FrancophonIA/ELRC3.0 huggingface dataset:
English: Considering potential insufficient coverage of pathogens responsible for meningitis by pefloxacin and risks associated with inappropriate treatment of meningitis, the overall benefit-risk balance of this indication is considered negative and therefore should be deleted.
Danish: I betragtning af pefloxacins potentielle utilstrækkelige virkning mod de patogener, der forårsager meningitis, og de risici, der er forbundet med uhensigtsmæssig behandling af meningitis, anses det overordnede benefit/risk-forhold som negativt, og indikationen bør derfor slettes.
English: Therefore in view of the risk related to the use of (fluoro)quinolones, including the risk of long-lasting, disabling or potentially permanent ADRs, the overall benefit-risk balance in the indication of otitis media (acute) has changed and should be only used in patients who have no alternative treatment option.
Danish: I lyset af risikoen ved brug af (fluor)quinoloner, herunder risikoen for langvarige, invaliderende og potentielt permanente bivirkninger, er det samlede benefit/risk-forhold i indikationen otitis media (akut) ændret, og stofferne bør kun anvendes hos patienter, der ikke har andre behandlingsmuligheder.
English: The PRAC considered the totality of the data submitted for (fluoro)quinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
Danish: PRAC vurderede alle de fremlagte data for (fluor)quinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger.
English: Considering the poor pneumococcal susceptibility of pefloxacine and the potential risks, PRAC concluded that the use of pefloxacin in the treatment of acute exacerbations of chronic sinusitis should be restricted to the patients in whom it is considered inappropriate to use other antibacterial agents for the treatment of these infections (last line option).
Danish: I betragtning af pneumokokkers ringe følsomhed over for pefloxacin og de mulige risici konkluderede PRAC, at anvendelsen af pefloxacin til behandling af akutte eksacerbationer af kronisk bihulebetændelse bør begrænses til de patienter, hos hvem det vurderes uhensigtsmæssigt at anvende andre antibakterielle stoffer til behandling af disse infektioner (sidstelinjebehandling).
English: Prevention of infection in surgical procedures
Danish: Forebyggelse af infektioner under kirurgiske indgreb
English: Therefore in view of the risk related to the use of (fluoro)quinolones, including the risk of long-lasting, disabling and potentially permanent serious ADRs, (fluoro)quinolones should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of ABS infections.
Danish: I lyset af risikoen ved anvendelse af (fluor)quinoloner, herunder risikoen for langvarige, invaliderende og potentielt permanente alvorlige bivirkninger, bør (fluor)quinoloner kun anvendes, når det vurderes uhensigtsmæssigt at bruge antibakterielle stoffer, der sædvanligvis anbefales til den indledende behandling af akut bakteriel rhinosinuit.
English: Considering the high resistance pattern to pefloxacin, possible development of cross resistance to other quinolones, and the newly recognised risk of long-lasting and potentially disabling adverse effects, the risks of using pefloxacin outweigh its benefits.
Danish: I betragtning af det høje resistensmønster over for pefloxacin, den mulige udvikling af krydsresistens over for andre quinoloner og den nyligt identificerede risiko for langvarige og potentielt invaliderende bivirkninger opvejer risiciene ved brug af pefloxacin stoffets fordele.
English: Pneumonia due to Gram-negative bacteria
Danish: Lungebetændelse forårsaget af gramnegative bakterier Tuberkulose
English: Taking into consideration the efficacy data, the risk of developing resistance and the risk profile of (fluoro)quinolones together with the new risk of long-lasting, disabling and potentially irreversible ADRs it is concluded that benefit-risk balance is unchanged only in severe episodes of AECB and COPD or where other therapeutic options are not effective or tolerable.
Danish: Under hensyntagen til effektdataene, risikoen for udvikling af resistens og risikoprofilen for (fluor)quinoloner samt den nye risiko for langvarige, invaliderende og potentielt irreversible bivirkninger vurderes det, at benefit/risk-forholdet kun er uændret i tilfælde af svære episoder af kronisk bronkitis og KOL, eller når andre behandlingsmuligheder ikke er effektive eller tåles.
English: Nosocomial pneumonia
Danish: Nosokomiel lungebetændelse
English: Considering potential insufficient coverage of pathogens responsible for endocarditis by pefloxacin and risks associated with inappropriate treatment of endocarditis, the benefit-risk balance of this indication is considered negative.
Danish: I betragtning af pefloxacins potentielle utilstrækkelige virkning mod de patogener, der forårsager endocarditis, og de risici, der er forbundet med uhensigtsmæssig behandling af endocarditis, anses benefit/risk-forholdet som negativt.
English: • The PRAC concluded that for patients with a serious infection that is susceptible to these antibiotics fluoroquinolones remain an important treatment option despite the very rare risk of long-lasting, disabling and potentially irreversible adverse reactions.
Danish: • PRAC fandt, at fluorquinoloner fortsat udgør en vigtig behandlingsmulighed for patienter med en alvorlig infektion, der er følsom over for disse antibiotika, på trods af risikoen for meget sjældne tilfælde af langvarige, invaliderende og potentielt irreversible bivirkninger.
English: • The PRAC also concluded that in case of mild and/or self-limiting infections, the benefit of quinolones and fluoroquinolones treatment does not outweigh the overall risk related to the use of these medicinal products including serious risk of long-lasting, disabling and potentially irreversible adverse drug reactions.
Danish: • For så vidt angår milde og/eller selvbegrænsende infektioner, vurderede PRAC også, at fordelen ved behandling med quinoloner og fluorquinoloner ikke opvejer den samlede risiko ved brug af disse lægemidler, herunder den alvorlige risiko for langvarige, invaliderende og potentielt irreversible bivirkninger.
English: • Exacerbations of broncho-pulmonary infections in cystic fibrosis
Danish: • Eksacerbationer af bronkopulmonale infektioner hos patienter med cystisk fibrose
English: The PRAC also concluded that the benefit-risk balance of the following quinolone medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine is no longer favourable and should be suspended.
Danish: PRAC konkluderede også, at benefit/risk-forholdet for de quinolonholdige lægemidler nalidixinsyre, pipemidinsyre, cinoxacin og flumequin ikke længere er positivt, og at markedsføringstilladelsen for dem bør suspenderes.
English: The MAHs should justify the dosage recommendation and consider appropriate PK/PD data in support of the indication.
Danish: Indehaverne af markedsføringstilladelse bør begrunde doseringsanbefalingen under hensyn til relevante farmakodynamiske og farmakokinetiske data, der støtter indikationen.
English: Ear, nose and throat infections Skin and soft tissue infections Genital tract infections
Danish: Øre-, næse- og halsinfektioner Hud- og bløddelsinfektioner Genitalinfektioner
English: This pharmacovigilance referral procedure focuses on the review of the impact of long-lasting, disabling and potentially irreversible known adverse drug reactions (ADRs) on the benefit-risk balance of quinolones and fluoroquinolones containing products for systemic and inhalation use and the need for adequate risk minimisation measures.
Danish: Denne indbringelsesprocedure er iværksat som følge af bivirkningsovervågning og fokuserer på indvirkningen af langvarige, invaliderende og potentielt irreversible bivirkninger på benefit/riskforholdet for quinolon- og fluorquinolonholdige lægemidler til systemisk anvendelse og inhalation og behovet for relevante risikominimeringsforanstaltninger.
English: Based on the efficacy data, current treatment guideline, known risks related to the use of (fluoro)quinolones including disabling ADRs the PRAC considered that benefit-risk balance of (fluoro)quinolones in vaginitis is negative.
Danish: På baggrund af effektdataene, den aktuelle behandlingsvejledning, de kendte risici ved brug af (fluor)quinoloner, herunder invaliderende bivirkninger, fandt PRAC, at benefit/risk-forholdet for (fluor)quinoloner til behandling af vaginitis er negativt.
English: Prevention of exacerbations in women with recurring urinary tract infections (UTI)
Danish: Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektioner
English: Taking into consideration the risk of long-lasting, disabling and potentially irreversible ADRs the benefit-risk balance of (fluoro)quinolones in the indication of prevention of exacerbations in women with recurring urinary tract infection is considered negative.
Danish: I betragtning af risikoen for langvarige, invaliderende og potentielt irreversible bivirkninger anses benefit/risk-forholdet for (fluor)quinoloner i indikationen "Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektioner" som negativt.
English: Based on the increasing resistance of pathogenic microorganisms to (fluoro)quinolones, the association of (fluoro)quinolones with C. difficile-associated diarrhoea, their other well-known risks in addition to the risk of rare, nevertheless persistent and disabling ADRs, the benefit/risk balance of (fluoro)quinolones in the prophylaxis of travellers´ diarrhoea is considered negative.
Danish: På grundlag af den stigende resistens blandt patogene mikroorganismer over for (fluor)quinoloner, sammenhængen mellem (fluor)quinoloner og C. difficile-associeret diarré, deres andre velkendte risici i tillæg til risikoen for sjældne, men vedvarende og invaliderende bivirkninger anses benefit/riskforholdet for (fluor)quinoloner til forebyggelse af turistdiarré som negativt.
English: Prophylaxis of travellers´ diarrhoea
Danish: Profylakse af turistdiarré
English: Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
Danish: Bronkopulmonale infektioner hos patienter med cystisk fibrose eller bronchiectasis Samfundserhvervet lungebetændelse
English: • Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
Danish: • Eksacerbation af kronisk obstruktiv lungesygdom Akut bakteriel bihulebetændelse
English: For lifting the suspension, the PRAC recommended that the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product in any indication.
Danish: For at få hævet suspenderingen anbefalede PRAC, at indehaveren af markedsføringstilladelsen bør fremlægge relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet i en given indikation.
English: • The PRAC considered the totality of the data submitted for quinolones and fluoroquinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
Danish: • PRAC vurderede alle de fremlagte data for quinolon- og fluorquinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger.
English: • Malignant external otitis
Danish: • Malign otitis externa
English: • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
Danish: • Akut eksacerbation af kronisk obstruktiv lungesygdom, herunder kronisk bronkitis
English: In view of the above, the benefit-risk balance for this indication is considered negative.
Danish: I lyset af ovenstående anses benefit/risk-forholdet i denne indikation som negativt.
English: Indication heading Pharyngitis-Tonsillitis
Danish: Indikationsoverskrift Faryngitis-tonsilitis
English: Infection of cerebrospinal fluid
Danish: Infektion af rygmarvsvæsken
English: Taking into consideration the frequently viral aetiology of acute bronchitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the potential risk of disabling ADRs, the benefit-risk balance of (fluoro)quinolone use in acute bronchitis is considered negative.
Danish: I betragtning af den hyppigt virale ætiologi ved akut bronkitis, dens som oftest selvbegrænsende karakter, den stigende resistens blandt almindelige mikroorganismer over for (fluor)quinoloner og den mulige risiko for invaliderende bivirkninger anses benefit/risk-forholdet for (fluor)quinolon-behandling af akut bronkitis som negativt.
English: Acute bacterial rhinosinusitis (ABS)
Danish: Akut bakteriel rhinosinuit
English: To lift the suspension, the MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of these medicinal products.
Danish: For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for disse lægemidler.
English: To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
Danish: For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet.
English: • Long term prophylaxis of recurrent urinary infections
Danish: • Langvarig profylakse af recidiverende urinvejsinfektion
English: Taking into consideration the predominant viral aetiology of laryngitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the identified risk of occurrence of long-lasting, disabling and potentially irreversible adverse drug reactions, the benefit-risk balance of (fluoro)quinolone use in laryngitis is considered negative.
Danish: I betragtning af laryngitis' primært virale ætiologi, dens som oftest selvbegrænsende karakter, den stigende resistens blandt almindelige mikroorganismer over for (fluor)quinoloner og den konstaterede risiko for forekomst af langvarige, invaliderende og potentielt irreversible bivirkninger anses benefit/risk-forholdet for (fluor)quinoloner til behandling af laryngitis som negativt.
English: Malignant external otitis
Danish: Malign otitis externa
English: Infections of kidney, urinary tract and genitals Urinary tract infection
Danish: Infektioner i nyrerne, urinvejene og kønsdelene Urinvejsinfektion
English: Septicaemia
Danish: Sepsis
English: The overall benefit-risk ratio for this indication for is therefore considered negative.
Danish: Det overordnede benefit/risk-forhold for denne indikation er derfor negativt.
English: Vaginal infections (AV)
Danish: Vaginale infektioner
English: Therefore, the benefit-risk in using pefloxacin in this indication is negative.
Danish: Derfor er benefit/risk-forholdet for pefloxacin i denne indikation negativt.
English: • Prophylaxis of infectious gastroenteritis (traveller's diarrhoea)
Danish: • Profylakse af smitsom mave-tarm-katar (turistdiarré)
English: • Prophylaxis of frequently repeating infections of urinary tract infections
Danish: • Profylakse af hyppigt gentagne infektioner af urinvejene
English: • Prophylaxis of systemic urinary tract infections Prevention of infection in surgical procedures
Danish: Profylakse af systemiske urinvejsinfektioner Forebyggelse af systemiske urinvejsinfektioner
English: • Frequent, recurrent urinary infection prophylaxis
Danish: • Profylakse af hyppigt recidiverende urinvejsinfektion
English: Acute exacerbation of chronic bronchitis (AECB) and COPD
Danish: Akut eksacerbation af kronisk bronkitis og KOL
English: Infection of the digestive system and bile ducts Prevention of infection in surgical procedures Prophylaxis of systemic urinary tract infections Prevention of systemic urinary tract infections
Danish: Infektion i fordøjelsessystemet og galdegangene Forebyggelse af infektioner under kirurgiske indgreb
English: Therefore, the benefit risk-balance of this indication is considered negative for pefloxacin.
Danish: Som følge deraf vurderes benefit/risk-forholdet for pefloxacin i denne indikation at være negativt.
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Danish: 90 (3 x 30) tabletter
English: Pharmaceutical Form
Danish: 30 tabletter
English: Immediate Packaging
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: Packaging Content Package size
Danish: Lægemiddelform Indgivelsesvej Emballage Indhold
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stivarga den 26. august 2013.
English: The full EPAR for Stivarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Stivarga 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 Stivarga.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Stivarga.
English: Stivarga is available as tablets (40 mg).
Danish: Stivarga fås som tabletter (40 mg).
English: What is Stivarga and what is it used for?
Danish: Hvad er Stivarga, og hvad anvendes det til?
English: Doses should be taken at the same time each day with a light meal.
Danish: Doserne skal tages på samme klokkeslæt hver dag sammen med et let måltid.
English: What measures are being taken to ensure the safe and effective use of Stivarga?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Stivarga?
English: It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg (4 tablets) once every day for three weeks, followed by a week without taking the medicine.
Danish: Det tages i behandlingsserier på 4 uger med en anbefalet startdosis på 160 mg (4 tabletter) én gang dagligt i tre uger, efterfulgt af en uge uden behandling.
English: It is not intended to provide practical advice on how to use Stivarga.
Danish: Det er ikke en praktisk vejledning i, hvordan Stivarga bør anvendes.
English: Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer.
Danish: Behandling med Stivarga skal ordineres af en læge med erfaring i behandling af kræft.
English: Why is Stivarga approved?
Danish: Hvorfor blev Stivarga godkendt?
English: All patients also received supportive care.
Danish: Alle patienterne i undersøgelsen fik også understøttende behandling.
English: It is used on its own to treat the following cancers:
Danish: Det anvendes som enkeltstofterapi til behandling af følgende kræfttyper:
English: All patients also received supportive care, including pain medicines and treatment for infections.
Danish: Alle patienterne fik desuden støttebehandling, herunder smertestillende medicin og behandling for infektioner.
English: Other information about Stivarga
Danish: Andre oplysninger om Stivarga
English: The side effects of Stivarga are manageable.
Danish: Bivirkningerne ved Stivarga kan håndteres.
English: What are the risks associated with Stivarga?
Danish: Hvilke risici er der forbundet med Stivarga?
English: This means that it blocks several enzymes that are important for the development of a blood supply to tumours and the growth and development of cancer cells.
Danish: Det vil sige, at det blokerer flere enzymer, som er vigtige for udviklingen af svulsters blodforsyning og kræftcellers vækst og udvikling.
English: Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments.
Danish: Stivarga anvendes hos patienter, der allerede er blevet behandlet med andre midler, eller som ikke kan behandles med andre midler.
English: Stivarga is a cancer medicine that contains the active substance regorafenib.
Danish: Stivarga er et lægemiddel mod kræft, som indeholder det aktive stof regorafenib.
English: By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.
Danish: Ved at blokere virkningen af disse enzymer medvirker Stivarga til at stoppe kræftens vækst og spredning.
English: The most common side effects with Stivarga (which may affect more than 3 in 10 people) are pain, weakness, tiredness, loss of appetite and eating less, hand-foot syndrome (rash and numbness affecting the palms and soles), diarrhoea, infection and hypertension (high blood pressure).
Danish: De hyppigste bivirkninger (som optræder hos mere end 3 ud af 10 patienter) er smerter, svaghed, træthed, manglende eller nedsat appetit, hånd-fod-syndrom (udslæt og følelsesløshed i håndflader og på fodsåler), diarré, infektion og hypertension (højt blodtryk).
English: For more information about treatment with Stivarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Stivarga, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For colorectal cancer, these include chemotherapy based on medicines called fluoropyrimidines and treatment with other cancer medicines known as anti-VEGF and anti-EGFR therapies.
Danish: Ved kolorektal cancer omfatter sådanne behandlinger kemoterapi baseret på såkaldte fluoropyrimidiner og behandling med andre kræftlægemidler, der kaldes antiVEGF-midler og anti-EGFR-midler.
English: For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger ved Stivarga fremgår af indlægssedlen.
English: The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse.
Danish: Det blev i undersøgelsen påvist, at Stivarga i kombination med støttebehandling var effektivt til at forlænge patienternes overlevelsestid, uden at deres sygdom blev værre.
English: The company that markets Stivarga will carry out studies to look for ways of identifying patients who are more likely to respond to treatment.
Danish: Den virksomhed, der markedsfører Stivarga, skal udføre undersøgelser, der skal finde frem til metoder til at udpege patienter, som har større sandsynlighed for at få gavn af behandlingen.
English: Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer.
Danish: Støttebehandlingen omfattede smertelindring, antibiotika og blodtransfusioner, som hjalp patienten uden dog at behandle kræften.
English: • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
Danish: • kolorektal cancer (kræft i tyktarm og endetarm), der har spredt sig til andre dele af kroppen
English: The European Medicines Agency decided that Stivarga's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede, at fordelene ved Stivarga opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The Committee noted that in colorectal cancer the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options.
Danish: Udvalget bemærkede, at fordelene i form af forlænget overlevelse var beskedne ved kolorektal cancer, men fandt, at de opvejede risiciene hos patienter, for hvem der ikke er nogen anden behandlingsmulighed.
English: Treatment should continue for as long as the patient benefits from treatment or until the side effects become too severe.
Danish: Behandlingen bør fortsættes, så længe patienten har fordel af den, eller indtil patienten får bivirkninger, som ikke kan tolereres.