FrancophonIA/ELRC3.0 huggingface dataset:
English: It 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: Daje se lahko samo pod skrbnim nadzorom izkušenega zdravnika in v ustanovi, kjer so nemudoma na voljo vsi pripomočki za oživljanje.
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a medicine to reduce fever).
Slovenian: Pred vsakim infundiranjem je treba bolniku dati antihistaminik (za preprečitev alergijskih reakcij) in antipiretik (zdravilo za znižanje povišane telesne temperature).
English: Depending on the condition being treated, the patients are also given other medicines to manage side effects.
Slovenian: Glede na zdravljeno bolezen bolnik prejme tudi druga zdravila, ki pomagajo obvladati neželene učinke.
English: An overview of Rixathon and why it is authorised in the EU
Slovenian: Pregled zdravila Rixathon in zakaj je odobreno v EU
English: The company marketing Rixathon will provide doctors with additional information about giving the medicine correctly.
Slovenian: Podjetje, ki trži zdravilo Rixathon, bo zdravnikom priskrbelo dodatno informativno gradivo o pravilnem dajanju zdravila.
English: For more information on biosimilar medicines, see here.
Slovenian: Za več informacij o podobnih bioloških zdravilih glejte dokument, ki je na voljo tukaj.
English: Side effects reported with Rixathon are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Rixathon, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: As for all medicines, data on the use of Rixathon are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rixathon stalno spremljajo.
English: Why is Rixathon authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Rixathon odobreno v EU?
English: For more information about using Rixathon, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Rixathon glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Rixathon
Slovenian: Druge informacije o zdravilu Rixathon
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rixathon 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 Rixathon upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What benefits of Rixathon have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Rixathon izkazalo v študijah?
English: The most common side effects with Rixathon are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Slovenian: Najpogostejši neželeni učinki zdravila Rixathon so reakcije, povezane z infuzijo (kot so povišana telesna temperatura, mrzlica in drgetanje), najpogostejši resni neželeni učinki pa so reakcije, povezane z infuzijo, okužbe in težave, povezane s srcem.
English: Rixathon must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Slovenian: Zdravilo Rixathon se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali katero koli drugo sestavino zdravila, ali bolniki s hudo okužbo ali močno oslabljenim imunskim sistemom (obrambnim mehanizmom telesa).
English: In addition, Rixathon was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Rixathon or MabThera were added to other chemotherapy for part of the treatment.
Slovenian: Poleg tega se je zdravilo Rixathon izkazalo za tako učinkovito kot zdravilo MabThera v eni glavni študiji, ki je vključevala 629 bolnikov z napredovalim, nezdravljenim folikularnim limfomom, v kateri so za del zdravljenja zdravilo Rixathon ali MabThera dodali k drugi vrsti kemoterapije.
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
Slovenian: • kronične limfocitne levkemije (KLL, druge vrste krvnega raka, ki prizadene bele krvne celice);
English: What is Rixathon and what is it used for?
Slovenian: Kaj je zdravilo Rixathon in za kaj se uporablja?
English: Rixathon is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Slovenian: Zdravilo Rixathon se uporablja za zdravljenje naslednjih krvnih rakov in vnetnih bolezni pri odraslih:
English: What are the risks associated with Rixathon?
Slovenian: Kakšna tveganja so povezana z zdravilom Rixathon?
English: The medicine is available for infusion (drip) into a vein.
Slovenian: Zdravilo se daje z infundiranjem (kapalno infuzijo) v veno.
English: Depending on the condition it is used to treat, Rixathon may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Slovenian: Zdravilo Rixathon se lahko odvisno od stanja, za katero se uporablja, daje samostojno, skupaj s kemoterapijo (zdravili za zdravljenje raka) ali z zdravili za zdravljenje vnetnih bolezni (metotreksatom ali kortikosteroidom).
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Rixathon if they have severe heart problems.
Slovenian: Bolniki z revmatoidnim artritisom, Wegenerjevo granulomatozo, mikroskopskim poliangiitisom ali navadnim pemfigusom prav tako ne smejo prejemati zdravila Rixathon, če imajo hude težave s srcem.
English: In GPA and MPA, destroying B cells 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 celic B zniža tvorba protiteles, ki naj bi imela pomembno vlogo pri napadanju krvnih žil in povzročanju vnetja.
English: The safety of Rixathon 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 Rixathon je bila ocenjena, na podlagi vseh izvedenih študij pa so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila MabThera.
English: The reference medicine for Rixathon is MabThera.
Slovenian: Referenčno zdravilo za zdravilo Rixathon je zdravilo MabThera.
English: It will also provide doctors and patients using the medicine for rheumatoid arthritis, GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Slovenian: Zdravnikom in bolnikom, ki uporabljajo zdravilo za revmatoidni artritis, Wegenerjevo granulomatozo, mikroskopski poliangiitis ali navadni pemfigus priskrbelo izobraževalno gradivo o tveganju za okužbe, vključno s hudo redko okužbo, znano kot progresivna multifokalna levkoencefalopatija (PML).
English: All these data were considered sufficient to conclude that Rixathon 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 Rixathon pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo MabThera.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Rixathon outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je agencija menila, da koristi zdravila Rixathon enako kot pri zdravilu MabThera odtehtajo znana tveganja in da se zdravilo lahko odobri za uporabo v EU.
English: For the full list of side effects and restrictions of Rixathon, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Rixathon glejte navodilo za uporabo.
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Slovenian: • granulomatoze s poliangiitisom (GPA ali Wegenerjeve granulomatoze) in mikroskopskega poliangiitisa (MPA), ki sta vnetni bolezni krvnih žil;
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rixathon has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Rixathon po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se enako porazdeli po telesu.
English: A supportive study in patients with rheumatoid arthritis also indicated similar effectiveness between MabThera and Rixathon.
Slovenian: Podporna študija pri bolnikih z revmatoidnim artritisom je prav tako pokazala podobno učinkovitost med zdravilom MabThera in zdravilom Rixathon.
English: Because Rixathon is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rixathon.
Slovenian: Zdravilo Rixathon je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti rituksimaba, izvedenih z zdravilom MabThera, z zdravilom Rixathon ni treba ponavljati.
English: Rixathon is a ‘biosimilar medicine'.
Slovenian: Zdravilo Rixathon je „podobno biološko zdravilo“.
English: • pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.
Slovenian: • navadnega pemfigusa, resne bolezni, za katero so značilni razširjeni mehurji po koži in sluznici ust,
English: In addition, a study in patients with follicular lymphoma has shown that the safety and effectiveness of Rixathon are equivalent to those of MabThera.
Slovenian: Poleg tega je študija pri bolnikih z folikularnim limfomom pokazala, da sta varnost in učinkovitost zdravila Rixathon enaki kot pri zdravilu MabThera.
English: Laboratory studies comparing Rixathon with the reference medicine MabThera have shown that the active substance in Rixathon is highly similar to that in MabThera in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Rixathon primerjali z referenčnim zdravilom MabThera, so pokazale, da je učinkovina v zdravilu Rixathin po zgradbi, čistosti in biološkem delovanju zelo podobna tisti v zdravilu MabThera.
English: How is Rixathon used?
Slovenian: Kako se zdravilo Rixathon uporablja?
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in rheumatoid arthritis and pemphigus (where B cells are involved in inflammation).
Slovenian: Učinkovina v zdravilu Rixathon, rituksimab, je monoklonsko protitelo, ki je zasnovano tako, da se veže na blejakovino, imenovano CD20, ki se nahaja na površini celic B. Rituksimab z vezavo na CD20 povzroči odmrtje celic B, kar pripomore pri zdravljenju limfoma in kronične limfocitne levkemije (pri katerih so celice B postale rakaste) ter pemfigusa (pri katerem celice B sodelujejo pri vnetju).
English: How does Rixathon work?
Slovenian: Kako zdravilo Rixathon deluje?
English: Rixathon can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Rixathon je le na recept.
English: Rixathon contains the active substance rituximab.
Slovenian: Zdravilo Rixathon vsebuje zdravilno učinkovino rituksimab.
English: Studies have also shown that giving Rixathon produces similar levels of the active substance in the body to giving MabThera.
Slovenian: Študije so pokazale tudi, da je količina učinkovine v telesu pri zdravilu Rixathon podobna kot pri zdravilu MabThera.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suliqua on 11 January 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Suliqua, veljavno po vsej Evropski uniji, izdala 11. januarja 2017.
English: What measures are being taken to ensure the safe and effective use of Suliqua?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Suliqua?
English: The full EPAR for Suliqua 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 Suliqua je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Suliqua.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Suliqua.
English: Other information about Suliqua
Slovenian: Druge informacije o zdravilu Suliqua
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Suliqua's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Suliqua večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The dose is adjusted individually for each patient, and the patient's blood glucose should be regularly tested to find the lowest effective dose.
Slovenian: Odmerek zdravila je treba prilagoditi posameznemu bolniku, bolnikovo raven glukoze v krvi pa je treba redno preverjati, da se določi najmanjši učinkoviti odmerek.
English: The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Slovenian: Družba, ki trži zdravilo Suliqua, bo priskrbela izobraževalno gradivo za zdravstvene delavce in bolnike, v katerem bo obrazloženo, kako varno uporabljati zdravilo, da se zmanjša tveganje za napake pri njegovi uporabi.
English: Suliqua has been shown to be effective at controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes.
Slovenian: Zdravilo Suliqua se je izkazalo za učinkovito pri uravnavanju glukoze v krvi v dveh glavnih študijah, ki sta vključevali 1 906 bolnikov s sladkorno boleznijo tipa 2.
English: Suliqua insulin glargine / lixisenatide
Slovenian: Suliqua insulin glargin/liksisenatid
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Slovenian: Z uravnavanjem ravni glukoze v krvi zmanjšamo simptome sladkorne bolezni in preprečimo zaplete.
English: What benefits of Suliqua have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Suliqua izkazalo v študijah?
English: What are the risks associated with Suliqua?
Slovenian: Kakšna tveganja so povezana z zdravilom Suliqua?
English: It is not intended to provide practical advice on how to use Suliqua.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Suliqua approved?
Slovenian: Zakaj je bilo zdravilo Suliqua odobreno?
English: Insulin glargine enters the bloodstream more slowly than human insulin after an injection and its action is therefore longer lasting.
Slovenian: Insulin glargin po injiciranju vstopi v krvni obtok počasneje kot humani insulin, zato deluje dlje časa.
English: For more information about treatment with Suliqua, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Suliqua preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Suliqua and what is it used for?
Slovenian: Kaj je zdravilo Suliqua in za kaj se uporablja?
English: It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Slovenian: To pomeni, da deluje enako kot GLP-1 (v črevesju proizvedeni hormoni), in sicer tako, da povečuje količino insulina, ki ga kot odziv na zaužito hrano izloči trebušna slinavka.
English: Results showed that Suliqua is more effective at controlling blood glucose levels than either components: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.
Slovenian: Rezultati so pokazali, da je zdravilo Suliqua učinkovitejše pri nadzoru ravni glukoze v krvi kot posamični sesstavini: povprečna vrednost HbA1c na začetku študije je bila 8,1 % in je po 30 tednih zdravljenja v skupini, ki je uporabljala zdravilo Suliqua, padla na 6,5 %, v primerjavi s 6,8 % v skupini, ki je uporabljalo insulin glargin, in 7,3 % v skupini, ki je uporabljala liksisenatid.
English: Type 2 diabetes is a disease in which the level of blood glucose is high because either the body does not produce enough insulin or the body is unable to use insulin effectively.
Slovenian: Pri sladkorni bolezni tipa 2 je raven glukoze v krvi previsoka, ker telo ne proizvaja dovolj insulina ali pa ga ne more učinkovito izrabiti.
English: Suliqua is a medicine that is used together with metformin (another diabetes medicine) for the treatment of adults with type 2 diabetes.
Slovenian: Zdravilo Suliqua se uporablja skupaj z metforminom (drugim zdravilom za zdravljenje sladkorne bolezni) za zdravljenje odraslih s sladkorno boleznijo tipa 2.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also 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 Benepali upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood.
Slovenian: Ena od zdravilnih učinkovin v zdravilu Suliqua, insulin glargin, je nadomestek insulina, ki deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice ter tako uravnava raven glukoze v krvi.
English: The CHMP concluded that combination treatments with a long-acting insulin and a GLP-1 agonist such as Suliqua are an important treatment option for patients who are eligible for insulin or who need intensive insulin therapy.
Slovenian: Odbor je zaključil, da so kombinirana zdravila z dolgodelujočim insulinom in agonistom GLP-1, kot je zdravilo Suliqua, pomembna možnost zdravljenja za bolnike, ki so primerni za insulin ali ki potrebujejo intenzivno insulinsko zdravljenje.
English: This helps with the control of blood glucose levels.
Slovenian: To pomaga pri uravnavanju ravni glukoze v krvi.
English: A reduction in HbA1c levels means an improvement in the control of blood sugar levels.
Slovenian: Znižanje ravni HbA1c pomeni boljše uravnavanje ravni glukoze v krvi.
English: In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain.
Slovenian: Pri teh bolnikih je bilo zdravilo Suliqua učinkovito pri uravnavanju ravni glukoze in je zmanjšalo tveganja za težave, povezane z intenzivnim insulinskim zdravljenjem, kot sta hipoglikemija in pridobivanje telesne mase.
English: After 30 weeks of treatment average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.
Slovenian: Po 30 tednih zdravljenja je povprečna vrednost HbA1c v skupini, ki je jemala zdravilo Suliqua, padla na 6,9 %, pri bolnikih, ki so jemali insulin glargin, pa na 7,5 %.
English: It is used when blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or by a combination of metformin and another medicine (either another glucose-lowering medicine taken by mouth or a long-acting insulin).
Slovenian: Uporablja se, kadar ravni glukoze (sladkorja) v krvi ni mogoče zadostno uravnavati samo z metforminom ali kombinacijo metformina in drugega zdravila (drugega peroralnega zdravila za zniževanje glukoze ali dolgodelujočega insulina).
English: In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.
Slovenian: V zvezi z varnostjo pri kombinaciji insulina glargin in liksisenatida v zdravilu Suliqua ni bilo nobenih novih pomislekov o varnosti v primerjavi z ločeno uporabljenimi sestavinami.
English: For practical information about using Suliqua, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Suliqua naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The other active substance in Suliqua, lixisenatide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Slovenian: Druga zdravilna učinkovina v zdravilu Suliqua, liksisenatid, spada v razred zdravil za zdravljenje sladkorne bolezni, znanih kot agonisti GLP-1.
English: In both studies, the main measure of effectiveness was the change after 30 weeks of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti sprememba ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), po 30 tednih zdravljenja.
English: For the full list of all side effects and restrictions with Suliqua, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Suliqua glejte navodilo za uporabo.
English: Before Suliqua is started the patient's insulin and diabetes medicines other than metformin must be stopped.
Slovenian: Pred uvedbo zdravila Suliqua je treba ukiniti bolnikov insulin in zdravila za zdravljenje sladkorne bolezni, razen metformina.
English: Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine.
Slovenian: Povprečna vrednost HbA1c pred začetkom jemanja zdravila Suliqua ali insulina glargin je bila 8,1 %.
English: The active substances in Suliqua are insulin glargine and lixisenatide.
Slovenian: Zdravilni učinkovini v zdravilu Suliqua sta insulin glargin in liksisenatid.
English: The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth.
Slovenian: V prvo študijo je bilo vključenih 1 170 bolnikov, pri katerih raven glukoze v krvi ni bila zadostno nadzorovana z metforminom ne glede na to, ali so jemali druga zdravila za peroralno uporabo za zdravljenje sladkorne bolezni ali jih niso.
English: Patients who entered the study, had to stop all medicines given by mouth except metformin and were then given either Suliqua or insulin glargine.
Slovenian: Bolniki, vključeni v študijo, so morali prenehati jemati vsa peroralna zdravila razen metformina in so prejemali zdravilo Suliqua ali insulin glargin.
English: Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription.
Slovenian: Zdravilo Suliqua je na voljo v napolnjenih peresnikih za enkratno uporabo v dveh jakostih.