1 til 3 minutter.
English: The dose reductions can be temporary or permanent.
Danish: Dosisreduktion kan være midlertidig eller permanent.
English: >50 to ≤60 >60 to ≤70 >70 to ≤80 >80 to ≤90 >90 to ≤100
Danish: >50 til ≤60 >60 til ≤70 >70 til ≤80 >80 til ≤90 >90 til ≤100
English: Wash your hands thoroughly with soap and water.
Danish: Vask dine hænder omhyggeligt med vand og sæbe.
English: to w.30
Danish: til u.30
English: Never inject Ceplene any faster or all at once.
Danish: Injicér aldrig Ceplene hurtigere eller det hele på en gang.
English: 08757 Corbera de Llobregat (Barcelona) Spain
Danish: 08757 Corbera de Llobregat (Barcelona) Spanien
English: Each dose is calculated from your body weight.
Danish: Hver dosis er beregnet ud fra din kropsvægt.
English: Find a comfortable, well-lit place to sit and where you can lie back.
Danish: Find et bekvemt, velbelyst sted at sidde, hvor du kan læne dig tilbage.
English: Read the following instructions carefully.
Danish: Læs omhyggeligt nedenstående vejledning.
English: Your doctor will also carry out some blood tests during treatment.
Danish: Din læge vil også tage nogle blodprøver under behandlingen.
English: • If you are pregnant.
Danish: • Hvis du er gravid.
English: Results of this pilot study were used to design and implement a multi-national phase 3 trial.
Danish: Resultaterne fra denne pilotundersøgelse blev anvendt til at udforme og gennemføre en multinational fase III-undersøgelse.
English: For the injection you will need the following:
Danish: Til injektionen skal du bruge følgende:
English: This is to be returned to the pharmacist for disposal.
Danish: Dette skal returneres til apoteket til destruktion.
English: The dispensing and storage directions in the section 6.6 are specific to aldesleukin.
Danish: Retningslinjer for dispensering og opbevaring i punkt 6.6 er specifikke for aldesleukin.
English: For possible injection sites, see Figure 4.
Danish: Mulige injektionssteder kan ses på Figur 4.
English: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italy
Danish: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italien
English: Your doctor may change your dose.
Danish: Din læge kan ændre dosis.
English: Patient weight (kg)
Danish: Patientens vægt (kg)
English: If you have an infection, your doctor will closely monitor you.
Danish: Hvis du har en infektion, vil din læge omhyggeligt overvåge dig.
English: The recommended dosing regimen is presented in Tables 1 and 2.
Danish: Det anbefalede doseringsregime er vist i tabel 1 og 2.
English: Frequencies are defined as very common ( 1/10), common ( 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Danish: Hyppighed defineres som meget almindelig ( 1/10), almindelig ( 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), sjældne (≥ 1/10.000 til < 1/1.000), meget sjældne (< 1/10.000), eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is used to maintain the remission (the period during which the disease is less severe or not detectable).
Danish: Det anvendes til at bevare remissionen (den periode, hvorunder sygdommen er mindre alvorlig eller ikke kan påvises).
English: Treatment*
Danish: Behandling*
English: Treatment-free (6 weeks)
Danish: Behandlingsfri (6 uger)
English: Do not touch the stopper with your hands.
Danish: Berør ikke proppen direkte med hænderne.
English: 6 week break (no treatment at all).
Danish: 6 ugers pause (overhovedet ingen behandlinger).
English: NOTE: Dispensing of aldesleukin must be carried out under controlled aseptic conditions.
Danish: Bemærk: Dispensering af aldesleukin skal udføres under kontrollerede aseptiske forhold.
English: The preferred injection areas are the thighs and the abdomen.
Danish: De foretrukne injektionsområder er lår og abdomen.
English: The mean half-life was 0.75 to 1.5 hours in patients.
Danish: Den gennemsnitlige halveringstid var 0,75 til 1,5 time i patientgrupperne
English: A timer, clock or watch with a second hand.
Danish: Et stopur eller et ur med sekundviser.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14(8) i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre følgende foranstaltninger/tiltag:
English: These medicines help the body's immune system fight diseases like cancer by improving the immune system's natural role in fighting disease.
Danish: Disse lægemidler hjælper kroppens immunsystem med at bekæmpe sygdomme som kræft ved at forbedre immunsystemets naturlige rolle i bekæmpelse af sygdommen.
English: (hypothyroidism)
Danish: (hypothyroidisme)
English: Ask your doctor if you have any questions about Ceplene or IL-2.
Danish: Spørg din læge, hvis du har spørgsmål om Ceplene eller IL-2.
English: • If you have received a stem cell transplant (a kind of bone marrow transplant) from a donor.
Danish: • Hvis du har fået en stamcelletransplantation (en slags knoglemarvstransplantation) fra en donor.
English: Your doctor or nurse will show you how to inject yourself.
Danish: Din læge eller sygeplejerske vil vise dig, hvordan du selv injicerer.
English: There were no clinically significant differences in safety parameters or in pharmacodynamics.
Danish: Der var ingen klinisk signifikante forskelle i sikkerhedsparametre eller farmakodynamik.
English: Maximum plasma concentration is reached approximately 10 minutes after end of subcutaneous infusion.
Danish: Maksimal plasmakoncentration opnås ca. 10 minutter efter afslutning af subkutan infusion.
English: Standard dosage (µg)
Danish: Standarddosis (µg)
English: Some of them must not be taken during treatment with Ceplene or may need special precautions:
Danish: Nogle af dem må ikke tages samtidigt med behandling med Ceplene eller kan kræve særlige forholdsregler:
English: Other oncology (advanced tumour) studies
Danish: Andre onkologiske undersøgelser (fremskreden tumor)
English: • Patients who have received an allogenic stem cell transplant.
Danish: • Patienter, der har modtaget allogent stamcelletransplantat.
English: The metabolites are mainly excreted in urine.
Danish: Metabolitterne udskilles hovedsageligt via urinen.
English: Histamine is rapidly absorbed after subcutaneous injection.
Danish: Histamin absorberes hurtigt efter subkutan injektion.
English: It is not known whether histamine crosses the placenta.
Danish: Det vides ikke, om histamin passerer placenta.
English: Recommended dose
Danish: Anbefalet dosis
English: Pinch up a section of the cleaned skin between your thumb and forefinger, without squeezing it. See Figure 5.
Danish: Tag fat om et stykke renset hud mellem tommel- og pegefinger uden at klemme det. Se Figur 5.
English: Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate.
Danish: Overvågning af patienten på dag 1 bør omfatte vitale tegn såsom puls, blodtryk og respirationsfrekvens.
English: The following adverse reactions, not listed above, were at least possibly related to the study medicine:
Danish: Følgende bivirkninger, som ikke er anført ovenfor, var i det mindste med en vis sandsynlighed relateret til studiemedicinen:
English: 20% dose reduction injection volume (mL)**
Danish: 20 % dosisreduktion, injektionsvolumen (ml)**
English: • Your body does not make enough thyroxine, a body chemical called a hormone
Danish: • Kroppen danner ikke tilstrækkeligt thyroxin, et kemikalie i kroppen, som kaldes et hormon
English: Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests.
Danish: Monitorering af laboratorieprøveresultater anbefales, herunder standard hæmatologiske analyser og blodprøver.
English: - Clonidine, a medicine used to reduce high blood pressure.
Danish: - Clonidin, et lægemiddel, der anvendes til at nedsætte forhøjet blodtryk.
English: Injection volume* (mL)
Danish: Injektionsvolumen* (ml)
English: Patients receiving the following medicinal products should be treated with caution (see section 4.5): - Beta-blockers or other anti-hypertensive agents.
Danish: Patienter, som får følgende lægemidler, bør behandles med forsigtighed (se punkt 4.5) - Beta-blokkere eller andre antihypertensive midler.
English: • During pregnancy.
Danish: • Under graviditet.
English: You must be monitored to check how you respond to treatment.
Danish: Du skal overvåges, for at lægen kan kontrollere, hvordan du reagerer på behandlingen.
English: Do not take any additional dose to make up for the forgotten doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: You must use this medicine exactly as it has been prescribed for you.
Danish: Du skal anvende dette lægemiddel nøjagtigt, som det er ordineret.
English: Your doctor will let you know how much it is and how to inject it.
Danish: Din læge vil fortælle dig, hvor meget det er, og hvordan du skal injicere det.
English: Patients should be monitored for the expected symptomatic adverse reactions and laboratory changes associated with this treatment.
Danish: Patienterne bør overvåges med hensyn til forventede symptomatiske bivirkninger og laboratorieændringer forbundet med denne behandling.
English: Ceplene must not be mixed with any other products and must not be diluted.
Danish: Ceplene må ikke blandes med andre produkter og må ikke fortyndes.
English: You may choose the inner or outer thighs, arms or stomach.
Danish: Du kan vælge mellem inder- eller ydersiden af låret, armene eller maven.
English: Ceplene belongs to a group of medicines called immunomodulatory medicines.
Danish: Ceplene hører til en medicingruppe kaldet immunmodulerende lægemidler.
English: Patients should be monitored during treatment for possible clinical complications due to hypotension or hypovolaemia.
Danish: Patienterne bør overvåges under behandlingen med hensyn til mulige kliniske komplikationer forårsaget af hypotension eller hypovolæmi.
English: The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
Danish: Ceplenes virkning er ikke påvist fuldstændigt hos patienter over 60 år.
English: It is recommended that dose modifications be addressed early in treatment.
Danish: Det anbefales, at dosisjustering foretages tidligt i behandlingsforløbet.
English: Continue with the treatment as prescribed.
Danish: Fortsæt med at behandle som ordineret.
English: • Anti-malarial or medicines used to treat infections responsible for sleeping sickness.
Danish: • Malariamedicin eller lægemidler, der anvendes til at behandle den infektion, der kaldes sovesyge.
English: 0.5 mL solution is sufficient for a single dose (see section 6.6).
Danish: 0,5 ml opløsning er tilstrækkeligt til en enkelt dosis (se punkt 6.6).
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 personer)
English: If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration.
Danish: Hvis der observeres signifikant hypotension eller relaterede symptomer i de efterfølgende behandlingscyklusser, bør dosisreduktion initieres, og om nødvendigt bør indgivelsen foretages på hospitalet, indtil responsen på behandlingen muliggør indgivelse i hjemmet.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX14.
Danish: Farmakoterapeutisk gruppe: Immunstimulerende midler, andre immunstimulerende ATC-kode: L03AX14.
English: Take the syringe and follow the “INSTRUCTIONS FOR INJECTION” information below.
Danish: Tag fat i sprøjten og følg informationen “VEJLEDNING I INJEKTION” nedenfor.
English: Check the expiry date (EXP) on the vial label.
Danish: Kontrollér udløbsdatoen (EXP) på hætteglassets etiket.
English: Treatment periods and treatment breaks
Danish: Behandlingsperioder og behandlingspauser
English: Ceplene is a clear, colourless liquid.
Danish: Ceplene er en klar, farveløs væske.
English: This treatment must be prescribed and supervised by a physician with knowledge of acute myeloid leukaemia.
Danish: Denne behandling skal ordineres og overvåges af en læge, der har kendskab til akut myeloid leukæmi.
English: IL-2 16 400 IU/kg followed by 0.5 mL Ceplene.
Danish: IL-2 16.400 IE/kg efterfulgt af 0,5 ml Ceplene.
English: • Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV.
Danish: • Patienter med betydelig hjerteinsufficiens, f.eks. NYHA klasse III/IV.
English: Pick up the sterile syringe.
Danish: Tag den sterile sprøjte.
English: The active substance in Ceplene is histamine dihydrochloride; it is identical to a naturally occurring substance in the body.
Danish: Det aktive indholdsstof i Ceplene er histamindihydrochlorid, som er identisk med et stof, der forekommer naturligt i kroppen.
English: Your doctor may want to increase the time you take to complete your injection, or change your dose.
Danish: Lægen vil måske øge den tid, injektionen skal foretages over, eller ændre din dosis.
English: Inject slowly over a period of 5-15 minutes.
Danish: Injiceres langsomt over en periode på 5-15 minutter.
English: *see dose modification for provisions for the modification to dose and dosage schedule
Danish: *se dosisjustering vedrørende bestemmelser for ændring af dosis og doseringsplan
English: The solution must be clear and colourless.
Danish: Opløsningen skal være klar og farveløs.
English: Treatment-free (3 weeks) *see dose modification for provisions for the modification to dose and dosage schedule
Danish: Behandlingsfri (3 uger) *se dosisjustering vedrørende bestemmelser for ændring af dosis og doseringsplan
English: This medicine has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity, local tolerance and genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af toksicitet efter gentagne doser, lokal tolerance og genotoksicitet.
English: The safety and efficacy of Ceplene in children below 18 years of age have not yet been established.
Danish: Ceplene's sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: If you are not sure about how to give yourself the injection or you have any questions, please ask your doctor or nurse for help.
Danish: Hvis du ikke er sikker på, hvordan du giver injektionen, eller hvis du har spørgsmål, bør du bede din læge eller sygeplejerske om hjælp.
English: To reduce potential adverse reactions, the administration time may be lengthened to a maximum of 15 minutes, see below.
Danish: For at mindske eventuelle bivirkninger kan indgivelsestiden forlænges til maksimalt 15 minutter, se nedenfor.
English: Ceplene use is not recommended in children and adolescents, as there is no information available about using this medicine in this age group.
Danish: Ceplene bør normalt ikke anvendes til børn og unge, da der ikke foreligger tilstrækkelige oplysninger om anvendelse af denne medicin til disse aldersgrupper.
English: If blood appears, do not inject Ceplene because the needle has entered a blood vessel.
Danish: Hvis der kommer blod til syne, må du ikke injicere Ceplene, da nålen er kommet ind i et blodkar.
English: There is no information about the use of Ceplene in pregnant women.
Danish: Der findes ingen oplysninger vedrørende anvendelse af Ceplene til gravide kvinder.
English: Your doctor will explain to you how to prepare and inject IL-2.
Danish: Din læge vil forklare dig, hvordan du skal klargøre og injicere IL-2.
English: w.4 to w.6 w.10 to w.12 w.16 to w.18
Danish: u.4 til u.6 u.10 til u.12 u.16 til u.18
English: During your treatment, you will always use IL-2 AND Ceplene.
Danish: Under behandlingen vil du altid få IL-2 OG Ceplene.