FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you have any questions regarding your treatment, please contact your doctor, pharmacist or nurse.
Slovenian: • Če imate o svojem zdravljenju dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The fact that Uptravi is available in different strengths and that the dose is changed usually weekly during the titration phase may lead to confusion and errors by patients when taking the medicine.
Slovenian: Dejstvo, da je zdravilo Uptravi na voljo v različnih jakostih in da se odmerek v fazi titriranja običajno tedensko spreminja, lahko pri bolnikih povzroči zmedenost in napake pri jemanju zdravila.
English: Measures to prevent medication errors due to weekly dose increases during initial titration phase
Slovenian: Ukrepi za preprečevanje napak pri uporabi zdravila zaradi tedenskega povečevanja odmerka med začetno fazo titriranja
English: Treatment with Uptravi includes an initial titration phase, whereby the patient receives a low starting dose which is gradually increased over several weeks to a maintenance dose, which is continued longterm.
Slovenian: Zdravljenje z zdravilom Uptravi obsega začetno fazo titriranja, v kateri bolnik prejme nizek začetni odmerek, ki se več tednov postopno povečuje do vzdrževalnega odmerka, ki ga prejema dolgotrajno.
English: Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Slovenian: Zdravilo Uptravi se uporablja za zdravljenje odraslih s pljučno arterijsko hipertenzijo (PAH, nenormalno visok krvni tlak v pljučnih arterijah).
English: Healthcare professionals expected to prescribe and dispense Uptravi (selexipag) will be given an educational brochure to ensure that the medicine is used correctly.
Slovenian: Zdravstveni delavci, za katere se pričakuje, da bodo predpisovali ali izdajali zdravilo Uptravi (seleksipag), bodo prejeli izobraževalno brošuro za zagotovitev pravilne uporabe zdravila.
English: • The first dose of Uptravi should always be taken in the evening.
Slovenian: • Prvi odmerek zdravila Uptravi je treba vedno vzeti zvečer.
English: When the dose is changed, the new dose should also be first taken in the evening.
Slovenian: Ob spremembi odmerka morate tudi novi odmerek najprej vzeti zvečer.
English: Patients will be given a diary to help them remember which dose to take.
Slovenian: Bolniki bodo prejeli dnevnik, s pomočjo katerega se bodo lažje spomnili, kateri odmerek morajo vzeti.
English: • Before prescribing or dispensing Uptravi, healthcare professionals should give patients a titration guide and diary to help them keep track of the number of tablets they take.
Slovenian: • Pred predpisovanjem ali izdajo zdravila Uptravi morajo zdravstveni delavci bolnikom dati navodilo in dnevnik za titriranje, ki jim bosta v pomoč pri sledenju števila tablet, ki jih bodo vzeli.
English: Once you have gone through the 4 steps of increasing the dose and are at step 5, you will be taking both the 200 microgram and the 800 microgram strengths at the same time.
Slovenian: Ko boste opravili štiri korake povečevanja odmerka in boste pri petem koraku, boste jemali 200-mikrogramske in 800-mikrogramske tablete hkrati.
English: Underdosing may result in lack of effect whereas overdosing may lead to side effects such as headache, diarrhoea, nausea and vomiting.
Slovenian: Premajhen odmerek lahko povzroči pomanjkanje učinka, prevelik pa neželene učinke, kot so glavobol, driska, slabost in bruhanje.
English: Uptravi is available in different strengths (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Slovenian: Zdravilo Uptravi je na voljo v različnih jakostih (200, 400, 600, 800, 1 000, 1 200, 1 400 in 1 600 mikrogramov).
English: • When prescribing Uptravi, healthcare professionals should follow the instructions provided in the summary of product characteristics and the educational material for Uptravi (brochure).
Slovenian: • Pri predpisovanju zdravila Uptravi morajo zdravstveni delavci upoštevati navodila v povzetku glavnih značilnosti zdravila in izobraževalnemu gradivu za zdravilo Uptravi (brošura).
English: Use these boxes to write down the number of tablets you take.
Slovenian: Te okvirčke uporabite za beleženje števila tablet, ki jih vzamete.
English: In addition, prescribers will only be able to prescribe Uptravi once they have registered with the company that markets Uptravi and received appropriate information on the safe and effective use of Uptravi.
Slovenian: Poleg tega se bodo morali zdravniki, ki bodo zdravilo predpisovali, pred začetkom predpisovanja zdravila Uptravi registrirati pri družbi, ki ga trži, in prejeti ustrezne informacije o varni in učinkoviti uporabi tega zdravila.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Slovenian: PAH je izčrpavajoča bolezen, pri kateri pride do hudega zoženja krvnih žil v pljučih.
English: The diary contains for each day and each strength two boxes for the patient to mark the number of tablets they take in the morning and evening.
Slovenian: Dnevnik vsebuje za vsak dan in vsako jakost zdravila dva okvirčka, v katerih bolniki označijo število tablet, ki jih vzamejo zjutraj in zvečer.
English: • If during titration it is difficult to tolerate certain side effects, your doctor may reduce the dose by reducing the number of tablets that you take.
Slovenian: • Če boste med povečevanjem odmerka težko prenašali nekatere neželene učinke, bo zdravnik odmerek morda zmanjšal z zmanjšanjem števila tablet, ki jih jemljete.
English: In case you are only using the 200 microgram strength, the diary pages look as follows:
Slovenian: Če jemljete le tablete jakosti 200 mikrogramov, bodo strani v dnevniku videti takole:
English: • Uptravi is available as tablets in different strengths (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Slovenian: • Zdravilo Uptravi je na voljo v obliki tablet z različnimi jakostmi (200, 400, 600, 800, 1 000, 1 200, 1 400 in 1 600 mikrogramov).
English: Once a maintenance dose has been established, a different strength may be prescribed so that the patient takes only a single tablet twice daily.
Slovenian: Ko je dosežen vzdrževalni odmerek, se lahko predpiše druga jakost, tako da bolnik jemlje le eno tableto dvakrat dnevno.
English: • Before prescribing Uptravi, healthcare professionals must register with the company's controlled access system.
Slovenian: • Zdravstveni delavci se morajo pred predpisovanjem zdravila Uptravi registrirati v sistemu nadzorovanega dostopa družbe.
English: • You will be given a diary to help you keep track of the number of tablets you need to take during the titration phase.
Slovenian: • Prejeli boste dnevnik, ki vam bo pomagal pri sledenju števila tablet, ki jih morate vzeti med povečevanjem odmerka.
English: • You will start treatment with one 200 microgram tablet twice a day, in the morning and in the evening (approximately 12 hours apart).
Slovenian: • Zdravljenje boste začeli z eno 200-mikrogramsko tableto dvakrat dnevno, zjutraj in zvečer (približno 12 ur narazen).
English: The diary contains for each strength two boxes for each day of treatment, one for the morning dose and one for the evening dose.
Slovenian: V dnevniku sta za posamezno jakost dva okvirčka za vsak dan zdravljenja, eden za jutranji in drugi za večerni odmerek.
English: • Once a suitable dose for you has been established (known as the maintenance dose), the doctor may prescribe a different strength of Uptravi tablet so you only need to take one tablet in the morning and one in the evening to get the right amount of the medicine.
Slovenian: • Ko boste dosegli primeren odmerek (t. i. vzdrževalni odmerek), vam bo zdravnik morda predpisal tableto zdravila Uptravi druge jakosti, tako da boste za vnos ustrezne količine zdravila morali vzeti le eno tableto zjutraj in eno zvečer.
English: It is available as tablets to be taken by mouth.
Slovenian: Na voljo je v obliki tablet, ki se jemljejo peroralno.
English: If side effects are manageable after stepping down the dose, your doctor may decide that you should stay on that dose.
Slovenian: Če bodo neželeni učinki po zmanjšanju odmerka obvladljivi, se bo zdravnik morda odločil, da morate ostati pri tem odmerku.
English: During titration, the 200 and 800 micrograms strengths are used.
Slovenian: Med titriranjem se uporabljata jakosti 200 in 800 mikrogramov.
English: During the titration phase only the 200 and 800 microgram strengths are used.
Slovenian: V fazi povečevanja odmerka se uporabljata le jakosti 200 in 800 mikrogramov.
English: Treatment should be started at a dose of 200 micrograms twice a day, in the morning and in the evening.
Slovenian: Zdravljenje je treba začeti z odmerkom 200 mikrogramov dvakrat dnevno, zjutraj in zvečer.
English: The 200 strength is used to step the dose up and down slowly during titration.
Slovenian: Jakost 200 mikrogramov se uporablja za počasno stopenjsko povečevanje in zmanjševanje odmerka med titriranjem.
English: If the patient does not tolerate the dose, the doctor may decrease the dose.
Slovenian: Če bolnik tega odmerka ne prenaša dobro, ga lahko zdravnik zmanjša.
English: • If you tolerate this dose, your doctor will then increase your dose usually every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily as detailed in the following diagram:
Slovenian: • Če boste ta odmerek dobro prenašali, vam bo zdravnik odmerek povečeval običajno vsak teden za 200 mikrogramov dvakrat dnevno, do največ 1 600 mikrogramov dvakrat dnevno, kot je razvidno iz naslednjega diagrama:
English: Once a maintenance dose is established, the other strengths can be used to allow patients to take only one tablet in the morning and one in the evening, instead of multiple tablets each time.
Slovenian: Ko je dosežen vzdrževalni odmerek, se lahko uporabijo druge jakosti, saj tako bolniki namesto več tablet hkrati jemljejo le eno tableto zjutraj in eno zvečer.
English: If you do not tolerate the dose, the doctor may decrease the dose to the previous step.
Slovenian: Če določenega odmerka ne prenašate dobro, bo zdravnik morda zmanjšal njegovo jakost na tisto v predhodnem koraku.
English: If patients do not tolerate the dose, the dose may be decreased to the previous step.
Slovenian: Če bolniki odmerka ne prenašajo dobro, je morda treba njegovo jakost zmanjšati na tisto v predhodnem koraku.
English: • If the patient tolerates the dose, the dose can be increased weekly by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Slovenian: • Če bolnik odmerek dobro prenaša, se lahko odmerek tedensko povečuje za 200 mikrogramov dvakrat dnevno, do največ 1 600 mikrogramov dvakrat dnevno.
English: If the patient tolerates the dose, the doctor may increase the dose every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Slovenian: Če bolnik ta odmerek dobro prenaša, lahko zdravnik odmerek tedensko povečuje za 200 mikrogramov dvakrat dnevno, do največ 1 600 mikrogramov dvakrat dnevno.
English: In this case you should refer to the following diary page to help you keep track of the number of tablets you need to take:
Slovenian: V tem primeru pri sledenju števila tablet, ki jih morate vzeti, upoštevajte naslednjo stran v dnevniku:
English: Use the diary boxes corresponding to the strength of tablets you take.
Slovenian: Ko vzamete tableto, to označite v okvirčku dnevnika, ki ustreza jakosti vzete tablete.
English: This overview was last updated in 01-2019.
Slovenian: Pregled je bil nazadnje posodobljen 01-2019.
English: This was switched to a full marketing authorisation on 18 June 2018.
Slovenian: To je bilo 18. junija 2018 spremenjeno v običajno dovoljenje za promet.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations.
English: What measures are being taken to ensure the safe and effective use of Blincyto?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Blincyto?
English: Patients will also be provided with a patient alert card.
Slovenian: Bolniki bodo prav tako prejeli opozorilno kartico za bolnika.
English: The European Medicines Agency decided that Blincyto's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Blincyto večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Blincyto received a conditional marketing authorisation valid throughout the EU on 23 November 2015.
Slovenian: Za zdravilo Blincyto je bilo 23. novembra 2015 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: Blincyto has also been studied in a main study in 116 patients with minimal residual disease.
Slovenian: Zdravilo Blincyto so proučevali tudi v eni glavni študiji s 116 bolniki z minimalno rezidualno boleznijo.
English: The company that markets Blincyto will provide data from two studies looking at the safety and use of Blincyto in clinical practice.
Slovenian: Podjetje, ki trži zdravilo Blincyto, bo zagotovilo podatke iz dveh študij, v katerih proučujejo varnost in uporabo zdravila Blincyto v klinični praksi.
English: Further information on Blincyto can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/blincyto.
Slovenian: Nadaljnje informacije o zdravilu Blincyto so na voljo na spletni strani agencije: ema.europa.eu/medicines/Human/EPAR/blincyto.
English: As for all medicines, data on the use of Blincyto are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Blincyto stalno spremljajo.
English: Treatment may be interrupted or stopped altogether in case of certain side effects.
Slovenian: Zdravljenje se lahko v primeru nekaterih neželenih učinkov začasno ali dokončno prekine.
English: It also attaches to a protein (CD3) on T cells (another type of white blood cell).
Slovenian: Veže se tudi na beljakovino (CD3) na celicah T (drugi vrsti belih krvnih celic).
English: Other information about Blincyto
Slovenian: Druge informacije o zdravilu Blincyto
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blincyto 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 Blincyto upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Patients lived for an average of around 6 months before the cancer came back, which could enable suitable patients to have a blood stem cell transplant.
Slovenian: Bolniki so pred ponovitvijo raka povprečno živeli približno šest mesecev, kar bi lahko primernim bolnikom omogočilo prejem presadka matičnih krvnih celic.
English: The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infections, fever, infusion-related reactions (like fever, changes in blood pressure and rash), headache, febrile neutropenia (low levels a type of white blood cell counts called neutrophils with fever), anaemia (low red blood cell counts), oedema (swelling because of fluid retention), neutropenia, leukopenia (low levels of white blood cell), thrombocytopenia (low platelet count), blood tests showing changes in liver function, tremor (shaking), back pain, chills, low blood pressure, low levels of immunoglobulins (antibodies), cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), rapid heartbeat, insomnia (difficulty sleeping), pain in the arms and legs, cough and rash.
Slovenian: Najpogostejši neželeni učinki zdravila Blincyto (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe, zvišana telesna temperatura, infuzijske reakcije (kot so zvišana telesna temperatura, spremembe krvnega tlaka in izpuščaj), glavobol, febrilna nevtropenija (nizke vrednosti vrste belih krvnih celic, imenovanih nevtrofilci, skupaj s povišano telesno temperaturo), anemija (nizke ravni rdečih krvnih celic), edem (otekanje zaradi zastajanja tekočine), nevtropenija, levkopenija (nizke ravni belih krvnih celic), trombocitopenija (nizke ravni trombocitov), rezultati krvnih preiskav, ki kažejo na spremembe delovanja jeter, tremor (tresenje), bolečine v hrbtu, mrzlica, nizek krvni tlak, nizke vrednosti imunoglobulinov (protiteles), sindrom sproščanja citokinov (možno smrtno nevarno stanje, ki lahko povzroči zvišano telesno temperaturo, bruhanje, zasoplost, bolečino in nizek krvni tlak), hiter srčni utrip, nespečnost (težave s spanjem), bolečine v rokah in nogah, kašelj in izpuščaj.
English: Side effects reported with Blincyto are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Blincyto, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Blincyto, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Blincyto glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Results showed that around 78% of patients did not have measurable residual cancer cells after treatment with Blincyto.
Slovenian: Rezultati so pokazali, da približno 78 % bolnikov po zdravljenju z zdravilom Blincyto ni imelo merljivih rezidualnih rakavih celic.
English: What benefits of Blincyto have been shown in studies?
Slovenian: Kakšne koristi zdravila Blincyto so se pokazale v študijah?
English: The study found that ALL improved in 43% (81 out of 189) of patients given Blincyto.
Slovenian: V študiji je bilo ugotovljeno, da se je stanje akutne limfoblastne levkemije izboljšalo pri 43 % (81 od 189) bolnikov, ki so prejemali zdravilo Blincyto.
English: An overview of Blincyto and why it is authorised in the EU
Slovenian: Pregled zdravila Blincyto in zakaj je odobreno v EU
English: Blincyto was given ‘conditional approval' but the company has provided more evidence about the medicine and the Agency has recommended that the Blincyto's marketing authorisation should no longer be conditional.
Slovenian: Zdravilo Blincyto je pridobilo „pogojno dovoljenje za promet“, vendar je podjetje zagotovilo več dokazov o zdravilu, zato je agencija priporočila, naj se dovoljenje za promet z zdravilom Blincyto iz pogojnega spremeni v običajno.
English: The safety profile of Blincyto was considered acceptable provided that recommendations on its use are observed.
Slovenian: Navedla je, da je varnostni profil zdravila Blincyto sprejemljiv ob upoštevanju priporočil za njegovo uporabo.
English: Why is Blincyto authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Blincyto odobreno v EU?
English: In this study, Blincyto was not compared with any other treatment.
Slovenian: V tej študiji zdravila Blincyto niso primerjali z nobenim drugim zdravilom.
English: For treatment of patients with minimal residual disease, the dose depends on the patient's bodyweight.
Slovenian: Pri zdravljenju bolnikov z minimalno rezidualno boleznijo je odmerek odvisen od bolnikove telesne mase.
English: What are the risks associated with Blincyto?
Slovenian: Kakšna tveganja so povezana z zdravilom Blincyto?
English: Patients who have no signs of cancer after 2 cycles may be treated with up to 3 additional cycles of Blincyto if the benefits outweigh the risks for the patient.
Slovenian: Bolniki, ki po dveh ciklusih zdravljenja nimajo znakov raka, lahko prejmejo do tri dodatne cikluse zdravljenja z zdravilom Blincyto, če pri posameznem bolniku koristi odtehtajo tveganja.
English: The company will also provide patients and healthcare professionals with educational materials on how to give Blincyto and how to manage risks with the medicine.
Slovenian: Bolnikom in zdravstvenim delavcem bo tudi zagotovilo izobraževalno gradivo o dajanju tega zdravila ter o obvladovanju tveganj, povezanih z njim.
English: Patients should also be given chemotherapy medicines injected in the spine area to prevent leukaemia in the nervous system.
Slovenian: Bolnikom je prav tako treba v hrbtenico injicirati kemoterapevtska zdravila, da bi preprečili levkemijo v živčevju.
English: ALL is rare, and Blincyto was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Slovenian: Akutna limfoblastna levkemija je redka bolezen, zato je bilo zdravilo Blincyto 24. julija 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: What is Blincyto and what is it used for?
Slovenian: Kaj je zdravilo Blincyto in za kaj se uporablja?
English: In most patients whose ALL improved, there was no evidence of cancer cells left.
Slovenian: Pri večini bolnikov, pri katerih se je stanje akutne limfoblastne levkemije izboljšalo, ni bilo znakov preostalih rakavih celic.
English: The most serious side effects were infections, neutropenia with or without fever, neurological events (such as confusion, shaking, dizziness, numbness or tingling), cytokine release syndrome, and tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Slovenian: Med najresnejšimi neželenimi učinki so bili okužbe, nevtropenija z zvišano telesno temperaturo ali brez nje, nevrološki dogodki (kot so zmedenost, tresenje, omotičnost, omrtvelost ali mravljinčenje), sindrom sproščanja citokinov in sindrom lize tumorja (zaplet zaradi razgradnje rakavih celic).
English: Blincyto is used in patients who are ‘Philadelphia-chromosome-negative' which means that the patients' cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).
Slovenian: Zdravilo Blincyto se uporablja pri bolnikih z negativnim kromosomom Philadelphia, kar pomeni, da rakave celice pri teh bolnikih nimajo nenormalnega kromosoma, imenovanega kromosom Philadelphia, in pri bolnikih, ki imajo na svojih rakavih celicah beljakovino CD19 (CD19-pozitivni).
English: Blincyto can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Slovenian: Predpisovanje in izdaja zdravila Blincyto je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
English: In B-precursor ALL, certain cells that give rise to B cells (a type of white blood cell) multiply too quickly and eventually these abnormal cells replace normal blood cells.
Slovenian: Pri akutni limfoblastni levkemiji predhodniških celic B se nekatere celice, iz katerih nastajajo celice B (vrsta belih krvnih celic), razmnožujejo prehitro, zaradi česar te nenormalne celice sčasoma nadomestijo normalne krvne celice.
English: The main measure of effectiveness was based on the percentage of patients whose ALL improved after 2 treatment cycles, measured as resolution of signs of leukaemia and complete or partial return of blood cell counts to normal.
Slovenian: Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, pri katerih se je stanje akutne limfoblastne levkemije izboljšalo po dveh ciklusih zdravljenja, kar je bilo merjeno kot izginotje znakov levkemije in popolna oziroma delna normalizacija števila krvničk.
English: Before receiving Blincyto, patients should be given medicines to prevent fever and reactions to the infusion.
Slovenian: Bolniki morajo pred prejemom zdravila Blincyto prejeti zdravila za preprečevanje zvišane telesne temperature in reakcij na infundiranje.
English: Blincyto is infused continuously during a treatment cycle of 4 weeks.
Slovenian: Zdravilo Blincyto se infundira neprestano med celotnim štiritedenskim ciklusom zdravljenja.