FrancophonIA/ELRC3.0 huggingface dataset:
English: • One Seebri Breezhaler inhaler
Slovenian: • en inhalator Enurev Breezhaler,
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Enurev Breezhaler and were well tolerated.
Slovenian: Zdravi prostovoljci so dobro prenašali najvišjo koncentracijo učinkovine v plazmi in celotno sistemsko izpostavljenost po intravenski aplikaciji 150 mikrogramov glikopironijevega bromida (kar ustreza 120 mikrogramom glikopironija).
English: What Enurev Breezhaler is
Slovenian: Kaj je zdravilo Enurev Breezhaler
English: Disposing of the inhaler after use
Slovenian: Vprašajte farmacevta o načinu odstranjevanja inhalatorja po uporabi.
English: Enurev Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Slovenian: Bolniki z blago do zmerno okvaro ledvic lahko uporabljajo zdravilo Enurev Breezhaler v priporočenem odmerku.
English: The dose is 3 capsules per day, taken together at the same time each day.
Slovenian: Odmerek so tri kapsule na dan, ki se vzamejo skupaj, vsak dan ob istem času.
English: Treatment should continue until the disease gets worse.
Slovenian: Zdravljenje je treba nadaljevati, dokler se stanje bolezni ne poslabša.
English: What measures are being taken to ensure the safe and effective use of Zejula?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zejula?
English: The most common side effects with Zejula (which may affect more than 1 in 10 people) are nausea (feeling sick), thrombocytopenia (low blood platelet counts), tiredness and weakness, anaemia (low red blood cell counts), constipation, vomiting, abdominal (belly) pain, neutropenia (low levels of neutrophils, a type of white blood cell), insomnia (difficulty sleeping), headache, lack of appetite, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dyspnoea (difficulty breathing), hypertension (high blood pressure), dyspepsia (heartburn), back pain, dizziness, cough, urinary tract infection (infection of the structures that carry urine), joint pain, palpitations and dysgeusia (taste disturbances).
Slovenian: Najpogostejši neželeni učinki zdravila Zejula (ki se lahko pojavijo pri več kot 1 bolnici od 10) so navzeja (slabost), trombocitopenija (nizka raven trombocitov v krvi), utrujenost in šibkost, anemija (nizka raven rdečih krvnih celic), zaprtje, bruhanje, bolečine v trebuhu, nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic), nespečnost (težave s spanjem), glavobol, pomanjkanje teka, nazofaringitis (vnetje nosu in grla), driska, dispneja (težave z dihanjem), hipertenzija (visok krvni tlak), dispepsija (zgaga), bolečine v hrbtu, omotica, kašelj, okužba sečil (okužba struktur, ki prenašajo urin), bolečine v sklepih, palpitacije in disgevzija (motnje okušanja).
English: Other information about Zejula
Slovenian: Druge informacije o zdravilu Zejula
English: Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again.
Slovenian: Čeprav so na voljo zdravila za napredovalega, ponovljenega raka jajčnikov, se bolezen neizogibno vrne.
English: This is a summary of the European public assessment report (EPAR) for Zejula.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zejula.
English: The European Medicines Agency therefore decided that Zejula's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Zejula večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Zejula is available as capsules (100 mg) to be taken by mouth.
Slovenian: Zdravilo Zejula je na voljo v obliki kapsul (100 mg), ki se jemljejo peroralno.
English: Serious side effects include thrombocytopenia and anaemia.
Slovenian: Resni neželeni učinki vključujejo trombocitopenijo in anemijo.
English: This may allow the next cycle of platinum-based therapy to be delayed.
Slovenian: S tem se naslednji cikel zdravljenja na osnovi platine odloži.
English: The medicine is given after treatment with platinumbased medicines, when the tumour is diminishing in size or has completely disappeared.
Slovenian: Zdravilo se daje po zdravljenju z zdravili na osnovi platine, ko se tumor zmanjšuje ali je popolnoma izginil.
English: The active substance in Zejula, niraparib, blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells.
Slovenian: Zdravilna učinkovina v zdravilu Zejula, niraparib, zavira delovanje encimov, imenovanih PARP-1 in PARP-2, ki pomagata popravljati poškodovano DNK v celicah med delitvijo celic, ko nastajajo nove celice.
English: It is not intended to provide practical advice on how to use Zejula.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: By blocking PARP enzymes, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Slovenian: Z zaviranjem encimov PARP se poškodovana DNK v rakavih celicah ne more popraviti in posledično rakave celice odmrejo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zejula 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 Zejula upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Regarding safety, side effects are generally manageable with dose reductions.
Slovenian: Kar zadeva varnost, so neželeni učinki z zmanjšanjem odmerka na splošno obvladljivi.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Zejula 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 Zejula je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Zejula approved?
Slovenian: Zakaj je bilo zdravilo Zejula odobreno?
English: What are the risks associated with Zejula?
Slovenian: Kakšna tveganja so povezana z zdravilom Zejula?
English: For more information about treatment with Zejula, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zejula preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Zejula have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zejula izkazalo v študijah?
English: Because the number of patients with ovarian cancer is low, the disease is considered ‘rare', and Zejula was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Slovenian: Ker je bolnic z rakom jajčnikov malo, velja ta bolezen za redko, zato je bilo zdravilo Zejula 4. avgusta 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Zejula must not be used in women who are breastfeeding.
Slovenian: Zdravila Zejula ne smejo uporabljati doječe matere.
English: What is Zejula and what is it used for?
Slovenian: Kaj je zdravilo Zejula in za kaj se uporablja?
English: Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).
Slovenian: Bolnice, zdravljene z zdravilom Zejula, so v povprečju živele 11,3 meseca brez poslabšanja bolezni, bolnice, zdravljene s placebom (zdravilom brez zdravilne učinkovine), pa 4,7 meseca.
English: Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers.
Slovenian: Bolnice v študiji so imeli serozni epitelijski karcinom jajčnika visoke stopnje, ki je vključeval tudi raka jajcevodov ali peritoneja.
English: Zejula is a cancer medicine used in adult women with a type of advanced cancer of the ovary called ‘high grade serous epithelial ovarian cancer', including cancer of the fallopian tubes (the tubes connecting the ovaries to the uterus) and cancer of the peritoneum (the membrane lining the abdomen).
Slovenian: Zejula je zdravilo za zdravljenje raka, ki se uporablja pri odraslih ženskah z vrsto napredovalega raka jajčnikov, imenovanega „serozni epitelijski karcinom jajčnika visoke stopnje“, ki vključuje tudi raka jajcevodov (cevastih organov, ki povezujejo jajčnike z maternico) in raka peritoneja (mrene v trebušni votlini).
English: The full EPAR for Zejula 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 Zejula je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients had undergone treatment with two or more platinum-based therapies, with a lasting response (the cancer had not progressed for at least 6 months) before the last platinum-based therapy.
Slovenian: Bolnice so se pred zadnjim zdravljenjem na osnovi platine zdravile z enim ali dvema zdravljenjema na osnovi platine, pri čemer je bil odziv dolgotrajen (rak vsaj šest mesecev ni napredoval).
English: For practical information about using Zejula, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zejula naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Zejula is used on its own for the ‘maintenance' treatment of patients who have relapsed disease (when the cancer comes back after previous treatment).
Slovenian: Zdravilo Zejula se uporablja samostojno za vzdrževalno zdravljenje bolnic z relapsom bolezni (ponovnim pojavom raka po predhodnem zdravljenju).
English: For the full list of all side effects reported with Zejula, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zejula, glejte navodilo za uporabo.
English: Zejula contains the active substance niraparib.
Slovenian: Zdravilo vsebuje zdravilno učinkovino niraparib.
English: How is Zejula used?
Slovenian: Kako se zdravilo Zejula uporablja?
English: How does Zejula work?
Slovenian: Kako zdravilo Zejula deluje?
English: Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies.
Slovenian: Dokazali so, da zdravilo Zejula pri bolnicah, ki so se odzvale na zdravljenje na osnovi platine, podaljša čas do poslabšanja bolezni.
English: Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients.
Slovenian: V glavni študiji, ki je vključevala 553 bolnic, so dokazali, da zdravilo Zejula podaljša čas brez poslabšanja bolezni.
English: Treatment may be interrupted and the dose may be reduced in patients who experience side effects.
Slovenian: Pri bolnicah, ki imajo neželene učinke, se zdravljenje lahko prekine ali odmerek zmanjša.
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Slovenian: Datum prve odobritve: 19. julij 2006 Datum zadnjega podaljšanja: 9. november 2016
English: You may require medical attention.
Slovenian: Morda boste potrebovali zdravniško oskrbo.
English: Long-term safety in MRCC
Slovenian: Dolgoročna varnost pri MRCC
English: e Median not achieved because the data were not yet mature.
Slovenian: e Mediana ni bila dosežena, ker podatki še niso bili popolni.
English: The median DR and OS had not yet been reached.
Slovenian: Mediani DR in OS še nista doseženi.
English: Patients were treated until disease progression or withdrawal from the study.
Slovenian: Bolnike so zdravili dokler bolezen ni napredovala ali do umika iz študije.
English: - If you are going to have surgery or if you had an operation recently.
Slovenian: - Če boste imeli kirurški poseg ali če ste pred kratkim imeli operacijo.
English: The primary active metabolite comprises 23% to 37% of the total exposure.
Slovenian: Primarni aktivni presnovek predstavlja od 23 % do 37 % celotne izpostavljenosti.
English: Most of these findings were reversible after 2 to 6 weeks without treatment.
Slovenian: Večina teh najdb je bila po 2 do 6 tednih brez zdravljenja reverzibilna.
English: Do not take Sutent:
Slovenian: Ne jemljite zdravila Sutent:
English: Invasive dental procedures are also an identified risk factor.
Slovenian: Invazivni zobozdravstveni posegi so prav tako znani dejavnik tveganja.
English: The study was closed at the time of planned interim analysis due to the lack of disease control.
Slovenian: Študijo so v času načrtovane vmesne analize zaključili zaradi pomanjkanja nadzora nad boleznijo.
English: What Sutent is and what it is used for
Slovenian: Kaj je zdravilo Sutent in za kaj ga uporabljamo
English: Daily dose should not exceed 75 mg nor be decreased below 25 mg.
Slovenian: Dnevni odmerek ne sme preseči 75 mg in ne sme biti manjši od 25 mg.
English: Fisher's Exact test
Slovenian: Fisherjev eksaktni test
English: OS (weeks)
Slovenian: OS (tedni)
English: • Abnormally decreased/increased sensitivity, particularly to touch.
Slovenian: • nenormalno zmanjšanje/povečanje občutljivosti, zlasti na dotik
English: Sutent with food and drink
Slovenian: Zdravilo Sutent skupaj s hrano in pijačo
English: No significant differences in safety or efficacy were observed between younger and older patients.
Slovenian: Med starejšimi in mlajšimi bolniki niso opazili pomembnih razlik v varnosti in učinkovitosti.
English: - If you have high blood pressure.
Slovenian: - Če imate visok krvni tlak.
English: • Pain in arms and legs.
Slovenian: • bolečine v rokah in nogah
English: • Decreased blood sugar level (see section 2)..
Slovenian: • znižana raven sladkorja v krvi (glejte poglavje 2)
English: Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent.
Slovenian: Zdravnik bo določil ustrezen odmerek, ki ga morate vzeti, pa tudi če in kdaj boste morali prekiniti zdravljenje z zdravilom Sutent.
English: • Changes in the electrical activity or abnormal rhythm of the heart.
Slovenian: • spremembe v električni aktivnosti ali nenormalen ritem srca
English: Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over.
Slovenian: Približno ena tretjina bolnikov v kliničnih študijah, ki so prejemali sunitinib, je bilo starih 65 let ali več.
English: In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Slovenian: Tako v klinični študiji kot tudi objavah se je varnostni profil ujemal s poznanim varnostnim profilom pri odraslih.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj posamezne razvrstitve pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The primary efficacy endpoint of this study was ORR.
Slovenian: Primarni opazovani dogodek učinkovitosti v tej študiji je bil ORR.
English: Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Sutent is not recommended for people aged under 18.
Slovenian: Uporaba zdravila Sutent ni priporočljiva za osebe, mlajše od 18 let.
English: Your doctor will decide when to start Sutent again.
Slovenian: Zdravnik bo odločil, kdaj ponovno pričeti z jemanjem zdravila Sutent.
English: These data suggest that sunitinib increases the risk of cardiomyopathy.
Slovenian: Ti podatki nakazujejo, da sunitinib povečuje tveganje za kardiomiopatijo.
English: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italy
Slovenian: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italija
English: Some medicines can affect the levels of Sutent in your body.
Slovenian: Nekatera zdravila lahko vplivajo na raven zdravila Sutent v vašem telesu.
English: If the diagnosis of SJS or TEN is confirmed, treatment must not be restarted.
Slovenian: Če je diagnoza SJS ali TEN potrjena, se zdravljenja ne sme ponovno uvesti.
English: If you forget to take Sutent
Slovenian: Če ste pozabili vzeti zdravilo Sutent
English: Sutent can raise blood pressure.
Slovenian: Zdravilo Sutent lahko zviša krvni tlak.
English: Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
Slovenian: Bisfosfonati so zdravila za preprečevanje kostnih zapletov, ki jih lahko prejemate za drugo bolezensko stanje.
English: • Abnormal sensations in extremities.
Slovenian: • nenormalni občutki v okončinah
English: Use of somatostatin analogues was allowed in the study.
Slovenian: V študiji je bila dovoljena uporaba analogov somatostatina.
English: Food has no effect on the bioavailability of sunitinib.
Slovenian: Hrana ne vpliva na biološko uporabnost sunitiniba.
English: Total oral clearance (CL/F) was 34-62 L/h.
Slovenian: Celotni peroralni očistek (CL/F) je bil 34-62 l/uro.
English: • Extreme tiredness, loss of strength.
Slovenian: • huda utrujenost, izguba moči
English: Paediatric population The safety and efficacy of Sutent in patients below 18 years of age have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Sutent pri bolnikih, mlajših od 18 let, nista bili dokazani.
English: These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
Slovenian: To so lahko simptomi težav s srcem, ki lahko vključujejo srčno popuščanje in težave s srčno mišico (kardiomiopatija).
English: IT-63100 Marino del Tronto (Ascoli Piceno) Italy
Slovenian: IT-63100 Marino del Tronto (Ascoli Piceno) Italija
English: The PK were similar in all solid tumours populations tested and in healthy volunteers.
Slovenian: FK je bila pri vseh testiranih populacijah s čvrstimi tumorji in pri zdravih prostovoljcih podobna.
English: Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated.
Slovenian: Zdravnik vam bo predpisal odmerek, ki je za vas primeren, v odvisnosti od vrste rakavega obolenja, ki ga je treba zdraviti.
English: You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):
Slovenian: Nemudoma obvestite zdravnika, če opazite katerega od naslednjih resnih neželenih učinkov (glejte tudi poglavje Kaj morate vedeti, preden boste vzeli zdravilo Sutent):
English: The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Slovenian: Varnosti nadaljnjega zdravljenja s sunitinibom pri bolnikih z zmerno do hudo proteinurijo niso sistematično ovrednotili.
English: The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Slovenian: Genotoksični potencial sunitiniba so ocenili in vitro in in vivo.
English: • Swelling caused by fluid under the skin and around the eye, deep allergic rash.
Slovenian: • otekanje, ki ga povzroča tekočina pod kožo in okoli oči, globok alergijski izpuščaj
English: (not exceeding the total dose of 50 mg/day).
Slovenian: (odmerki niso presegli celokupnega odmerka 50 mg/dan).
English: It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
Slovenian: Uporablja se za zdravljenje raka, deluje pa tako, da zavira aktivnost posebne skupine beljakovin, ki sodelujejo pri rasti in razširjanju rakavih celic.
English: These patients should be monitored closely and treated as clinically indicated, and prophylactic hydration should be considered.
Slovenian: Te bolnike je treba skrbno spremljati in obravnavati, kot je klinično indicirano, ter razmisliti o profilaktični hidraciji.
English: Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Slovenian: Opisali so primere proteinurije in redke primere nefrotskega sindroma.
English: The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in Table 2:
Slovenian: Analize primarnih in sekundarnih opazovanih dogodkov v fazi odprte študije so potrdile rezultate, pridobljene v času vmesne analize, kot je prikazano v spodnji Preglednici 2:
English: - If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
Slovenian: - če ste alergični na sunitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Slovenian: Preglednica 4 - Rezultati učinkovitosti pri pNET v študiji 3. faze Parameter učinkovitosti
English: What you need to know before you take Sutent
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sutent
English: The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Slovenian: Primarni opazovani dogodek učinkovitosti v tej študiji je bil TTP, opredeljen kot čas od randomizacije do prvega dokumentiranega objektivnega napredovanja tumorja.
English: No patients had a QTc interval > 500 msec.
Slovenian: Noben bolnik ni imel vrednosti intervala QTc > 500 milisekund.
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Slovenian: - Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali kaže znake, da ga je že kdo odpiral.
English: There were no Grade 5 adverse reactions in either group.
Slovenian: V nobeni skupini ni bilo neželenih učinkov 5. stopnje.
English: - If you have heart problems.
Slovenian: - Če imate težave s srcem.
English: • Loss of protein in the urine sometime resulting in swelling.
Slovenian: • izguba beljakovin z urinom, ki včasih povzroči otekanje
English: Median PFS was 2.3 months in the HGG group and 2.7 months in the ependymoma group.
Slovenian: Mediano PFS je bilo 2,3 meseca v skupini s HGG in 2,7 meseca v skupini z ependimomom.
English: Treatment with Sutent may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot.
Slovenian: Zdravljenje z zdravilom Sutent lahko povzroči večje tveganje za krvavitve ali privede do sprememb v številu določenih celic v krvi, kar lahko privede do slabokrvnosti ali vpliva na sposobnost strjevanja vaše krvi.
English: Other side effects with Sutent may include:
Slovenian: Drugi neželeni učinki med zdravljenjem z zdravilom Sutent lahko vključujejo:
English: Other medicines and Sutent
Slovenian: Druga zdravila in zdravilo Sutent