FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintaining the quality of scientific assessment and ensuring the safety of medicines remains paramount, and introducing a more comprehensive approach to planning and generation of post-authorisation data is an important component in these efforts.
Slovenian: Uvajanje celovitejšega pristopa k načrtovanju in pridobivanju podatkov iz obdobja po odobritvi je pomemben del teh prizadevanj.
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to infectiousdisease pandemics.
Slovenian: Resnost težave priznava tudi Svetovna zdravstvena organizacija (SZO), ki z razvojem svetovnega akcijskega načrta za boj proti protimikrobni odpornosti poudarja, da je protimikrobna odpornost svetovna zdravstvena kriza, ki je po pomembnosti na podobni ravni kot pandemija nalezljive bolezni.
English: Workload indicators
Slovenian: Razvoj delovnih obremenitev
English: The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.
Slovenian: Na prvem mestu ostajata ohranjanje kakovosti znanstvenega ocenjevanja in zagotavljanje varnosti zdravil.
English: From these sessions, significant risks are selected for further assessments.
Slovenian: Tveganje za te bolezni se je namreč v zadnjih letih močno povečalo.
English: Further information can be found on the Agency's website ema.europa.eu/medicines/EPAR/kiovig.
Slovenian: Nadaljnje informacije o zdravilu Kiovig so na voljo na spletni strani agencije ema.europa.eu/medicines/EPAR/kiovig.
English: IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection.
Slovenian: IgG se kot zdravilo uporablja od osemdesetih let prejšnjega stoletja in ima širok razpon delovanja proti organizmom, ki lahko povzročijo okužbo.
English: Kiovig received a marketing authorisation valid throughout the EU on 19 January 2006.
Slovenian: Za zdravilo Kiovig je bilo 19. januarja 2006 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: • Patients with certain immune disorders.
Slovenian: • pri bolnikih z določenimi imunskimi motnjami.
English: What measures are being taken to ensure the safe and effective use of Kiovig?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kiovig?
English: Therefore, the European Medicines Agency concluded that Kiovig's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Kiovig večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: The dose and frequency of infusions depend on the disease being treated and how well the disease is being controlled.
Slovenian: Odmerek in pogostost infuzij sta odvisna od bolezni, ki se zdravi, in od tega, kako dobro je bolezen nadzorovana.
English: As for all medicines, data on the use of Kiovig are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kiovig stalno spremljajo.
English: What benefits of Kiovig have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kiovig izkazalo v študijah?
English: An overview of Kiovig and why it is authorised in the EU
Slovenian: Pregled zdravila Kiovig in zakaj je odobreno v EU
English: Kiovig is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Slovenian: Zdravilo Kiovig se uporablja kot podpora imunskemu sistemu (naravnemu obrambnemu mehanizmu telesa) pri dveh glavnih skupinah bolnikov:
English: Why is Kiovig authorised in the EU?
Slovenian: Zakaj je zdravilo Kiovig odobreno v EU?
English: The third and fourth studies were in a total of 28 patients with MMN.
Slovenian: V tretjo in četrto študijo je bilo vključenih skupno 28 bolnikov z multifokalno motorično nevropatijo.
English: Other information about Kiovig
Slovenian: Druge informacije o zdravilu Kiovig
English: Kiovig was shown to be effective in PID, ITP and MMN.
Slovenian: Zdravilo Kiovig se je izkazalo kot učinkovito pri PID, ITP in MMN.
English: Side effects reported with Kiovig are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Kiovig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Based on its effectiveness in these diseases, Kiovig can be approved for use in the treatment of other types of immunodeficiency, as well as low antibody levels due to Guillain-Barré syndrome, Kawasaki disease or CIPD, without the need for specific studies in these diseases.
Slovenian: Glede na njegovo učinkovitost pri teh boleznih se zdravilo Kiovig lahko odobri za uporabo pri zdravljenju drugih vrst imunske pomanjkljivosti, kot tudi nizkih ravni protiteles zaradi Guillain-Barréjevega sindroma, Kawasakijeve bolezni ali CIPD, ne da bi bile pri tem potrebne posebne študije.
English: For more information about using Kiovig, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Kiovig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • Patients at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease).
Slovenian: • pri bolnikih, pri katerih obstaja nevarnost okužbe zaradi nezadostnega števila protiteles (imenovanih tudi imunoglobulini, tj. beljakovine v krvi, ki pomagajo telesu pri premagovanju bolezni).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kiovig have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kiovig upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Kiovig can only be obtained with a prescription and treatment for patients with a lack of antibodies should be started and monitored by a doctor experienced in treating such conditions.
Slovenian: Predpisovanje in izdaja zdravila Kiovig je le na recept, zdravljenje bolnikov s pomanjkanjem protiteles pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem tovrstnih stanj.
English: As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, 4 small studies were needed to establish the effectiveness and safety of Kiovig in patients.
Slovenian: Ker se humani polispecifični imunoglobulin že dlje časa uporablja za zdravljenje teh bolezni, so za potrditev učinkovitosti in varnosti zdravila Kiovig pri bolnikih v skladu z veljavnimi smernicami zadostovale štiri manjše študije.
English: At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.
Slovenian: Pri večjih odmerkih lahko prispeva k uravnavanju nenormalnega imunskega sistema in imunskega odziva.
English: Kiovig was effective in maintaining muscle strength and reducing disability.
Slovenian: Zdravilo Kiovig je bilo učinkovito pri ohranjanju mišične moči in zmanjševanju prizadetosti.
English: What is Kiovig and what is it used for?
Slovenian: Kaj je zdravilo Kiovig in za kaj se uporablja?
English: The most common side effects with Kiovig (seen in more than 1 patient in 10) are headache, hypertension (high blood pressure), nausea (feeling sick), rash, tiredness, local reactions such as pain, swelling or itching at the site of injection, and fever.
Slovenian: Najpogostejši neželeni učinki zdravila Kiovig (opaženi pri več kot 1 bolniku od 10) so glavobol, hipertenzija (povišan krvni tlak), navzeja (siljenje na bruhanje), izpuščaji, utrujenost, lokalne reakcije, kot so bolečine, otekanje ali srbenje na mestu injiciranja ter povišana telesna temperatura.
English: These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID).
Slovenian: Ti bolniki so lahko osebe s prirojenim pomanjkanjem protiteles (sindromom primarne imunske pomanjkljivosti, PID).
English: Kiovig works by restoring abnormally low IgG levels to their normal range in the blood.
Slovenian: Zdravilo Kiovig deluje tako, da nenormalno nizko koncentracijo IgG v krvi vrne v območje njene normalne vrednosti.
English: These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.
Slovenian: Ta skupina vključuje bolnike s primarno imunsko trombocitopenijo (ITP), ki nimajo dovolj trombocitov (sestavin v krvi, ki prispevajo k strjevanju krvi) in pri katerih obstaja veliko tveganje za krvavitve, bolnike z Guillain-Barréjevim sindromom ali kronično vnetno demielinizacijsko polinevropatijo (CIDP), tj. vnetnim obolenjem živcev, ki povzroča slabitev in otrplost mišic, bolnike s Kawasakijevim sindromom, tj. boleznijo, ki je prisotna predvsem pri otrocih in povzroča vnetje krvnih žil, in bolnike z multifokalno motorično nevropatijo (MMN), tj. poškodbo živcev, ki povzroča oslabelost rok in nog.
English: The active substance in Kiovig, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Slovenian: Učinkovina v zdravilu Kiovig, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz človeške plazme (dela krvi).
English: Kiovig must not be used in people who are hypersensitive (allergic) to human normal immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of human immunoglobulin, especially where they have very low levels of immunoglobulin A (IgA) and they have antibodies against IgA.
Slovenian: Zdravila Kiovig ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani polispecifični imunoglobulin ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge vrste humanih imunoglobulinov, še posebno, če imajo zelo nizke ravni imunoglobulina A (IgA) ter imajo protitelesa proti IgA.
English: How does Kiovig work?
Slovenian: Kako zdravilo Kiovig deluje?
English: The medicine contains the active substance human normal immunoglobulin.
Slovenian: Zdravilo vsebuje učinkovino humani polispecifični imunoglobulin.
English: These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections;
Slovenian: To lahko vključuje tudi osebe, pri katerih je pomanjkanje protiteles nastopilo po rojstvu (sindrom sekundarne imunske pomanjkljivosti, SID), ki imajo nizke ravni določenih protiteles (imenovanih IgG) in ki trpijo zaradi hudih, ponavljajočih se okužb ter se jih ne more zdraviti z drugimi zdravili za zdravljenje okužb.
English: Kiovig was as effective as the standard treatment in preventing infections and reducing antibiotic use.
Slovenian: Zdravilo Kiovig je bilo pri preprečevanju okužb in zmanjševanju uporabe antibiotikov enako učinkovito kot standardno zdravljenje.
English: Some side effects are more likely when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Kiovig before or for a long time.
Slovenian: Verjetnost pojava nekaterih neželenih učinkov je večja ob uporabi hitrejšega infundiranja pri bolnikih z nizkimi ravnmi imunoglobulina ali bolnikih, ki v preteklosti niso prejemali zdravila Kiovig ali ga niso prejemali dalj časa.
English: The medicine is given by infusion (drip) into a vein.
Slovenian: Zdravilo Kiovig se daje z infundiranjem (kapalno infuzijo) v veno.
English: The second study looked at using Kiovig to adjust the immune system in 23 patients with ITP.
Slovenian: V drugi študiji so proučevali uporabo zdravila Kiovig pri uravnavanju delovanja imunskega sistema pri 23 bolnikih z idiopatsko trombocitopenično purpuro.
English: What are the risks associated with Kiovig?
Slovenian: Kakšna tveganja so povezana z zdravilom Kiovig?
English: In the first study, Kiovig was used to replace antibodies in 22 patients with PID who had very low or no levels of immunoglobulin.
Slovenian: V prvi študiji je bilo zdravilo Kiovig uporabljeno za nadomestitev protiteles pri 22 bolnikih s sindromom primarne imunske pomanjkljivosti, ki so imeli zelo nizko koncentracijo imunoglobulina oziroma ga sploh niso imeli.
English: Kiovig was shown to be effective in increasing the platelet count.
Slovenian: Zdravilo Kiovig se je izkazalo kot učinkovito pri povečevanju števila trombocitov.
English: Kiovig (human normal immunoglobulin)
Slovenian: Kiovig (humani polispecifični imunoglobulin) EMA/138579/2019
English: 3 x 28 film-coated tablets
Slovenian: 3 x 28 filmsko obloženih tablet
English: -- Each dose (2 ml) contains:
Slovenian: --1 Vsak odmerek (2 ml) vsebuje:
English: Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* * Relative Potency (ELISA)
Slovenian: Podenotni antigen VP2 prašičjega parvovirusa seva 27a ≥ 1,0 RU* * Relativni učinek (ELISA)
English: Content
Slovenian: Vsebina
English: Invented name
Slovenian: EU (MA) številka Izmišljeno ime
English: Immediate packaging
Slovenian: Način uporabe Pakiranje
English: This summary was last updated in May 2014.
Slovenian: Povzetek je bil nazadnje posodobljen maja 2014.
English: The duration of protection was confirmed to be six months.
Slovenian: Potrjeno je bilo, da zaščita traja šest mesecev.
English: In the control group more than 80% of pigs showed specific skin lesions.
Slovenian: V kontrolni skupini so se pri več kot 80 % prašičev pojavile specifične kožne lezije.
English: The onset of immunity was shown to be three weeks.
Slovenian: Imunost je nastopila po treh tednih.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eryseng on 4 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Eryseng, veljavno po vsej Evropski uniji, izdala 4. julija 2014.
English: A single injection is given two to three weeks before each mating so approximately every six months.
Slovenian: Eno injekcijo je treba dati dva do tri tedne pred vsakim parjenjem, torej približno vsakih šest mesecev.
English: It contains a bacterial strain called R32E11.
Slovenian: Vsebuje bakterijski sev R32E11.
English: Other information about Eryseng:
Slovenian: Druge informacije o zdravilu Eryseng:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Eryseng exceed the risks for the approved indication and recommended that Eryseng be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Eryseng večje od z njim povezanih tveganj za odobreno indikacijo, in priporočil izdajo dovoljenja za promet z zdravilom Eryseng.
English: The vaccine is given to pigs from six months of age as an injection into the neck muscles, repeated after three to four weeks.
Slovenian: Cepivo se daje prašičem od šestega meseca starosti z injiciranjem v vratno mišičevje, kar je treba ponoviti čez tri do štiri tedne.
English: Swine erysipelas vaccine (inactivated)
Slovenian: cepivo proti svinjski rdečici (inaktivirano)
English: Eryseng is a bacterial vaccine.
Slovenian: Zdravilo Eryseng je bakterijsko cepivo.
English: The most common side effect (seen in more than 1 in 10 pigs) with Eryseng is mild to moderate inflammation at the injection site, which typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Slovenian: Najpogostejši neželeni učinek (opažen pri več kot 1 prašiču od 10) zdravila Eryseng je blago do zmerno vnetje na mestu injiciranja, ki običajno izzveni v štirih dneh, v nekaterih primerih pa vztraja do 12 dni po cepljenju.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
English: Eryseng is available as a suspension for injection.
Slovenian: Zdravilo Eryseng je na voljo v obliki suspenzije za injiciranje.
English: In a laboratory study involving 40 pigs, 30 pigs were vaccinated with two doses, separated by three weeks, while a control group of 10 pigs received placebo (dummy treatment).
Slovenian: V laboratorijski študiji, v katero je bilo vključenih 40 prašičev, je bilo 30 prašičev cepljenih z dvema odmerkoma v presledku treh tednov, kontrolna skupina 10 prašičev pa je prejela placebo (zdravilo brez zdravilne učinkovine).
English: What benefit has Eryseng shown during the studies?
Slovenian: Kakšne koristi je zdravilo Eryseng izkazalo med študijami?
English: The measure of effectiveness was the percentage of vaccinated pigs free from specific (diamond shaped) skin lesions at the challenge site.
Slovenian: Merilo učinkovitosti je bil odstotek cepljenih prašičev brez specifičnih kožnih lezij (v obliki romba) na mestu injiciranja.
English: This will help protect them against swine erysipelas.
Slovenian: To bo pripomoglo k zaščiti prašičev pred svinjsko rdečico.
English: In the future, if the animals are exposed to Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Slovenian: Ob morebitni ponovni izpostavitvi bakteriji Erysipelothrix rhusiopathiae se bo imunski sistem lahko odzval hitreje.
English: Eryseng contains an adjuvant (aluminium hydroxide, DEAE-dextran and ginseng) to enhance the immune response.
Slovenian: Zdravilo Eryseng vsebuje tudi adjuvans (aluminijev hidroksid, DEAE-dekstran in ženšen) za povečanje imunskega odziva.
English: Swine erysipelas is a bacterial disease of pigs characterised by sudden death, fever associated with diamond skin lesions, arthritis and by abortion in pregnant sows.
Slovenian: Svinjska rdečica je bakterijska bolezen prašičev, ki povzroča nenadno smrt, vročico, povezano s kožnimi lezijami v obliki romba, artritis in splav pri brejih svinjah.
English: A second laboratory study involved 15 gilts (female pigs that have not yet had piglets) which were vaccinated according to the basic vaccination schedule with a booster dose six months later.
Slovenian: V drugo laboratorijsko študijo je bilo vključenih 15 mladic (prašičjih samic, ki še niso prasile), ki so jih cepili v skladu z osnovnim razporedom cepljenja, šest mesecev pozneje pa so prejele še poživitveni odmerek.
English: Eryseng is a veterinary vaccine that contains inactivated (killed) Erysipelothrix rhusiopathiae bacteria.
Slovenian: Zdravilo Eryseng je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktivirano (uničeno) bakterijo Erysipelothrix rhusiopathiae.
English: What is the risk associated with Eryseng?
Slovenian: Kakšna tveganja so povezana z zdravilom Eryseng?
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Slovenian: Samice so nadaljnjih šest mesecev pozneje prejele injekcijo z bakterijami Erysipelothrix rhusiopathiae serotipov 1 in 2, merilo učinkovitosti pa je bil odstotek samic, ki jih je cepivo zaščitilo.
English: When Eryseng is given to pigs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašiče cepimo z zdravilom Eryseng, njihov imunski sistem bakterije prepozna kot „tujke“ in proti njim razvije protitelesa.
English: Eryseng is used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae bacteria of specific types called serotype 1 and serotype 2.
Slovenian: Zdravilo Eryseng se uporablja za zaščito prašičjih samcev in samic pred svinjsko rdečico, ki jo povzroča bakterija Erysipelothrix rhusiopathiae posebnih vrst, imenovanih serotip 1 in serotip 2.
English: The first laboratory study showed 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions.
Slovenian: Prva laboratorijska študija je pokazala, da je bilo 90 % (27 od 30) cepljenih prašičev zaščitenih pred serotipom 1 bakterije Erysipelothrix rhusiopathiae, kar pomeni, da se pri njih niso pojavile specifične kožne lezije, pred serotipom 2 bakterije Erysipelothrix rhusiopathiae pa je bilo zaščitenih 93 % (28 od 30) cepljenih prašičev, kar prav tako pomeni, da se pri njih niso pojavile specifične kožne lezije.
English: Why has Eryseng been approved?
Slovenian: Zakaj je bilo zdravilo Eryseng odobreno?
English: All pigs were challenged 22 days after the second vaccination dose with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2.
Slovenian: Vsi prašiči so 22 dni po prejemu drugega odmerka cepiva prejeli injekcijo z bakterijami Erysipelothrix rhusiopathiae serotipov 1 in 2.
English: The second laboratory study showed 93% (14 out of 15) of pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2.
Slovenian: Druga laboratorijska študija je pokazala, da je bilo 93 % (14 od 15) samic zaščitenih pred serotipoma 1 in 2 bakterije Erysipelothrix rhusiopathiae.
English: The withdrawal period for Eryseng is zero days.
Slovenian: Karenca za zdravilo Eryseng je nič dni.
English: How does Eryseng work?
Slovenian: Kako zdravilo Eryseng deluje?
English: What is Eryseng used for?
Slovenian: Za kaj se zdravilo Eryseng uporablja?
English: How has Eryseng been studied?
Slovenian: Kako je bilo zdravilo Eryseng raziskano?
English: What is Eryseng?
Slovenian: Kaj je zdravilo Eryseng?
English: 60 months.
Slovenian: 60 mesecev.
English: • feel tired
Slovenian: • se počutite utrujeno
English: - if you have any serious infections.
Slovenian: - če imate resne okužbe.
English: AST/ALT increases:
Slovenian: Povišan AST/ALT:
English: Long-term carcinogenicity studies have not been performed.
Slovenian: Dolgoročnih študij karcinogenosti niso izvajali.
English: Caution should be taken in such situations.
Slovenian: V takih primerih se priporoča previdnost.
English: • You may lose hair (alopecia).
Slovenian: • Morda boste izgubili lase (alopecija).
English: (fever).
Slovenian: (vročine).
English: Your doctor will tell you how long your treatment lasts.
Slovenian: Zdravnik vam bo povedal, kako dolgo zdravljenje traja.
English: Otherwise treatment must be delayed for up to 3 weeks until the criteria are met.
Slovenian: V nasprotnem primeru je treba zdravljenje prestaviti za do 3 tedne, dokler niso pogoji izpolnjeni.
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Slovenian: Gensko svetovanje se priporoča tudi za bolnike, ki želijo po terapiji imeti otroke.
English: * Primary efficacy analysis a
Slovenian: * Analiza primarne učinkovitosti a
English: If this occurs, active supportive therapy should be started immediately.
Slovenian: Če se to pojavi, je treba nemudoma uvesti aktivno podporno terapijo.
English: Treatment continued whilst clinical benefit was noted.
Slovenian: Zdravljenje se je nadaljevalo, dokler so se kazale klinične koristi.
English: A total of 76 Japanese patients were enrolled in the study, among which 73 patients were included in the final analysis set.
Slovenian: V študijo je bilo vključenih skupno 76 japonskih bolnikov, od katerih jih je bilo 73 zajetih v končni nabor za analizo.