natgillin/translations-raw huggingface dataset:
• PRAC konkluderede, at nogle af de alvorlige bivirkninger, der er forbundet med brug af quinoloner og fluorquinoloner, i meget sjældne tilfælde kan være langvarige, invaliderende og potentielt irreversible, og at disse risici er en klasseeffekt. 
• The PRAC concluded that some of the serious adverse drug reactions associated with the use of quinolones and fluoroquinolones could very rarely be long-lasting, disabling and potentially irreversible and that these risks are a class effect.
På grundlag af den manglende videnskabelige evidens for virkning og anbefalingen fra IDWP anses benefit/risk-forholdet for anvendelse af (fluor)quinoloner til "Selektiv dekontaminering af mave-tarmkanalen hos patienter med kompromitteret immunsystem" som negativt. 
Based on the lack of scientific evidence on efficacy and the recommendation of the IDWP, the benefit/risk balance of (fluoro)quinolone use in “Selective decontamination of gastrointestinal tract in patients with compromised immune system” is considered negative.
Luftvejsinfektioner 
Respiratory infections
I betragtning af den utilstrækkelige virkning over for de patogener, der er involveret i disse infektioner, konkluderede PRAC, at anvendelsen af pefloxacin bør begrænses til de patienter, hos hvem det vurderes uhensigtsmæssigt at anvende andre antibakterielle stoffer til behandling af disse infektioner (sidstelinjebehandling). 
Considering insufficient coverage of the pathogens involved in these infections, PRAC conclude that the use of pefloxacin 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).
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. 
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.
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. 
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.
PRAC vurderede alle de fremlagte data for (fluor)quinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger. 
The PRAC considered the totality of the data submitted for (fluoro)quinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
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). 
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).
Forebyggelse af infektioner under kirurgiske indgreb 
Prevention of infection in surgical procedures
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. 
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.
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. 
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.
Lungebetændelse forårsaget af gramnegative bakterier Tuberkulose 
Pneumonia due to Gram-negative bacteria
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. 
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.
Nosokomiel lungebetændelse 
Nosocomial pneumonia
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. 
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.
• 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. 
• 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.
• 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. 
• 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.
• Eksacerbationer af bronkopulmonale infektioner hos patienter med cystisk fibrose 
• Exacerbations of broncho-pulmonary infections in cystic fibrosis
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. 
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.
Indehaverne af markedsføringstilladelse bør begrunde doseringsanbefalingen under hensyn til relevante farmakodynamiske og farmakokinetiske data, der støtter indikationen. 
The MAHs should justify the dosage recommendation and consider appropriate PK/PD data in support of the indication.
Øre-, næse- og halsinfektioner Hud- og bløddelsinfektioner Genitalinfektioner 
Ear, nose and throat infections Skin and soft tissue infections Genital tract infections
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. 
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.
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. 
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.
Forebyggelse af eksacerbationer hos kvinder med recidiverende urinvejsinfektioner 
Prevention of exacerbations in women with recurring urinary tract infections (UTI)
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. 
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.
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. 
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.
Profylakse af turistdiarré 
Prophylaxis of travellers´ diarrhoea
Bronkopulmonale infektioner hos patienter med cystisk fibrose eller bronchiectasis Samfundserhvervet lungebetændelse 
Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
• Eksacerbation af kronisk obstruktiv lungesygdom Akut bakteriel bihulebetændelse 
• Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
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. 
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.
• PRAC vurderede alle de fremlagte data for quinolon- og fluorquinolonholdige lægemidler med hensyn til langvarige, invaliderende og potentielt irreversible bivirkninger. 
• 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.
• Malign otitis externa 
• Malignant external otitis
• Akut eksacerbation af kronisk obstruktiv lungesygdom, herunder kronisk bronkitis 
• Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
I lyset af ovenstående anses benefit/risk-forholdet i denne indikation som negativt. 
In view of the above, the benefit-risk balance for this indication is considered negative.
Indikationsoverskrift Faryngitis-tonsilitis 
Indication heading Pharyngitis-Tonsillitis
Infektion af rygmarvsvæsken 
Infection of cerebrospinal fluid
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. 
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.
Akut bakteriel rhinosinuit 
Acute bacterial rhinosinusitis (ABS)
For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for disse lægemidler. 
To lift the suspension, the MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of these medicinal products.
For at få hævet suspenderingen bør indehaveren af markedsføringstilladelsen indsende relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet. 
To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
• Langvarig profylakse af recidiverende urinvejsinfektion 
• Long term prophylaxis of recurrent urinary infections
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. 
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.
Malign otitis externa 
Malignant external otitis
Infektioner i nyrerne, urinvejene og kønsdelene Urinvejsinfektion 
Infections of kidney, urinary tract and genitals Urinary tract infection
Sepsis 
Septicaemia
Det overordnede benefit/risk-forhold for denne indikation er derfor negativt. 
The overall benefit-risk ratio for this indication for is therefore considered negative.
Vaginale infektioner 
Vaginal infections (AV)
Derfor er benefit/risk-forholdet for pefloxacin i denne indikation negativt. 
Therefore, the benefit-risk in using pefloxacin in this indication is negative.
• Profylakse af smitsom mave-tarm-katar (turistdiarré) 
• Prophylaxis of infectious gastroenteritis (traveller's diarrhoea)
• Profylakse af hyppigt gentagne infektioner af urinvejene 
• Prophylaxis of frequently repeating infections of urinary tract infections
Profylakse af systemiske urinvejsinfektioner Forebyggelse af systemiske urinvejsinfektioner 
• Prophylaxis of systemic urinary tract infections Prevention of infection in surgical procedures
• Profylakse af hyppigt recidiverende urinvejsinfektion 
• Frequent, recurrent urinary infection prophylaxis
Akut eksacerbation af kronisk bronkitis og KOL 
Acute exacerbation of chronic bronchitis (AECB) and COPD
Infektion i fordøjelsessystemet og galdegangene Forebyggelse af infektioner under kirurgiske indgreb 
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
Som følge deraf vurderes benefit/risk-forholdet for pefloxacin i denne indikation at være negativt. 
Therefore, the benefit risk-balance of this indication is considered negative for pefloxacin.
90 (3 x 30) tabletter 
Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
30 tabletter 
Pharmaceutical Form
Lægemiddelform Administration Emballage Pakningsstørrelse 
Immediate Packaging
Lægemiddelform Indgivelsesvej Emballage Indhold 
Packaging Content Package size
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stivarga den 26. august 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Den fuldstændige EPAR for Stivarga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Stivarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Stivarga. 
This is a summary of the European public assessment report (EPAR) for Stivarga.
Stivarga fås som tabletter (40 mg). 
Stivarga is available as tablets (40 mg).
Hvad er Stivarga, og hvad anvendes det til? 
What is Stivarga and what is it used for?
Doserne skal tages på samme klokkeslæt hver dag sammen med et let måltid. 
Doses should be taken at the same time each day with a light meal.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Stivarga? 
What measures are being taken to ensure the safe and effective use of Stivarga?
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. 
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.
Det er ikke en praktisk vejledning i, hvordan Stivarga bør anvendes. 
It is not intended to provide practical advice on how to use Stivarga.
Behandling med Stivarga skal ordineres af en læge med erfaring i behandling af kræft. 
Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer.
Hvorfor blev Stivarga godkendt? 
Why is Stivarga approved?
Alle patienterne i undersøgelsen fik også understøttende behandling. 
All patients also received supportive care.
Det anvendes som enkeltstofterapi til behandling af følgende kræfttyper: 
It is used on its own to treat the following cancers:
Alle patienterne fik desuden støttebehandling, herunder smertestillende medicin og behandling for infektioner. 
All patients also received supportive care, including pain medicines and treatment for infections.
Andre oplysninger om Stivarga 
Other information about Stivarga
Bivirkningerne ved Stivarga kan håndteres. 
The side effects of Stivarga are manageable.
Hvilke risici er der forbundet med Stivarga? 
What are the risks associated with Stivarga?
Det vil sige, at det blokerer flere enzymer, som er vigtige for udviklingen af svulsters blodforsyning og kræftcellers vækst og udvikling. 
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.
Stivarga anvendes hos patienter, der allerede er blevet behandlet med andre midler, eller som ikke kan behandles med andre midler. 
Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments.
Stivarga er et lægemiddel mod kræft, som indeholder det aktive stof regorafenib. 
Stivarga is a cancer medicine that contains the active substance regorafenib.
Ved at blokere virkningen af disse enzymer medvirker Stivarga til at stoppe kræftens vækst og spredning. 
By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.
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). 
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).
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. 
For more information about treatment with Stivarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Ved kolorektal cancer omfatter sådanne behandlinger kemoterapi baseret på såkaldte fluoropyrimidiner og behandling med andre kræftlægemidler, der kaldes antiVEGF-midler og anti-EGFR-midler. 
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.
Den fuldstændige liste over begrænsninger og bivirkninger ved Stivarga fremgår af indlægssedlen. 
For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Det blev i undersøgelsen påvist, at Stivarga i kombination med støttebehandling var effektivt til at forlænge patienternes overlevelsestid, uden at deres sygdom blev værre. 
The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse.
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. 
The company that markets Stivarga will carry out studies to look for ways of identifying patients who are more likely to respond to treatment.
Støttebehandlingen omfattede smertelindring, antibiotika og blodtransfusioner, som hjalp patienten uden dog at behandle kræften. 
Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer.
• kolorektal cancer (kræft i tyktarm og endetarm), der har spredt sig til andre dele af kroppen 
• colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
CHMP konkluderede, at fordelene ved Stivarga opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
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. 
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.