FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact your <doctor><midwife> if the pain and/or fever are not reduced or if you need to take the medicine more often.
Slovenian: Posvetujte se z <zdravnikom> <babico>, če bolečina ne mine in/ali se telesna temperatura ne zniža ali če morate zdravilo vzeti pogosteje.
English: Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache, decreased blood levels of calcium and visual disturbances.
Slovenian: Znaki in simptomi okvare delovanja teh žlez lahko vključujejo izčrpanost (ekstremno utrujenost), spremembe telesne mase ali glavobol, znižane ravni kalcija v krvi in motnje vida.
English: Nivolumab - Hypoparathyroidism (EPITT no 19310)
Slovenian: Nivolumab - hipoparatiroidizem (št. EPITT 19310)
English: You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.
Slovenian: Uporabljati morate najmanjši možni odmerek, ki še lajša bolečino in/ali zniža povišano telesno temperaturo, ter ga uporabljati čim krajši čas.
English: What you need to know before you use OPDIVO Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO
English: Other immune-related adverse reactions: […] Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported post-marketing (see section 4.8).
Slovenian: Drugi imunsko pogojeni neželeni učinki […] V obdobju trženja zdravila so poročali o primerih sindroma Vogt-Koyanagi-Harada in hipoparatiroidizma (glejte poglavje 4.8).
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/157160/2019
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/189303/2019
English: A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity.
Slovenian: Veliko število podatkov pri nosečnicah ne kaže na pojav prirojenih napak niti na toksičnost za plod oziroma novorojenčka.
English: Frequency: Not known for nivolumab monotherapy / nivolumab in combination with ipilimumab [Table key: h Post-marketing event (also see section 4.4)]
Slovenian: Pogostnost: Neznana pogostnost pri nivolumabu v monoterapiji/nivolumabu v kombinaciji z ipilimumabom [Legenda preglednice: h Neželeni učinek v obdobju trženja zdravila (glejte tudi poglavje 4.4)] Navodilo za uporabo
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Slovenian: Opozorila in previdnostni ukrepi težave z žlezami, ki izločajo hormone (vključno s hipofizo, ščitnico, obščitnično žlezo in nadledvičnimi žlezami).
English: The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 13. aprila 2004 in 13. aprila 2009.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Beromun to Boehringer Ingelheim International GmbH on 13 April 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Beromun, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 13. aprila 1999.
English: The replacement TNFα acts in same way as the naturally produced protein.
Slovenian: Nadomestni TNFα deluje enako kot naravno proizvedena beljakovina..
English: Other information about Beromun:
Slovenian: Druge informacije o zdravilu Beromun:
English: Beromun is not recommended for patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Slovenian: Uporaba zdravila Beromun pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: Beromun is usually only used once, but a second perfusion can be considered six to eight weeks after the first.
Slovenian: Zdravilo Beromun se običajno uporabi samo enkrat, vendar pa se ponovna perfuzija lahko izvede najmanj šest do osem tednov po prvi.
English: What benefit has Beromun shown during the studies?
Slovenian: Kakšne koristi je zdravilo Beromun izkazalo med študijami?
English: Therefore, the main measure of effectiveness was based on the experts' assessment of the outcome of these 145 patients, in comparison with the outcome that would be expected without using Beromun.
Slovenian: Glavno merilo učinkovitosti je zato temeljilo na ocenah, ki so jih podali strokovnjaki o rezultatih pri teh 145 bolnikih, v primerjavi s pričakovanim rezultatom brez uporabe zdravila Beromun.
English: It contains the active substance tasonermin.
Slovenian: Vsebuje zdravilno učinkovino tasonermin.
English: There were too few patients also receiving interferon-gamma to determine whether this improved the patients' outcome further.
Slovenian: Bolnikov, ki so prejemali tudi interferon gama, je bilo premalo, da bi lahko potrdili, ali je to pri bolnikih dodatno izboljšalo izid.
English: It can be used before surgery to reduce the size of a tumour, or instead of surgery when the tumour cannot be removed by surgery alone.
Slovenian: Lahko se uporablja pred operacijo za zmanjšanje velikosti tumorja ali namesto operacije, kadar tumorja ni mogoče odstraniti samo z operacijo.
English: The Committee recommended that Beromun be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Beromun odobri dovoljenje za promet.
English: The remains of the tumour should be removed whenever this is possible, usually after several weeks.
Slovenian: Če je le mogoče, je treba preostanke tumorja kirurško odstraniti, navadno po nekaj tednih.
English: Beromun has been studied in four main studies involving a total of 188 patients, in which it was given in combination with melphalan.
Slovenian: Zdravilo Beromun so proučevali v štirih glavnih študijah s skupno 188 bolniki, v katerih je bilo to zdravilo uporabljeno v kombinaciji z melfalanom.
English: The exact way that TNFα works against certain types of cancer is not fully understood, but it is thought that it can kill tumour cells directly, as well as destroy the blood vessels supplying tumours and stimulate the immune system to attack them.
Slovenian: Natančen način delovanja TNFα proti določenim vrstam raka ni v celoti znan, vendar se domneva, da lahko neposredno ubija tumorske celice, uničuje krvne žile, ki dovajajo snovi v tumorje, ter spodbudi imunski sistem, da jih napade.
English: A review of the studies by three independent experts found that only 145 of these patients were candidates for amputation or surgical removal of the tumour that would have resulted in significant loss of function (disability).
Slovenian: Ob pregledu študij so trije neodvisni strokovnjaki ugotovili, da je bilo izmed teh bolnikov samo 145 takšnih, ki bi bili primerni za amputacijo ali kirurško odstranitev tumorja, ki bi povzročila bistveno zmanjšano funkcionalnost (invalidnost).
English: The centres must also have intensive care units readily available and facilities to continuously look out for leakage of the medicine into the rest of the body using radioactive tracers.
Slovenian: Centri morajo imeti tudi oddelek za intenzivno nego in opremo za neprekinjeno spremljanje uhajanja zdravila v preostalo telo z radioaktivnimi sledilci.
English: Sixty-two of the patients also received interferon-gamma (another anticancer medicine).
Slovenian: Dvainšestdeset bolnikov je prejemalo tudi interferon gama (drugo zdravilo proti raku).
English: This leads to the tumour dying back and getting smaller, particularly when the medicine is combined with other cytotoxic (cellkilling) medicines and raised temperature.
Slovenian: To povzroči, da tumor odmira in se manjša, še zlasti takrat, kadar se zdravilo daje v kombinaciji z drugimi citotoksičnimi zdravili (zdravili za uničenje celic) in ob povišani temperaturi.
English: What is the risk associated with Beromun?
Slovenian: Kakšna tveganja so povezana z zdravilom Beromun?
English: It must also not be used in patients who cannot receive vasopressors (medicines to increase the blood pressure), anticoagulants (medicines to prevent blood clotting) or medicines that can harm the heart.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki ne smejo prejemati vazopresornih sredstev (zdravil za povečanje krvnega tlaka), antikoagulantov (zdravil za preprečevanje krvnih strdkov) ali zdravil, ki lahko škodijo srcu.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BEROMUN EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) BEROMUN Povzetek EPAR za javnost
English: The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function.
Slovenian: Neodvisni pregledovalci so se strinjali, da je imelo 62 % bolnikov, ki so prejeli zdravilo Beromun in melfalan (90 bolnikov od 145), boljši izid od pričakovanega, saj je bila njihova okončina ohranjena, ne da bi bila izvedena operativna odstranitev tumorja, oziroma je bil tumor odstranjen, ne da bi to povzročilo bistveno zmanjšanje funkcionalnosti.
English: The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNFα).
Slovenian: Zdravilna učinkovina zdravila Beromun, tasonermin, je kopija človeške beljakovine tumorjenekrotizirajočega faktorja alfa-1a (TNFα).
English: Beromun is then injected into the perfusion solution at a dose of 3 mg for an arm and 4 mg for a leg, given over 90 minutes.
Slovenian: Zdravilo Beromun se nato injicira v perfuzijsko raztopino v odmerku 3 mg za roko in 4 mg za nogo, ki se daje 90 minut.
English: Some side effects of Beromun are serious and could require a patient to spend time in an intensive care unit after treatment.
Slovenian: Nekateri neželeni učinki zdravila Beromun so resni in lahko povzročijo, da mora bolnik nekaj časa po zdravljenju ostati na oddelku za intenzivno nego.
English: The blood circulation in the limb is then replaced by the ‘perfusion' of a special liquid and the limb is warmed to a temperature of between 38 and 39°C.
Slovenian: Krvni obtok v okončini nato nadomesti „perfuzija“ (pretok) posebne tekočine, pri čemer okončino ogrevamo na temperaturo med 38 in 39 °C.
English: Other side effects seen very commonly (in more than 1 patient in 10) are infection, cardiac arrhythmia (unstable heartbeat), nausea (feeling sick), vomiting, liver damage, fatigue (tiredness), chills, pain in the limb, nerve injury, skin reactions, oedema (swelling) and wound infection.
Slovenian: Drugi zelo pogosti neželeni učinki (pri več kot 1 bolniku izmed 10) so okužba, srčna aritmija (neenakomerno bitje srca), navzeja (slabost), bruhanje, okvara jeter, utrujenost, mrzlica, bolečina v okončini, poškodba živca, kožne reakcije, edemi (otekline) in okužba ran.
English: The active substance in Beromun, tasonermin, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce TNFα.
Slovenian: Zdravilno učinkovino v zdravilu Beromun, tasonermin, proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori TNFα.
English: Beromun should not be used in people who may be hypersensitive (allergic) to tasonermin or any of the other ingredients.
Slovenian: Zdravila Beromun ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) tasonermin ali katero koli drugo sestavino zdravila.
English: Most patients taking Beromun experience fever, which is usually mild to moderate.
Slovenian: Večina bolnikov, ki prejme zdravilo Beromun, dobi vročino, ki je navadno blaga do zmerna.
English: Melphalan is given during the same operation over 60 minutes, beginning 30 minutes after the start of the Beromun perfusion, when the temperature should be increased to 39 to 40°C.
Slovenian: Med istim postopkom, 30 minut po začetku perfuzije z zdravilom Beromun, se doda melfalan v trajanju 60 minut, pri čemer je treba temperaturo povečati na 39 do 40 °C.
English: Why has Beromun been approved?
Slovenian: Zakaj je bilo zdravilo Beromun odobreno?
English: It must not be used in patients with significant cardiovascular (heart and blood vessel) disease, severe lung disease, a recent or active stomach ulcer, severe ascites (fluid accumulation in the abdomen), blood disorders, kidney or liver disease, or hypercalcaemia (high blood calcium levels), or in women who are pregnant or breast-feeding.
Slovenian: Ne smejo ga uporabljati bolniki z večjo srčnožilno boleznijo, hudo boleznijo pljuč, nedavno ali aktivno želodčno razjedo, hudim ascitesom (nabiranjem tekočine v trebušni votlini), krvnimi motnjami, obolenjem ledvic ali jeter ali hiperkalcemijo (visokimi ravnmi kalcija v krvi) ter ženske, ki so noseče ali dojijo.
English: Before Beromun is given, the limb is first isolated: while the patient is under general anaesthetic, a tight band is placed around the top of the limb to isolate its blood supply and prevent the medicine reaching the rest of the body.
Slovenian: Pred dajanjem zdravila Beromun je treba najprej izolirati okončino: medtem ko je bolnik v splošni anesteziji, se okoli zgornjega dela okončine zaveže tesen trak, ki prekine dotok krvi in preprečuje, da bi zdravilo prešlo v preostalo telo.
English: Beromun must not be used in patients who cannot receive melphalan or who cannot undergo ILP.
Slovenian: Zdravila Beromun ne smejo uporabljati bolniki, ki ne smejo prejemati melfalana ali pri katerih se izolirana perfuzija okončine ne sme izvesti.
English: Beromun is used in patients with soft tissue sarcoma (a type of cancer) of the limb (arm or leg), together with melphalan (an anticancer medicine), using a technique called ‘isolated limb perfusion' (ILP): both medicines are injected into the limb while the blood circulation in the limb is kept isolated (cut off) from the rest of the body.
Slovenian: Zdravilo Beromun se uporablja pri bolnikih s sarkomom mehkega tkiva (vrsto raka) okončin (roke ali noge) v kombinaciji z melfalanom (zdravilom proti raku), pri čemer se uporablja tehnika, imenovana „izolirana perfuzija okončine“: obe zdravili se injicirata v okončino, pri čemer je krvni obtok v tej okončini izoliran (ločen) od preostalega telesa.
English: For a more complete list of the side effects reported with Beromun, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Beromun, glejte navodilo za uporabo.
English: The full EPAR for Beromun can be found here.
Slovenian: Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Beromun je na voljo tukaj.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun's benefits are greater than its risks as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic ILP.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Beromun kot pomožni ukrep ob poznejši kirurški odstranitvi tumorja, s katerim preprečimo ali odložimo amputacijo, ali pri paliativnem zdravljenju neoperabilnih sarkomov v mehkem tkivu okončin v kombinaciji z melfalanom z blago hipertermično izolirano perfuzijo okončine večje od z njim povezanih tveganj.
English: See the Summary of Product Characteristics (also part of the EPAR) for the full list of restrictions.
Slovenian: Za celoten seznam omejitev glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Beromun is a powder and solvent that are made up into a solution for infusion.
Slovenian: Zdravilo Beromun je prašek in vehikel za pripravo raztopine za infundiranje.
English: What is Beromun used for?
Slovenian: Za kaj se zdravilo Beromun uporablja?
English: Beromun treatment should only be carried out in special centres by surgical teams who have experience in the treatment of this type of cancer and ILP.
Slovenian: Zdravljenje z zdravilom Beromun smejo izvajati samo kirurške ekipe, ki imajo izkušnje z zdravljenjem te vrste raka in s postopkom izolirane perfuzije okončin, in sicer v specialističnih centrih.
English: What is Beromun?
Slovenian: Kaj je zdravilo Beromun?
English: How has Beromun been studied?
Slovenian: Kako je bilo zdravilo Beromun raziskano?
English: The dose of melphalan depends on the size of the arm or leg. At the end of the 90-minute procedure, the medicines are flushed out of the limb using a suitable fluid.
Slovenian: Ob koncu tega 90-minutnega postopka se zdravili s primerno tekočino izpereta iz okončine.
English: How is Beromun used?
Slovenian: Kako se zdravilo Beromun uporablja?
English: How does Beromun work?
Slovenian: Kako zdravilo Beromun deluje?
English: 2 vials + 2 syringes
Slovenian: 2 viali + 2 injekcijski brizgi
English: 1 vial + 1 syringe
Slovenian: 1 viala + 1 injekcijska brizga
English: Packaging Content (concentration)
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: The main measure of effectiveness was response to treatment.
Slovenian: Glavno merilo učinkovitosti je bil odziv na zdravljenje.
English: What measures are being taken to ensure the safe and effective use of Besponsa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Besponsa?
English: What is Besponsa and what is it used for?
Slovenian: Kaj je zdravilo Besponsa in za kaj se uporablja?
English: An analysis of the first 218 patients treated showed that after at least 2 cycles of treatment, 81% (88 out of 109) of patients receiving Besponsa responded to treatment compared with 29% (32 out of 109) of patients receiving other chemotherapy.
Slovenian: Analiza prvih 218 zdravljenih bolnikov je pokazala, da se je po vsaj dveh ciklih zdravljenja na zdravljenje odzvalo 81 % (88 od 109) bolnikov, ki so prejemali zdravilo Besponsa, v primerjavi z 29 % (32 od 109) bolnikov, ki so prejemali drugo kemoterapijo.
English: What benefits of Besponsa have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Besponsa izkazalo v študijah?
English: The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle.
Slovenian: Infuzije se dajejo 1., 8. in 15. dan tri- ali štiritedenskega cikla zdravljenja.
English: It is not intended to provide practical advice on how to use Besponsa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Besponsa'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 Besponsa večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Besponsa is given as an infusion (drip) into a vein lasting for at least one hour.
Slovenian: Zdravilo Besponsa se daje kot (kapalna) infuzija v veno v trajanju vsaj ene ure.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Besponsa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Besponsa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Besponsa.
English: Why is Besponsa approved?
Slovenian: Zakaj je bilo zdravilo Besponsa odobreno?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa have 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 Besponsa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Besponsa?
Slovenian: Kakšna tveganja so povezana z zdravilom Besponsa?
English: With regard to safety, the side effects with Besponsa are similar to those of other chemotherapy medicines and can usually be managed by dose reduction or treatment interruption.
Slovenian: Kar zadeva varnost, so neželeni učinki zdravila Besponsa podobni učinkom drugih kemoterapevtskih zdravil in se jih običajno lahko obvlada z zmanjševanjem odmerka ali prekinitvijo zdravljenja.
English: In patients who do not respond to treatment, Besponsa should be stopped after 3 cycles.
Slovenian: Pri bolnikih, ki se na zdravljenje ne odzivajo, je treba zdravljenje po treh ciklih ustaviti.
English: For more information about treatment with Besponsa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Besponsa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Besponsa is used on its own in adults whose cancer has come back or did not respond to previous treatment.
Slovenian: Zdravilo Besponsa se samostojno uporablja pri odraslih, pri katerih se je rak ponovil ali ki se na prejšnje zdravljenje niso odzvali.
English: The full EPAR for Besponsa 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 Besponsa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare', and Besponsa was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 June 2013.
Slovenian: Ker je bolnikov s prekurzorsko B-celično ALL malo, velja ta bolezen za redko, zato je bilo zdravilo Besponsa 7. junija 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment.
Slovenian: Bolniki, pri katerih je zdravljenje učinkovito, vendar pri njih matične celice ne bodo presajene, lahko prejmejo do največ 6 ciklov zdravljenja.
English: Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment.
Slovenian: Bolniki, pri katerih je zdravilo Besponsa učinkovito, morajo prejeti dva ali tri cikle, čemur lahko sledi presaditev matičnih celic za zamenjavo kostnega mozga, kar je edino kurativno zdravljenje.