FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Volibris have also 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 Volibris upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Volibris
Slovenian: Druge informacije o zdravilu Volibris
English: An overview of Volibris and why it is authorised in the EU
Slovenian: Pregled zdravila Volibris in zakaj je odobreno v EU
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Volibris should be 5 mg a day and the patient should be closely monitored by their doctor.
Slovenian: Kadar se zdravilo Volibris jemlje sočasno s ciklosporinom (zdravilom, ki zmanjšuje aktivnost imunskega sistema), mora biti odmerek zdravila Volibris 5 mg na dan, bolniki pa morajo biti pod skrbnim nadzorom svojega zdravnika.
English: The company that markets Volibris will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Slovenian: Podjetje, ki trži zdravilo Volibris, bo bolnikom priskrbelo kartico, ki bo vključevala pomembne informacije o neželenih učinkih zdravila in o potrebi po preprečevanju zanositve med zdravljenjem.
English: Results showed that Volibris was more effective than placebo at improving exercise capacity (the ability to carry out physical activity).
Slovenian: Rezultati so pokazali, da je zdravilo Volibris pri izboljšanju vadbene zmogljivosti (zmožnosti izvajanja telesne aktivnosti) učinkovitejše od placeba.
English: What benefits of Volibris have been shown in studies?
Slovenian: Kakšne koristi zdravila Volibris so se pokazale v študijah?
English: Results showed that 18% of patients (46 out of 253) given combination treatment died or their disease got worse compared with 31% (77 out of 247) given either Volibris or tadalafil alone.
Slovenian: Rezultati so pokazali, da je 18 % (46 od 253) bolnikov, ki so prejemali kombinacijo zdravil, umrlo ali se je njihova bolezen poslabšala, v primerjavi z 31 % (77 od 247) bolnikov, ki so prejemali samo zdravilo Volibris ali samo tadalafil.
English: Side effects reported with Volibris are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Volibris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Volibris, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Volibris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: It must not be used in patients with idiopathic pulmonary fibrosis (long-term disease in which hard fibrous tissue continuously forms in the lungs), with or without secondary pulmonary hypertension (high blood pressure in the lungs).
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z idiopatsko pljučno fibrozo (dolgotrajnim obolenjem, pri katerem se v pljučih nenehno tvori fibrozno tkivo) s sekundarno pljučno hipertenzijo (visokim krvnim tlakom v pljučih) ali brez nje.
English: Volibris must not be used in people who are hypersensitive (allergic) to soya, ambrisentan or any of the other ingredients.
Slovenian: Zdravila Volibris ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sojo, ambrisentan ali katero koli drugo sestavino zdravila.
English: What is Volibris and what is it used for?
Slovenian: Kaj je zdravilo Volibris in za kaj se uporablja?
English: The most common side effects with Volibris (seen in more than 1 patient in 10) are headache (including sinus headache and migraine), peripheral oedema (swelling, especially of the ankles and feet) and fluid retention.
Slovenian: Najpogostejši neželeni učinki zdravila Volibris (opaženi pri več kot 1 od 10 bolnikov) so glavobol (vključno s sinusnim glavobolom in migreno), periferni edem (otekanje, zlasti gležnjev in stopal) ter zastajanje tekočin.
English: What are the risks associated with Volibris?
Slovenian: Kakšna tveganja so povezana z zdravilom Volibris?
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the flow of blood to the lungs.
Slovenian: To povzroči zelo visok krvni tlak v žilah, po katerih se kri pretaka iz srca v pljuča, in zmanjšuje pretok krvi v pljuča.
English: Various doses of Volibris (2.5, 5 and 10 mg) have been compared with placebo (a dummy treatment) in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease that was of unknown cause or caused by connective tissue disease.
Slovenian: Različne odmerke zdravila Volibris (2,5 mg, 5 mg in 10 mg) so primerjali s placebom (zdravilom brez učinkovine) v dveh glavnih študijah, v kateri je bilo vključenih skupaj 394 bolnikov s pljučno arterijsko hipertenzijo, od katerih jih je večina imela bolezen funkcijskega razreda II ali III, ki ni imela znanega vzroka oziroma je bila povezana z boleznijo vezivnega tkiva.
English: Over a three-year period the likelihood of the disease getting worse was 32% with the combined treatment and 44% with a single medicine.
Slovenian: V triletnem obdobju je verjetnost poslabšanja stanja pri zdravljenju s kombinacijo obeh zdravil 32-odstotna, pri zdravljenju s samostojnima zdraviloma pa 44-odstotna.
English: Treatment is started at a dose of 5 mg once a day and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Slovenian: Zdravljenje se uvede v odmerku 5 mg enkrat na dan, zdravnik pa lahko glede na odziv in neželene učinke, ki jih občuti bolnik, odmerek poveča do 10 mg na dan.
English: By blocking the effect of endothelin, Volibris allows the vessels to expand, helping to lower the blood pressure and improving symptoms.
Slovenian: Zdravilo Volibris z zaviranjem učinka endotelina omogoči širjenje žil, kar prispeva k znižanju krvnega tlaka in izboljšanju simptomov.
English: It must not be used in patients who are breastfeeding, who have severe liver problems or who have high levels of liver enzymes in the blood.
Slovenian: Ne sme se uporabljati pri doječih materah ter bolnikih, ki imajo hude težave z jetri ali visoke vrednosti jetrnih encimov v krvi.
English: Why is Volibris approved?
Slovenian: Zakaj je bilo zdravilo Volibris odobreno?
English: Patients with class III disease and those with PAH caused by connective tissue disease gained a greater benefit from the 10 mg dose than from the 5 mg dose.
Slovenian: Bolniki z boleznijo funkcijskega razreda III in bolniki s pljučno arterijsko hipertenzijo, ki je posledica bolezni vezivnega tkiva, so imeli več koristi pri uporabi 10miligramskega kot 5-miligramskega odmerka.
English: In addition, treatment with a combination of Volibris (10 mg) and tadalafil has been compared with either Volibris or tadalafil alone in another main study involving 605 patients with PAH.
Slovenian: Zdravljenje s kombinacijo zdravila Volibris (10 mg) in tadalafila so poleg tega primerjali bodisi z zdravilom Volibris bodisi s tadalafilom kot samostojnima zdraviloma v drugi glavni študiji, ki je zajela 605 bolnikov s pljučno arterijsko hipertenzijo.
English: Volibris is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Slovenian: Zdravilo Volibris se uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje odraslih s pljučno arterijsko hipertenzijo (PAH).
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Slovenian: Zdravilo Volibris se uporablja pri bolnikih z boleznijo funkcijskega razreda II ali III. Funkcijski razred odraža resnost bolezni: razred II pomeni rahlo omejitev telesne zmogljivosti, razred III pa znatno omejitev telesne zmogljivosti.
English: Volibris contains the active substance ambrisentan.
Slovenian: Zdravilo Volibris vsebuje učinkovino ambrisentan.
English: The risk of the disease getting worse or the patient dying within a year was 11% in patients given the combination treatment and 24% in those given a single medicine (Volibris or tadalafil).
Slovenian: Tveganje za poslabšanje bolezni ali smrt bolnika v enem letu je pri bolnikih, ki so prejemali kombinacijo obeh zdravil, znašalo 11 %, pri bolnikih, ki so prejemali bodisi zdravilo Volibris bodisi tadalafil kot samostojni zdravili, pa 24 %.
English: The increased dose of 10 mg is recommended when the medicine is used with tadalafil (another medicine for PAH).
Slovenian: Povečani 10-miligramski odmerek se priporoča, kadar se zdravilo Volibris uporablja v kombinaciji s tadalafilom (drugim zdravilom za zdravljenje pljučne arterijske hipertenzije).
English: The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to become narrow.
Slovenian: Učinkovina v zdravilu Volibris, ambrisentan, zavira receptorje za hormon, imenovan endotelin, ki povzroča zožitev žil.
English: Volibris can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.
Slovenian: Predpisovanje in izdaja zdravila Volibris je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
English: For the full list of side effects with Volibris, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Volibris, glejte navodilo za uporabo.
English: Volibris has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Slovenian: Učinkovitost zdravila Volibris je bila dokazana pri pljučni arterijski hipertenziji brez znanega vzroka in pljučni arterijski hipertenziji, povezani z boleznijo vezivnega tkiva.
English: How is Volibris used?
Slovenian: Kako se zdravilo Volibris uporablja?
English: After 12 weeks of treatment, patients taking 5 mg Volibris once a day could walk an average of 36 m more while patients taking placebo had got worse and could walk 9 m less.
Slovenian: Rezultati obeh študij skupaj so pokazali, da so lahko bolniki na začetku študije v šestih minutah v povprečju prehodili 345 m. Po 12 tednih zdravljenja so bolniki, ki so prejemali zdravilo Volibris v odmerku 5 mg enkrat na dan, lahko prehodili v povprečju 36 m več, medtem ko so bolniki, ki so prejemali placebo, prehodili 9 m manj.
English: How does Volibris work?
Slovenian: Kako zdravilo Volibris deluje?
English: The risk of such reactions decreases in subsequent infusions.
Slovenian: Tveganje takih reakcij je z vsako naslednjo infuzijo manjše.
English: It must also not be used in patients with a severe infection or a severely weakened immune system.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih s hudo okužbo ali zelo oslabljenim imunskim sistemom.
English: Truxima received a marketing authorisation valid throughout the EU on 17 February 2017.
Slovenian: Za zdravilo Truxima je bilo 17. februarja 2017 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: What measures are being taken to ensure the safe and effective use of Truxima?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Truxima?
English: This means that Truxima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Truxima (rituximab)
Slovenian: Truxima (rituksimab)
English: The full EPAR for Truxima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/truxima.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Truxima je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/truxima.
English: An overview of Truxima and why it is authorised in the EU
Slovenian: Pregled zdravila Truxima in zakaj je odobreno v EU
English: What benefits of Truxima have been shown in studies?
Slovenian: Kakšne koristi zdravila Truxima so se pokazale v študijah?
English: In addition, the two medicines had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73% (43 of 59 patients) with MabThera.
Slovenian: Poleg tega sta zdravili primerljivo vplivali na simptome artritisa: po 24 tednih je delež bolnikov, pri katerih je bilo izboljšanje po lestvici simptomov (imenovani ACR20) 20-odstotno in ki so jemali zdravilo Truxima, znašal 74 % (114 bolnikov od 155), pri tistih, ki so jemali zdravilo MabThera, pa 73 % (43 bolnikov od 59).
English: Why is Truxima authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Truxima odobreno v EU?
English: As for all medicines, data on the use of Truxima are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Truxima stalno spremljajo.
English: Other information about Truxima
Slovenian: Druge informacije o zdravilu Truxima
English: What is Truxima and what is it used for?
Slovenian: Kaj je zdravilo Truxima in za kaj se uporablja?
English: What are the risks associated with Truxima?
Slovenian: Kakšna tveganja so povezana z zdravilom Truxima?
English: The most common serious side effects are infusion reactions, infections (which may affect more than half of all patients) and heart-related problems.
Slovenian: Najpogostejši hudi neželeni učinki so reakcije na infuzijo, okužbe (do katerih lahko pride pri več kot polovici vseh bolnikov) in težave, povezane s srcem.
English: Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Slovenian: Bolniki morajo prejeti tudi opozorilno kartico, ki jo morajo imeti stalno pri sebi in na kateri je navedeno, da se morajo takoj posvetovati z zdravnikom, če občutijo kakršne koli navedene simptome okužbe.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Slovenian: Drugi hudi neželeni učinki vključujejo reaktivacijo hepatitisa B (ponovitev predhodne aktivne okužbe jeter z virusom hepatitisa B) in redko hudo okužbo, znano kot progresivna multifokalna levkoencefalopatija (PML).
English: Side effects reported with Truxima are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Truxima, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Truxima is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Slovenian: Truxima je zdravilo, ki se uporablja pri odraslih za zdravljenje naslednjih krvnih rakavih obolenj in vnetnih bolezni:
English: In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Slovenian: Poleg tega se lahko zdravilo daje samo pod skrbnim nadzorom izkušenega zdravstvenega delavca in v ustanovi, kjer je nemudoma na voljo oprema za oživljanje.
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Slovenian: • granulomatoze s poliangiitisom (GPA, Wegenerjeve granulomatoze) in mikroskopskega poliangiitisa
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to prevent fever).
Slovenian: Pred vsakim infundiranjem je treba bolniku dati antihistaminik (za preprečitev alergijskih reakcij) in antipiretik (zdravilo za znižanje povišane telesne temperature).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima have also 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 Truxima upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Truxima, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Truxima glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The reference medicine for Truxima is MabThera.
Slovenian: Referenčno zdravilo za zdravilo Truxima je zdravilo MabThera.
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Truxima if they have severe heart problems.
Slovenian: Bolniki z revmatoidnim artritisom, Wegenerjevo granulomatozo, mikroskopskim poliangiitisom ali navadnim pemfigusom prav tako ne smejo prejemati zdravila Truxima, če imajo hude težave s srcem.
English: Doctors prescribing Truxima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Slovenian: Zdravniki, ki predpisujejo zdravilo Truxima za zdravljenje raka, bodo prejeli izobraževalno gradivo, v katerem bodo opozorjeni o tem, da je zdravilo treba dajati le z infundiranjem v veno.
English: The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B lymphocytes (types of white blood cells).
Slovenian: Učinkovina v zdravilu Truxima, rituksimab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino, imenovano CD20, ki je prisotna na površini limfocitov B (vrste belih krvnih celic), in se veže nanjo.
English: Depending on the condition it is used to treat, Truxima may be given on its own, or with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Slovenian: Zdravilo Truxima se odvisno od bolezni, za katero se uporablja, lahko daje samostojno, skupaj s kemoterapijo (z drugimi zdravili za zdravljenje raka) ali z zdravili za zdravljenje vnetnih bolezni (metotreksatom ali kortikosteroidom).
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells)
Slovenian: • kronične limfocitne levkemije (KLL, druge vrste krvnega raka, ki prizadene bele krvničke);
English: Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the medicines produced similar responses.
Slovenian: Podporne študije pri bolnikih z revmatoidnim artritisom in bolnikih z napredovalim folikularnim limfomom so prav tako pokazale, da sta zdravili povzročili podobne odzive.
English: All these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Truxima pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo MabThera.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in the majority of patients after the first infusion.
Slovenian: Najpogostejši neželeni učinki rituksimaba so reakcije, povezane z infuzijo (kot so zvišana telesna temperatura, mrazenje in drgetanje), ki se po prvi infuziji pojavljajo pri večini bolnikov.
English: Truxima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Slovenian: Zdravila Truxima ne smejo jemati osebe, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: The safety of Truxima has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Slovenian: Varnost zdravila Truxima je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila MabThera.
English: Because Truxima is a biosimilar medicine, the studies on effectiveness and safety carried out for MabThera do not need to be repeated for Truxima.
Slovenian: Zdravilo Truxima je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti, že izvedenih za zdravilo MabThera, za zdravilo Truxima ni treba ponavljati.
English: How does Truxima work?
Slovenian: Kako zdravilo Truxima deluje?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Truxima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Truxima po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se po telesu enako prenaša.
English: The study showed that Truxima and MabThera led to similar levels of rituximab in the blood.
Slovenian: Študija je pokazala, da sta zdravili Truxima in MabThera povzročili podobne ravni rituksimaba v krvi.
English: The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Slovenian: Podjetje, ki trži zdravilo Truxima, bo za zdravnike in bolnike, ki uporabljajo zdravilo za zdravljenje nerakavih obolenj, pripravilo izobraževalno gradivo, v katerem bo opisano, da je zdravilo treba dajati v ustanovah, kjer je na voljo oprema za oživljanje, in da obstaja tveganje okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML).
English: In GPA and MPA, destroying the B lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Slovenian: Pri Wegenerjevi granulomatozi in mikroskopskem poliangiitisu se z uničenjem limfocitov B zniža tvorba protiteles, ki naj bi imela pomembno vlogo pri napadu na krvne žile in povzročanju vnetja.
English: (MPA), which are inflammatory conditions of the blood vessels
Slovenian: (MPA), ki sta vnetni bolezni krvnih žil;
English: Depending on the condition being treated, patients may also receive other medicines as well.
Slovenian: Bolniki lahko glede na bolezen, ki se zdravi, prejmejo tudi druga zdravila.
English: When rituximab attaches to CD20, it causes the death of B lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B lymphocytes are involved in joint inflammation).
Slovenian: Rituksimab z vezavo na CD20 povzroči odmrtje limfocitov B, kar pripomore pri zdravljenju limfoma in kronične limfocitne levkemije (pri katerih so limfociti B postali rakasti) ter revmatoidnega artritisa (pri katerem limfociti B sodelujejo pri vnetju sklepov).
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer)
Slovenian: • folikularnega limfoma in difuznega velikoceličnega B ne-Hodgkinovega limfoma (dveh vrst ne