FrancophonIA/ELRC3.0 huggingface dataset:
English: Investigator's choice (inv choice) n = 54
Slovenian: Po izbiri raziskovalca (inv choice) n = 54
English: The fatal events included those due to progression of disease; however a causal relationship cannot be excluded.
Slovenian: Ti primeri so vključevali tiste, do katerih je prišlo zaradi napredovanja bolezni; vendar pa vzročne povezave ni mogoče izključiti.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
Slovenian: neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: if you have recently undertaken a surgery.
Slovenian: - če ste bili pred kratkim operirani.
English: The effect may also be more pronounced at a 25 mg dose.
Slovenian: Učinek je lahko izrazitejši tudi pri odmerku 25 mg.
English: This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Slovenian: To zdravilo se mora uporabljati pod nadzorom zdravnika, izkušenega v uporabi antineoplastičnih zdravil.
English: Some patients did not have symptoms or had minimal symptoms.
Slovenian: Nekateri bolniki simptomov niso imeli ali pa so bili le-ti minimalni.
English: As this medicine is prepared and given by a healthcare professional, it is unlikely you will be given too much or that you will miss a dose.
Slovenian: Ker to zdravilo pripravi in vam ga da zdravstveni delavec, ni verjetno, da bi prejeli prevelik odmerek ali da bi bil odmerek izpuščen.
English: Torisel may weaken your immune system.
Slovenian: Zdravilo Torisel lahko oslabi vaš imunski sistem.
English: This leaflet was last revised in <{MM/YYYY}>
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>
English: Torisel with food and drink
Slovenian: Zdravilo Torisel skupaj s hrano in pijačo
English: if you are going to have surgery or if you had an operation recently.
Slovenian: - če vas bodo operirali ali če ste pred kratkim imeli operacijo.
English: Table 1: Adverse reactions from clinical trials in RCC (study 3066K1-304) and in MCL (study 3066K1-305)
Slovenian: Preglednica 1: Neželeni učinki iz kliničnih preskušanj pri RCC (študija 3066K1-304) in pri MCL (študija 3066K1-305)
English: As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Slovenian: Kot je običajno pri bolnikih s povečanim tveganjem za kožnega raka, je treba omejiti izpostavljenost sončni in ultravijolični (UV) svetlobi z nošenjem zaščitnih oblačil in uporabo sredstva za zaščito kože pred soncem z visokim zaščitnim faktorjem.
English: if the number of white cells in your blood has decreased.
Slovenian: - če je število belih krvničk v vaši krvi zmanjšano.
English: • Appropriate administration materials must be used to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
Slovenian: • Uporabljati je treba materiale, primerne za dajanje zdravila, s čimer se izognemo večjim izgubam zdravila in zmanjšamo hitrost ekstrakcije DEHP.
English: Do not use if particulates are present, or if discoloured.
Slovenian: Ne uporabljajte, če so prisotni delci ali če je prišlo do obarvanja.
English: Date of the latest renewal: 13 July 2017
Slovenian: Datum prve odobritve: 19. november 2007 Datum zadnjega podaljšanja: 13. julij 2017
English: This incompatibility has to be considered during the preparation and administration of Torisel.
Slovenian: To nekompatibilnost je treba upoštevati pri pripravi in uporabi zdravila Torisel.
English: Torisel contains alcohol and can be harmful to those who drink alcohol or to those suffering from alcoholism.
Slovenian: Zdravilo Torisel vsebuje alkohol in je lahko škodljivo za tiste, ki pijejo alkohol ali trpijo za alkoholizmom.
English: None of the 3 cohorts met the criterion for advancing to the second stage of the Simon 2-stage design.
Slovenian: Nobena izmed 3 skupin ni dosegla merila za napredovanje v drugo stopnjo Simonove 2-stopenjske sheme.
English: Adverse events were generally similar to those observed in adults (see section 4.8).
Slovenian: Neželeni učinki so bili na splošno podobni tistim, ki so jih opažali pri odraslih (glejte poglavje 4.8).
English: This may increase the risk of getting fever and infections.
Slovenian: To lahko poveča tveganje za pojav vročine in okužb.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden začnete prejemati to zdravilo.
English: (50,000 cells/mm3), the doses should be modified to the next lower dose level according to the table above.
Slovenian: (50.000 celic/mm 3) je treba odmerke spremeniti na naslednjo nižjo raven zmanjšanih odmerkov v skladu z zgornjo preglednico.
English: This may increase the risk of bleeding/bruising and infection (see section “Possible side effects").
Slovenian: To lahko poveča tveganje za krvavitve/podplutbe in okužbe (glejte poglavje “Možni neželeni učinki”).
English: Women of childbearing potential/Contraception in males and females
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah
English: The contribution of the initial 175 mg doses to the efficacy outcome is currently not known.
Slovenian: Prispevek začetnih 175 mg odmerkov k učinkovitosti zdravljenja je trenutno neznan.
English: If you experience any of them, seek medical advice immediately.
Slovenian: Če se pojavi katerikoli izmed njih, nemudoma poiščite zdravniško pomoč.
English: For some animals, there were no specific clinical observations or histological changes that suggested inflammation.
Slovenian: Pri nekaterih živalih ni bilo nobenih specifičnih kliničnih opažanj ali histoloških sprememb, ki bi kazale na vnetje.
English: During treatment with temsirolimus, vaccination may be less effective.
Slovenian: Med zdravljenjem s temsirolimusom je lahko cepljenje manj učinkovito.
English: Gender, weight, race, age
Slovenian: Spol, telesna masa, rasa, starost
English: This medicine is not for children and adolescents below 18 years of age because advanced cancer of the kidney and mantle cell lymphoma are not relevant for these patients, and it did not work in other cancers.
Slovenian: To zdravilo ni za otroke in mladostnike, mlajše od 18 let, ker napredovali rak ledvic in limfom plaščnih celic pri teh bolnikih nista relevantna, pri drugih vrstah raka pa to zdravilo ni bilo učinkovito.
English: There are no adequate data from the use of temsirolimus in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi temsirolimusa pri nosečnicah.
English: Sufficient time should be allowed for air bubbles to subside.
Slovenian: Počakati je treba dovolj dolgo, da izginejo zračni mehurčki.
English: Keep the vials in the outer carton in order to protect from light.
Slovenian: Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Twenty-four (24, 67%) were Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, and 12 (33%) were ECOG PS = 0.
Slovenian: Štiriindvajset (24, 67 %) jih je imelo stanje zmogljivosti (PS) po Eastern Cooperative Oncology Group (ECOG) = 1, 12 (33 %) pa je imelo PS po ECOG = 0.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo.
English: Concomitant use of temsirolimus with sunitinib
Slovenian: Sočasna uporaba temsirolimusa s sunitinibom
English: All grades n (%)
Slovenian: Vseh stopenj n (%)
English: The evaluations of PFS and ORR were based on blinded independent radiologic assessment of tumour response using the International Workshop Criteria.
Slovenian: Ocene PFS in ORR so temeljile na neodvisni slepi radiološki oceni tumorskega odziva z uporabo meril International Workshop Criteria.
English: Patients may be immunosuppressed and should be carefully observed for the occurrence of infections, including opportunistic infections.
Slovenian: Pri bolnikih lahko pride do imunosupresije in jih je treba skrbno spremljati glede pojava okužb, vključno z oportunističnimi okužbami.
English: Bags/containers that come in contact with Torisel must be made of glass, polyolefin, or polyethylene.
Slovenian: Vrečke/vsebniki, ki pridejo v stik z zdravilom Torisel, morajo biti izdelani iz stekla, poliolefina ali polietilena.
English: What Torisel is and what it is used for 2.
Slovenian: Kaj je zdravilo Torisel in za kaj ga uporabljamo 2.
English: Do not throw away any medicines via wastewater.
Slovenian: Zdravila ne smete odvreči v odpadne vode.
English: Empiric treatment with corticosteroids and/or antibiotics may be considered.
Slovenian: Razmisliti je treba o empiričnem zdravljenju s kortikosteroidi in/ali antibiotiki.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: Other medicines and Torisel
Slovenian: Druga zdravila in zdravilo Torisel
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o kateremkoli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: CI = confidence interval; NA = not applicable.
Slovenian: IZ = interval zaupanja; NA = ne velja za ta primer.
English: Antihistamines are given to help prevent an allergic reaction to Torisel, including some lifethreatening and rare fatal allergic reactions.
Slovenian: Antihistaminike se daje, da bi poskusili preprečiti alergijsko reakcijo na zdravilo Torisel, vključno z nekaterimi življenjsko ogrožajočimi in redkimi smrtnimi alergijskimi reakcijami.
English: Store in a refrigerator (2°C - 8°C)
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: If you feel sick (nausea and vomiting) or you have difficulty in falling or staying asleep, take special care when driving or using machines.
Slovenian: Če vam je slabo (navzea in bruhanje) ali če težko zaspite ali se zbujate, bodite posebno pazljivi pri vožnji ali upravljanju strojev.
English: What you need to know before you receive Torisel 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Torisel 3.
English: The results for the MCL clinical trial are summarised in the following table.
Slovenian: Rezultati kliničnega preskušanja MCL so povzeti v naslednji preglednici.
English: Women should not breast-feed during treatment with Torisel, as this medicine may interfere with the growth and development of the baby.
Slovenian: Ženske med zdravljenjem z zdravilom Torisel ne smejo dojiti, ker utegne to zdravilo ovirati rast in razvoj otroka.
English: Frequencies are defined as follows: 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) and not known (cannot be estimated from the available data).Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of temsirolimus.
Slovenian: Izpostavljenosti pri živalih so bile manjše od tistih, ki so jih ugotovili pri ljudeh, ki so prejemali klinično pomembne odmerke temsirolimusa.
English: Abbreviation: ANC = absolute neutrophil count.
Slovenian: Okrajšava: ANC (ANC - Absolute Neutrophil Count) - absolutno število nevtrofilcev
English: These transcription factors regulate the ability of tumours to adapt to hypoxic microenvironments and to produce the angiogenic factor vascular endothelial growth factor (VEGF).
Slovenian: Ta transkripcijska faktorja regulirata sposobnost tumorjev, da se prilagodijo na hipoksično mikrookolje in da izdelujejo angiogeni faktor z imenom rastni faktor vaskularnega endotelija (VEGF).
English: Post-marketing experience
Slovenian: Izkušnje v obdobju trženja
English: In addition to regulating cell cycle proteins, mTOR can regulate translation of the hypoxia-inducible factors, HIF-1 and HIF-2 alpha.
Slovenian: Poleg tega, da uravnava beljakovine celičnega cikla, lahko mTOR uravnava translacijo faktorjev, ki se inducirajo s hipoksijo, to sta HIF-1 in HIF-2 alfa.
English: Your doctor may prescribe you an x-ray examination of your chest.
Slovenian: Zdravnik vam bo morda naročil, da opravite rentgenski pregled prsnega koša.
English: • Mix the solvent and the concentrate well by inversion of the vial.
Slovenian: • Dobro zmešajte vehikel in koncentrat z obračanjem viale.
English: This may increase the risk of bleeding in your body.
Slovenian: To lahko poveča tveganje za krvavitve v vašem telesu.
English: Adverse reactions that were reported in post-marketing experience are listed below (Table 2).
Slovenian: Neželeni učinki, o katerih so poročali v obdobju trženja, so našteti spodaj (preglednica 2).
English: Interaction with medicinal products metabolised by CYP2D6 or CYP3A4/5
Slovenian: Medsebojno delovanje z zdravili, ki se presnavljajo preko CYP2D6 ali CYP3A4/5
English: Some patients required discontinuation of temsirolimus or treatment with corticosteroids and/or antibiotics, while some patients continued treatment without additional intervention.
Slovenian: Pri nekaterih bolnikih je bilo treba temsirolimus ukiniti ali pa jih je bilo treba zdraviti s kortikosteroidi in/ali antibiotiki, medtem ko so drugi bolniki nadaljevali z zdravljenjem brez dodatne intervencije.
English: Torisel has not been studied in pregnant women, and it must not be used during pregnancy, unless clearly necessary.
Slovenian: Zdravila Torisel pri nosečnicah niso raziskovali in ga v nosečnosti ne smete uporabljati, razen če je to nujno potrebno.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Torisel in all subsets of the paediatric population in MCL (see section 4.2 on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Torisel za vse podskupine pediatrične populacije pri MCL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: It is important that the recommendations in section 4.2 be followed closely.
Slovenian: Pomembno je, da natančno sledimo priporočilom v poglavju 4.2.
English: In the MCL clinical trial, there was no difference in efficacy in patients with respect to age, sex, race, geographic region, or baseline disease characteristics.
Slovenian: V kliničnem preskušanju MCL ni bilo razlik v učinkovitosti pri bolnikih glede na starost, spol, raso, zemljepisno območje ali izhodiščne značilnosti bolezni.
English: The starting dose of 175 mg was associated with a significant incidence of adverse events and required dose reductions/delays in the majority of patients.
Slovenian: Začetni odmerek 175 mg je bil povezan s pomembno pogostnostjo pojavljanja neželenih učinkov in je zahteval zmanjšanje/zakasnitev odmerka pri večini bolnikov.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Concentrate
Slovenian: Koncentrat
English: The most important side effects you may experience during the treatment with Torisel are listed below.
Slovenian: Najpomembnejši neželeni učinki, ki se lahko pojavijo med zdravljenjem z zdravilom Torisel, so našteti spodaj.
English: The amount of alcohol in this medicine may impair your ability to drive or alter the effects of other medicines (see sections “Warning and precautions” and “Driving and using machines”).
Slovenian: Količina alkohola v tem zdravilu lahko zmanjša vašo sposobnost vožnje ali spremeni učinke drugih zdravil (glejte poglavji “Opozorila in previdnostni ukrepi” ter “Vpliv na sposobnost upravljanja vozil in strojev”).
English: b Disease assessment is based on radiographic review by independent radiologists and review of clinical data by independent oncologists.
Slovenian: Ocena bolezni temelji na radiografskem pregledu neodvisnih radiologov in pregledu kliničnih podatkov s strani neodvisnih onkologov.
English: if you have or have had high cholesterol levels.
Slovenian: - če imate ali ste kdaj imeli zvišane ravni holesterola.
English: Torisel contains ethanol (alcohol)
Slovenian: Zdravilo Torisel vsebuje etanol (alkohol)
English: If a patient develops a hypersensitivity reaction during the temsirolimus infusion despite the premedication, the infusion must be stopped and the patient observed for at least 30 to 60 minutes (depending on the severity of the reaction).
Slovenian: Če pri bolniku med infuzijo temsirolimusa kljub premedikaciji pride do preobčutljivostne reakcije, je treba infuzijo prekiniti in bolnika opazovati vsaj 30 do 60 minut (odvisno od resnosti reakcije).
English: if you are allergic to antihistamines or cannot use antihistamines for other medical reasons.
Slovenian: - če ste alergični na antihistaminike ali iz kakšnega drugega medicinskega razloga ne smete uporabljati antihistaminikov.
English: Interactions with medicinal products that are P-glycoprotein substrates
Slovenian: Medsebojno delovanje z zdravili, ki so substrati P-glikoproteina
English: Your doctor will do blood tests to check your liver function and then may decide to lower the dose of Torisel.
Slovenian: Zdravnik bo naročil preiskave krvi, da bi preveril delovanje jeter, in se nato morda odločil za zmanjšanje odmerka zdravila Torisel.
English: Patients should be monitored early during the infusion and appropriate supportive care should be available.
Slovenian: Bolnike je treba spremljati ob začetku infuzije, na voljo pa mora biti ustrezno podporno zdravljenje.
English: If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i.e., an end-filter) before the admixture reaches the vein of the patient.
Slovenian: Če infuzijski sistem, ki je na voljo, nima zaporedno vključenega filtra, morate dodati filter na koncu infuzijskega sistema (tj. končni filter), preden mešanica doseže bolnikovo veno.
English: b Based on Cox proportional hazard model stratified by prior nephrectomy and region (95% CI are descriptive only).
Slovenian: Na podlagi Coxovega modela proporcionalnega tveganja, stratificiranega po predhodni nefrektomiji in regiji (95% IZ je samo opisnega).
English: Swelling of the face, lips, tongue, and throat, possibly causing difficulty breathing.
Slovenian: Otekanje obraza, ustnic, jezika in žrela, ki lahko oteži dihanje.
English: It is recommended that patients be followed closely for occurrence of clinical respiratory symptoms and patients should be advised to report promptly any new or worsening respiratory symptoms.
Slovenian: Bolnike je priporočljivo skrbno spremljati glede kliničnih respiratornih simptomov in jim svetovati, naj čim prej poročajo o poslabšanju ali novih respiratornih simptomih.
English: The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity.
Slovenian: Kombinacija temsirolimusa in sunitiniba je povzročila toksičnost, ki je omejila odmerek.
English: Your doctor will monitor your kidney function.
Slovenian: Zdravnik bo spremljal delovanje vaših ledvic.
English: The use of temsirolimus was associated with increases in serum triglycerides and cholesterol.
Slovenian: Uporaba temsirolimusa je bila povezana z zvišanjem ravni serumskih trigliceridov in holesterola.
English: Cases of PCP, some with fatal outcomes, have been reported (see section 4.4).
Slovenian: Poročali so o primerih PCP, nekaterih s smrtnim izidom (glejte poglavje 4.4).
English: What you need to know before you receive Torisel
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Torisel
English: Torisel is for intravenous use only.
Slovenian: Zdravilo Torisel je samo za intravensko uporabo.
English: The safety and efficacy of temsirolimus in the treatment of advanced RCC were studied in the following two randomised clinical trials:
Slovenian: Varnost in učinkovitost temsirolimusa pri zdravljenju napredovalega RCC so proučevali v naslednjih dveh randomiziranih kliničnih preskušanjih:
English: In RCC clinical trial 1, 31% of patients treated with temsirolimus were 65 or older.
Slovenian: V kliničnem preskušanju RCC 1 je bilo 31 % bolnikov, zdravljenih s temsirolimusom, starih 65 let ali več.
English: Therefore, inhibitors of these metabolic pathways are not expected to affect the elimination of temsirolimus.
Slovenian: Zato ni pričakovati, da bi zaviralci teh presnovnih poti vplivali na odstranjevanje temsirolimusa iz telesa.
English: Lung infection caused by Pneumocystis jiroveci (Pneumocystis jiroveci pneumonia).
Slovenian: Okužba pljuč, ki jo povzroča Pneumocystis jiroveci (pljučnica zaradi Pneumocystis jiroveci).
English: if you have or have had tumours in your brain or spinal cord, bleeding problems or bruising, or if you are taking medicines which prevent your blood from clotting (such as warfarin and acenocoumarole).
Slovenian: - če imate ali ste kdaj imeli tumorje v možganih ali hrbtenjači, težave s krvavitvami ali podplutbami ali če jemljete zdravila, ki preprečujejo strjevanje krvi (kot sta varfarin ali acenokumarol).
English: Tell your doctor if you have a drinking problem or consume alcohol (see section “Torisel contains ethanol [alcohol]”).
Slovenian: Zdravniku povejte, če imate težave z alkoholom ali pijete alkohol (glejte poglavje “Zdravilo Torisel vsebuje etanol (alkohol)”).
English: In rats, these changes were accompanied by a decreased weight of accessory sex organs (epididymides, prostate, seminal vesicles).
Slovenian: Pri podganah je te spremembe spremljala zmanjšana teža pomožnih spolnih organov (obmodkov, prostate, semenjakov).
English: General inflammatory responses, as indicated by increased fibrinogen and neutrophils, and/or changes in serum protein, were observed in mice, rats, and monkeys, although in some cases these clinical pathology changes were attributed to skin or intestinal inflammation as noted above.
Slovenian: Splošne vnetne odzive, na katere kažejo zvišan fibrinogen in nevtrofilci in/ali spremembe serumskih beljakovin, so opazili pri miših, podganah in opicah, čeprav so v nekaterih primerih te kliničnopatološke spremembe pripisali vnetju kože ali črevesa, kot je opisano zgoraj.
English: A vaccination may be less effective or the use of certain vaccinations should be avoided during treatment with Torisel.
Slovenian: Cepljenje bo morda manj učinkovito, nekaterih cepljenj pa se morate med zdravljenjem z zdravilom Torisel izogibati.
English: For intravenous use.
Slovenian: za intravensko uporabo
English: Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
Slovenian: Uporabljate lahko različne končne filtre, pri katerih sega velikost filtrirnih por od 0,2 mikrona do 5 mikronov.
English: if you have shortness of breath, cough, and/or fever.
Slovenian: - če imate kratko sapo, kašljate in/ali imate vročino.
English: Torisel will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
Slovenian: Zdravilo Torisel bo vedno pripravil in vam ga dal v obliki intravenske infuzije (v vašo veno) zdravnik ali drug zdravstveni delavec.
English: Hyperglycaemia/glucose intolerance/diabetes mellitus
Slovenian: Hiperglikemija/intoleranca za glukozo/sladkorna bolezen