FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines containing tolperisone are available as tablets and/or solution for injection in Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia, under various trade names.
Danish: Lægemidler indeholdende tolperison fås under forskellige handelsnavne som tabletter og/eller injektionsvæske i Bulgarien, Cypern, Tjekkiet, Tyskland, Ungarn, Letland, Litauen, Polen, Rumænien og Slovakiet.
English: On 15 July 2011, it asked the CHMP to issue an opinion on whether the marketing authorisations for tolperisone-containing products should be maintained, varied, suspended or withdrawn across the EU.
Danish: Den 15. juli 2011 anmodede den CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende tolperison burde opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: The Committee therefore recommended that the product information should be updated to reflect this risk and include a warning on the signs of hypersensitivity.
Danish: Udvalget anbefalede derfor, at produktoplysningerne opdateres, så de afspejler denne risiko, og udvides med en advarsel om tegn på hypersensitivitet.
English: In Germany, several indications approved in other countries were not authorised because the German medicines agency considered that tolperisone's effectiveness had not been proven in those indications.
Danish: I Tyskland blev flere af de indikationer, der er godkendt i andre lande, ikke godkendt, da den tyske lægemiddelstyrelse fandt, at virkningen af tolperison ikke var påvist til disse indikationer.
English: Tolperisone-containing medicines have been authorised in several countries in the EU since the 1960s for the treatment of muscle spasms (involuntary contractions) and spasticity caused by different conditions.
Danish: Lægemidler indeholdende tolperison har været godkendt i flere lande i EU siden 1960'erne til behandling af muskelspasmer (ufrivillige muskelsammentrækninger) og spasticitet forårsaget af forskellige sygdomme.
English: The available data to support the use of tolperisone-containing medicines in locomotor diseases, vascular diseases, rehabilitation following surgery and Little's disease are limited and not convincing.
Danish: De foreliggende data til underbyggelse af anvendelsen af tolperison ved sygdomme i bevægeapparatet, karsygdomme, rehabilitering efter operationer og Littles sygdom er begrænsede og ikke overbevisende.
English: Tolperisone is a muscle relaxant.
Danish: Tolperison er et muskelafslappende middel.
English: Doctors should stop prescribing tolperisone for any other indication.
Danish: Lægerne bør ophøre med at ordinere tolperison til andre indikationer.
English: The CHMP reviewed data on the effectiveness of oral and injectable tolperisone in the different indications, including data from published clinical studies and analyses of various studies provided by the companies that market these medicines.
Danish: CHMP gennemgik data om virkningen af tolperison ved oral indgift og ved injektion til de forskellige indikationer, herunder data fra offentliggjorte kliniske undersøgelser og analyser fremlagt af de virksomheder, der markedsfører disse lægemidler.
English: The Committee also recommended that the marketing authorisations for tolperisonecontaining medicines given by injection should be revoked throughout the European Union (EU).
Danish: Udvalget anbefalede desuden, at markedsføringstilladelserne for lægemidler, at der indeholder tolperison og gives ved injektion, inddrages i hele Den Europæiske Union (EU).
English: Consequently, the German medicines agency considered that a full assessment of the benefit-risk balance of tolperisone should be carried out in all approved indications.
Danish: Den tyske lægemiddelstyrelse var derfor af den opfattelse, at der burde foretages en fuldstændig vurdering af forholdet mellem fordele og risici ved tolperison til alle de godkendte indikationer.
English: • Patients should note that symptoms of hypersensitivity can include flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty breathing, difficulty in swallowing, fast heartbeat, low blood pressure and fast decrease in blood pressure.
Danish: • Patienterne bør være opmærksomme på symptomer på hypersensitivitet i form af rødme, udslæt, stærk hudkløe (med hævede områder), hvæsende vejrtrækning, vejrtrækningsbesvær, synkebesvær, hurtig hjerterytme, for lavt blodtryk og hurtigt blodtryksfald.
English: These include neurological diseases (related to the brain or nerves, such as multiple sclerosis), locomotor diseases (related to the spine and large joints such as the hip), vascular diseases (related to the blood vessels), rehabilitation following surgery, and Little's disease (also known as cerebral palsy, a rare disease where there is damage to parts of the brain that control movement).
Danish: Disse sygdomme er neurologiske sygdomme (sygdomme, der berører hjernen eller nerverne, såsom multipel sklerose), sygdomme i bevægeapparatet (sygdomme i rygsøjlen og store led som hofteleddene), karsygdomme, rehabilitering efter operationer og Littles sygdom (også kaldet cerebral parese, en sjælden sygdom, der skyldes beskadigelse af de dele af hjernen, der styrer bevægelserne).
English: • Patients should be informed of the possibility of hypersensitivity reactions during treatment with tolperisone.
Danish: • Patienterne bør informeres om mulighederne for hypersensitivitetsreaktioner under behandling med tolperison.
English: By reducing these impulses, tolperisone is believed to reduce muscle contraction, helping to relieve the stiffness.
Danish: Ved at dæmpe disse impulser menes tolperison at nedsætte muskelsammentrækningerne, så stivheden mindskes.
English: Regarding the safety of tolperisone, the CHMP noted that more than half of the spontaneous reports of side effects with tolperisone were hypersensitivity reactions, while only a small number of hypersensitivity reports had been observed during the clinical trials that supported tolperisone's marketing authorisation.
Danish: Vedrørende sikkerheden af tolperison bemærkede CHMP, at over halvdelen af de spontane indberetninger af bivirkninger med tolperison var hypersensitivitetsreaktioner, hvorimod der kun var indberettet få hypersensitivitetsreaktioner under de kliniske undersøgelser til støtte for markedsføringstilladelsen for tolperison.
English: • Prescribers are advised that injectable tolperisone should no longer be used in the EU.
Danish: • De ordinerende læger bør være opmærksomme på, at tolperison som injektionspræparat ikke længere må anvendes i EU.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Danish: Det vides ikke nøjagtigt, hvordan tolperison virker, men det antages at virke på hjernen og rygmarven ved at dæmpe de nerveimpulser, der får musklerne til at trække sig sammen og blive stive.
English: As tolperisone-containing medicines have been developed by different companies and have been authorised through national procedures in the EU Member States, they are used to treat different conditions in different countries.
Danish: Lægemidler indeholdende tolperison er blevet udviklet af forskellige virksomheder og er godkendt ved nationale procedurer i EU's medlemsstater.
English: • Patients currently using tolperisone for any other indication or using injectable tolperisone should speak to their doctor at their next routine appointment so they can switch to an appropriate alternative treatment.
Danish: • Patienter, der aktuelt får tolperison til andre indikationer eller får tolperison som injektionspræparat, bør tage dette op med lægen ved næste planlagte besøg, så de kan overgå til anden passende behandling.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet.
English: In addition, numerous reports of hypersensitivity (allergic) reactions to tolperisone had been reported post marketing in Germany.
Danish: Desuden er der efter markedsføring kommet talrige indberetninger om hypersensitivitetsreaktioner (allergiske reaktioner) over for tolperison i Tyskland.
English: The Committee also reviewed the available postmarketing data on spontaneous reports of side effects.
Danish: Udvalget gennemgik desuden de foreliggende data om bivirkninger, der var indberettet spontant efter markedsføring.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of tolperisone-containing medicines given orally (by mouth) continue to outweigh their risks, but that their use should be restricted to the treatment of adults with post-stroke spasticity (stiffness).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved lægemidler, der indeholder tolperison og gives oralt (gennem munden), fortsat er større end risiciene, men at deres anvendelse bør indskrænkes til behandling af voksne med postapoplektisk spasticitet (muskelstivhed efter slagtilfælde).
English: In addition, since extremely limited data are available to support the safety and dosing recommendations of injectable tolperisone, the CHMP concluded that the benefits of this formulation do not outweigh the identified risks, and that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked.
Danish: Da der kun findes meget begrænsede data til underbyggelse af sikkerheden og dosisanbefalingerne for tolperison til injektion, konkluderede CHMP, at fordelene ved denne formulering ikke overstiger de konstaterede risici, og at markedsføringstilladelserne for lægemidler indeholdende tolperison til injektion bør inddrages.
English: • Patients should be aware that the benefits of oral tolperisone continue to outweigh its risks only for the treatment of post-stroke spasticity in adults.
Danish: • Patienterne bør være opmærksomme på, at fordelene ved tolperison til oral indgift fortsat kun overstiger risiciene til behandling af postapoplektisk spasticitet hos voksne.
English: Only in the treatment of spasticity caused by neurological diseases was a study considered to be of acceptable quality, showing a moderate improvement of 32% in spasticity with oral tolperisone, compared with a 14% improvement in the placebo (a dummy treatment) group.
Danish: Undersøgelsen viste en moderat bedring på 32% i spasticitet ved oral indgift af tolperison, sammenholdt med en bedring på 14% med placebo (virkningsløs behandling).
English: Therefore, based on the evaluation of the currently available data and considering that the risk of hypersensitivity reactions is more significant than previously identified, the CHMP concluded that the benefits of oral tolperisone-containing medicines continue to outweigh its risks only when used in the treatment of post-stroke spasticity in adults.
Danish: På baggrund af de foreliggende data og i betragtning af, at risikoen for hypersensitivitetsreaktioner er større end det tidligere er fremgået, konkluderede CHMP derfor, at fordelene ved lægemidler til oral indtagelse af tolperison fortsat kun overstiger risiciene til behandling af postapoplektisk spasticitet hos voksne.
English: • Prescribers are advised that the indication for oral tolperisone has been restricted to the treatment of post-stroke spasticity in adults.
Danish: • De ordinerende læger bør være opmærksomme på, at indikationen for tolperison til oral indgift er blevet indskrænket til behandling af postapoplektisk spasticitet hos voksne.
English: Patients should stop taking tolperisone and inform their doctor if they experience any of these symptoms.
Danish: Patienter, der får nogen af disse symptomer, bør stoppe med at bruge tolperison og kontakte lægen.
English: Content (concentration)
Danish: Indhold (Koncentration
English: Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.
Danish: Rubraca fik en betinget markedsføringstilladelse med gyldighed i hele EU den 24. maj 2018.
English: Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment.
Danish: Med hensyn til sikkerheden forekommer der ofte bivirkninger, men de er generelt ikke alvorlige og kan lindres med passende behandling.
English: Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur eventuelle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt denne oversigt.
English: The recommended dose of Rubraca is 600 mg twice a day.
Danish: Den anbefalede dosis af Rubraca er 600 mg to gange dagligt.
English: Further information on Rubraca can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rubraca.
Danish: Yderligere information om Rubraca findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Rubraca.
English: Rubraca is available as tablets of 200, 250 and 300 mg.
Danish: Rubraca fås som tabletter på 200, 250 og 300 mg.
English: Rubraca has been given ‘conditional authorisation'.
Danish: Rubraca har fået en "betinget godkendelse".
English: In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.
Danish: Derudover er der færre lever- og blodrelaterede problemer med Rubraca end med andre eksisterende behandlinger til disse patienter.
English: As for all medicines, data on the use of Rubraca are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Rubraca løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Rubraca?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rubraca?
English: The company will also provide further data on maintenance treatment, including data on how long patients survived with Rubraca.
Danish: Virksomheden skal også fremlægge flere data vedrørende vedligeholdelsesbehandling, herunder data om, hvor længe patienterne overlevede ved behandling med Rubraca.
English: Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.
Danish: Kvinder må ikke amme under behandling med Rubraca og i mindst 2 uger efter behandlingen.
English: Treatment may be interrupted and doses may be reduced in patients who have certain side effects.
Danish: Behandlingen kan afbrydes, og dosis kan sættes ned hos patienter, der får visse bivirkninger.
English: For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Danish: Sådanne patienter bør først undersøges for en genetisk mutation (BRCA-mutation) for at se, om der er sandsynlighed for, at Rubraca vil virke.
English: An overview of Rubraca and why it is authorised in the EU
Danish: En oversigt over Rubraca, og hvorfor det er godkendt i EU
English: Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Rubraca vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Other information about Rubraca
Danish: Andre oplysninger om Rubraca
English: In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes.
Danish: I normale celler er der en alternativ mekanisme til at reparere DNA, men denne alternative mekanisme fungerer ikke korrekt i kræftceller med mutationer i BRCA-generne.
English: What is Rubraca and what is it used for?
Danish: Hvad er Rubraca, og hvad anvendes det til?
English: Of the 79 patients whose disease had responded in the past to platinumbased medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).
Danish: Ud af de 79 patienter, hos hvem platinbaserede lægemidler tidligere havde virket, opnåede de 65 % (51 patienter) en virkning af behandlingen med Rubraca, som i gennemsnit varede 294 dage (ca. 10 måneder).
English: Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.
Danish: Rubraca fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i kræftbehandling.
English: Why is Rubraca authorised in the EU?
Danish: Hvorfor er Rubraca godkendt i EU?
English: For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Rubraca, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.
Danish: Når PARPproteinerne blokeres, kan det beskadigede DNA i disse kræftceller derfor ikke repareres, og det gør, at kræftcellerne dør.
English: The European Medicines Agency decided that although further study was needed to better understand the size of the benefit, Rubraca's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Selvom der var brug for flere studier for bedre at forstå omfanget af fordelene ved Rubraca, konkluderede Det Europæiske Lægemiddelagentur, at fordelene ved Rubraca opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The treatment should continue until the cancer progresses or the patient has unacceptable side effects.
Danish: Behandlingen bør fortsætte, indtil kræftsygdommen skrider frem eller patienten får bivirkninger, som ikke kan tolereres.
English: The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADPribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells).
Danish: Det aktive stof i Rubraca, rucaparib, blokerer aktiviteten af en gruppe proteiner, der kaldes poly(ADPribose)-polymeraser (PARP'er), som hjælper med at reparere beskadiget DNA i celler (både normale celler og kræftceller).
English: The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, thrombocytopenia (low levels of platelets) and abdominal pain (belly ache).
Danish: De hyppigste bivirkninger ved Rubraca (som kan forekomme hos mere end 1 ud af 5 personer) er træthed eller svaghed, kvalme, forhøjede niveauer for kreatinin (som kan være tegn på nyreproblemer) og leverenzymer i blodet (som kan være tegn på leverskade), opkastning, blodmangel (et lavt antal røde blodlegemer), nedsat appetit, smagsforstyrrelser, diarré, lavt antal blodplader (trombocytopeni) og mavesmerter.
English: Two other studies looked at 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines.
Danish: I to andre studier undersøgte man 106 patienter med æggestokkræft og BRCA-mutation, hvor kræftsygdommen var kommet igen efter mindst to tidligere kræftbehandlinger, herunder i mange tilfælde behandling med platinbaserede lægemidler.
English: It can also be used if the patient's cancer has returned or is worsening after two treatments with platinum-based medicines and they can no longer have these medicines.
Danish: Det kan også anvendes, hvis patientens kræftsygdom er vendt tilbage eller er i forværring efter to behandlinger med platinbaserede lægemidler, og hvor patienten ikke længere kan behandles med disse lægemidler.
English: What are the risks associated with Rubraca?
Danish: Hvilke risici er der forbundet med Rubraca?
English: What information is still awaited for Rubraca?
Danish: Hvilke oplysninger afventes der stadig for Rubraca?
English: Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).
Danish: Patienterne i behandling med Rubraca levede i 11 måneder, uden at sygdommen vendte tilbage eller blev forværret, mens det tilsvarende tal for patienterne i behandling med placebo (en virkningsløs behandling) var 5 måneder.
English: For maintenance treatment, Rubraca should be used no later than 8 weeks after the patient has finished their treatment with platinum-based medicine.
Danish: Som vedligeholdelsesbehandling bør Rubraca anvendes senest 8 uger efter, at patientens behandling med platinbaseret medicin er afsluttet.
English: This benefit was seen in patients with or without the BRCA mutation.
Danish: Denne gunstige virkning blev både set hos patienter med og uden BRCA-mutationen.
English: Rubraca was also beneficial to patients whose cancer had come back after 2 previous cancer treatments, although these benefits have only been shown in patients with a BRCA mutation.
Danish: Rubraca havde også en gunstig virkning hos patienter, hvis kræftsygdom var vendt tilbage efter to tidligere kræftbehandlinger, men dette blev kun set hos patienter med en BRCA-mutation.
English: Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.
Danish: Da Rubraca har fået en betinget godkendelse, skal virksomheden, der markedsfører Rubraca, fremlægge resultaterne af et igangværende studie, der sammenligner Rubraca og kemoterapi (et andet kræftlægemiddel) hos patienter med malign overfladevævskræft i æggestokkene, æggelederne eller bughinden samt BRCA-mutation, hvor kræftsygdommen er vendt tilbage efter kemoterapi.
English: This benefit with Rubraca was seen in patients with or without the BRCA mutation.
Danish: Denne gunstige virkning af Rubraca blev både set hos patienter med og uden BRCA-mutationen.
English: For the full list of side effects of Rubraca, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Rubraca fremgår af indlægssedlen.
English: How is Rubraca used?
Danish: Hvordan anvendes Rubraca?
English: Rubraca as maintenance treatment was investigated in a study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines.
Danish: Rubraca som vedligeholdelsesbehandling er blevet undersøgt i et studie med 564 patienter med æggestokkræft, hvor kræftsygdommen helt eller delvist var stoppet efter behandling med platinbaserede kræftlægemidler.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca 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 Rubraca.
English: It can be used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.
Danish: Det kan anvendes som vedligeholdelsesbehandling hos patienter, hvor et tilbagefald af kræftsygdommen helt eller delvist er stoppet efter behandling med platinbaserede kræftlægemidler.