FrancophonIA/ELRC3.0 huggingface dataset:
English: Soliris is also used to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a disease where the immune system damages nerve cells causing problems mostly with the optic (eye) nerve and the spinal cord.
Slovenian: Zdravilo Soliris se uporablja tudi za zdravljenje odraslih s specifično obliko nevromielitisa vidnega živca (NMOSD), tj. boleznijo, pri kateri imunski sistem poškoduje živčne celice, kar povzroča težave predvsem z vidnim (očesnim) živcem in hrbtenjačo.
English: Because of the increased risk of developing meningococcal sepsis, Soliris must not be given to people who have an infection caused by Neisseria meningitides; it must also not be given to patients who have not been vaccinated against this bacterium, unless they have the vaccination and take appropriate antibiotics to reduce the risk of infection for two weeks after vaccination.
Slovenian: Prav tako se ne sme dajati bolnikom, ki niso bili cepljeni proti tej bakteriji, razen če se cepijo in dva tedna po cepljenju jemljejo ustrezne antibiotike za znižanje tveganja okužbe.
English: Soliris led to a reduction of 4.7 points on the scale whereas placebo led to 2.8 point reduction after 26 weeks.
Slovenian: Po 26 tednih je znižanje na lestvici pri zdravljenju z zdravilom Soliris znašalo 4,7 točke, s placebom pa 2,8 točke.
English: Six out of seven patients did not need any transfusion of red blood cells, and haemoglobin levels improved during 12 weeks of treatment with Soliris.
Slovenian: Šest od sedmih bolnikov med 12-tedenskim zdravljenjem z zdravilom Soliris ni potrebovalo nobene transfuzije rdečih krvnih celic, raven hemoglobina pa se je izboljšala.
English: How is Soliris used?
Slovenian: Kako se zdravilo Soliris uporablja?
English: In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients' own cells.
Slovenian: Pri bolnikih s paroksizmalno nočno hemoglobinurijo, atipičnim hemolitično-uremičnim sindromom, miastenijo gravis in specifično obliko nevromielitisa vidnega živca so beljakovine komplementa preveč dejavne, kar škoduje bolnikovim lastnim celicam.
English: For myasthenia gravis, Soliris was compared with placebo in one main study involving 126 adults with myasthenia gravis who had previously received standard treatment which had failed.
Slovenian: Pri miasteniji gravis so zdravilo Soliris primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 126 odraslih z miastenijo gravis, ki so bili prej zdravljeni standardno, a zdravljenje ni bilo uspešno.
English: For PNH, Soliris was compared with placebo (a dummy treatment) in one main study involving 87 adults with PNH who had had at least four blood transfusions for anaemia in the previous year.
Slovenian: Pri paroksizmalni nočni hemoglobinuriji so zdravilo Soliris primerjali s placebom (zdravilom brez učinkovine) v eni glavni študiji, v katero je bilo vključenih 87 odraslih s paroksizmalno nočno hemoglobinurijo, ki so v preteklem letu zaradi slabokrvnosti prejeli najmanj štiri transfuzije krvi.
English: Treatment with Soliris increased platelet counts in 82% of the patients, and platelet counts rose to normal levels in 87% (13 out of 15 patients) who had low platelet counts at the start.
Slovenian: Zaradi zdravljenja z zdravilom Soliris je število trombocitov naraslo pri 82 % bolnikov, na normalne ravni pa je naraslo pri 87 % (13 od 15 bolnikov) bolnikov, ki so imeli na začetku nizke ravni trombocitov.
English: Treatment increased platelet counts to normal levels in 83% of the patients, while the platelet count rose to normal levels in 77% (10 out of 13 patients) who initially had low platelet counts.
Slovenian: Zaradi zdravljenja je število trombocitov naraslo na normalne ravni pri 83 % bolnikov, pri tistih, ki so imeli na začetku nizke ravni trombocitov, pa je na normalne ravni naraslo pri 77 % (10 od 13 bolnikov) bolnikov.
English: Soliris contains the active substance eculizumab.
Slovenian: Zdravilo Soliris vsebuje učinkovino ekulizumab.
English: How does Soliris work?
Slovenian: Kako zdravilo Soliris deluje?
English: For NMOSD, Soliris was compared with placebo in one main study involving 143 adults with NMOSD whose disease was relapsing.
Slovenian: Pri specifični obliki nevromielitisa vidnega živca so zdravilo Soliris primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 143 odraslih s specifično obliko nevromielitisa vidnega živca, pri katerih je bila bolezen recidivna.
English: In patients with PNH, the breakdown of red blood cells leads to a reduction in haemoglobin levels.
Slovenian: Pri bolnikih s paroksizmalno nočno hemoglobinurijo se je z razgradnjo rdečih krvnih celic raven hemoglobina zmanjšala.
English: Levels of LDH rise as breakdown of red blood cells increases.
Slovenian: Če rdeče krvne celice hitreje razpadajo, se ravni LDH zvišajo.
English: It is available in three forms:
Slovenian: Na voljo je v treh oblikah:
English: This summary was last updated in 01-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 01-2016.
English: PCV-1 is not known to cause any disease.
Slovenian: Za PCV-1 ni znano, da bi povzročal bolezen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix on 21 February 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rotarix, veljavno po vsej Evropski uniji, izdala 21. februarja 2006.
English: The virus is alive, but it has been weakened so that it does not cause the disease, which makes it suitable for use in a vaccine.
Slovenian: Virus je živ, vendar oslabljen, tako da ne povzroči bolezni, zato je primeren za uporabo v cepivu.
English: The full EPAR for Rotarix 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 Rotarix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European Public Assessment Report (EPAR) for Rotarix.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rotarix.
English: What measures are being taken to ensure the safe and effective use of Rotarix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rotarix?
English: • an oral suspension in a squeezable tube.
Slovenian: • kot peroralna suspenzija v iztisljivi tubi.
English: Other information about Rotarix:
Slovenian: Druge informacije o zdravilu Rotarix:
English: Rotarix should never be injected under any circumstances.
Slovenian: Cepivo Rotarix se pod nobenim pogojem ne sme injicirati.
English: Rotarix can be given at the same time as other vaccines.
Slovenian: Cepivo Rotarix se lahko daje sočasno z drugimi cepivi.
English: In addition, the company that markets Rotarix is developing a vaccine free of porcine circovirus type 1 (PCV-1) after a very small amount of viral particles was found in the vaccine in 2010.
Slovenian: Poleg tega družba, ki trži cepivo Rotarix, razvija cepivo, ki ne bo vsebovalo prašičjega cirkovirusa tipa 1 (PCV-1), po tem ko je bila v cepivu iz leta 2010 najdena zelo mala količina virusnih delcev.
English: For more information about treatment with Rotarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rotarix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The vaccine can only be obtained with a prescription.
Slovenian: Izdaja cepiva je le na recept.
English: Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Slovenian: Cepivo Rotarix vsebuje živo atenuirano (oslabljeno) obliko humanega rotavirusa (sev RIX4414).
English: Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide.
Slovenian: Klinične študije cepiva Rotarix so skupaj zajele prek 75 000 dojenčkov in so potekale v različnih državah po vsem svetu.
English: A risk management plan has been developed to ensure that Rotarix is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Rotarix je bil pripravljen načrt obvladovanja tveganj.
English: The same vaccination course can be used in babies born up to 13 weeks prematurely (from 27 weeks gestational age).
Slovenian: Enaka shema se lahko uporabi pri dojenčkih, ki so se rodili največ 13 tednov prezgodaj (po 27. tednu gestacijske starosti).
English: The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability.
Slovenian: Najpogostejša neželena učinka cepiva Rotarix (opažena pri 1 do 10 bolnikih od 100) sta driska in razdražljivost.
English: Rotarix rotavirus vaccine, live
Slovenian: Rotarix cepivo proti rotavirusu, živo
English: It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception.
Slovenian: Ne sme se uporabljati pri bolnikih z obolenji, ki povzročajo resne nepravilnosti imunskega sistema, imenovane „huda kombinirana imunodeficienca“, ki so v preteklosti imeli invaginacijo ali ki imajo težave s črevesjem, zaradi česar obstaja nevarnost za invaginacijo.
English: The first dose is given when the baby is older than six weeks.
Slovenian: Prvi odmerek dojenček prejme po šestem tednu starosti.
English: This helps to protect against gastroenteritis caused by rotavirus.
Slovenian: To pomaga pri zaščiti pred gastroenteritisom, ki ga povzroča rotavirus.
English: What benefit has Rotarix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Rotarix izkazalo med študijami?
English: These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Slovenian: Te rezultate so primerjali z ugotovitvami študije pri polno donošenih dojenčkih, ki so bili cepljeni s cepivom Rotarix.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rotarix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Slovenian: Cepivo Rotarix se uporablja pri dojenčkih, starih od 6 do 24 tednov, za zaščito pred gastroenteritisom (drisko in bruhanjem), ki ga povzroča okužba z rotavirusi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rotarix, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Rotarix must not be used in babies who are hypersensitive (allergic) to any of the ingredients of the vaccine or those who showed signs of allergy after receiving a dose of rotavirus vaccine in the past.
Slovenian: Cepivo Rotarix se ne sme uporabiti pri dojenčkih, ki so preobčutljivi za (alergični na) katero koli sestavino zdravila, ali dojenčkih, ki so v preteklosti kazali znake alergije po prejemu odmerka cepiva proti rotavirusom.
English: In the main study, the number of cases of severe rotavirus gastroenteritis was lower following vaccination with Rotarix: 0.1% of the babies vaccinated with Rotarix in whom effectiveness was assessed developed severe rotavirus gastroenteritis (12 out of over 9,000) compared with 0.9% of the babies who received placebo (77 out of almost 9,000).
Slovenian: V glavni študiji je bilo število primerov hudega rotavirusnega gastroenteritisa po cepljenju s cepivom Rotarix manjše: hud rotavirusni gastroenteritis se je razvil pri 0,1 % (12 od več kot 9 000) dojenčkov, cepljenih s cepivom Rotarix, pri katerih so ugotavljali učinkovitost cepiva, v primerjavi z 0,9 % (77 od skupno 9 000)dojenčkov, ki so prejeli placebo.
English: If the ready-made oral suspension is used, the contents of the prefilled oral applicator or tube should be given into the mouth of the baby.
Slovenian: Če se za cepljenje uporablja že pripravljena peroralna suspenzija, je treba vsebino predhodno napolnjenega peroralnega aplikatorja ali tube dati v dojenčkova usta.
English: If the powder and solvent are used, they should be mixed together just before the vaccine is given, and the resulting suspension given directly into the mouth of the baby using the oral applicator provided.
Slovenian: Če se za cepljenje uporabljata prašek in vehikel, ju je treba zmešati tik pred cepljenjem, tako dobljeno suspenzijo pa je treba dojenčku dati neposredno v usta s pomočjo priloženega peroralnega aplikatorja.
English: A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
Slovenian: V dodatni študiji so proučevali varnost cepiva Rotarix ter njegovo sposobnost spodbujanja tvorbe protiteles pri 1 009 dojenčkih, rojenih največ 13 tednov prezgodaj.
English: Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Slovenian: Cepivo Rotarix vsebuje majhno količino rotavirusa, tj. virusa, ki povzroča gastroenteritis.
English: The CHMP decided that Rotarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Rotarix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
Slovenian: V štirih dodatnih študijah, v katerih je sodelovalo več kot 3 000 dojenčkov, so ugotavljali, ali so formulacije cepiva, ki so že pripravljene za uporabo, enako varne in učinkovite pri stimulaciji tvorbe protiteles proti rotavirusom kot formulacija, ki zajema prašek in vehikel.
English: Vaccination with Rotarix should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Slovenian: Cepljenje s cepivom Rotarix je treba preložiti pri dojenčkih, ki imajo nenadno povišano telesno temperaturo, drisko ali bruhajo.
English: Rotarix is given as two doses, at least four weeks apart.
Slovenian: Cepivo Rotarix se daje v dveh odmerkih, med katerima mora biti najmanj štiritedenski premor.
English: The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
Slovenian: V glavni študiji so cepivo Rotarix primerjali s placebom (cepivom brez zdravilne učinkovine) pri več kot 63 000 polno donošenih dojenčkih (rojenih po 36. tednu nosečnosti).
English: • an oral suspension in a prefilled oral applicator;
Slovenian: • kot peroralna suspenzija v predhodno napolnjenem peroralnem aplikatorju;
English: The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
Slovenian: Koristnost cepiva so merili na podlagi števila dojenčkov, pri katerih se je v obdobju po cepljenju in pred dopolnjenim enim letom starosti razvil hud rotavirusni gastroenteritis.
English: What is the risk associated with Rotarix?
Slovenian: Kakšna tveganja so povezana z zdravilom Rotarix?
English: When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Slovenian: Ko dojenček prejme cepivo, imunski sistem (sistem, ki se bori proti boleznim) prepozna oslabljeni virus kot „tujek“ in proti njemu začne tvoriti protitelesa.
English: For the full list of all side effects reported with Rotarix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Rotarix, glejte navodilo za uporabo.
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Slovenian: Zelo redko (pri manj kot 1 bolniku od 10 000) so po uporabi cepiv proti rotavirusom poročali o resnem neželenem učinku, imenovanem invaginacija (pri katerem se del črevesja uviha v drug del črevesja, kar povzroči zaporo).
English: Ideally, both doses should be given before the baby is aged 16 weeks and they must be given by the time the baby is 24 weeks old.
Slovenian: Najbolje je, da se cepljenje z obema odmerkoma opravi pred dopolnjenim 16. tednom starosti, vsekakor pa mora biti zaključeno pred dopolnjenim 24. tednom starosti.
English: • a powder and solvent that are made up into an oral suspension in an oral applicator;
Slovenian: • kot prašek in vehikel, ki se v peroralnem aplikatorju zmešata v peroralno suspenzijo;
English: Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Slovenian: Cepivo Rotarix je bilo pri preprečevanju hudega gastroenteritisa, ki ga povzroča rotavirus, učinkovitejše od placeba.
English: Why has Rotarix been approved?
Slovenian: Zakaj je bilo zdravilo Rotarix odobreno?
English: The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Slovenian: Študija pri nedonošenčkih je pokazala, da cepivo Rotarix dobro prenašajo in da je cepivo spodbudilo tvorbo podobnih ravni protiteles kot pri polno donošenih novorojenčkih.
English: Rotarix is given according to official recommendations.
Slovenian: Daje se le v skladu z uradnimi priporočili.
English: Rotarix is a vaccine that is given by mouth.
Slovenian: Zdravilo Rotarix je cepivo, ki se jemlje peroralno.
English: How has Rotarix been studied?
Slovenian: Kako je bilo zdravilo Rotarix raziskano?
English: What is Rotarix?
Slovenian: Kaj je zdravilo Rotarix?
English: What is Rotarix used for?
Slovenian: Za kaj se zdravilo Rotarix uporablja?
English: How does Rotarix work?
Slovenian: Kako zdravilo Rotarix deluje?
English: How is Rotarix used?
Slovenian: Kako se zdravilo Rotarix uporablja?
English: The European Commission issued a decision on this opinion on 30 May 2011.
Slovenian: Evropska komisija je odločbo v zvezi s tem mnenjem izdala dne 30. maja 2011.
English: The questions and answers document published in September 2010 can be found here.
Slovenian: Dokument z vprašanji in odgovori, ki je bil objavljen septembra 2010, najdete tukaj.
English: The current review was initiated in October 2010 at the request of Germany.
Slovenian: Trenutni pregled je bil sprožen oktobra 2010 na zahtevo Nemčije.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršnakoli vprašanja, naj se posvetujejo z zdravnikom ali s farmacevtom.
English: The CHMP noted at the time that the exact cause of the problems could not be identified with certainty.
Slovenian: CHMP je takrat ugotovil, da natančnega vzroka težav ni bilo mogoče z gotovostjo določiti.
English: • Post-marketing safety studies will be performed.
Slovenian: • Izvedene bodo varnostne študije v obdobju trženja.
English: The Committee noted that appropriate corrective measures are now in place at the manufacturing sites.
Slovenian: Odbor je ugotovil, da se v proizvodnih obratih zdaj izvajajo ustrezni korektivni ukrepi.
English: As with all medicines, doctors are reminded to continue reporting any suspected adverse effects.
Slovenian: Kot pri vseh zdravilih zdravnike opozarjamo, naj še naprej poročajo o morebitnih neželenih učinkih.
English: What are the recommendations for prescribers and patients?
Slovenian: Kakšna so priporočila za bolnike in zdravnike, ki zdravila predpisujejo?
English: What data has the CHMP reviewed?
Slovenian: Katere podatke je pregledal CHMP?
English: • With the new safeguards and improvements to the manufacturing process, doctors are advised that the benefits of the Octagam outweigh its risks and that they can start using the medicine again when it becomes available.
Slovenian: • Na podlagi novih zaščitnih ukrepov in izboljšav proizvodnega postopka se zdravnikom sporoči, da koristi zdravila Octagam odtehtajo z njim povezana tveganja ter da lahko ponovno uporabljajo zdravilo, ko bo na voljo.
English: What is Octagam?
Slovenian: Kaj je zdravilo Octagam?
English: The CHMP reviewed investigations that were carried out into the root cause of the problem and proposed corrective measures, including changes to the manufacturing process and tests to be performed during the manufacturing process and on the final products.
Slovenian: CHMP je pregledal preiskave, ki so bile izvedene, da bi se odkrili glavni vzroki težav, in predlagal primerne korektivne ukrepe, vključno s spremembo proizvodnega postopka in preverjanji, ki se morajo izvajati med proizvodnim postopkom in na končnih izdelkih.
English: The Committee also looked at results of batch analyses and independent testing of batches by Member States, as well as information from inspections of two of the manufacturing sites.
Slovenian: Odbor je tudi preučil rezultate analiz serij in neodvisnih preverjanj serij, ki so jih izvedle države članice, ter informacije inšpekcijskih pregledov v dveh proizvodnih obratih.
English: Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Slovenian: Imunoglobulini so protitelesa (vrsta beljakovin), ki jih običajno najdemo v krvi ter pomagajo telesu pri premagovanju okužb in drugih bolezni.
English: In addition, critical steps were identified in the manufacturing process that could explain the presence of substances that triggered the thromboembolic events.
Slovenian: Določene so bile tudi kritične točke proizvodnega postopka, s katerimi bi bilo mogoče razložiti prisotnost snovi, ki so sprožile tromboembolične dogodke.
English: The aim of the review was to assess all available data on the safety and quality issues related to the thromboembolic events seen with Octagam.
Slovenian: Cilj pregleda je bil oceniti vse razpoložljive podatke o varnosti in kakovosti, povezane s tromboemboličnimi dogodki, opaženimi pri jemanju zdravila Octagam.
English: It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.
Slovenian: Uporablja se tudi pri osebah z nekaterimi imunskimi motnjami, kot je na primer idiopatska trombocitopenična purpura, in pri bolnikih s presajenim kostnim mozgom.
English: Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Octagam se uporablja pri bolnikih, pri katerih obstaja tveganje okužb zaradi nezadostnega števila protiteles, vključno z bolniki s sindromom primarne imunske pomanjkljivosti ali otroki, rojenimi s sindromom pridobljene imunske pomanjkljivosti (AIDS).