FrancophonIA/ELRC3.0 huggingface dataset:
English: • Prophylaxis after surgeries or interventions in the urogenital system o prophylaxis after surgeries or interventions in the urogenital system o Prophylaxis of recurrent urinary infections following trans-urethral surgery or transrectal prostatic biopsy
Slovenian: • Profilaksa po kirurških operacijah ali posegih v sečilih in spolovilih o Profilaksa po kirurških operacijah ali posegih v sečilih in spolovilih o Profilaksa ponavljajočih se okužb sečil po transuretralnem kirurškem posegu ali
English: • 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.
Slovenian: • Odbor PRAC je ugotovil, da so nekateri resni neželeni učinki zdravila, povezani z uporabo kinolonov in fluorokinolonov, v zelo redkih primerih lahko dolgotrajni, onesposobljajoči in možno nepopravljivi ter da so ta tveganja povezana z razredom zdravil.
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.
Slovenian: Glede na vzorec pogoste odpornosti proti pefloksacinu, možnost razvoja navzkrižne odpornosti proti drugim kinolonom in novo ugotovljeno tveganje za dolgotrajne in možne onesposobljajoče neželene učinke so tveganja uporabe pefloksacina večja od koristi.
English: To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za odpravo začasnega umika predložiti ustrezne znanstvene dokaze, ki bodo pokazali pozitivno razmerje med tveganji in koristmi uporabe zdravila.
English: Indication heading Complicated urinary tract infections/pyelonephritis
Slovenian: Naslov indikacije Zapletene okužbe sečil/pielonefritis
English: • Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
Slovenian: • Poslabšanje kronične obstruktivne pljučne bolezni Akutni bakterijski sinuzitis
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.
Slovenian: Zaradi tveganja, povezanega z uporabo (fluoro)kinolonov, vključno s tveganjem za dolgotrajne, onesposobljajoče ali možne trajne neželene učinke, se je celotno razmerje med tveganji in koristmi pri indikaciji vnetja srednjega ušesa (akutnega) spremenilo, zato se lahko zdravilo uporablja le pri bolnikih, ki nimajo možnosti nadomestnega zdravljenja.
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.
Slovenian: Na podlagi podatkov o učinkovitosti, trenutnih priporočil za zdravljenje, znanih tveganj, povezanih z uporabo (fluoro)kinolonov, vključno z onesposobljajočimi neželenimi učinki, je odbor PRAC menil, da je razmerje med tveganji in koristmi uporabe (fluoro)kinolonov pri vaginitisu negativno.
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.
Slovenian: Odbor PRAC je upošteval celotno količino podatkov, predloženih za zdravila s (fluoro)kinoloni, v zvezi z dolgotrajnimi, onesposobljajočimi in možnimi nepopravljivimi neželenimi učinki.
English: Ear, nose and throat infections Skin and soft tissue infections Genital tract infections
Slovenian: Okužbe ušes, nosu in grla Okužbe kože in mehkih tkiv Okužbe spolovil Ginekološke okužbe
English: • Acute exacerbations of chronic bronchitis
Slovenian: • Akutno poslabšanje kroničnega bronhitisa
English: Nosocomial pneumonia
Slovenian: Bolnišnična pljučnica
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.
Slovenian: Ob upoštevanju tveganja za dolgotrajne, onesposobljajoče in možne nepopravljive neželene učinke se razmerje med tveganji in koristmi uporabe (fluoro)kinolonov pri indikaciji preprečevanja poslabšanj pri ženskah s ponavljajočimi se okužbami sečil šteje za negativno.
English: Indication heading Vaginal infections Meningitis
Slovenian: Naslov indikacije transrektalni biopsiji prostate Okužbe nožnice Meningitis
English: Prevention of exacerbations in women with recurring urinary tract infections (UTI)
Slovenian: Preprečevanje poslabšanj pri ženskah s ponavljajočimi se okužbami sečil
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.
Slovenian: • Odbor PRAC je upošteval vse podatke, predložene za zdravila s kinoloni in fluorokinoloni, v zvezi z dolgotrajnimi, onesposobljajočimi in možnimi nepopravljivimi neželenimi učinki.
English: • Prophylaxis of systemic urinary tract infections Prevention of infection in surgical procedures
Slovenian: • Profilaksa sistemskih okužb sečil Preprečevanje okužb po kirurških posegih
English: In view of the above, the benefit-risk balance for this indication is considered negative.
Slovenian: Glede na zgoraj navedeno je razmerje med tveganji in koristmi za to indikacijo negativno.
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
Slovenian: Okužba prebavil in žolčevodov Preprečevanje okužb po kirurških posegih Profilaksa sistemskih okužb sečil Preprečevanje sistemskih okužb sečil
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.
Slovenian: Priporočil je, da mora imetnik dovoljenja za promet z zdravilom za odpravo začasnega umika predložiti ustrezne znanstvene dokaze, ki bodo pokazali pozitivno razmerje med tveganji in koristmi uporabe zdravila pri kateri koli indikaciji.
English: Therefore, the benefit-risk in using pefloxacin in this indication is negative.
Slovenian: Zato je razmerje med tveganji in koristmi pri uporabi pefloksacina pri tej indikaciji negativno.
English: Respiratory infections
Slovenian: Okužba likvorja
English: Selective decontamination of gastrointestinal tract in patients with compromised immune system
Slovenian: Selektivna dekontaminacija prebavil pri imunsko oslabljenih bolnikih
English: Malignant external otitis
Slovenian: Maligno vnetje zunanjega ušesa
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.
Slovenian: Ker odpornost bolezenskih povzročiteljev proti (fluoro)kinolonom narašča in ker so (fluoro)kinoloni povezani z drisko zaradi bakterije C. difficile, zaradi drugih znanih tveganj in tveganjem redkih, vendar trdovratnih in onesposobljajočih neželenih učinkov, se razmerje med tveganji in koristmi uporabe (fluoro)kinolonov za profilakso potovalne driske šteje za negativno.
English: Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
Slovenian: Bronhialne in pljučne okužbe pri cistični fibrozi ali bronhiektaziji Zunajbolnišnične pljučnice
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.
Slovenian: Če upoštevamo, da laringitis večinoma povzročajo virusi, da večinoma izzveni sam od sebe, da narašča odpornost pogostih mikroorganizmov proti (fluoro)kinolonom in ugotovljeno tveganje za pojav dolgotrajnih, onesposobljajočih in možnih nepopravljivih neželenih učinkov zdravila, se razmerje med tveganji in koristmi uporabe (fluoro)kinolonov pri laringitisu šteje za negativno.
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.
Slovenian: Če upoštevamo, da akutni bronhitis večinoma povzročajo virusi, da večinoma izzveni sam od sebe, da narašča odpornost pogostih mikroorganizmov proti (fluoro)kinolonom in možno tveganje za pojav onesposobljajočih neželenih učinkov zdravila, se razmerje med tveganji in koristmi uporabe (fluoro)kinolonov pri akutnem bronhitisu šteje za negativno.
English: • Acute uncomplicated pyelonephritis
Slovenian: • Akutni nezapleteni pielonefritis
English: • Intra-abdominal infections
Slovenian: • Okužbe v trebuhu
English: The overall benefit-risk ratio for this indication for is therefore considered negative.
Slovenian: Splošna ocena razmerja med tveganji in koristmi pri tej indikaciji je torej negativna.
English: Therefore, the benefit risk-balance of this indication is considered negative for pefloxacin.
Slovenian: Zato se razmerje med tveganji in koristmi pefloksacina pri tej indikaciji šteje za negativno.
English: Nosocomial pneumonia External otitis
Slovenian: Bolnišnična pljučnica Vnetje zunanjega ušesa
English: • Long term prophylaxis of recurrent urinary infections
Slovenian: • Dolgotrajna profilaksa pri pogostih, ponavljajočih se okužbah sečil
English: Septicaemia
Slovenian: Septikemija
English: Acute exacerbation of chronic bronchitis (AECB) and COPD
Slovenian: Akutno poslabšanja kroničnega bronhitisa in KOPB
English: Prophylaxis of travellers´ diarrhoea
Slovenian: Profilaksa potovalne driske
English: Being one of the most common paediatric diseases, AOM with its spontaneous cure rate above 80% might be considered as a non-serious and inmost cases self-limited infection.
Slovenian: Akutno vnetje srednjega ušesa je ena najpogostejših pediatričnih bolezni in ima stopnjo spontane ozdravitve več kot 80 %, zato ga lahko štejemo za manj resno okužbo, ki večinoma izzveni sama od sebe. Zdravljenje s (fluoro)kinoloni bi lahko bilo koristno pri bolnikih s ponavljajočimi se in/ali neodzivnimi primeri akutnega vnetja srednjega ušesa, ki jih povzročajo bakterije, odporne proti več zdravilom, pri katerih so drugi običajni antibiotiki verjetno neučinkoviti.
English: Intra-abdominal infections
Slovenian: Okužbe v trebuhu
English: • Acute bacterial sinusitis Acute otitis media
Slovenian: • Akutni bakterijski sinuzitis
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Slovenian: 90 (3 x 30) tablet
English: Name Strength Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina
English: All patients also received supportive care.
Slovenian: Vsi bolniki so prejemali tudi podporno zdravljenje.
English: Doses should be taken at the same time each day with a light meal.
Slovenian: Odmerke je treba vzeti ob lahkem obroku vsak dan ob istem času.
English: What measures are being taken to ensure the safe and effective use of Stivarga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Stivarga?
English: Stivarga is available as tablets (40 mg).
Slovenian: Zdravilo Stivarga je na voljo v obliki tablet (40 mg).
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Stivarga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Stivarga, veljavno po vsej Evropski uniji, izdala 26. avgusta 2013.
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.
Slovenian: Jemlje se v štiritedenskih ciklih zdravljenja v priporočenem začetnem odmerku 160 mg (4 tablete) enkrat na dan tri tedne, čemur sledi en teden brez zdravljenja.
English: This is a summary of the European public assessment report (EPAR) for Stivarga.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Stivarga.
English: It is used on its own to treat the following cancers:
Slovenian: Uporablja se kot samostojno zdravilo za zdravljenje naslednjih vrst raka:
English: It is not intended to provide practical advice on how to use Stivarga.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Other information about Stivarga
Slovenian: Druge informacije o zdravilu Stivarga
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stivarga have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Stivarga upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer.
Slovenian: Zdravljenje z zdravilom Stivarga mora predpisati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: • hepatocellular carcinoma (HCC, a cancer of the liver).
Slovenian: • hepatocelularnega karcinoma (HCC, raka jeter).
English: What are the risks associated with Stivarga?
Slovenian: Kakšna tveganja so povezana z zdravilom 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.
Slovenian: To pomeni, da zavira nekatere encime, ki imajo pomembno vlogo pri zagotavljanju preskrbe tumorjev s krvjo ter pri rasti in razvoju rakavih celic.
English: What is Stivarga and what is it used for?
Slovenian: Kaj je zdravilo Stivarga in za kaj se uporablja?
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.
Slovenian: Odbor je poudaril, da so pri kolorektalnem raku koristi v smislu podaljšanja preživetja bolnikov skromne, vendar je menil, da odtehtajo tveganja pri bolnikih, za katere ni več drugih možnosti zdravljenja.
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.
Slovenian: Družba, ki trži zdravilo Stivarga, bo izvedla študije, s katerimi bo poskušala poiskati načine za opredelitev bolnikov, pri katerih obstaja večja verjetnost, da se bodo odzvali na zdravljenje.
English: Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer.
Slovenian: Podporna oskrba je vključevala zdravljenje v obliki protibolečinskih zdravil, antibiotikov in transfuzije krvi, ki sicer pomagajo bolniku, a ne zdravijo raka.
English: Why is Stivarga approved?
Slovenian: Zakaj je bilo zdravilo Stivarga odobreno?
English: The most serious side effects are severe liver injury, bleeding, gastrointestinal perforation (development of a hole in the wall of the gut) and infection.
Slovenian: Najresnejši neželeni učinki so huda poškodba jeter, krvavitev, gastrointestinalne perforacije (pojav lukenj v črevesni steni) in okužba.
English: For more information about treatment with Stivarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Stivarga preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Stivarga večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: All patients also received supportive care, including pain medicines and treatment for infections.
Slovenian: Vsi bolniki so prejemali podporno oskrbo, ki je vključevala zdravila proti bolečinam in zdravljenje okužb.
English: • gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;
Slovenian: • gastrointestinalnega stromalnega tumorja (GIST; vrste raka želodca in črevesja), ki se je razširil ali ga ni mogoče kirurško odstraniti;
English: • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
Slovenian: • kolorektalnega raka (raka debelega črevesa in danke), ki se je razširil na druge dele telesa;
English: What benefits of Stivarga have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Stivarga izkazalo v študijah?
English: Treatment should continue for as long as the patient benefits from treatment or until the side effects become too severe.
Slovenian: Zdravljenje mora trajati, dokler je za bolnika koristno ali dokler neželeni učinki za bolnika ne postanejo prehudi.
English: By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.
Slovenian: Zdravilo Stivarga z zaviranjem delovanja teh encimov pripomore k ustavitvi rasti in širjenja raka.
English: Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.
Slovenian: Bolniki, ki so bili zdravljeni z zdravilom Stivarga, so v povprečju živeli 4,8 meseca brez poslabšanja bolezni v primerjavi z 0,9 meseca pri bolnikih, ki so prejemali placebo in podporno oskrbo.
English: Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments.
Slovenian: Zdravilo Stivarga se uporablja pri bolnikih, ki so že prejemali druge razpoložljive oblike zdravljenja ali pa teh ne morejo prejemati.
English: For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Stivarga naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substance in Stivarga, regorafenib, is a ‘protein kinase inhibitor'.
Slovenian: Zdravilna učinkovina v zdravilu Stivarga, regorafenib, je „zaviralec proteinkinaze“.
English: The side effects of Stivarga are manageable.
Slovenian: Neželeni učinki zdravila Stivarga so obvladljivi.
English: Stivarga had been shown to delay the worsening of the disease in these patients.
Slovenian: Dokazano je bilo, da zdravilo Stivarga pri teh bolnikih odloži poslabšanje bolezni.
English: The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse.
Slovenian: Študija je pokazala, da je bilo zdravilo Stivarga ob sočasni podporni oskrbi učinkovito pri podaljševanju časa preživetja bolnikov brez poslabšanja bolezni.
English: In another main study, Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care.
Slovenian: V drugi glavni študiji so zdravilo Stivarga primerjali s placebom pri 199 bolnikih z gastrointestinalnim stromalnim tumorjem, ki se je razširil ali ga ni bilo mogoče kirurško odstraniti in ki so prejemali tudi najboljšo možno podporno oskrbo.
English: Stivarga is a cancer medicine that contains the active substance regorafenib.
Slovenian: Stivarga je zdravilo proti raku, ki vsebuje zdravilno učinkovino regorafenib.
English: For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov pri uporabi zdravila Stivarga glejte navodilo za uporabo.
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).
Slovenian: Najpogostejši neželeni učinki zdravila Stivarga (ki se lahko pojavijo pri več kot 3 bolnikih od 10) so bolečina, oslabelost, utrujenost, izguba apetita in zmanjšano uživanje hrane, sindrom roka-noga
English: In a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived).
Slovenian: V glavni študiji, v katero je bilo vključenih 760 bolnikov z metastatskim kolorektalnim rakom, ki je napredoval po standardnem zdravljenju, so zdravilo Stivarga primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo skupni čas preživetja (kako dolgo so bolniki živeli).
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.
Slovenian: Pri kolorektalnem raku te zajemajo kemoterapijo na podlagi zdravil, imenovanih fluoropirimidini, in zdravljenja z drugimi zdravili proti raku, imenovanimi terapije proti žilnemu endotelijskemu rastnemu dejavniku (VEGF) in zaviralcem receptorja za epidermalni rastni dejavnik (EGFR).
English: With regard to GIST and HCC, the Committee noted that the outlook is poor for patients whose disease gets worse despite previous treatment.
Slovenian: Kar zadeva gastrointestinalni stromalni tumor in hepatocelularni karcinom, je odbor CHMP poudaril, da so obeti za bolnike, pri katerih se je bolezen poslabšala kljub predhodnemu zdravljenju, slabi.
English: How is Stivarga used?
Slovenian: Kako se zdravilo Stivarga uporablja?
English: However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.
Slovenian: Glede na neželene učinke je odbor CHMP menil, da je pomembno opredeliti skupine bolnikov, pri katerih obstaja večja verjetnost, da se bodo odzvali na zdravilo Stivarga.
English: In a main study involving 573 patients with HCC that had worsened after treatment with sorafenib, Stivarga was compared with placebo and the main measure of effectiveness was overall survival.
Slovenian: V glavni študiji, ki je vključevala 573 bolnikov s hepatocelularnim karcinomom, ki se je poslabšal po zdravljenju s sorafenibom, so zdravilo Stivarga primerjali s placebom, glavno merilo učinkovitosti pa je bil skupni čas preživetja.