FrancophonIA/ELRC3.0 huggingface dataset:
English: In Trevicta as in Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
Slovenian: V zdravilu Trevicta je paliperidon tako kot v zdravilu Xeplion vezan na maščobno kislino, ki omogoča njegovo počasno sproščanje po vbrizganju.
English: Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia.
Slovenian: Zdravilo Trevicta, ki se daje z injiciranjem vsake tri mesece, je pri preprečevanju relapsov shizofrenije učinkovitejše od placeba in enako učinkovito kot mesečno injiciranje paliperidona.
English: Trevicta contains the active substance paliperidone.
Slovenian: Zdravilo Trevicta vsebuje zdravilno učinkovino paliperidon.
English: How is Trevicta used?
Slovenian: Kako se zdravilo Trevicta uporablja?
English: In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia.
Slovenian: V prvi študiji (pri 1 016 bolnikih) je bilo zdravilo Trevicta pri preprečevanju relapsov shizofrenije enako učinkovito kot mesečne injekcije paliperidona.
English: How does Trevicta work?
Slovenian: Kako zdravilo Trevicta deluje?
English: Results will be provided on a yearly basis.
Slovenian: Rezultati bodo letno predloženi.
English: Probability of survival (%)
Slovenian: Verjetnost preživetja (%)
English: In the overall population, 72.7 % of the patients were male.
Slovenian: Pri splošni populaciji je bilo kar 72,7 % bolnikov moških.
English: Safety data for Black and African American patients are limited.
Slovenian: Podatki o varnosti za črnce in Afroameričane so omejeni.
English: (see section 4.4)
Slovenian: (glejte poglavje 4.8).
English: Date of latest renewal: 26 August 2019
Slovenian: Datum zadnjega podaljšanja: 26. avgust 2019
English: If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.
Slovenian: Če tega zdravila ne jemljete, kot vam ga je predpisal zdravnik, zdravljenje raka morda ne bo uspešno.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. november 2014
English: If you are allergic to peanut or soya, do not use this medicine.
Slovenian: Če ste alergični na arašide ali sojo, tega zdravila ne uporabljajte.
English: Therefore close monitoring is recommended in patients weighing < 50 kg.
Slovenian: Zato je priporočljivo skrbno spremljanje bolnikov, ki tehtajo < 50 kg.
English: wrapped in plastic foil).
Slovenian: kapsul, zaviti v plastično folijo).
English: This medicine has not been studied in children or adolescents and is therefore not to be taken by children and adolescents below the age of 18 years.
Slovenian: Otroci in mladostniki Tega zdravila niso proučevali pri otrocih ali mladostnikih, zato ga mlajši od 18 let ne smejo jemati.
English: This medicine can interact with certain other medicines.
Slovenian: To zdravilo lahko medsebojno deluje z drugimi zdravili.
English: Based on this information your doctor may carry out some blood tests, for example to check your liver function and to determine how fast your blood can clot.
Slovenian: Na podlagi teh podatkov lahko zdravnik opravi nekatere krvne preiskave, na primer preveri delovanje vaših jeter, in ugotovi, kako hitro se strjuje vaša kri.
English: The age range covered by the analysis was 29 to 85 years; approximately 5 % of the population were older than 75 years.
Slovenian: Obravnavani razpon starosti v analizi je bil 29 do 85 let; približno 5 % populacije je bilo starejše od 75 let.
English: Do not take more than this dose.
Slovenian: Ne jemljite večjega odmerka od tega.
English: * CTCAE: Common Terminology Criteria for Adverse Events
Slovenian: * CTCAE - enotna terminološka merila za poimenovanje neželenih dogodkov (Common Terminology Criteria for Adverse Events)
English: Your doctor will decide when to resume your treatment with this medicine - if you have cancer that has spread to the brain
Slovenian: Vaš zdravnik se bo odločil, kdaj boste lahko zdravljenje s tem zdravilom nadaljevali; - če imate raka, ki se je razširil v možgane;
English: • Periodic safety update reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila
English: In the majority of patients, elevations of liver parameters were reversible.
Slovenian: Pri večini bolnikov so bila povečanja jetrnih parametrov reverzibilna.
English: Data from black individuals was very limited but in the same range as for Caucasians.
Slovenian: Podatki za črnce so zelo omejeni, vendar v enakem razponu kot za belce.
English: The overall recovery was considered complete (above 90 %) within 4 days after dosing.
Slovenian: Skupno izločanje je veljalo za končano (nad 90 %) v 4 dneh po odmerjanju.
English: HR: hazard ratio; CI: confidence interval
Slovenian: RO: razmerje ogroženosti; IZ: interval zaupanja
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Slovenian: Med nosečnostjo ne jemljite tega zdravila, ker lahko škodi vašemu nerojenemu otroku in povzroči prirojene okvare.
English: The following terms are used to rank the ADRs by frequency: 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: Za izražanje pogostnosti so uporabili izraze: 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) in zelo redki (<1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: DCE-MRI effects were seen 24 - 48 h after the first intake of the medicinal product and were preserved or even increased after continuous treatment over several weeks.
Slovenian: Učinki na DCE-MRI so bili vidni 24 do 48 ur po prvi uporabi zdravila in so se ohranili ali celo povečali po neprekinjenem večtedenskem zdravljenju.
English: It is not known if the medicine passes into breast milk and could cause harm to a breast-fed child.
Slovenian: Ni znano ali zdravilo prehaja v materino mleko in če lahko škodi dojenemu otroku.
English: See leaflet for further information.
Slovenian: Za več informacije glejte navodila.
English: Your doctor will discuss the results of these tests with you and decide whether you can be given Vargatef.
Slovenian: Zdravnik se bo z vami pogovoril o izvidih teh preiskav in se odločil, ali lahko dobite zdravilo Vargatef.
English: Approximately one third of these patients had liver-related adverse reactions of ≥ grade 3 severity.
Slovenian: Približno ena tretjina teh bolnikov je imela z jetri povezane neželene učinke ≥ 3. stopnje.
English: Cases of pulmonary embolism have been reported.
Slovenian: Poročali so o primerih pljučne embolije.
English: Vargatef should therefore only be initiated at least 4 weeks after major surgery.
Slovenian: Zato smemo zdravilo Vargatef uvesti šele vsaj 4 tedne po veliki operaciji.
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations in liver enzymes.
Slovenian: Pri bolnikih z majhno telesno maso (< 65 kg), bolnikih azijske rase in ženskah obstaja večje tveganje za povečanje ravni jetrnih encimov.
English: The disease stage was determined at the time of diagnosis using Union Internationale Contre le Cancer (UICC) / American Joint Committee on Cancer (AJCC) Edition 6 or Edition 7.
Slovenian: Stopnja bolezni je bila določena v času diagnoze po lestvici Union Internationale Contre le Cancer (UICC)/American Joint Committee on Cancer (AJCC), 6. ali 7. izdaja.
English: Submission of final study report of the single-arm study: Q4 2020
Slovenian: Predložitev končnega poročila študije za enoskupinsko študijo: Q4
English: Patient characteristics were balanced between treatment arms within the overall population and within subgroups according to histology.
Slovenian: Značilnosti bolnikov so bile med skupinami zdravljenja uravnotežene po celotni populaciji in med podskupinami glede na histologijo.
English: The majority of these events were reported for patients in the IPF indication.
Slovenian: O večini teh dogodkov so poročali pribolnikih z indikacijo IPF.
English: These two doses should be taken at around the same time each day.
Slovenian: Ta dva odmerka vsak dan vzemite približno ob istem času dneva.
English: The frequency of arterial thromboembolic events was comparable between the two treatment arms in the phase 3 trial 1199.13 (LUME-Lung 1).
Slovenian: Pogostnost arterijskih trombemboličnih dogodkov je bila primerljiva med dvema skupinama zdravljenja v preskušanju 3. faze 1199.13 (LUME-Lung 1).
English: Median OS improved by 3 months (nintedanib: 10.9 months; placebo: 7.9 months).
Slovenian: Mediana celokupnega preživetja se je izboljšala za 3 mesece (nintedanib: 10,9 mesecev; placebo: 7,9 mesecev).
English: Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pretisni omot, ki vsebuje kapsule, odprt ali če je kapsula zlomljena.
English: `Locally recurrent´ was defined as local re-occurrence of the tumour without metastases at trial entry.
Slovenian: »Lokalno ponovljen« je bilo opredeljeno kot lokalna ponovitev tumorja brez metastaz ob vstopu v preskušanje.
English: Tell your doctor immediately if you develop fever.
Slovenian: Zdravniku takoj povejte, če se vam zviša telesna temperatura.
English: Take your next dose of Vargatef as planned at the next scheduled time and at the dose recommended by your doctor or pharmacist.
Slovenian: Naslednji načrtovani odmerek zdravila Vargatef vzemite ob naslednjem načrtovanem času v odmerku, ki ga priporoča zdravnik ali farmacevt.
English: Alternative causes of the liver enzyme elevations should be investigated and respective action should be taken as necessary.
Slovenian: Raziskati je treba morebitne druge vzroke za povečane jetrne encime in po potrebi ustrezno ukrepati.
English: The recommended maximum daily dose of 400 mg should not be exceeded.
Slovenian: Ne smete prekoračiti niti največjega priporočenega dnevnega odmerka 400 mg.
English: The safety and efficacy of Vargatef in children aged 0-18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Vargatef pri otrocih, starih 0 do 18 let, še nista dokazani.
English: In preclinical in vivo experiments, BIBF 1202 did not show efficacy despite its activity at target receptors of the substance.
Slovenian: V predkliničnih eksperimentih in vivo BIBF 1202 ni pokazala učinkovitosti, in to kljub njeni aktivnosti na ciljnih receptorjih .
English: Therapeutic anticoagulation
Slovenian: Terapevtska antikoagulacija
English: Patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours have been excluded from clinical trials.
Slovenian: Bolniki z nedavno krvavitvijo v pljučih (> 2,5 ml rdeče krvi) in bolniki s centralno lego tumorjev z radiografsko dokazano lokalno invazijo velikih krvnih žil ali z radiografsko dokazanimi kavitiranimi ali nekrotičnimi tumorji so bili iz kliničnih preskušanj izključeni.
English: However, such patients should be closely monitored for signs and symptoms of cerebral bleeding.
Slovenian: Vendar jih je treba skrbno spremljati zaradi možnega pojava znakov in simptomov možganskih krvavitev.
English: Fertility The effect of this medicine on human fertility has not been investigated.
Slovenian: Plodnost Učinka tega zdravila na plodnost pri ljudeh niso proučevali.
English: You should discuss the most appropriate methods of contraception for you with your doctor.
Slovenian: O izbiri najboljših kontracepcijskih metod se posvetujte z zdravnikom.
English: Efficacy in the pivotal phase 3 trial LUME-Lung 1
Slovenian: Učinkovitost v osrednjem preskušanju 3. faze LUME-Lung 1
English: Vargatef + Docetaxel Placebo + Docetaxel
Slovenian: Vargatef + docetaksel Placebo + docetaksel
English: The applicant will implement collection of material for biomarker investigation and analyses of biomarker data into the study protocol of all new oncology studies planned for nintedanib in the future, wherever clinically appropriate.
Slovenian: Vlagatelj bo vključil zbiranje materialov za preiskave biomarkerjev in analize podatkov o biomarkerjih v protokol študije pri vseh na novo načrtovanih onkoloških študijah za nintedanib, kadar je to klinično primerno.
English: Swallow the capsules whole with water and do not chew or crush them.
Slovenian: Kapsule pogoltnite cele z vodo in jih ne žvečite niti drobite.
English: As a consequence of neutropenia, fever (febrile neutropenia) and blood poisoning (sepsis) may occur.
Slovenian: Kot posledica nevtropenije se lahko pojavita zvišana telesna temperatura (febrilna nevtropenija) in zastrupitev krvi (sepsa).
English: In line with these observations, related trial endpoints such as disease control and change in tumour size showed significant improvements.
Slovenian: Skladno s temi opažanji so povezani opazovani dogodki v preskušanju, na primer kontrola bolezni in spremenjena velikost tumorja, pokazali značilna izboljšanja.
English: Mild liver enzyme increases, which were not due to serious adverse effects such as diarrhoea, were only observed in Rhesus monkeys.
Slovenian: Blaga povečanja jetrnih encimov, ki niso posledica resnih neželenih učinkov, kot je driska, so opazili le pri opicah Rhesus.
English: As nintedanib may cause foetal harm also in humans, it should not be used during pregnancy unless the clinical condition requires treatment.
Slovenian: Ker lahko nintedanib tudi pri ljudeh poškoduje plod, ga nosečnice ne smejo uporabljati, razen če je zdravljenje potrebno zaradi njihovega kliničnega stanja.
English: Treatment with Vargatef may lead to a higher risk of bleeding - if you have recently had a surgery or plan to have a surgery.
Slovenian: Zdravljenje z zdravilom Vargatef lahko poveča tveganje za krvavitev; - če ste pred kratkim imeli kirurški poseg ali ga načrtujete.
English: However, close monitoring is recommended in patients with several of these risk factors (see section 4.4).
Slovenian: Vendar priporočajo skrbno spremljanje bolnikov z več dejavniki tveganja (glejte poglavje 4.4).
English: There is no information on the use of Vargatef in pregnant women, but preclinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Slovenian: Ni podatkov o uporabi zdravila Vargatef pri nosečnicah, vendar predklinične študije pri živalih kažejo na reproduktivno toksičnost te zdravilne učinkovine (glejte poglavje 5.3).
English: Other efficacy outcomes included objective response, disease control, change in tumour size and health-related quality of life.
Slovenian: Preostali opazovani dogodki za ocenjevanje učinkovitosti so bili: objektivni odziv, nadzor bolezni, sprememba velikosti tumorja in zdravstvena kakovost življenja.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, vključno z zdravili rastlinskega izvora in zdravili, ki ste jih dobili brez recepta.
English: The pharmacokinetics of nintedanib can be considered linear with respect to time (i.e. single-dose data can be extrapolated to multiple-dose data).
Slovenian: Farmakokinetiko nintedaniba je mogoče smatrati kot linearno glede na čas (to pomeni, da je podatke o enkratnem odmerku mogoče ekstrapolirati na podatke za večkratne odmerke).
English: By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer.
Slovenian: S preprečevanjem aktivnosti teh beljakovin lahko nintedanib pomaga ustaviti rast in širjenje raka.
English: Number of Deaths or Progressions, n (%) Median PFS [months]
Slovenian: Število smrti ali napredovanja bolezni, n (%) Mediana PFS [meseci]
English: Overall survival (OS) was the key secondary endpoint.
Slovenian: Celokupno preživetje (overall survival - OS) je bilo drugi opazovani dogodek.
English: This result was confirmed in the follow-up PFS analysis (HR 0.85, 95 % CI: 0.75 - 0.96; p = 0.0070) which included all events collected at the time of the final OS analysis.
Slovenian: Ta rezultat je bil potrjen v kontrolnih analizah PFS (RO 0,85, 95-odstotni IZ: 0,75-0,96; p = 0,0070), ki so vključevale vse dogodke, zbrane v času končne analize celokupnega preživetja.
English: The absolute bioavailability of a 100 mg dose was 4.69 % (90 % CI: 3.615 - 6.078) in healthy volunteers.
Slovenian: Absolutna biološka uporabnost odmerka 100 mg je bila 4,69 % (90-odstotni IZ: 3,615 do 6,078) pri zdravih prostovoljcih.
English: Dose adjustments in 100 mg steps per day (i.e. a 50 mg reduction per dosing) based on individual safety and tolerability are recommended as described in Table 1 and Table 2.
Slovenian: Priporočljivo je postopno prilagajanje odmerka po 100 mg na dan (to je zmanjšanje za 50 mg na odmerek) na podlagi individualne varnosti in prenašanja, kot je opisano v preglednicah 1 in 2.
English: Within each frequency grouping adverse reactions are presented in order of decreased seriousness.
Slovenian: Za vsako skupino pogostnosti so neželeni učinki prikazani po padajoči resnosti.
English: In the event of dehydration, administration of electrolytes and fluids is required.
Slovenian: V primeru dehidracije je treba dodajati elektrolite in tekočine.
English: Caution should be used especially in patients with additional risk factors for thromboembolic events.
Slovenian: Previdnost je potrebna zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombembolične dogodke.
English: What Vargatef is and what it is used for
Slovenian: Kaj je zdravilo Vargatef in za kaj ga uporabljamo
English: It was not clearly dose dependent, but most responses were seen at doses of ≥ 200 mg. Logistic regression revealed a statistically significant association of the anti-angiogenic effect to nintedanib exposure.
Slovenian: Čeprav ni bil povsem očitno odvisen od odmerka, so največ odzivov opazili pri odmerkih ≥ 200 mg. Logistična regresija je pokazala statistično značilno povezavo antiangiogenega učinka z izpostavljenostjo nintedanibu.
English: Nintedanib blocks the activity of a group of proteins which are involved in the development of new blood vessels that cancer cells need to supply them with food and oxygen.
Slovenian: Nintedanib zavira aktivnost skupine beljakovin, ki sodelujejo pri razvoju novih krvnih žil, ki jih rakave celice potrebujejo za oskrbo s hrano in kisikom.
English: Based on the high inter-individual variability of exposure these effects are not considered clinically relevant.
Slovenian: Na podlagi velike variabilnosti izpostavljenosti med posamezniki, našteti učinki ne veljajo za klinično pomembne.
English: Tumour shrinkage [%]° p-value°
Slovenian: Skrčenje tumorja [%]° vrednost p°
English: VEGFR inhibition might be associated with an increased risk of bleeding.
Slovenian: Zaviranje VEGFR lahko poveča tveganje za krvavitev.
English: However, the sample size was small, there was no significant interaction and the CI was wide and included the HR for OS of the overall adenocarcinoma population.
Slovenian: Vendar pa je bil vzorec majhen, ni bilo pomembne interakcije in IZ je bil širok ter je vključeval RO celokupnega preživetja celotne populacije bolnikov z adenokarcinomom.
English: Nintedanib reached maximum plasma concentrations approximately 2 - 4 hours after oral administration as soft gelatin capsule under fed conditions (range 0.5 - 8 hours).
Slovenian: Nintedanib je dosegel največje koncentracije v plazmi približno po 2 do 4 urah po zaužitju mehke želatinske kapsule na tešče (razpon 0,5 do 8 ur).
English: The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Slovenian: Priporočeni odmerek nintedaniba je 200 mg dvakrat na dan, ki ga je treba jemati v približno 12-urnem razmiku, od 2. do 21. dne standardnega 21-dnevnega cikla zdravljenja z docetakselom.
English: Before initiating Vargatef, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Vargatef je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: Data on bio-/tumour markers from all clinical studies in the clinical program for nintedanib.
Slovenian: 3. podatki o bio-/tumorskih markerjih iz vseh kliničnih študij v kliničnem programu za ninetanib.
English: Elevation of liver enzymes (ALT, AST, ALKP, gammaglutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Slovenian: Povečanja ravni jetrnih encimov (ALT, AST, ALKP in gama-glutamiltransferaze (GGT)) in bilirubina so bila v večini primerov reverzibilna po zmanjšanju odmerka ali prekinitvi uporabe.
English: The potential for interactions of nintedanib with hormonal contraceptives was not explored.
Slovenian: Možnega medsebojnega delovanja nintedaniba s hormonskimi kontraceptivi niso proučevali.
English: The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC) based on the intent-to-treat (ITT) population and tested by histology.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (progression-free survivalPFS), kar je ocenila neodvisna komisija (independent review committee - IRC) na podlagi podatkov za populacijo ITT (intent-to-treat ) in kot so pokazale histološke preiskave.
English: Nevertheless, the overall treatment benefit of nintedanib was observed without adversely affecting self-reported quality of life.
Slovenian: Kljub temu so opazili celokupno korist zdravljenja z nintedanibom brez negativnega vpliva na samoocenjeno kakovost življenja.
English: There were no imbalances of respiratory or fatal bleedings and no intracerebral bleeding was reported.
Slovenian: O neravnovesjih pri krvavitvah v dihalih ali usodnih krvavitvah ter o intracerebralnih krvavitvah niso poročali.
English: Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Slovenian: Bolniki lahko z zdravljenjem z nintedanibom nadaljujejo po prekinitvi docetaksela, dokler so vidne klinične koristi ali do pojava nesprejemljive toksičnosti.
English: AST: Aspartate aminotransferase; ALT: Alanine aminotransferase ALKP: Alkaline phosphatase; ULN: Upper limit normal
Slovenian: AST - aspartat-aminotransferaza; ALT - alanin-aminotransferaza ALKP - alkalna fosfataza; ULN - zgornja meja normalnih vrednosti
English: Population pharmocokinetic analysis in special populations The pharmacokinetic properties of nintedanib were similar in healthy volunteers, cancer patients, and patients of the target population.
Slovenian: Analiza populacijske farmakokinetike pri posebnih populacijah Farmakokinetične lastnosti nintedaniba so bile pri zdravih prostovoljcih podobne kot pri bolnikih z rakom in bolnikih v ciljni populaciji.
English: Treatment with nintedanib did not significantly change the time to deterioration of the pre-specified symptoms cough, dyspnoea and pain, but resulted in a significant deterioration in the diarrhoea symptom scale.
Slovenian: Zdravljenje z nintedanibom ni pomembno spremenilo časa do poslabšanja predhodno opredeljenih simptomov kašlja, dispneje in bolečine, povzročil pa je pomembno poslabšanje na lestvici simptomov driske.
English: Other medicines and Vargatef
Slovenian: Druga zdravila in zdravilo Vargatef