FrancophonIA/ELRC3.0 huggingface dataset:
English: The Company informed the Agency that at the time of the withdrawal, all clinical trials in the European Union are closed to enrolment and there is no ongoing compassionate use programmes.
Danish: Firmaet har til agenturet oplyst, at der på tilbagetrækningstidspunktet var lukket for tilgang af patienter til alle kliniske undersøgelser i EU, og at der ikke er noget igangværende program for anvendelse med særlig udleveringstilladelse.
English: Camptothecins are able to block one of the proteins that can remove twists in the DNA.
Danish: Camptotheciner kan blokere et af de proteiner, der kan fjerne snoninger i DNA'et.
English: The studies included approximately 800 patients with advanced or metastatic cancer of the pancreas.
Danish: Undersøgelserne omfatter ca. 800 patienter med fremskreden eller metastaserende pancreascancer.
English: Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.
Danish: Patienterne fik orathecin, indtil deres kræftsygdom udviklede sig videre, eller indtil de ikke tålte behandlingen længere.
English: The studies looked at how long the patients survived after receiving orathecin, compared to those receiving the standard medicines used to treat pancreatic cancer, including 5-fluorouracil (5-FU) or gemcitabine.
Danish: I undersøgelserne er det blevet registreret, hvor længe patienterne overlevede efter at have fået orathecin, sammenlignet med de patienter, der fik sædvanligt anvendte midler mod pancreascancer, dvs. 5-fluoruracil (5-FU) eller gemcitabin.
English: How is Orathecin expected to work?
Danish: Hvordan forventes Orathecin at virke?
English: Orathecin was to be used to treat patients with advanced cancer of the pancreas, who cannot be operated or who have metastasis (cancer cells that spread from the original site to other parts of the body), and who do not respond to the other anticancer drugs used for the treatment of their disease.
Danish: Orathecin skulle anvendes til behandling af patienter med fremskreden pancreascancer, som er inoperabel eller har metastaseret (dvs. at kræftcellerne har bredt sig fra det oprindelige sygdomssted til andre dele af kroppen), og som ikke reagerer på behandling med andre midler mod kræft, der anvendes til behandling af sygdommen.
English: Based on the review of the data and the Company's response to the CHMP list of questions, at the time the withdrawal, the CHMP had concerns and was of the provisional opinion that Orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at Orathecin ikke kunne godkendes til behandling af patienter med fremskreden eller metastaserende pancreascancer.
English: Cells have several proteins, which help to remove any twists in the DNA.
Danish: Celler har forskellige proteiner, der medvirker til at fjerne eventuelle snoninger i cellens DNA.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orathecin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Orathecin eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The indication applied for was the treatment of patients with advanced or metastatic pancretic cancer.
Danish: Indikation i ansøgningen var behandling af patienter med fremskreden eller metastaserende pancreascancer (kræft i bugspytkirtlen).
English: London, 26 January 2006 Doc.Ref.
Danish: London, den 26. januar 2006 Ref. EMEA/604207/2007
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before give an opinion, ask any remaining questions (at day 180) to the Company.
Danish: afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180) til firmaet.
English: The recommended dose is one capsule taken three times a day.
Danish: Den anbefalede dosis er én kapsel tre gange dagligt.
English: Patients should be assessed every six months and treatment should be stopped if no improvement is seen.
Danish: Patienterne bør vurderes hver 6. måned, og behandlingen bør stoppes, hvis der ikke ses nogen bedring.
English: The full EPAR for Elmiron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Elmiron findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Elmiron.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Elmiron.
English: No major safety concerns were identified, and the possible risk of bleeding can be minimised with appropriate precautions.
Danish: Der er ikke konstateret nogen alvorlige sikkerhedsproblemer, og risikoen for blødning kan minimeres med en række passende forholdsregler.
English: Other information about Elmiron
Danish: Andre oplysninger om Elmiron
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Elmiron's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Elmiron opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Elmiron?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Elmiron?
English: Elmiron is available as 100-mg capsules and can only be obtained with a prescription.
Danish: Elmiron fås som 100-mg-kapsler og udleveres kun efter recept.
English: The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall.
Danish: Undersøgelserne omfattede i alt 454 patienter med små blødninger og læsioner i blærevæggen.
English: This reinforcement of the protective layer may reduce inflammation and bladder pain.
Danish: Styrkelsen af det beskyttende lag kan reducere betændelse og blæresmerter.
English: It is not intended to provide practical advice on how to use Elmiron.
Danish: Det er ikke en praktisk vejledning i, hvordan Elmiron bør anvendes.
English: Since Elmiron may have a weak anticoagulant effect (i.e. it may stop the blood from clotting properly), it must not be used in patients who actively bleed (but this does not include women during menstrual cycle).
Danish: Da Elmiron har en svag antikoagulerende virkning (dvs. det kan forhindre blodet i at størkne korrekt), må det ikke anvendes hos patienter, der har en aktiv blødning (dette omfatter ikke kvinder, der menstruerer).
English: Why is Elmiron approved?
Danish: Hvorfor blev Elmiron godkendt?
English: Elmiron pentosan polysulfate sodium
Danish: Elmiron pentosanpolysulfatnatrium
English: Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature.
Danish: Da pentosanpolysulfatnatrium er et velkendt stof, og da dets anvendelse ved blæresmertesyndrom er velkendt, fremlagde den virksomhed, der markedsfører Elmiron, data fra den videnskabelige litteratur.
English: Looking at the results of the 4 studies together, 1 in 3 (33%) patients taking pentosan polysulfate sodium showed an overall improvement in their condition compared with around 1 in 6 (16%) patients taking placebo (a dummy treatment).
Danish: Samlet set for de fire undersøgelser sås en overordnet forbedring af patienternes tilstand hos 1 ud af 3 (33 %) blandt de patienter, der tog pentosanpolysulfatnatrium, sammenholdt med 1 ud af 6 (16 %) blandt de patienter, der fik placebo (en uvirksom behandling).
English: What is Elmiron and what is it used for?
Danish: Hvad er Elmiron, og hvad anvendes det til?
English: For more information about treatment with Elmiron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Elmiron, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU.
Danish: Blæresmertesyndrom er en belastende tilstand, og tidligere har der ikke været noget godkendt lægemiddel i EU til behandlingen af tilstanden.
English: What are the risks associated with Elmiron?
Danish: Hvilke risici er der forbundet med Elmiron?
English: The most common side effects with Elmiron (which may affect up to 1 in 10 people) include headache, dizziness, and effects in the digestive systems such as diarrhoea, nausea (feeling sick), abdominal (belly) pain and bleeding from the rectum.
Danish: De hyppigste bivirkninger ved Elmiron (som kan forekomme hos op til 1 ud af 10 personer) omfatter hovedpine, svimmelhed og forskellige bivirkninger i fordøjelsessystemet, som f.eks. diarré, kvalme, mavesmerter og blødning fra endetarmen.
English: A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
Danish: En gennemgang af fire hovedundersøgelser fra litteraturen viste, at pentosanpolysulfatnatrium reducerer symptomer som f.eks. smerter og den hyppige trang til akut vandladning.
English: Elmiron contains the active substance pentosan polysulfate sodium.
Danish: Elmiron indeholder det aktive stof pentosanpolysulfatnatrium.
English: The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome.
Danish: Det vides ikke præcist, hvordan det aktive stof i Elmiron (pentosanpolysulfatnatrium) virker, men det passerer over i urinen og menes at binde sig til og reparere blærens beskyttende slimhinde, som ikke fungerer korrekt hos patienter med blæresmertesyndrom.
English: Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.
Danish: Elmiron anvendes hos patienter med moderate til svære smerter, som har små blødninger eller læsioner (sår) i blærevæggen.
English: For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Elmiron fremgår af indlægssedlen.
English: Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.
Danish: Elmiron er et lægemiddel til behandling af voksne med blæresmertesyndrom, som er en tilstand i blæren, der medfører smerter i skridtet og en hyppig akut trang til at lade vandet.
English: For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Elmiron, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In patients with small bleeds and lesions in the bladder wall, treatment with Elmiron led to significantly more patients having an overall improvement in symptoms.
Danish: Behandling med Elmiron hos patienter med små blødninger og læsioner i blærevæggen har medført, at betydeligt flere patienter oplever en samlet bedring af deres symptomer.
English: How is Elmiron used?
Danish: Hvordan anvendes Elmiron?
English: What benefits of Elmiron have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Elmiron?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elmiron have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Elmiron.
English: How does Elmiron work?
Danish: Hvordan virker Elmiron?
English: Wash your hands before continuing.
Danish: Vask hænder, inden du fortsætter.
English: It may take up to five tries.
Danish: Det kan tage op til 5 forsøg.
English: Tell your relatives, friends and close colleagues the following:
Danish: Fortæl familie, venner og nære kollegaer følgende:
English: Always check both dates!
Danish: Kontroller altid begge datoer!
English: Your dose number may be different than the one in this example.
Danish: Din dosis kan være forskellig fra den, der er anført i dette eksempel.
English: No new safety signals were observed in this study.
Danish: Der blev ikke observeret nye sikkerhedssignaler i dette studie.
English: ATC Code: A10AE04.
Danish: ATC-kode: A10AE04.
English: • Keep it away from direct heat and light.
Danish: • Opbevar den væk fra direkte varme og lys.
English: Always check you have the right pen.
Danish: Kontroller altid, at du har den rigtige pen.
English: • Always carry some sugar (at least 20 grams) with you.
Danish: • Du skal altid have noget sukker (mindst 20 gram) på dig.
English: The following graph shows the results from a study in patients:
Danish: Følgende diagram viser resultater fra et studie med patienter:
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Danish: Fortæl lægen, hvis du planlægger at blive gravid, eller hvis du allerede er gravid.
English: This kills germs that might make you sick.
Danish: Dette dræber bakterier, som kan gøre dig syg.
English: Count to 10 slowly after you see 0 and the green stripe.
Danish: Tæl langsomt til 10, når du har set 0 og den grønne stribe.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Danish: Det skal overvejes, om bilkørsel eller betjening af maskiner er tilrådeligt under disse omstændigheder.
English: You can give from 1 to 60 units in a single injection.
Danish: Du kan tage fra 1 til 60 enheder i en enkelt injektion.
English: • Your doctor or nurse will show you how to use your pen.
Danish: • Lægen eller sygeplejersken vil vise dig, hvordan du skal bruge pennen.
English: Please, consult your doctor for further information.
Danish: Kontakt din læge for yderligere information.
English: The pen contains a total of 300 units.
Danish: Pennen indeholder i alt 300 enheder.
English: Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
Danish: Omhyggelig metabolisk overvågning anbefales ved præparatskift og i de første uger herefter.
English: If the hypoglycaemia comes back again, take another 10 to 20 g sugar.
Danish: Hvis du igen får hypoglykæmi, skal du indtage yderligere 10-20 g sukker.
English: Glucose Utilization Rate* (mg/kg/min)
Danish: Hastighed af glucoseforbruget* (mg/kg/min)
English: Repeat until you see insulin
Danish: Gentag, indtil du kan se insulinet
English: Animal studies do not indicate direct harmful effects with respect to fertility.
Danish: Dyrestudier indikerer ikke direkte skadelige virkninger hvad angår fertilitet.
English: If you have not yet cleaned your injection site, do it now before you inject.
Danish: Hvis du endnu ikke har rengjort injektionsstedet, skal du gøre det nu inden injektionen.
English: Do a safety check
Danish: Udfør en sikkerhedstest
English: To prevent the possible transmission of disease, never share your pen with anyone else.
Danish: For at undgå overførsel af sygdomme må du aldrig dele din pen med andre.
English: Figure 1: Activity Profile in Patients with Type 1 Diabetes
Danish: Figur 1: Virkningsprofil for type 1-diabetikere
English: You must use the pen as described in these Instructions for Use.
Danish: Du skal anvende pennen som beskrevet i denne brugsanvisning.
English: This can spread around the injection site.
Danish: Dette kan brede sig til området omkring injektionsstedet.
English: This will allow quick identification of new safety information.
Danish: Dermed kan der hurtigt tilvejebringes nye sikkerhedsoplysninger.
English: Make sure that you contact a doctor early.
Danish: Sørg for at kontakte lægen så tidligt som muligt.
English: • You can clean the outside of your pen by wiping it with a damp cloth.
Danish: • Du kan rengøre ydersiden af pennen ved at tørre den med en fugtig klud.
English: • Never use the pen if it is damaged or if you are not sure that it is working properly.
Danish: • Anvend aldrig pennen, hvis den er beskadiget, eller hvis du er usikker på, om den virker
English: - concomitant treatment with certain other medicinal products (see section 4.5).
Danish: - samtidig behandling med visse andre lægemidler (se pkt.
English: This pen works with most kinds and sizes of pen needles such as those manufactured by Becton, Dickinson & Company and Ypsomed.
Danish: Denne pen passer til de fleste typer og størrelser af pennåle såsom nåle fremstillet af Becton, Dickinson & Company og Ypsomed.
English: • This pen is only for your use.
Danish: • Denne pen er kun til personlig brug.
English: In your body
Danish: I kroppen
English: Place a new sterile needle, two alcohol swabs and a pen on a clean, dry surface.
Danish: Læg en ny steril nål, to spritservietter og en pen på en ren, tør overflade.
English: Your doctor will show you in which area of the skin you should inject LUSDUNA.
Danish: Din læge vil vise dig i hvilke hudområder, du skal injicere Lusduna.
English: Illnesses and injuries
Danish: Sygdom eller tilskadekomst
English: • If you use more than one type of medicine, make sure you have the right medicine before
Danish: • Hvis du tager mere end en type medicin, skal du sikre dig, at du har den rette medicin inden
English: Caring for your pen New pens you haven't used before:
Danish: Vedligeholdelse af pennen Nye penne, som ikke er taget i brug:
English: Tell a doctor straight away if you notice signs of severe allergic reaction.
Danish: Du skal straks kontakte lægen, hvis du får symptomer på alvorlige allergiske reaktioner.
English: If it does not work, you will need to try with a new needle.
Danish: Hvis det ikke virker, skal du prøve med en ny nål.
English: Remove the outer needle cap and keep it. You'll need it again later.
Danish: Fjern den ydre nålehætte og gem den. Du får brug for den senere.
English: • Always have a spare pen in case your pen is lost or damaged.
Danish: • Opbevar altid en ekstra pen i tilfælde af, at din pen bliver væk eller går i stykker.
English: Don't use your pen if it has been removed from the refrigerator for more than 28 days.
Danish: Brug ikke pennen, hvis den har været taget ud af køleskabet i mere end 28 dage.
English: LUSDUNA is a biosimilar medicinal product.
Danish: LUSDUNA er et biosimilært lægemiddel.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
Danish: Alt efter din levevis og resultatet af dine blodsukkermålinger (glucosemålinger) og din tidligere anvendelse af insulin vil din læge
English: Since LUSDUNA is a solution, it does not require resuspension before use.
Danish: Da LUSDUNA er en opløsning, er resuspension ikke nødvendig før brug.
English: Do not stop LUSDUNA without speaking to a doctor, who will tell you what needs to be done.
Danish: Stop ikke med at tage Lusduna uden at tale med din læge, som vil fortælle dig, hvad der skal gøres.
English: In your brain
Danish: I hjernen
English: It is important that you know how your insulin helps you and how to avoid the most common side effect - low blood sugar (hypoglycaemia), which can be serious.
Danish: Det er vigtigt, at du ved, hvordan insulinen virker, og hvordan du kan undgå den mest almindelige bivirkning, lavt blodsukker (hypoglykæmi), som kan være alvorlig.
English: Use a new needle each time.
Danish: Brug en ny nål hver gang.
English: This is a modified insulin, very similar to human insulin.
Danish: Dette er et modificeret insulin, der ligner humant insulin meget.
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Danish: Generelt er sikkerhedsprofilen for børn og unge (≤ 18 år) den samme som for voksne.
English: Read about this in the Package leaflet supplied in every carton.
Danish: Læs om dette i Indlægssedlen, som medfølger i hver pakning.
English: There is no experience in children under 2 years.
Danish: Der er ingen erfaring hos børn under 2 år.
English: This step helps to ensure that you will get your full dose later on.
Danish: Herved sikres det, at du får den fulde dosis senere.
English: Don't use your pen after the expiration date.
Danish: Brug ikke pennen efter udløbsdatoen.
English: If you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose.
Danish: Hvis du har behov for at injicere flere enheder end det antal enheder, som er tilbage i pennen, kan du enten: - injicere den mængde, som er tilbage i pennen, og herefter injicere resten af din dosis med en ny pen, eller - injicere den fulde dosis med en ny pen.
English: Do not reuse the needle; throw it away safely following the directions.
Danish: Genbrug ikke nålen; kasser den på sikker vis i henhold til anvisningerne.
English: It is very important that you dial the dose your healthcare provider recommended.
Danish: Det er meget vigtigt, at du vælger den dosis, som din læge anbefaler.
English: Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Danish: Mål dit blodsukker og undersøg urinen for ketonstoffer, så snart et eller flere af ovenstående symptomer opstår.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Danish: Nogle lægemidler kan påvirke blodsukkeret (få det til at falde, stige eller begge dele afhængigt af situationen).
English: Instructions for use online at www.lusdunanexvue.com
Danish: Brugsanvisning online kan ses på www.lusdunanexvue.com
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Danish: Såfremt normale eller nedsatte værdier af glykosyleret hæmoglobin observeres, skal muligheden for tilbagevendende, ikke-erkendte (især natlige) hypoglykæmiske episoder overvejes.
English: Animal data do not indicate reproductive toxicity.
Danish: Data fra dyrestudier indikerer ikke reproduktionstoksicitet.
English: This should be kept in mind if treatment with the combination of pioglitazone and LUSDUNA is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og LUSDUNA overvejes.
English: You need one injection of LUSDUNA every day, at the same time of the day.
Danish: Du skal have en injektion af Lusduna hver dag på samme tid af dagen.
English: QR code linking to the instructions for use to be included.
Danish: QR-kode med link til brugsanvisning inkluderes.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms (see section 4.4).
Danish: Generelt gælder det, at jo større og hurtigere faldet i blodglucosen er, des mere udtalt er modregulationen og dens symptomer (se pkt.
English: In patients with type 2 diabetes mellitus, LUSDUNA can also be given together with oral antidiabetic medicinal products.
Danish: Til patienter med type 2-diabetes mellitus kan LUSDUNA også indgives sammen med orale antidiabetika.
English: If not, get a new pen.
Danish: Hvis dette ikke er tilfældet, skal du bruge en ny pen.
English: It is completely soluble at the acidic pH of the LUSDUNA injection solution (pH 4).
Danish: Det er fuldstændig opløseligt ved den sure pH i LUSDUNA-injektionsvæsken (pH 4).