FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Symkevi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Symkevi odobreno v EU?
English: Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Symkevi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi have 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 Symkevi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Symkevi and why it is authorised in the EU
Slovenian: Pregled zdravila Symkevi in zakaj je odobreno v EU
English: Symkevi is available as tablets.
Slovenian: Zdravilo Symkevi je na voljo v obliki tablet.
English: For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Symkevi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor.
Slovenian: Ena tableta vsebuje 100 mg tezakaftorja in 150 mg ivakaftorja.
English: What is Symkevi and what is it used for?
Slovenian: Kaj je zdravilo Symkevi in za kaj se uporablja?
English: What are the risks associated with Symkevi?
Slovenian: Kakšna tveganja so povezana z zdravilom Symkevi?
English: Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection.
Slovenian: Kopičenje gostih in lepljivih izločkov v pljučih povzroča vnetje in dolgotrajno okužbo.
English: Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.
Slovenian: Pri bolnikih, ki so jemali zdravilo Symkevi in ivakaftor, se je FEV1 povprečno povečal za 6,5 odstotne točke, v primerjavi s povečanjem za 4,4 odstotne točke pri bolnikih, ki so jemali samo ivakaftor, in zmanjšanjem za 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Slovenian: Cistična fibroza je dedna bolezen, ki ima resne učinke na pljuča, prebavila in druge organe.
English: These actions make mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Slovenian: S temi učinkovanji se razredčijo sluz in prebavni sokovi, s čimer se ublažijo simptomi bolezni.
English: Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone.
Slovenian: Zdravilo Symkevi je treba jemati skupaj s še enim zdravilom, ki vsebuje samo 150 mg ivakaftorja.
English: The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.
Slovenian: Te mutacije zmanjšujejo število beljakovin CFTR na celični površini ali pa vplivajo na način delovanja beljakovine.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Slovenian: Cistično fibrozo povzročajo mutacije v genu CFTR.
English: Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017.
Slovenian: Cistična fibroza je redka bolezen, zato je bilo zdravilo Symkevi 27. februarja 2017 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Symkevi should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Slovenian: Zdravilo Symkevi lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze, in sicer samo bolnikom, ki imajo potrjene zgoraj opisane mutacije.
English: As a result, these secretions become thick and cause blockage.
Slovenian: Posledično se tovrstni izločki zgostijo in povzročajo zaporo.
English: Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above.
Slovenian: Symkevi je zdravilo za zdravljenje cistične fibroze pri bolnikih, starejših od 12 let.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Slovenian: Po 24 tednih zdravljenja se je FEV1 pri bolnikih, ki so jemali zdravilo Symkevi v kombinaciji z ivakaftorjem, povprečno povečal za 3,4 odstotne točke, pri bolnikih, ki so jemali placebo, pa se je zmanjšal za 0,6 odstotne točke.
English: In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking.
Slovenian: V prvi skupini je zdravilo Symkevi lahko možnost zdravljenja zlasti pri tistih, ki zaradi neželenih učinkov ali medsebojnega vplivanja drugih zdravil, ki jih prejemajo, ne morejo prejemati kombinacije ivakaftorja in lumakaftorja (še enega zdravila za zdravljenje cistične fibroze).
English: One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein.
Slovenian: Ena od učinkovin v zdravilu Symkevi, tezakaftor, poveča število beljakovin CFTR na celični površini, druga učinkovina, ivakaftor, pa poveča delovanje okvarjene beljakovine CFTR.
English: Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Slovenian: Zdravilo Symkevi se uporablja pri bolnikih z mutacijo (spremembo), imenovano F508del, v genu za beljakovino, imenovano „regulator transmembranske prevodnosti pri cistični fibrozi“ (CFTR).
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Slovenian: V črevesju zapora vodov iz trebušne slinavke upočasni prebavo hrane in povzroča slabšo rast.
English: For the full list of side effects and restrictions with Symkevi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Symkevi glejte navodilo za uporabo.
English: This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices.
Slovenian: Ta gen proizvaja beljakovino CFTR, ki deluje na površini celic in uravnava nastajanje sluzi in prebavnih sokov.
English: How does Symkevi work?
Slovenian: Kako zdravilo Symkevi deluje?
English: The doses may also need to be adjusted in patients with reduced liver function.
Slovenian: Pri bolnikih z zmanjšanim delovanjem jeter je treba odmerke včasih zmanjšati.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Slovenian: V prvo študijo je bilo vključenih 510 bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od obeh staršev.
English: How is Symkevi used?
Slovenian: Kako se zdravilo Symkevi uporablja?
English: Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Slovenian: Zdravilo Symkevi se uporablja pri bolnikih, ki so podedovali mutacijo F508del od obeh staršev, zato je ta prisotna v obeh kopijah gena CFTR.
English: The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Slovenian: „zmerni ali močni zaviralec CYP3A“, kakršni so nekateri antibiotiki ali zdravila proti glivičnim okužbam.
English: Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Symkevi v kombinaciji z ivakaftorjem so primerjali s placebom (zdravilom brez učinkovine).
English: Symkevi contains the active substances tezacaftor and ivacaftor.
Slovenian: Zdravilo Symkevi vsebuje učinkovini tezakaftor in ivakaftor.
English: Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations.
Slovenian: Zdravilo Symkevi je učinkovito zdravljenje bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od obeh staršev, ali bolnikov, ki so mutacijo F508del podedovali od enega starša in imajo nekatere druge mutacije.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Slovenian: V drugi študiji, v katero je bilo vključenih 248 bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od enega starša in so imeli še eno mutacijo CFTR.
English: Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo.
Slovenian: Zdravilo Symkevi v kombinaciji z ivakaftorjem so primerjali z ivakaftorjem samim in placebom.
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Slovenian: Prizadene celice, ki proizvajajo sluz in prebavne sokove.
English: Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above.
Slovenian: V dveh glavnih študijah pri bolnikih s cistično fibrozo, starejših od 12 let, se je pokazalo, da zdravilo Symkevi v kombinaciji z ivakaftorjem učinkovito izboljšuje pljučno funkcijo.
English: Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o trenutnih uporabah zdravila Sutent je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: Sutent has been authorised since July 2006 and contains the active substance sunitinib.
Slovenian: Zdravilo Sutent je odobreno od julija 2006 in vsebuje učinkovino sunitinib.
English: The evaluation had finished and the CHMP had given a negative opinion.
Slovenian: Postopek ocenjevanja je bil zaključen in odbor CHMP je izrazil negativno mnenje.
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Slovenian: Učinkovina v zdravilu Sutent, sunitinib, je zaviralec protein kinaze.
English: In addition, the medicine has known side effects that affect patients' quality of life.
Slovenian: Poleg tega ima to zdravilo znane neželene učinke, ki vplivajo na kakovost življenja bolnikov.
English: Sutent is a cancer medicine currently authorised for treating the following cancers:
Slovenian: Zdravilo Sutent je zdravilo za zdravljenje raka, ki je trenutno odobreno za zdravljenje naslednjih vrst raka:
English: Patients were treated for around a year and the study looked at how long it took for the cancer to come back (disease-free survival).
Slovenian: Bolnike so zdravili približno eno leto, v študiji pa so proučevali, kako dolgo je trajalo, da se je rak ponovil (preživetje brez ponovitve bolezni).
English: This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them.
Slovenian: To pomeni, da zavira specifične encime, imenovane protein kinaze, ki sodelujejo pri rasti in širjenju rakavih celic ter razvoju novih krvnih žil, ki jih oskrbujejo.
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Slovenian: Družba je zahtevala ponovno presojo negativnega mnenja, ki pa še ni bila zaključena, ko se je družba odločila za umik vloge.
English: When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing.
Slovenian: Tudi ko so bili podatki bolnikov z največjim tveganjem za ponovitev raka obravnavani ločeno, koristi zdravila Sutent še vedno niso bile prepričljive.
English: What is Sutent?
Slovenian: Kaj je zdravilo Sutent?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da jo umika, ker predloženi podatki odboru CHMP ne omogočajo zaključka, da koristi odtehtajo tveganja.
English: • metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body).
Slovenian: • metastatskega karcinoma ledvičnih celic (raka ledvic, ki se je razširil na druge dele telesa).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Sutent.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Sutent.
English: What is happening with Sutent for treatment in other uses?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Sutent za druge uporabe?
English: On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Slovenian: Družba Pfizer Limited je 26. junija 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za razširitev uporabe zdravila Sutent na zdravljenje bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
English: There are no consequences for Sutent in its authorised uses.
Slovenian: Umik vloge nima posledic za odobrene uporabe zdravila Sutent.
English: • gastrointestinal stromal tumour (a cancer of the stomach and bowel);
Slovenian: • gastrointestinalnega stromalnega tumorja (raka želodca in črevesja);
English: What was Sutent expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Sutent uporabljalo?
English: The CHMP considered that the evidence that Sutent delays the return of the cancer was not convincing.
Slovenian: Odbor CHMP je presodil, da dokazi, da zdravilo Sutent odloži ponovitev raka, niso bili prepričljivi.
English: The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery.
Slovenian: Družba je predstavila rezultate glavne študije, v kateri so zdravilo Sutent primerjali s placebom (zdravilom brez učinkovine) pri 615 bolnikih z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Slovenian: Zdravilo Sutent lahko z njihovim zaviranjem upočasni rast in širjenje raka ter prekine oskrbo s krvjo, ki omogoča rast rakavih celic.
English: Sutent was expected to be used to delay or prevent the return of kidney cancer in patients who have had surgery and are at high risk of their cancer coming back.
Slovenian: Zdravilo Sutent naj bi se uporabljalo za odložitev ali preprečitev ponovitve raka ledvic pri bolnikih, ki so bili operirani in pri katerih obstaja veliko tveganje za ponovitev raka.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas);
Slovenian: • nevroendokrinega tumorja trebušne slinavke (tumorja celic v trebušni slinavki, ki tvorijo hormone);
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Sutent in the treatment of patients at high risk of kidney cancer returning after surgery did not outweigh its risks.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Sutent pri zdravljenju bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu ne odtehtajo z njim povezanih tveganj.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Sutent not be changed to add the treatment of patients at high risk of kidney cancer returning after surgery.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil negativno mnenje in priporočil, da se dovoljenje za promet z zdravilom Sutent ne spremeni tako, da bi dodali zdravljenje bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
English: How does Sutent work?
Slovenian: Kako zdravilo Sutent deluje?
English: Never change the dose yourself.
Slovenian: Odmerka nikoli ne spreminjajte sami.
English: After first opening: 100 days
Slovenian: Po prvem odprtju: 100 dni
English: The usual supportive measures should be employed.
Slovenian: Izvesti je treba običajne podporne ukrepe.
English: There is no specific antidote.
Slovenian: Ni specifičnega antidota.
English: If it is almost time for the next dose, just give one dose.
Slovenian: Če je že skoraj čas za naslednji odmerek, dajte le en odmerek.
English: Children (from 8 to 12 years old)
Slovenian: Otroci (stari od 8 do 12 let)
English: • Wait until the tablet has broken down completely.
Slovenian: • Počakajte, dokler se tableta popolnoma ne razgradi.
English: - Observed at inclusion - Observed at first conclusive evaluation - Observed at last conclusive evaluation
Slovenian: - Opaženo ob vključitvi - Opaženo ob prvem zaključnem vrednotenju - Opaženo ob zadnjem zaključnem vrednotenju
English: The maximum recommended dose should not be exceeded.
Slovenian: Največji priporočeni odmerek ne sme biti presežen.
English: Date of first authorisation: 20 September 2018
Slovenian: Datum pridobitve dovoljenja za promet: 20. septembra 2018
English: Frequencies found in an open clinical study are presented in section 4.8.
Slovenian: Pogostnosti, ugotovljene v odprti klinični študiji, so predstavljene v poglavju 4.8.
English: Time to reach maximum plasma concentrations (tmax) is approximately 1 hour.
Slovenian: Čas do doseganja najvišjih plazemskih koncentracij (tmax) je približno 1 uro.
English: Such patients may respond to a lower maintenance dose.
Slovenian: Takšni bolniki se lahko odzovejo na nižji vzdrževalni odmerek.
English: In the monkey these lesions are minimal or equivocal.
Slovenian: Pri opicah so te lezije minimalne ali nejasne.
English: Males may be at greater risk than females.
Slovenian: Tveganje je pri moških lahko večje kot pri ženskah.
English: The following table presents the main findings at inclusion and the first and last conclusive evaluations in the evaluable population (n=524):
Slovenian: V spodnji preglednici so predstavljene glavne ugotovitve ob vključitvi ter prve in zadnje zaključne ocene v populaciji, ki jo je mogoče ovrednotiti (n = 524):
English: Oral and gastric use.
Slovenian: Peroralna in gastrična uporaba.
English: The doctor will adjust the dose during treatment as necessary.
Slovenian: Zdravnik bo med zdravljenjem po potrebi prilagodil odmerek.
English: Measures to remove unabsorbed medicinal product should be considered.
Slovenian: Razmisliti je treba o ukrepih za odstranjevanje neabsorbiranega zdravila.
English: N=150 N=151 N=97
Slovenian: N = 38 N = 47 N = 41 N = 150 N = 151 N = 97
English: In a few patients, the lesion resolved despite continued use.
Slovenian: Pri nekaj bolnikih je bila lezija odpravljena kljub nadaljevanju uporabe.
English: Very common: excitation, agitation
Slovenian: Zelo pogosti: razburjenje, vznemirjenje
English: Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives.
Slovenian: Zato je treba vigabatrin uporabljati le po skrbni presoji koristi/tveganja v primerjavi z drugimi možnostmi.
English: Suicidal ideation and behaviour
Slovenian: Samomorilne misli in vedenje
English: Binding to plasma proteins is negligible.
Slovenian: Vezava na plazemske beljakovine je zanemarljiva.
English: How to give this medicine
Slovenian: Kako dajati zdravilo
English: This efficacy is particularly marked in patients with seizures of partial origin.
Slovenian: Ta učinkovitost je posebej izražena pri bolnikih z napadi delnega izvora.
English: The tablet can be cut into equal halves.
Slovenian: Tablete je mogoče prerezati na enaki polovici.
English: This is normal and the cloudiness is because the tablet contains some non-active ingredients that do not dissolve completely
Slovenian: To je normalno, motnost pa nastane zato, ker tableta vsebuje nekaj neaktivnih sestavin, ki se ne raztopijo v celoti.
English: These responses are delayed and reduced beyond the normal limits.
Slovenian: Ti odzivi so zakasnjeni in zmanjšani bolj, kot je običajno.
English: The mechanism of this effect is not known and the available data do not exclude the possibility of an increased risk for vigabatrin.
Slovenian: Mehanizem tega učinka ni znan in razpoložljivi podatki ne vključujejo možnosti povečanega tveganja pri vigabatrinu.
English: In the study above, in post-marketing experience, and in published literature reports, these changes generally resolved with discontinuation of treatment.
Slovenian: V zgornji študiji, pri izkušnjah iz dejavnosti v obdobju trženja in v objavljenih poročilih v literaturi so bile te spremembe s prekinitvijo zdravljenja običajno odpravljene.
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France
Slovenian: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Francija
English: If you forget to give your child a dose, give the dose as soon as you remember.
Slovenian: Če otroku pozabite dati odmerek, ga dajte takoj, ko se spomnite.
English: For instructions on dissolution and handling of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede raztapljanja zdravila in ravnanja z njim pred dajanjem glejte poglavje 6.6.
English: The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance.
Slovenian: Prava narava tega medsebojnega delovanja trenutno ni znana, vendar je v večini primerov malo verjetno, da je pomembna za zdravljenje.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki.
English: Use only water to prepare solution.
Slovenian: Za pripravo raztopine uporabljajte le vodo.
English: Currently, there is no established method to diagnose or exclude visual field defects in children in whom a standardised perimetry cannot be performed.
Slovenian: Trenutno ni nobene uveljavljene metode za diagnosticiranje ali izključitev izpadov vidnega polja pri otrocih, pri katerih ni mogoče opraviti standardizirane perimetrije.
English: Vigabatrin can cause permanent vision loss.
Slovenian: Vigabatrin lahko povzroči trajno izgubo vida.
English: They are not specific to the paediatric population.
Slovenian: Ti se ne nanašajo le na pediatrično populacijo.
English: This medicine has been prescribed for your child. Do not pass it on to others.
Slovenian: - Zdravilo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
English: Adjustment of dose should be considered.
Slovenian: Razmisliti je treba o prilagoditvi odmerka.
English: Vigabatrin should be gradually withdrawn under close medical supervision.
Slovenian: Vigabatrin je treba ukiniti postopoma pod strogim zdravniškim nadzorom.