FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Tuginedes patogeensete mikroorganismide üha suurenevale resistentsusele (fluoro)kinoloonide suhtes, seosele (fluoro)kinoloonide ja C. difficile põhjustatud kõhulahtisuse vahel, muudele hästi teadaolevate riskidele peale harvaesinevate, ent püsivate ja invaliidistavate kõrvaltoimete riski, on (fluoro)kinoloonide kasulikkuse ja riski suhe reisijate kõhulahtisuse profülaktikas negatiivne.
English: To lift the suspension, the MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of these medicinal products.
Estonian: Müügiloa peatamise lõpetamiseks peab müügiloa hoidja esitama asjakohased teaduslikud tõendid, et tõendada nende ravimite kasulikkuse ja riski positiivset suhet.
English: Indication heading Complicated urinary tract infections/pyelonephritis
Estonian: Näidustuse nimetus Tüsistunud kuseteede infektsioonid / püelonefriit
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.
Estonian: • ravimiohutuse riskihindamise komitee arutas kõiki kinoloonide ja fluorokinoloonide kohta esitatud andmeid pikaajaliste, invaliidistavate ja potentsiaalselt pöördumatute kõrvaltoimete esinemise osas.
English: Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
Estonian: Bronhopulmonaalne infektsioon tsüstilise fibroosi või bronhiektaasiate korral Keskkonnatekkene pneumoonia
English: The overall benefit-risk ratio for this indication for is therefore considered negative.
Estonian: Selle näidustuse üldine kasulikkuse ja riski suhe on seega negatiivne.
English: • Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
Estonian: • Kroonilise obstruktiivse kopsuhaiguse ägenemine Äge bakteriaalne sinusiit
English: To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
Estonian: Müügiloa peatamise lõpetamiseks peab müügiloa hoidja esitama asjakohased teaduslikud tõendid, et tõendada ravimi kasulikkuse ja riski positiivset suhet;
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.
Estonian: Efektiivsusandmete, kehtivate ravijuhiste ja (fluoro)kinoloonide kasutamisega seonduvate teadaolevate riskide, sealhulgas invaliidistavate kõrvaltoimete alusel järeldas ravimiohutuse riskihindamise komitee, et (fluoro)kinoloonide kasulikkuse ja riski suhe on vaginiidi korral negatiivne.
English: However, lack of symptoms relief and risk of complications (specifically pyelonephritis) have been found to be higher in non-antibiotic group.
Estonian: Leiti, et mitteantibiootikumide rühmas puudus sagedamini sümptomite leevenemine ja tüsistuste tekkerisk (konkreetselt püelonefriit) oli suurem.
English: • Acute uncomplicated infection of lower urinary tract (simple cystitis) Acute exacerbation of COPD including chronic bronchitis
Estonian: • Äge tüsistumata alumiste kuseteede infektsioon (tüsistumata tsüstiit) Kroonilise obstruktiivse kopsuhaiguse, sealhulgas kroonilise bronhiidi akuutne ägenemine
English: Urethritis and cervicitis
Estonian: Uretriit ja tservitsiit
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.
Estonian: Võttes arvesse ägeda bronhiidi sagedat viiruslikku etioloogiat, selle enamasti iseparanevat loomust, sagedamate haigust põhjustavate mikroorganismide üha suurenevat resistentsust (fluoro)kinoloonide suhtes ning invaliidistavate kõrvaltoimete esinemise riski, on (fluoro)kinoloonide kasulikkuse ja riski suhe ägeda bronhiidi ravis negatiivne.
English: Malignant external otitis
Estonian: Pahaloomuline väliskõrvapõletik
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.
Estonian: Võttes arvesse pikaajaliste, invaliidistavate ja potentsiaalselt pöördumatute kõrvaltoimete riski, on (fluoro)kinoloonide kasulikkuse ja riski suhe näidustuse „ägenemiste vältimine korduvate kuseteede infektsioonidega naistel“ korral negatiivne.
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.
Estonian: Võttes arvesse larüngiidi peamiselt viiruslikku etioloogiat, selle enamasti iseparanevat loomust, sagedamate haigust põhjustavate mikroorganismide üha suurenevat resistentsust (fluoro)kinoloonide suhtes ning pikaajaliste, invaliidistavate ja potentsiaalselt pöördumatute kõrvaltoimete esinemise riski, on (fluoro)kinoloonide kasulikkuse ja riski suhe larüngiidi ravis negatiivne.
English: • Long term prophylaxis of recurrent urinary infections
Estonian: • Korduvate kuseteede infektsioonide pikaajaline profülaktika
English: Prevention of exacerbations in women with recurring urinary tract infections (UTI)
Estonian: Ägenemiste vältimine korduvate kuseteede infektsioonidega naistel
English: • Pharyngitis
Estonian: • Farüngiit
English: Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone
Estonian: Kroonilise kolesteatomatoosse otiidi ja luukoesse levinud kroonilise otiidi preoperatiivne ettevalmistus
English: • Acute exacerbations of chronic bronchitis
Estonian: • Kroonilise bronhiidi akuutne ägenemine
English: • Simple uncomplicated acute cystitis
Estonian: • Äge tüsistumata tsüstiit
English: • Prevention of systemic urinary tract infections
Estonian: • Süsteemsete kuseteede infektsioonide ennetamine
English: Prophylaxis of travellers´ diarrhoea
Estonian: Reisijate kõhulahtisuse profülaktika
English: Respiratory infections
Estonian: Kõhuõõneinfektsioonid
English: Bone and joint infections
Estonian: Luu- ja liigeseinfektsioonid
English: Indication heading Pharyngitis-Tonsillitis
Estonian: Näidustuse nimetus Farüngiit-tonsilliit
English: Therefore, the benefit risk-balance of this indication is considered negative for pefloxacin.
Estonian: Seepärast peetakse kõnealuse näidustuse kasulikkuse ja riski suhet pefloksatsiini puhul negatiivseks.
English: Therefore, the benefit-risk in using pefloxacin in this indication is negative.
Estonian: Seetõttu on pefloksatsiini kasutamise kasulikkuse ja riski suhe selle näidustuse korral negatiivne.
English: • Prophylaxis of systemic urinary tract infections Prevention of infection in surgical procedures
Estonian: Seedetrakti ja sapiteede infektsioon Infektsiooni ennetamine kirurgiliste protseduuride korral
English: Acute exacerbation of chronic bronchitis (AECB) and COPD
Estonian: Kroonilise bronhiidi ja kroonilise obstruktiivse kopsuhaiguse (KOK) akuutne ägenemine
English: Table 3 - Category 3 indications
Estonian: 3. kategooria näidustused
English: The current role of pefloxacin for the treatment of this indication is considered as not established.
Estonian: Praegu ei saa pefloksatsiini rolli selle näidustuse korral lugeda tõendatuks.
English: Intra-abdominal infections
Estonian: Seedetrakti infektsioonid
English: Tuberculosis
Estonian: Tupeinfektsioonid
English: Table 2 - Category 2 indications
Estonian: 2. kategooria näidustused
English: Chronic sinusitis
Estonian: Krooniline mädane keskkõrvapõletik
English: Whereas,
Estonian: • Äge sinusiit
English: • Intra-abdominal infections
Estonian: • Kõhuõõneinfektsioonid
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Estonian: 90 (3 x 30) tabletti
English: Packaging Content Package size
Estonian: Pakendi sisu Pakendi suurus
English: Name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Estonian: Euroopa Komisjon andis Stivarga müügiloa, mis kehtib kogu Euroopa Liidus, 26. augustil 2013.
English: Stivarga regorafenib
Estonian: Stivarga regorafeniib
English: What measures are being taken to ensure the safe and effective use of Stivarga?
Estonian: Mis meetmed võetakse, et tagada Stivarga ohutu ja efektiivne kasutamine?
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.
Estonian: Euroopa avaliku hindamisaruande täistekst Stivarga kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Stivarga is available as tablets (40 mg).
Estonian: Stivargat turustatakse tablettidena (40 mg).
English: Doses should be taken at the same time each day with a light meal.
Estonian: Annus tuleb võtta iga päev samal kellaajal koos kerge einega.
English: It is used on its own to treat the following cancers:
Estonian: Seda kasutatakse järgmiste vähiliikide ravimiseks:
English: What is Stivarga and what is it used for?
Estonian: Mis on Stivarga ja milleks seda kasutatakse?
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.
Estonian: Euroopa Ravimiamet (EMA) otsustas, et Stivarga kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
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.
Estonian: Ravimit võetakse 4-nädalaste ravitsüklitena, soovitatav algannus on 160 mg (4 tabletti) üks kord ööpäevas kolme nädala vältel; sellele järgneb nädalane paus, mil ravimit ei võeta.
English: Treatment should continue for as long as the patient benefits from treatment or until the side effects become too severe.
Estonian: Ravi jätkatakse, kuni see on patsiendile kasulik või kuni kõrvalnähud muutuvad liiga raskeks.
English: By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.
Estonian: Blokeerides nende ensüümide toimet, aitab Stivarga peatada vähi kasvu ja leviku.
English: What are the risks associated with Stivarga?
Estonian: Mis riskid Stivargaga kaasnevad?
English: All patients also received supportive care, including pain medicines and treatment for infections.
Estonian: Kõik patsiendid said ka toetusravi, sealhulgas valuvaigisteid ning ravi infektsioonide vastu.
English: It is not intended to provide practical advice on how to use Stivarga.
Estonian: Hindamisaruandes ei anta Stivarga kasutamise praktilisi nõuandeid.
English: Other information about Stivarga
Estonian: Muu teave Stivarga kohta
English: Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments.
Estonian: Stivargat kasutatakse patsientidel, kes on juba saanud muud olemasolevat ravi või kellel ei saa muid olemasolevaid raviviise kasutada.
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).
Estonian: Stivarga kõige sagedamad kõrvalnähud (võivad esineda enam kui 3 patsiendil 10st) on valu, nõrkus, väsimus, isutus ja vähem söömine, käe-jala sündroom (peopesade ja jalataldade lööve ja tuimus), kõhulahtisus, infektsioon ja hüpertensioon (kõrge vererõhk).
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.
Estonian: Stivarga ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Why is Stivarga approved?
Estonian: Miks Stivarga heaks kiideti?
English: How is Stivarga used?
Estonian: Kuidas Stivargat kasutatakse?
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.
Estonian: Stivarga turustaja korraldab uuringud, et otsida viise selliste patsientide tuvastamiseks, kellel tekib ravivastus suurema tõenäosusega.
English: Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer.
Estonian: Stivarga-ravi peab määrama vähiravis kogenud arst.
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.
Estonian: Komitee märkis, et kolorektaalvähiga patsientide elumuse pikendamisel oli kasulikkus mõõdukas, kuid leiti, et see ületas riske patsientidel, kelle jaoks muid ravivõimalusi enam ei ole.
English: All patients also received supportive care.
Estonian: Kõik uuringus osalenud patsiendid said ka toetusravi.
English: Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer.
Estonian: Toetusravi oli muu hulgas ravi valuvaigistitega, antibiootikumid ja vereülekanded, mis leevendavad patsiendi seisundit, kuid ei ravi vähki.
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.
Estonian: See tähendab, et regorafeniib blokeerib mitmeid ensüüme, mis on olulised kasvajate verevarustuse arengus ning vähirakkude kasvus ja arengus.
English: For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Estonian: Stivarga piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The side effects of Stivarga are manageable.
Estonian: Stivarga kõrvalnähud on kontrolli all hoitavad.
English: • hepatocellular carcinoma (HCC, a cancer of the liver).
Estonian: • hepatotsellulaarne kartsinoom (HCC, teatud maksavähk).
English: For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Stivarga kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
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.
Estonian: Kõige raskemad kõrvalnähud on raske maksakahjustus, verejooks, seedetrakti perforatsioon (sooleseina mulgustumine) ja infektsioon.
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.
Estonian: Arvestades siiski kõrvalnähte, pidas inimravimite komitee oluliseks leida viisid, kuidas teha kindlaks kõik patsiendirühmad, kellel tekib ravivastus suurema tõenäosusega.
English: This is a summary of the European public assessment report (EPAR) for Stivarga.
Estonian: See on ravimi Stivarga Euroopa avaliku hindamisaruande kokkuvõte.
English: For more information about treatment with Stivarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Stivargaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Stivarga is a cancer medicine that contains the active substance regorafenib.
Estonian: Stivarga on vähiravim, mis sisaldab toimeainena regorafeniibi.
English: • gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;
Estonian: • gastrointestinaalne stromaaltuumor (GIST, teatud mao- ja soolevähk), mis on metastaatiline (siiretega) või mida ei saa kirurgiliselt eemaldada;
English: With regard to GIST and HCC, the Committee noted that the outlook is poor for patients whose disease gets worse despite previous treatment.
Estonian: Seoses gastrointestinaalse stromaaltuumoriga ja hepatotsellulaarse kartsinoomiga märkis inimravimite komitee, et prognoos on halb patsientidel, kelle haigus süveneb hoolimata varasemast ravist.
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.
Estonian: Kolorektaalvähi korral on sellised raviviisid fluoropürimidiinidele tuginev keemiaravi ning ravi VEGF- ja EGFR-ravimitega (samuti vähiravimid).
English: The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse.
Estonian: Uuring tõendas, et Stivarga koos toetusraviga oli efektiivne progresseerumiseta elumuse pikendamisel (ajavahemik, mil patsiendid elasid haiguse süvenemiseta).
English: Stivarga had been shown to delay the worsening of the disease in these patients.
Estonian: Neil patsientidel tõendati, et Stivarga lükkab haiguse süvenemise edasi.
English: What benefits of Stivarga have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Stivarga kasulikkus?
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).
Estonian: Põhiuuringus, milles osales 760 patsienti, kelle metastaatiline kolorektaalvähk oli pärast standardravi progresseerunud, võrreldi Stivargat platseeboga (näiv ravim) ja efektiivsuse põhinäitaja oli üldine elumus.
English: • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
Estonian: • metastaatiline kolorektaalvähk (soole- ja pärasoolevähk, mis on levinud organismis ka mujale);
English: The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
Estonian: Uuring tõendas, et Stivarga pikendas patsientide üldist elumust - Stivargat saanud patsiendid elasid keskmiselt 10,6 kuud ja platseebot saanud patsiendid 7,8 kuud.
English: Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.
Estonian: Enne Stivarga-ravi alustamist peab gastrointestinaalse stromaaltuumoriga patsientidel olema proovitud imatiniib- ja sunitiniibravi ning hepatotsellulaarse kartsinoomiga patsientidel sorafeniibravi.
English: The active substance in Stivarga, regorafenib, is a ‘protein kinase inhibitor'.
Estonian: Stivarga toimeaine regorafeniib on proteiinkinaasiinhibiitor.
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.
Estonian: Stivargaga ravitud patsientide progresseerumiseta elumus oli keskmiselt 4,8 kuud ning platseebot ja toetusravi saanud patsientidel 0,9 kuud.
English: Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects.
Estonian: Teatud kõrvalnähtude esinemisel võib olla vaja ravi katkestada või lõpetada või annust vähendada.
English: The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.
Estonian: Uuringus selgus, et Stivarga parandas elumust: ravi saanud patsiendid elasid keskmiselt 6,4 kuud ja platseebot saanud patsiendid 5 kuud.
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.
Estonian: Põhiuuringus 573 patsiendiga, kelle hepatotsellulaarne kartsinoom oli pärast sorafeniibravi progresseerunud, võrreldi Stivargat platseeboga ja efektiivsuse põhinäitaja oli üldine elumus.
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.
Estonian: Teises põhiuuringus võrreldi Stivargat platseeboga 199-l toetusravi saanud patsiendil, kelle gastrointestinaalne stromaaltuumor oli siiretega või seda ei saanud kirurgiliselt eemaldada.
English: The medicine can only be obtained with a prescription.
Estonian: Stivarga on retseptiravim.
English: For patients with HCC, this led to an improvement in the length of time patients lived.
Estonian: Hepatotsellulaarse kartsinoomiga patsientidel parandas see elumust.
English: How does Stivarga work?
Estonian: Kuidas Stivarga toimib?
English: This will help protect them against leptospirosis.
Estonian: See aitab kaitsta looma leptospiroosi eest.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014.
Estonian: Euroopa Komisjon andis vaktsiini Versican Plus L4 müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 31. juulil 2014.
English: The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs.
Estonian: Vaktsiini Versican Plus L4 efektiivsust uuriti väliuuringus, kus osales 129 koera.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et heakskiidetud näidustustel on vaktsiini Versican Plus L4 kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini Versican Plus L4 müügiloa.
English: The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later.
Estonian: Vaktsiini süstitakse kutsikatele naha alla alates 6 nädala vanusest ja veel üks kord 3...4 nädalat hiljem.
English: Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Estonian: Versican Plus L4 on veterinaarvaktsiin, mis sisaldab Leptospira bakterite inaktiveeritud (hävitatud) tüvesid (Icterohaemorrhagiae, Canicola, Bratislava ja Grippotyphosa).
English: For revaccination a single dose of Versican Plus L4 is required annually.
Estonian: Kordusvaktsineerimiseks tuleb manustada üks annus vaktsiini Versican Plus L4 üks kord aastas.
English: the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad Leptospira bakteritega hiljem uuesti kokku, tekivad antikehad kiiremini.