FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the unknown risk related to potential exposure during early pregnancy, women of childbearing potential must be advised not to become pregnant while using Torisel.
Croatian: Zbog nepoznatog rizika povezanog s mogućom izloženošću tijekom rane trudnoće, ženama reproduktivne dobi mora se savjetovati da ne zatrudne za vrijeme primjene lijeka Torisel.
English: if you are receiving Torisel, you may be at increased risk of heart attack.
Croatian: - ako primate Torisel, možete biti izloženi povećanom riziku od srčanog udara.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Hyperglycaemia/glucose intolerance/diabetes mellitus
Croatian: Hiperglikemija/intolerancija glukoze/šećerna bolest
English: Talk to your doctor, pharmacist, nurse if you have any concern.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako Vas bilo što zabrinjava.
English: Sulfate or glucuronide conjugates were not detected in the human faecal samples, suggesting that sulfation and glucuronidation do not appear to be major pathways involved in the excretion of temsirolimus.
Croatian: Sulfatni ili glukuronidni konjugati nisu otkriveni u uzorcima stolice u ljudi, što ukazuje na to da sulfacija i glukuronidacija nisu glavni putevi koji sudjeluju u izlučivanju temsirolimusa.
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).
Croatian: - ako imate ili ste imali tumor na mozgu ili leđnoj moždini, tegobe s krvarenjem ili stvaranjem modrica ili ako uzimate lijekove koji sprječavaju zgrušavanje krvi (kao što su varfarin i acenokumarol).
English: The most important side effects you may experience during the treatment with Torisel are listed below.
Croatian: Najvažnije nuspojave koje možete dobiti tijekom liječenja Toriselom navedene su niže.
English: Cases of anaemia have been reported in RCC and MCL (see section 4.8).
Croatian: Slučajevi anemije zabilježeni su u RCC-u i u MCL-u (vidjeti dio 4.8).
English: In the paediatric population, clearance of temsirolimus was lower and exposure (AUC) was higher than in adults.
Croatian: U pedijatrijskoj populaciji, klirens temsirolimusa bio je niži i izloženost (AUC) je bila viša nego u odraslih.
English: After 12 weeks of treatment, no response was observed in subjects with rhabdomyosarcoma or high-grade glioma.
Croatian: Nakon 12 tjedana liječenja nije opažen nikakav odgovor u ispitanika s rabdomiosarkomom ili gliomom visokog stupnja.
English: Phospholipidosis has not been observed in mice or monkeys treated with temsirolimus, nor has it been documented in patients treated with temsirolimus.
Croatian: Fosfolipidoza nije opažena u miševa ili majmuna liječenih temsirolimusom, niti je zabilježena u bolesnika liječenih temsirolimusom.
English: 6 hours when stored below 25°C and protected from light.
Croatian: 6 sati kad se čuva na temperaturi ispod 25°C i zaštićeno od svjetlosti.
English: During treatment with temsirolimus, vaccination may be less effective.
Croatian: Tijekom liječenja temsirolimusom, cijepljenje može biti manje učinkovito.
English: Temsirolimus exhibits a polyexponential decline in whole blood concentrations, and distribution is attributable to preferential binding to FKBP-12 in blood cells.
Croatian: Temsirolimus pokazuje polieksponencijalni pad koncentracije u punoj krvi, a distribucija se pripisuje preferencijalnom vezivanju za FKBP-12 u krvnim stanicama.
English: Your doctor may delay the administration of Torisel until the wound is fully recovered as this medicine could interfere with the healing processes of pre-existing wounds.
Croatian: Liječnik može odgoditi primjenu Torisela dok rana potpuno ne zacijeli, jer ovaj lijek može ometati proces cijeljenja postojećih rana.
English: b Disease assessment is based on radiographic review by independent radiologists and review of clinical data by independent oncologists.
Croatian: Procjena bolesti temelji se na radiološkom pregledu neovisnih radiologa i pregledu kliničkih podataka neovisnih onkologa.
English: Temsirolimus is not recommended for use in paediatric patients (see sections 4.2, 4.8 and 5.1).
Croatian: Temsirolimus se ne preporučuje u pedijatrijskih bolesnika (vidjeti dijelove 4.2, 4.8 i 5.1).
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.
Croatian: Ako Vam je mučno i povraćate ili imate poteškoće s usnivanjem ili prosnivanjem, budite posebno oprezni kad upravljate vozilima ili radite sa strojevima.
English: Some patients required discontinuation of temsirolimus or treatment with corticosteroids and/or antibiotics, while some patients continued treatment without additional intervention.
Croatian: U nekih je bolesnika bilo potrebno prekinuti primjenu temsirolimusa ili uvesti liječenje kortikosteroidima i/ili antibioticima, dok su drugi nastavili liječenje bez dodatne intervencije.
English: if you have shortness of breath, cough, and/or fever.
Croatian: - ako osjećate nedostatak zraka, imate kašalj i/ili vrućicu.
English: Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na temsirolimus, njegove metabolite (uključujući sirolimus), polisorbat 80 ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: There are no adequate data from the use of temsirolimus in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni temsirolimusa u trudnica.
English: • At the request of the European Medicines Agency;
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: Investigator's choice therapies included: gemcitabine (intravenous: 22 [41.5%]), fludarabine (intravenous: 12 [22.6%] or oral: 2 [3.8%]), chlorambucil (oral: 3 [5.7%]), cladribine (intravenous: 3 [5.7%]), etoposide (intravenous: 3 [5.7%]), cyclophosphamide (oral: 2 [3.8%]), thalidomide (oral: 2 [3.8%]), vinblastine (intravenous: 2 [3.8%]), alemtuzumab (intravenous: 1 [1.9%]), and lenalidomide (oral: 1 [1.9%]).
Croatian: Terapije po izboru ispitivača uključivale su: gemcitabin (intravenski: 22 [41,5%]), fludarabin (intravenski: 12 [22,6%] ili peroralno: 2 [3,8%]), klorambucil (peroralno: 3 [5,7%]), kladribin (intravenski: 3 [5,7%]), etoposid (intravenski: 3 [5,7%]), ciklofosfamid (peroralno: 2 [3,8%]), talidomid (peroralno: 2 [3,8%]), vinblastin (intravenski: 2 [3,8%]), alemtuzumab (intravenski: 1 [1,9%]) i lenalidomid (peroralno: 1 [1,9%]).
English: The temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered.
Croatian: Infuziju temsirolimusa treba prekinuti u svih bolesnika s teškim reakcijama na infuziju i primijeniti odgovarajuću medicinsku terapiju.
English: In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12.
Croatian: In vitro, pri visokim koncentracijama (10-20 µM), temsirolimus se može vezati za mTOR i inhibirati ga u odsutnosti FKBP-12.
English: Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
Croatian: Mogu se koristiti različiti završni filtri s veličinom pora u rasponu od 0,2 mikrona do 5 mikrona.
English: Teratogenic effects (omphalocele) were seen in rabbits (see section 5.3).
Croatian: Teratogeni učinci (omfalokela) opaženi su u kunića (vidjeti dio 5.3).
English: The contribution of the initial 175 mg doses to the efficacy outcome is currently not known.
Croatian: Koliko početna doza od 175 mg pridonosi ishodu djelotvornosti trenutno nije poznato.
English: Because it is recommended that an H1 antihistamine be administered to patients before the start of the intravenous temsirolimus infusion, temsirolimus should be used with caution in patients with known hypersensitivity to the antihistamine or in patients who cannot receive the antihistamine for other medical reasons.
Croatian: Budući da se bolesnicima preporučuje dati H1 antihistaminik prije početka intravenske infuzije temsirolimusa, temsirolimus treba primjenjivati s oprezom u bolesnika s poznatom preosjetljivošću na antihistaminik ili u bolesnika koji ne mogu primiti antihistaminik zbog drugih medicinskih razloga.
English: For subjects with neuroblastoma, the objective response rate was 5.3% (95% CI: 0.1%, 26.0%).
Croatian: U ispitanika s neuroblastomom, stopa objektivnog odgovora iznosila je 5,3% (95% CI: 0,1%; 26,0%).
English: In population pharmacokinetic-based data analysis, increased body weight (between 38.6 and 158.9 kg) was associated with a two-fold range of trough concentration of sirolimus in whole blood.
Croatian: U analizi podataka na temelju populacijske farmakokinetike, povećana tjelesna težina (između 38,6 i 158,9 kg) bila je povezana s dvostruko većim rasponom najnižih koncentracija sirolimusa u punoj krvi.
English: You may be at risk of getting an infection of the blood, skin, upper respiratory tract (including pneumonia), and/or urinary tract while you are taking Torisel.
Croatian: Možete biti pod rizikom od dobivanja infekcije krvi, kože, gornjih dišnih puteva (uključujući i upalu pluća) i/ili mokraćnih puteva dok uzimate Torisel.
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.
Croatian: Početna doza od 175 mg bila je povezana sa značajnom incidencijom štetnih događaja pa je u većine bolesnika bilo potrebno smanjiti dozu ili odgoditi primjenu.
English: It is harmful if you are suffering from alcoholism, and it is to be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Croatian: To je štetno ako patite od alkoholizma te je to potrebno uzeti u obzir kod primjene u trudnica ili dojilja, djece i u bolesnika s visokim rizikom, kao što su bolesnici s oštećenjem jetre ili epilepsijom.
English: Patients should be monitored early during the infusion and appropriate supportive care should be available.
Croatian: Bolesnike je potrebno početi promatrati od početka infuzije i imati na raspolaganju odgovarajuću potpornu skrb.
English: The mean ±standard deviation (SD) dissociation constant (Kd) of binding was 5.1 ± 3.0 ng/ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Croatian: Srednja vrijednost ± standardna devijacija (SD) konstante disocijacije (Kd) vezanja iznosila je 5,1 ± 3,0 ng/ml, pokazujući koncentraciju pri kojoj je 50% mjesta vezanja u krvnim stanicama bilo zauzeto.
English: (50,000 cells/mm3), the doses should be modified to the next lower dose level according to the table above.
Croatian: 9/l (50 000 stanica/mm 3), doze treba prilagoditi na sljedeću nižu razinu sukladno gornjoj tablici.
English: If clinically significant respiratory symptoms develop, temsirolimus administration may be withheld until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.
Croatian: Ako se razviju klinički značajni respiratorni simptomi, primjena temsirolimusa može biti privremeno prekinuta sve do oporavka simptoma i poboljšanja radiografskih nalaza pneumonitisa.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Torisel u svim podskupinama pedijatrijske populacije u limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: CI = confidence interval; NA = not applicable.
Croatian: CI = interval pouzdanosti; Np = nije primjenjivo.
English: c Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Croatian: Na temelju Cochran-Mantel-Hanselovog testa stratificirani prema prethodnoj nefrektomiji i regiji.
English: Torisel is for intravenous use only.
Croatian: Torisel je namijenjen samo za intravensku primjenu.
English: Torisel is unlikely to influence the ability to drive and use machines.
Croatian: Malo je vjerojatno da će Torisel utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Other side effects with Torisel may include:
Croatian: Druge nuspojave Torisela mogu uključivati:
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.
Croatian: Opći upalni odgovori, kako pokazuju povišeni fibrinogen i neutrofili i/ili promjene serumskih proteina, bili su opaženi u miševa, štakora i majmuna, iako su u nekim slučajevima ove kliničke patološke promjene bile pripisane upali kože ili crijeva, kako je navedeno gore.
English: How to store Torisel
Croatian: Kako primjenjivati Torisel
English: The safety and efficacy of temsirolimus in the treatment of advanced RCC were studied in the following two randomised clinical trials:
Croatian: Djelotvornost i sigurnost temsirolimusa u liječenju uznapredovalog RCC-a bile su ispitane u sljedeća dva randomizirana klinička ispitivanja:
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers
Croatian: Istodobna primjena inhibitora angiotenzin-konvertirajućeg enzima (ACE) i/ili blokatora kalcijevih kanala
English: The use of temsirolimus was associated with increases in serum triglycerides and cholesterol.
Croatian: Primjena temsirolimusa bila je povezana s povećanjem serumskih triglicerida i kolesterola.
English: Torisel may lead to a higher risk of bleeding into your brain.
Croatian: Torisel može dovesti do povećanog rizika od krvarenja u mozak.
English: Torisel may elevate triglycerides and/or cholesterol, and this may require treatment with lipid-lowering agents (medicines used to reduce cholesterol in the blood).
Croatian: Torisel može povisiti razinu triglicerida i/ili kolesterola, a to može zahtijevati liječenje lijekovima za snižavanje lipida (lijekovi za snižavanje kolesterola u krvi).
English: Mean half-lives of temsirolimus and sirolimus were 17.7 hours and 73.3 hours, respectively.
Croatian: Srednja vrijednost poluvijeka temsirolimusa iznosila je 17,7 sati, a sirolimusa 73,3 sata.
English: Pericardial effusion (fluid around the heart that may require drainage and can affect the pumping of blood).
Croatian: Perikardijalni izljev (tekućina oko srca koju će možda trebati drenirati i koja može ometati pumpanje krvi).
English: if you are receiving Torisel, you may be at increased risk of cancers such as skin cancers and lymph node cancers (lymphoma).
Croatian: - ako primate Torisel, možete biti izloženi povećanom riziku od raka kao što su rak kože i rak limfnih čvorova (limfoma).
English: The excretion of temsirolimus in milk has not been studied in animals.
Croatian: Izlučivanje temsirolimusa u mlijeko nije ispitano u životinja.
English: Thrombocytopenia, neutropenia, and anaemia
Croatian: Trombocitopenija, neutropenija i anemija
English: Bleeding in the brain
Croatian: Krvarenje u mozak
English: Torisel can decrease the number of blood cells that help in clotting and resisting infection.
Croatian: - Torisel može sniziti broj krvnih stanica koje pomažu zgrušavanju krvi i obrani od infekcije.
English: Carcinogenicity studies have not been conducted with temsirolimus; however, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats.
Croatian: Ispitivanja kancerogenosti temsirolimusa nisu provedena; međutim, sirolimus, glavni metabolit temsirolimusa u ljudi, bio je kancerogen u miševa i štakora.
English: if you have or have had eye problems like cataracts.
Croatian: - ako imate ili ste imali tegobe s očima poput katarakte.
English: Temsirolimus distribution is dose-dependent with mean (10th, 90th percentiles) maximal specific binding in blood cells of 1.4 mg (0.47 to 2.5 mg).
Croatian: Distribucija temsirolimusa je ovisna o dozi uz srednju vrijednost (10.-90. percentila) maksimalno specifičnog vezanja u krvnim stanicama od 1,4 mg (0,47 do 2,5 mg).
English: Do not use this medicine after the expiry date, which is stated on the vial label and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji.
English: High concentrations resulted in complete cell growth inhibition in vitro, whereas inhibition mediated by FKBP-12/temsirolimus complex alone resulted in approximately 50% decrease in cell proliferation.
Croatian: Visoke koncentracije rezultirale su potpunom inhibicijom rasta stanica in vitro, dok je inhibicija posredovana kompleksom FKBP-12/temsirolimus rezultirala smanjenjem stanične proliferacije za približno 50%.
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).
Croatian: Ovi transkripcijski čimbenici reguliraju sposobnost tumora da se prilagodi hipoksičnom mikrookruženju i stvara angiogeni čimbenik - vaskularni endotelni čimbenik rasta (VEGF).
English: It is important that the recommendations in sections 4.2 and 6.6 be followed closely.
Croatian: Važno je strogo se pridržavati preporuka u dijelovima 4.2 i 6.6.
English: Sirolimus, an equally potent metabolite to temsirolimus, was observed as the principal metabolite in humans following intravenous treatment.
Croatian: Sirolimus, jednako potentan metabolit kao i temsirolimus, opažen je kao glavni metabolit u ljudi kod intravenskog liječenja.
English: Adverse reactions that were reported in post-marketing experience are listed below (Table 2).
Croatian: Nuspojave zabilježene nakon stavljanja lijeka u promet navedene su niže (tablica 2).
English: Temsirolimus is cleared predominantly by the liver.
Croatian: Temsirolimus se pretežno uklanja putem jetre.
English: Temsirolimus has been associated with phospholipidosis in rats.
Croatian: Temsirolimus je povezan s fosfolipidozom u štakora.
English: The use of both an in-line and end-filter is not recommended (see sections 6.1 and 6.2).
Croatian: Ne preporučuje se uporaba oba filtra, tj. i ugrađenog i završnog (vidjeti dijelove 6.1 i
English: Unexplained muscle pain, tenderness or weakness which could indicate muscle damage
Croatian: Neobjašnjiva bol u mišićima, osjetljivosti ili slabost, što može ukazivati na oštećenje mišića (rabdomioliza).
English: Although phospholipidosis has not been shown to be a risk for patients administered temsirolimus, it is possible that combined administration of temsirolimus with other amphiphilic agents such as amiodarone or statins could result in an increased risk of amphiphilic pulmonary toxicity.
Croatian: Iako se pokazalo da nema rizika od fosfolipidoze u bolesnika kojima se daje temsirolimus, moguće je da kombinirana primjena temsirolimusa s drugim amfifilnim sredstvima, kao što su amiodaron ili statini, dovede do povećanja rizika od amfifilne plućne toksičnosti.
English: Concomitant use of temsirolimus with sunitinib
Croatian: Istodobna primjena temsirolimusa sa sunitinibom
English: Concentrate and solvent for solution for infusion (sterile concentrate).
Croatian: Koncentrat i otapalo za otopinu za infuziju (sterilni koncentrat).
English: The amount of alcohol in this medicinal product may impair the ability to drive or use machines (see section 4.7).
Croatian: Količina alkohola u ovom lijeku može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.7).
English: Therefore, when temsirolimus is co-administered with medicinal products which are P-gp substrates (e.g. digoxin, vincristine, colchicine, dabigatran, lenalidomide, and paclitaxel) close monitoring for adverse events related to the co-administered medicinal products should be observed.
Croatian: Stoga, kad se temsirolimus primjenjuje istodobno s lijekovima koji su supstrati P-gp (npr. digoksin, vinkristin, kolhicin, dabigatran, lenalidomid i paklitaksel) potreban je pažljiv nadzor zbog štetnih događaja povezanih s istodobnom primjenom ovih lijekova.
English: The safety and efficacy of intravenous temsirolimus for the treatment of relapsed and/or refractory MCL were studied in the following Phase 3 clinical study.
Croatian: Sigurnost i djelotvornost intravenskog temsirolimusa za liječenje relapsa i/ili refraktornog MCL-a ispitane su u sljedećem kliničkom ispitivanju faze III.
English: Abbreviations: CI = confidence interval; NA = not applicable.
Croatian: Skraćenice: CI = interval pouzdanosti; Np = nije primjenjivo.
English: Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).
Croatian: Torisel je indiciran za prvu liniju liječenja odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) koji imaju najmanje tri od šest prognostičkih čimbenika rizika (vidjeti dio 5.1).
English: Temsirolimus also was associated with statistically significant advantages over investigator's choice in the secondary endpoint of ORR.
Croatian: Temsirolimus je također bio povezan sa statistički značajnim prednostima nad terapijom po izboru ispitivača u sekundarnoj mjeri ishoda ORR.
English: When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked.
Croatian: Kad se inhibira aktivnost mTOR, blokira se njegova sposobnost da fosforilira i tako kontrolira aktivnost translacijskih čimbenika (4EBP1 i S6K, oba se nalaze niže od mTOR na P13 kinaze/AKT putu) koji kontroliraju diobu stanice.
English: Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Croatian: Analiza populacijske farmakokinetike bazirana na rijetkom uzorkovanju ukazuje da nema klinički značajnih učinaka interakcija na AUC i Cmax CYP2D6 supstrata desipramina.
English: The diluted solution must be administered by intravenous infusion.
Croatian: Razrijeđena se otopina mora primijeniti intravenskom infuzijom.
English: Bleeding into the brain in patients with brain tumours or who are on blood thinners, eye bleeding.
Croatian: Krvarenje u mozak u bolesnika s tumorima mozga ili bolesnika koji uzimaju lijekove za razrjeđivanje krvi, krvarenje u oku.
English: MCL clinical trial
Croatian: MCL kliničko ispitivanje
English: The administration materials must consist of nonDEHP, non-PVC tubing with appropriate filter.
Croatian: Pribor za primjenu mora imati cijevi koje ne sadrže DEHP i PVC i imaju odgovarajući filtar.
English: Lung infection caused by Pneumocystis jiroveci (Pneumocystis jiroveci pneumonia).
Croatian: Infekcija pluća uzrokovana s Pneumocystis jirovecii (pneumonija uzrokovana s Pneumocystis jirovecii).
English: Cases of pneumocystis jiroveci pneumonia (PCP) some with fatal outcomes, have been reported in patients who received temsirolimus, many of whom also received corticosteroids or other immunosuppressive agents.
Croatian: Slučajevi pneumonije uzrokovane s Pneumocystis jirovecii, od kojih neki sa smrtonosnim ishodima, zabilježeni su u bolesnika koji su primali temsirolimus, od kojih su mnogi također primali kortikosteroide ili druga imunosupresivna sredstva.
English: Others presented with symptoms such as dyspnoea, cough, and fever.
Croatian: Drugi su imali simptome poput dispneje, kašlja i vrućice.