FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Avastin 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 Avastin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated.
Slovenian: Odmerek zdravila znaša med 5 in 15 mg na kilogram telesne mase vsaka dva do tri tedne, odvisno od vrste raka, ki se zdravi.
English: This is a summary of the European public assessment report (EPAR) for Avastin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Avastin.
English: The first infusion of Avastin should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Slovenian: Prva infuzija zdravila Avastin naj traja 90 minut, poznejše infuzije pa so lahko krajše, če je bolnik prvo infuzijo dobro prenesel.
English: In all of the studies, the main measure of effectiveness was either overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti bodisi skupni čas preživetja (kako dolgo je bolnik živel) bodisi čas preživetja brez napredovanja bolezni (kako dolgo je bolnik živel, ne da bi se bolezen poslabšala).
English: The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan.
Slovenian: V tretjo študijo je bilo vključenih 829 bolnikov, pri katerih predhodno zdravljenje, ki je vključevalo fluoropirimidin in irinotekan, ni bilo uspešno.
English: The CHMP decided that Avastin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila Avastin večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Other information about Avastin
Slovenian: Druge informacije o zdravilu Avastin
English: Several studies have shown that Avastin is effective at treating the types of cancers for which it is approved.
Slovenian: Več študij je pokazalo, da je zdravilo Avastin učinkovito pri zdravljenju vrst raka, za katere je odobreno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avastin have 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 Avastin upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Slovenian: Zaradi tega se rakave celice ne morejo več oskrbovati s krvjo ter dobivajo premalo kisika in hranil, kar pripomore k upočasnjeni rasti tumorjev.
English: • advanced or metastatic kidney cancer, in combination with interferon alfa-2a;
Slovenian: • napredovalega ali metastatskega raka ledvic v kombinaciji z interferonom alfa-2a;
English: For more information about treatment with Avastin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Avastin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Avastin have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Avastin izkazalo v študijah?
English: • advanced non-small cell lung cancer in patients whose cancer cells are not mainly of the squamous type, where it is given with platinum-based chemotherapy;
Slovenian: • napredovalega nedrobnoceličnega pljučnega raka pri bolnikih, katerih rakave celice večinoma niso skvamoznega tipa, kadar se daje s kemoterapijo na osnovi platine;
English: What is Avastin and what is it used for?
Slovenian: Kaj je zdravilo Avastin in za kaj se uporablja?
English: • metastatic breast cancer, in combination with paclitaxel or capecitabine;
Slovenian: • metastatskega raka dojke v kombinaciji s paklitakselom ali kapecitabinom;
English: For the full list of all side effects reported with Avastin, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Avastin, glejte navodilo za uporabo.
English: Avastin must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Slovenian: Zdravila Avastin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bevacizumab ali katero koli drugo sestavino zdravila, na pripravke iz celic jajčnika kitajskih hrčkov ali druga rekombinantna protitelesa.
English: It is not intended to provide practical advice on how to use Avastin.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Slovenian: Zdravilna učinkovina v zdravilu Avastin, bevacizumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano tako, da prepozna in se veže na endotelijski rastni faktor v žilah (VEGF), tj. beljakovino, ki kroži po krvi in omogoča rast krvnih žil.
English: What is the risk associated with Avastin?
Slovenian: Kakšna tveganja so povezana z zdravilom Avastin?
English: For practical information about using Avastin, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Avastin naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Why has Avastin been approved?
Slovenian: Zakaj je bilo zdravilo Avastin odobreno?
English: Avastin is used in combination with certain chemotherapy medicines in newly diagnosed patients when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent).
Slovenian: Zdravilo Avastin se uporablja v kombinaciji z nekaterimi zdravili za kemoterapijo pri bolnikih z novo postavljeno diagnozo, če je bolezen napredovala, in pri predhodno zdravljenih bolnikih, pri katerih se je rak ponovil (ponavljajoči se rak).
English: • cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a ‘fluoropyrimidine';
Slovenian: • raka kolona (debelega črevesa) ali danke, ki je metastaziral (se je razširil v druge predele telesa), v kombinaciji z zdravili za kemoterapijo, ki vključujejo „fluoropirimidin“;
English: Avastin is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Avastin je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Avastin can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer treatments.
Slovenian: Predpisovanje in izdaja zdravila Avastin je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem raka.
English: The first two studies included patients whose cancer came back 6 months or more after previous treatment (‘platinum-sensitive disease'), while the third study was in patients with more aggressive cancer that had come back within 6 months of previous treatment (‘platinum-resistant disease').
Slovenian: V prvo študijo so vključili bolnike, pri katerih se je rak ponovno pojavil šest ali več mesecev po predhodnem zdravljenju („bolezen, občutljiva za platino“), v drugi študiji pa so sodelovali bolniki z agresivnejšo obliko raka, ki se je ponovno pojavil v šestih mesecih po predhodnem zdravljenju („bolezen, odporna proti platini“).
English: Avastin is given in combination with paclitaxel and either the platinum-based medicine cisplatin or, if this cannot be used, another chemotherapy medicine, topotecan.
Slovenian: Zdravilo Avastin se daje v kombinaciji s paklitakselom in bodisi zdravilom s cisplatinom na osnovi platine bodisi, če to ni mogoče, drugim zdravilom, ki se uporablja pri kemoterapiji, topotekanom.
English: The most common side effects with Avastin are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Slovenian: Najpogostejši neželeni učinki zdravila Avastin so hipertenzija (povišan krvni tlak), utrujenost ali astenija (šibkost), driska in bolečine v trebuhu.
English: When the type of chemotherapy was taken into account, there was a tendency for patients given cisplatin-based treatment to live on average about 2 months longer than those given topotecan-based treatment, independently of giving Avastin as part of the treatment regimens.
Slovenian: Če se je upoštevala tudi vrsta kemoterapije, so bolnice, ki so prejemale zdravljenje na osnovi cisplatina, običajno živele približno dva meseca dlje od tistih, ki so prejemale zdravljenje na osnovi topotekana, ne glede na to, ali so kot del zdravljenja prejemale tudi zdravilo Avastin.
English: Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:
Slovenian: Zdravilo Avastin se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka za zdravljenje naslednjih vrst raka pri odraslih:
English: • Recurrent disease: three studies with Avastin in recurrent ovarian, fallopian tube and peritoneal cancers were performed in a total of 1,518 patients.
Slovenian: • Ponavljajoča se bolezen: pri ponavljajočem se raku jajčnikov, jajcevodov in potrebušnice so bile z zdravilom Avastin opravljene tri študije s 1 518 bolniki.
English: • advanced non-small cell lung cancer in patients whose cancer cells have a certain change (‘activating mutations') in the gene for a protein called EGFR, where it is given in combination with erlotinib;
Slovenian: • napredovalega nedrobnoceličnega pljučnega raka pri bolnikih, pri katerih se na rakavih celicah pojavljajo spremembe (aktivirajoče mutacije) na genu za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR), ki se daje v kombinaciji z erlotinibom;
English: Overall survival was 12.9 months in patients adding Avastin and 10.8 months in those receiving chemotherapy alone.
Slovenian: Skupni čas preživetja je pri bolnikih, ki so jim dodajali zdravilo Avastin, znašal 12,9 meseca in 10,8 meseca pri tistih, ki so prejemali samo kemoterapijo.
English: In the second study, overall survival in patients given Avastin in combination with carboplatin and paclitaxel was 42.6 months, compared with 37.3 months in patients treated with carboplatin and paclitaxel only.
Slovenian: V drugi študiji je bil čas skupnega preživetja pri bolnikih, ki so prejemali zdravilo Avastin, 42,6 meseca, v primerjavi s 37,3 meseca pri bolnikih, zdravljenih samo s karboplatinom in paklitakselom.
English: In the first study, average progression-free survival was 12.4 months when Avastin was added to carboplatin and gemcitabine, compared with 8.4 months when placebo was added.
Slovenian: V prvi študiji je povprečni čas preživetja brez napredovanja bolezni znašal 12,4 meseca, ko je bilo zdravilo Avastin dodano karboplatinu in gemcitabinu, v primerjavi z 8,4 meseca, ko je bil dodan placebo.
English: The study compared the effect of adding Avastin to chemotherapy using paclitaxel plus cisplatin or topotecan to results in patients given chemotherapy alone.
Slovenian: V študiji so učinek dodajanja zdravila Avastin h kemoterapiji z uporabo paklitaksela in cisplatina ali topotekana primerjali z rezultati pri bolnicah, ki so prejemale samo kemoterapijo.
English: The first two studies involved patients whose metastatic disease was being treated for the first time (‘first-line' treatment): in the first study (923 patients),the average overall survival was 20.3 months in patients adding Avastin and 15.6 months in those receiving chemotherapy alone; in the second study in 1,401 patients, progression-free survival was 9.4 months in patients adding Avastin and 8.0 months in those receiving chemotherapy alone.
Slovenian: Prvi dve študiji sta vključevali bolnike, pri katerih so metastatsko bolezen zdravili prvič (zdravljenje prve izbire): v prvi študiji (923 bolnikov) je bil povprečni čas skupnega preživetja pri bolnikih, dodatno zdravljenih z zdravilom Avastin, 20,3 meseca, pri bolnikih, ki so prejemali samo kemoterapijo, pa 15,6 meseca; v drugi študiji (1401 bolnik) je bil čas preživetja brez napredovanja pri dodajanju zdravila Avastin 9,4 meseca, pri bolnikih, ki so prejemali samo kemoterapijo, pa 8,0 meseca.
English: • In advanced, metastatic or recurrent lung cancer, Avastin plus platinum-based chemotherapy has been shown to increase overall survival in one study in 878 patients: the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.
Slovenian: • Pri napredovalem, metastatskem ali ponavljajočem se pljučnem raku se je v eni glavni študiji z 878 bolniki pokazalo, da zdravilo Avastin s kemoterapijo na osnovi platine podaljšuje čas skupnega preživetja: povprečni skupni čas preživetja je pri bolnikih, ki so prejemali zdravilo Avastin s kemoterapijo na osnovi platine, znašal 12,3 meseca in 10,3 meseca pri bolnikih, ki so prejemali samo kemoterapijo.
English: In the third study in patients with more aggressive cancer, progression-free survival was 6.7 months when Avastin was added to paclitaxel, topotecan, or pegylated liposomal doxorubicin, compared with 3.4 months when these chemotherapies were used on their own.
Slovenian: V študiji, v kateri so sodelovali bolniki z agresivnejšo obliko raka, je čas preživetja brez napredovanja bolezni znašal 6,7 meseca, kadar so paklitakselu, topotekanu in pegiliranemu liposomskemu doksorubicinu dodajali zdravilo Avastin, in 3,4 meseca, kadar so se ta zdravila za kemoterapijo uporabljala samostojno.
English: In advanced or metastatic kidney cancer, Avastin plus interferon alfa-2a has been shown to increase progression-free survival in one study in 649 patients: the average progression-free survival was 10.2 months in the patients receiving Avastin plus interferon alfa-2a and 5.4 months in those receiving interferon alfa-2a.
Slovenian: Pri napredovalem ali metastatskem raku ledvic se je v eni študiji s 649 bolniki pokazalo, da zdravilo Avastin v kombinaciji z interferonom alfa-2a podaljšuje preživetje brez napredovanja bolezni: pri bolnikih, ki so prejemali zdravilo Avastin in interferon alfa-2a, je čas preživetja brez napredovanja bolezni znašal 10,2 meseca, pri bolnikih, ki so prejemali interferon alfa-2a pa 5,4 meseca.
English: In metastatic breast cancer, Avastin has been shown to increase progression-free survival in two main studies.
Slovenian: Pri metastatskem raku dojke se je v dveh glavnih študijah pokazalo, da zdravilo Avastin podaljšuje čas preživetja brez napredovanja bolezni.
English: How is Avastin used?
Slovenian: Kako se zdravilo Avastin uporablja?
English: • epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen).
Slovenian: • epitelijskega raka jajčnikov, raka jajcevodov (ki povezujejo jajčnike z maternico) ali potrebušnice (mrene v trebušni votlini).
English: • cancer of the cervix (the neck of the womb) that is persistent, recurrent or metastatic.
Slovenian: • raka materničnega vratu, ki je kroničen, se ponavlja ali pa je metastaziral.
English: In the first study (722 patients), progression-free survival was 11.4 months in patients receiving Avastin with paclitaxel, compared with 5.8 months in those receiving paclitaxel alone.
Slovenian: V prvi študiji (722 bolnikov) je pri bolnikih, ki so prejemali zdravilo Avastin s paklitakselom, čas preživetja znašal 11,4 meseca, v primerjavi s 5,8 meseca pri tistih, ki so prejemali samo paklitaksel.
English: • Newly diagnosed disease (including advanced disease, first-line treatment): in newly diagnosed ovarian, fallopian tube and peritoneal cancer, Avastin, in combination with carboplatin and paclitaxel, has been shown to increase progression-free survival in two main studies involving 3,401 patients: the average progression-free survival was 19.3 months in patients adding Avastin versus 16.9 months with carboplatin and paclitaxel alone in one study, and 14.7 months versus 10.6 months in the second study.
Slovenian: • Novoodkrita bolezen (vključno z napredovalo boleznijo, zdravljenje prve izbire): pri novoodkritem raku jajčnikov, jajcevodov in potrebušnice se je v dveh glavnih študijah s 3 401 bolnikom pokazalo, da zdravilo Avastin v kombinaciji s karboplatinom in paklitakselom podaljšuje čas preživetja brez napredovanja bolezni: povprečni čas preživetja brez napredovanja bolezni je pri bolnikih, pri katerih je bilo dodano zdravilo Avastin, v eni študiji znašal 19,3 meseca, v primerjavi z bolniki, zdravljenimi samo s karboplatinom in paklitakselom, pri katerih je znašal 16,9 meseca, v drugi študiji pa je bil ta čas 14,7 meseca oziroma 10,6 meseca.
English: In the second study (1,237 patients), when Avastin was added to capecitabine, the average progression-free survival was 8.6 months, compared with 5.7 months in those receiving capecitabine with placebo.
Slovenian: V drugi študiji (1 237 bolnikov) je povprečni čas brez napredovanja bolezni, ko je bilo zdravilo Avastin dodano kapecitabinu, znašal 8,6 meseca, v primerjavi s 5,7 meseca pri tistih, ki so prejemali kapecitabin s placebom.
English: How does Avastin work?
Slovenian: Kako zdravilo Avastin deluje?
English: • In patients with a certain subtype of non-small cell lung cancer with activating mutations in the EGFR gene, Avastin plus erlotinib has been shown to increase progression-free survival in one study in 152 patients: patients on Avastin plus erlotinib had progression-free survival of 16.0 months on average compared with 9.7 months in patients given erlotinib alone.
Slovenian: • Pri bolnikih z določeno podvrsto nedrobnoceličnega pljučnega raka z aktivirajočimi mutacijami v genu za EGFR se je v eni študiji s 152 bolniki pokazalo, da zdravilo Avastin v kombinaciji z erlotinibom podaljšuje čas preživetja brez napredovanja bolezni: pri bolnikih, zdravljenih s kombinacijo zdravila Avastin in erlotiniba, je povprečni čas preživetja brez napredovanja bolezni znašal 16,0 meseca, v primerjavi z 9,7 meseca pri bolnikih, ki so prejemali samo erlotinib.
English: Results showed that the average overall survival was 16.8 months with chemotherapy including Avastin compared with 12.9 months on chemotherapy alone.
Slovenian: Pri raku materničnega vratu je znašal povprečni skupni čas preživetja 16,8 meseca pri kemoterapiji, ki je vključevala tudi zdravilo Avastin, v primerjavi z 12,9 meseca pri kemoterapiji, ki se je uporabljala samostojno.
English: Avastin contains the active substance bevacizumab.
Slovenian: Zdravilo Avastin vsebuje zdravilno učinkovino bevacizumab.
English: In metastatic cancer of the colon or rectum, Avastin used with chemotherapy including a fluoropyrimidine has been shown to increase overall and progression-free survival in three main studies.
Slovenian: V treh glavnih študijah se je pokazalo, da pri metastatskem raku debelega črevesa ali danke zdravilo Avastin v kombinaciji s kemoterapijo, ki vključuje fluoropirimidin, podaljšuje čas skupnega preživetja in čas preživetja brez napredovanja bolezni.
English: In cancer of the cervix, Avastin has been shown to increase overall survival in one main study involving 452 patients with advanced persistent, recurrent or metastatic cancer of the cervix.
Slovenian: Pri raku materničnega vratu se je v eni glavni študiji s 452 bolnicami z napredovalim kroničnim, ponavljajočim se ali metastatskim rakom materničnega vratu pokazalo, da podaljšuje skupni čas preživetja.
English: Cancer of the colon or rectum
Slovenian: Rak debelega črevesa ali danke
English: By attaching to VEGF, Avastin stops it having an effect.
Slovenian: Zdravilo Avastin z vezavo na endotelijski rastni faktor v žilah zaustavi njegovo delovanje.
English: Ovarian, fallopian tube and peritoneal cancer
Slovenian: Rak jajčnikov, jajcevodov in potrebušnice
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Generics on 9 January 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tadalafil Generics, veljavno po vsej Evropski uniji, izdala 9. januarja 2017.
English: What measures are being taken to ensure the safe and effective use of Talmanco?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Talmanco?
English: Previously known as Tadalafil Generics.
Slovenian: Prej znano kot Tadalafil Generics.
English: The full EPAR for Talmanco 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 Talmanco je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee recommended that Talmanco be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Talmanco odobri za uporabo v EU.
English: As for every medicine, the company provided studies on the quality of Talmanco.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Talmanco.
English: Other information about Talmanco
Slovenian: Druge informacije o zdravilu Talmanco
English: Talmanco is not recommended for patients with severe kidney or liver problems.
Slovenian: Zdravilo Talmanco ni priporočeno za bolnike z resnimi težavami z ledvicami ali jetri.
English: Because Talmanco is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Talmanco generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Talmanco.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Talmanco.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Talmanco has been shown to have comparable quality and to be bioequivalent to Adcirca.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Talmanco primerljivo raven kakovosti kot zdravilo Adcirca ter da mu je biološko enakovredno.
English: What are the benefits and risks of Talmanco?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Talmanco?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Adcirca, and do not need to be repeated for Talmanco.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Adcirca, zato jih ni treba ponoviti za zdravilo Talmanco.
English: The name of the medicine was changed to Talmanco on 1 March
Slovenian: Ime zdravila je bilo 1. marca 2017 spremenjeno v Talmanco.
English: This means that Talmanco contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adcirca.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Adcirca, ki je že odobreno v Evropski uniji (EU).