FrancophonIA/ELRC3.0 huggingface dataset:
English: Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Croatian: Primjena talidomida mora se trajno obustaviti u slučaju angioedema, osipa 4. stupnja, eksfolijativnog ili buloznog osipa ili sumnje na Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu ili reakciju na lijek s eozinofilijom i sistemskim simptomima.
English: Thalidomide dosed once daily at bedtime on Days 1 to 42 of each 42-day cycle.
Croatian: * ABN: apsolutni broj neutrofila a Doza talidomida primijenjena jedanput na dan prije spavanja od 1. do 42. dana svakog 42-dnevnog ciklusa.
English: Posology
Croatian: Prednizonf
English: Do not use if you notice any damage or signs of tampering.
Croatian: Ne uzimajte lijek ako primijetite oštećenje ili znakove otvaranja.
English: Hepatic and renal impairment
Croatian: Poremećaj jetre i žući
English: If you forget to take Thalidomide Celgene
Croatian: Za žene koje uzimaju Thalidomide Celgene
English: • Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment
Croatian: o prije liječenja o svaka 4 tjedna tijekom liječenja o 4 tjedna nakon završetka liječenja.
English: f
Croatian: A.
English: if you are over 65 years of age.
Croatian: - ako ste stariji od 65 godina.
English: The potential risk for humans is unknown.
Croatian: Mogući rizik za ljude nije poznat.
English: OS was similar.
Croatian: Mjera OS bila je slična.
English: Unopened vial 3 years.
Croatian: Neotvorene bočice 3 godine.
English: This leaflet was last revised in <{MM/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}>
English: Torisel with food and drink
Croatian: Torisel s hranom i pićem
English: 100% of planned dose
Croatian: 100% planirane doze
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6 .
English: Discuss alternatives with your doctor.
Croatian: Razgovarajte o drugim mogućnostima sa svojim liječnikom.
English: Torisel is used to treat the following types of cancer in adults:
Croatian: Torisel se primjenjuje za liječenje sljedećih vrsta raka u odraslih:
English: Other medicines and Torisel
Croatian: Drugi lijekovi i Torisel
English: Some patients did not have symptoms or had minimal symptoms.
Croatian: Neki bolesnici nisu imali simptome ili su imali minimalne simptome.
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Croatian: Količina alkohola u ovom lijeku može promijeniti učinak drugih lijekova.
English: These reactions can occur very early in the first infusion, but may also occur with subsequent infusions.
Croatian: Te reakcije mogu nastati vrlo rano kod prve infuzije, ali se mogu pojaviti i kod naknadnih infuzija.
English: Harmful for those suffering from alcoholism.
Croatian: Štetno za ljude koji pate od alkoholizma.
English: See section 4.4 for additional information concerning serious adverse reactions, including appropriate actions to be taken if specific reactions occur.
Croatian: Vidjeti dio 4.4 za dodatne informacije o ozbiljnim nuspojavama, uključujući odgovarajuće mjere koje treba poduzeti ako nastupi određena reakcija.
English: Date of the latest renewal: 13 July 2017
Croatian: Datum posljednje obnove odobrenja: 13. srpnja 2017.
English: If you are concerned about this, tell your doctor immediately.
Croatian: Ako ste zabrinuti zbog toga, odmah se obratite liječniku.
English: Do not throw away any medicines via wastewater.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: Studies in animals have shown reproductive toxicity.
Croatian: Ispitivanja u životinja pokazala su reproduktivnu toksičnost.
English: Do not use Torisel:
Croatian: Nemojte primjenjivati Torisel:
English: if you are allergic to antihistamines or cannot use antihistamines for other medical reasons.
Croatian: - ako ste alergični na antihistaminike ili ne možete koristiti antihistaminike zbog drugih medicinskih razloga.
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.
Croatian: Budući da ovaj lijek pripremaju i primjenjuju zdravstveni radnici, nije vjerojatno da ćete dobiti previše lijeka ili da ćete propustiti dozu.
English: Torisel may weaken your immune system.
Croatian: Torisel Vam može oslabiti imunološki sustav.
English: If you experience any of them, seek medical advice immediately.
Croatian: Ako dobijete neku od njih, odmah potražite savjet liječnika.
English: Therefore, inhibitors of these metabolic pathways are not expected to affect the elimination of temsirolimus.
Croatian: Stoga se ne očekuje da će inhibitori ovih metaboličkih puteva utjecati na eliminaciju temsirolimusa.
English: The fatal events included those due to progression of disease; however a causal relationship cannot be excluded.
Croatian: Smrtni slučajevi uključivali su one zbog progresije bolesti; međutim, ne može se isključiti uzročnoposljedična veza.
English: Side effects for which frequency is not known (cannot be estimated from available data):
Croatian: Nuspojave čija učestalost nije poznata (ne može se procijeniti iz dostupnih podataka):
English: None of the 3 cohorts met the criterion for advancing to the second stage of the Simon 2-stage design.
Croatian: Niti jedna od 3 kohorte nije zadovoljila kriterij za napredovanje na drugi stadij Simonove 2-stadijske sheme.
English: Store in a refrigerator (2°C - 8°C)
Croatian: Čuvati u hladnjaku (2°C-8°C)
English: Use a new vial.
Croatian: Koristite novu bočicu.
English: This includes any possibleside effects not listed in this leaflet.
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: The incidence and severity of adverse events is dose-dependent.
Croatian: Incidencija i težina štetnih događaja ovise o dozi.
English: Torisel contains alcohol and can be harmful to those who drink alcohol or to those suffering from alcoholism.
Croatian: Torisel sadrži alkohol i može naškoditi onima koji piju alkohol ili boluju od alkoholizma.
English: Swelling of the face, lips, tongue, and throat, possibly causing difficulty breathing.
Croatian: Oticanje lica, usana, jezika i grla, koji može uzrokovati otežano disanje.
English: What you need to know before you receive Torisel
Croatian: Što morate znati prije nego počnete primati Torisel
English: What Torisel looks like and contents of the pack
Croatian: Kako Torisel izgleda i sadržaj pakiranja
English: What Torisel is and what it is used for
Croatian: Što je Torisel i za što se koristi
English: Adverse events were generally similar to those observed in adults (see section 4.8).
Croatian: Nuspojave su općenito bile slične onima opaženima u odraslih (vidjeti dio 4.8).
English: if you have recently undertaken a surgery.
Croatian: - ako ste nedavno bili na operaciji.
English: Pharmacokinetic data on temsirolimus and sirolimus are available in patients up to age 79 years.
Croatian: Farmakokinetički podaci o temsirolimusu i sirolimusu dostupni su za bolesnike u dobi do 79 godina.
English: Periodical follow-up assessments may be considered.
Croatian: Mogu se razmotriti povremeni kontrolni pregledi.
English: Gender, weight, race, age
Croatian: Spol, tjelesna težina, rasa, dob
English: Your doctor will decide when to start Torisel again.
Croatian: Liječnik će odlučiti kada ćete ponovno početi liječenje Toriselom.
English: This incompatibility has to be considered during the preparation and administration of Torisel.
Croatian: Ova inkompatibilnost mora se uzeti u obzir tijekom pripreme i primjene Torisela.
English: Parameter temsirolimus 175/75 mg n = 54
Croatian: Temsirolimus 175/75 mg n = 54
English: This may increase the risk of bleeding/bruising and infection (see section “Possible side effects").
Croatian: To može povećati rizik od krvarenja/podljeva i infekcije (pogledajte dio “Moguće nuspojave").
English: Sufficient time should be allowed for air bubbles to subside.
Croatian: Treba ostaviti dovoljno vremena da nestanu mjehurići zraka.
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.
Croatian: Kao i inače za bolesnike s povećanim rizikom od raka kože, izlaganje sunčevoj svjetlosti i ultraljubičastom (UV) svjetlu treba ograničiti na način da se nosi zaštitna odjeća i koristi krema za sunčanje s visokim zaštitnim faktorom.
English: What Torisel contains
Croatian: Što Torisel sadrži
English: Talk to your doctor, pharmacist or nurse before receiving Torisel:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Torisel:
English: Torisel will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
Croatian: Torisel će uvijek pripremiti liječnik ili drugi zdravstveni radnik i dati Vam ga u obliku intravenske infuzije (u venu).
English: This may increase the risk of getting fever and infections.
Croatian: To može povećati rizik od dobivanja vrućice i infekcija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2007
Croatian: Datum prvog odobrenja: 19. studenog 2007.
English: Your doctor will do blood tests to check your liver function and then may decide to lower the dose of Torisel.
Croatian: Liječnik će Vam napraviti krvne pretrage kako bi provjerio funkciju Vaše jetre i potom odlučio treba li sniziti dozu Torisela.
English: System organ class
Croatian: Klasa organskog sustava
English: No relevant differences in exposure were apparent when data from the Caucasian population was compared with either the Japanese or Black population.
Croatian: Nije bilo vidljivih važnih razlika u izloženosti kad su se podaci za bjelačku populaciju usporedili s podacima za japansku ili crnačku populaciju.
English: Bags/containers that come in contact with Torisel must be made of glass, polyolefin, or polyethylene.
Croatian: Vrećice/spremnici koji dolaze u kontakt s Toriselom moraju biti napravljeni od stakla, poliolefina ili polietilena.
English: Immunosuppressants may affect responses to vaccination.
Croatian: Imunosupresivi mogu utjecati na odgovor na cijepljenje.
English: Investigator's choice (inv choice) n = 54
Croatian: Izbor ispitivača n = 54
English: Administration in infusion.
Croatian: Primijeniti u infuziji.
English: Table 1: Adverse reactions from clinical trials in RCC (study 3066K1-304) and in MCL (study 3066K1-305)
Croatian: Tablica 1: Nuspojave u kliničkim ispitivanjima RCC-a (ispitivanje 3066K1-304) i MCL-a (ispitivanje 3066K1-305)
English: Antihistamines are given to help prevent an allergic reaction to Torisel, including some lifethreatening and rare fatal allergic reactions.
Croatian: Antihistaminici se daju kao pomoć u sprječavanju alergijske reakcije na Torisel, uključujući neke životno opasne i rijetke smrtonosne alergijske reakcije.
English: Patients may be immunosuppressed and should be carefully observed for the occurrence of infections, including opportunistic infections.
Croatian: Bolesnici mogu biti imunosuprimirani i potrebno ih je pažljivo promatrati zbog moguće pojave infekcija, uključujući oportunističke infekcije.
English: The effect on the unbound concentrations of sirolimus has not been determined, but is expected to be larger than the effect on whole-blood concentrations due to the saturable binding to red blood cells.
Croatian: Učinak na koncentraciju nevezanog sirolimusa nije utvrđen, ali očekuje se da će biti veći od učinka na koncentracije u punoj krvi zbog zasićenja vezanja za crvene krvne stanice.
English: In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Croatian: Osobito trebate obavijestiti svog liječnika ili ljekarnika ako uzimate nešto od sljedećeg:
English: This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Croatian: Ovaj lijek se mora primjenjivati pod nadzorom liječnika s iskustvom u primjeni antineoplastičkih lijekova.
English: Tell your doctor if you have a drinking problem or consume alcohol (see section “Torisel contains ethanol [alcohol]”).
Croatian: Obavijestite svog liječnika ako imate problema s alkoholom ili konzumirate alkohol (pogledajte dio „Torisel sadrži etanol [alkohol]“).
English: • Appropriate administration materials must be used to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
Croatian: • Odgovarajući materijali za primjenu moraju se koristiti kako bi se izbjegao pretjerani gubitak lijeka i smanjila stopa ekstrakcije DEHP.
English: if you are going to have surgery or if you had an operation recently.
Croatian: - ako ćete uskoro ići na operaciju ili ste nedavno bili na operaciji.
English: Torisel contains ethanol (alcohol)
Croatian: Torisel sadrži etanol (alkohol)
English: Your doctor will monitor your kidney function.
Croatian: Liječnik će pratiti funkciju Vaših bubrega.
English: For some animals, there were no specific clinical observations or histological changes that suggested inflammation.
Croatian: U nekih životinja nije bilo posebnih kliničkih opažanja niti histoloških promjena koje bi ukazivale na upalu.
English: Interactions with medicinal products that are P-glycoprotein substrates
Croatian: Interakcije s lijekovima koji su supstrati P-glikoproteina
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01X E09
Croatian: Farmakoterapijska skupina: antineoplastička sredstva, inhibitori protein kinaze; ATK oznaka: L01X E09
English: Torisel may cause non-specific interstitial pneumonitis.
Croatian: Torisel može prouzročiti nespecifični intersticijski pneumonitis.
English: Administration of corticosteroids may be considered; however, the efficacy of corticosteroid treatment in this setting has not been established.
Croatian: Može se razmotriti primjena kortikosteroida; međutim, djelotvornost liječenja kortikosteroidima u takvom slučaju nije utvrđena.
English: If you experience any of these during the administration of Torisel, the doctor or nurse will stop the infusion.
Croatian: Ako osjetite nešto od toga tijekom primjene Torisela, liječnik ili medicinska sestra zaustavit će infuziju.
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.
Croatian: Preporučuje se pažljivo pratiti bolesnike zbog moguće pojave kliničkih respiratornih simptoma, a bolesnicima treba savjetovati da odmah prijave sve nove respiratorne simptome ili njihovo pogoršanje.
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).
Croatian: Ako bolesnik razvije reakciju preosjetljivosti tijekom infuzije temsirolimusa usprkos premedikaciji, infuzija se mora prekinuti, a bolesnika promatrati najmanje 30 do 60 minuta (ovisno o težini reakcije).
English: Women of childbearing potential/Contraception in males and females
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena
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”).
Croatian: Količina alkohola u ovom lijeku može narušiti Vašu sposobnost upravljanja vozilima ili promijeniti učinke drugih lijekova (pogledajte dio “Upozorenja i mjere opreza” i “Upravljanje vozilima i strojevima”).
English: The results for the MCL clinical trial are summarised in the following table.
Croatian: Rezultati MCL kliničkog ispitivanja sažeti su u sljedećoj tablici.
English: Torisel must not be used during pregnancy, unless the risk for the embryo is justified by the expected benefit for the mother.
Croatian: Torisel se ne smije primjenjivati tijekom trudnoće, osim ako je rizik za embrij opravdan očekivanom koristi za majku.
English: No specific dose adjustment is necessary in elderly patients.
Croatian: Nije potrebno posebno prilagođavati dozu u starijih bolesnika.
English: In addition to regulating cell cycle proteins, mTOR can regulate translation of the hypoxia-inducible factors, HIF-1 and HIF-2 alpha.
Croatian: Uz to što regulira proteine staničnog ciklusa, mTOR može regulirati i translaciju čimbenika induciranih hipoksijom, HIF-1 i HIF-2 alfa.
English: This may increase the risk of bleeding in your body.
Croatian: To može povećati rizik od krvarenja u tijelu.
English: The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity.
Croatian: Kombinacija temsirolimusa i sunitiniba rezultirala je toksičnošću koja je ograničavala dozu.
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.
Croatian: U MCL kliničkom ispitivanju nije bilo razlike u djelotvornosti među bolesnicima s obzirom na dob, spol, rasu, geografsku regiju ili početne značajke bolesti.
English: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Croatian: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgija
English: • Torisel is infused over a 30- to 60-minute period once a week.
Croatian: • Torisel se daje infuzijom u trajanju od 30 do 60 minuta jedanput na tjedan.
English: Starting dose 175 mg
Croatian: Početna doza 175 mg
English: Empiric treatment with corticosteroids and/or antibiotics may be considered.
Croatian: Može se razmotriti empirijsko liječenje kortikosteroidima i/ili antibioticima.
English: if you drink alcohol or are an alcoholic.
Croatian: - ako pijete alkohol ili bolujete od alkoholizma.
English: P-value
Croatian: P-vrijednost
English: All grades n (%)
Croatian: Svi stupnjevi n (%)
English: Excipient with known effect
Croatian: Pomoćna tvar s poznatim učinkom
English: Tell your doctor if you experience new or worsening symptoms, or if you are taking or have recently taken medicines that weaken your immune system.
Croatian: Obavijestite liječnika ako osjetite nove simptome ili pogoršanje postojećih ili ako uzimate ili ste nedavno uzimali lijekove koji slabe Vaš imunološki sustav.
English: Interaction with medicinal products metabolised by CYP2D6 or CYP3A4/5
Croatian: Interakcije s lijekovima koji se metaboliziraju putem CYP2D6 ili CYP3A4/5
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.
Croatian: Ovaj lijek nije namijenjen za djecu i adolescente mlađe od 18 godina zato što u ovih bolesnika uznapredovali karcinom bubrega i limfom plaštenih stanica nisu relevantni, a lijek ne djeluje protiv drugih vrsta raka.
English: Women should not breast-feed during treatment with Torisel, as this medicine may interfere with the growth and development of the baby.
Croatian: Žene ne smiju dojiti tijekom liječenja Toriselom, jer taj lijek može omesti rast i razvoj djeteta.
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of temsirolimus.
Croatian: Izloženost životinja bila je niža od izloženosti opažene u ljudi koji su primali klinički važne doze temsirolimusa.
English: The effect may also be more pronounced at a 25 mg dose.
Croatian: Taj učinak mora biti izraženiji pri dozi od 25 mg.
English: if you have or have had high cholesterol levels.
Croatian: - ako imate ili ste imali visoke razine kolesterola.
English: In RCC clinical trial 1, 31% of patients treated with temsirolimus were 65 or older.
Croatian: U RCC kliničkom ispitivanju 1, 31% bolesnika liječenih temsirolimusom bilo je u dobi od 65 ili više godina.
English: b Based on Cox proportional hazard model stratified by prior nephrectomy and region (95% CI are descriptive only).
Croatian: Na temelju Coxovog modela proporcionalnih hazarda stratificirani prema prethodnoj nefrektomiji i regiji (95% CI su samo deskriptivni).
English: These symptoms might be caused by a sudden decrease of kidney function.
Croatian: Ovi simptomi mogu biti uzrokovani iznenadnim smanjenjem funkcije bubrega.
English: In rats, these changes were accompanied by a decreased weight of accessory sex organs (epididymides, prostate, seminal vesicles).
Croatian: U štakora su ove promjene bile praćene smanjenom težinom muških spolnih organa (pasjemenika, prostate, sjemenih mjehurića).
English: Torisel has not been studied in pregnant women, and it must not be used during pregnancy, unless clearly necessary.
Croatian: Torisel nije ispitan u trudnica i ne smije se primjenjivati tijekom trudnoće, osim ako je to prijeko potrebno.
English: Concentrate
Croatian: Koncentrat
English: Store in a refrigerator
Croatian: Čuvati u hladnjaku
English: Read the package leaflet before use and for dilution instructions.
Croatian: Prije uporabe pročitajte uputu o lijeku i upute za razrjeđivanje.
English: Grapefruit and grapefruit juice may increase blood concentrations of Torisel and should be avoided.
Croatian: Grejp i sok od grejpa mogu povećati koncentracije Torisela u krvi pa ih treba izbjegavati.
English: It is important that the recommendations in section 4.2 be followed closely.
Croatian: Važno je strogo se pridržavati preporuka u dijelu 4.2.
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.
Croatian: Učestalosti se definiraju na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: if you are planning to have a vaccination during treatment with Torisel.
Croatian: - ako se planirate cijepiti tijekom liječenja Toriselom.
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.
Croatian: Ako dostupni komplet za primjenu nema ugrađen unutarnji filtar, filtar treba dodati na kraj linije (tj. završni filtar) prije nego što mješavina dopre do vene bolesnika.
English: Some patients were asymptomatic or had minimal symptoms with pneumonitis detected on computed tomography scan or chest radiograph.
Croatian: Neki su bolesnici bili asimptomatski ili su imali minimalne simptome, a pneumonitis je otkriven na snimkama kompjutoriziranom tomografijom ili rendgenskoj snimci pluća.
English: Keep the vials in the outer carton in order to protect from light.
Croatian: Bočice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.
Croatian: Tu mješavinu treba promiješati okretanjem vrećice ili boce, ali bez previše potresanja, jer se tako može stvoriti pjena.
English: Hypersensitivity/infusion reactions
Croatian: Reakcije preosjetljivosti/infuzijske reakcije