FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Slovenian: Pri odraslih in otrocih, ki tehtajo več kot 35 kg, je priporočeni celotni odmerek 40 mg, ki ga bolnik prejme kot dva odmerka po 20 mg.
English: Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.
Slovenian: V dveh dodatnih študijah so opazovali, kakšni so odzivi na zdravilo Simulect v telesu otrok, starejših od enega leta, ali mladostnikov.
English: Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients.
Slovenian: Zdravila Simulect ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za baziliksimab ali katero koli drugo sestavino zdravila.
English: In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines.
Slovenian: Neželeni učinki v študijah so bili podobni pri bolnikih, ki so jemali zdravilo Simulect in placebo v kombinaciji z drugimi zdravili.
English: In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘triple therapy').
Slovenian: V tretji študiji je vseh 345 odraslih jemalo ciklosporin, steroide in azatioprin (trotirno zdravljenje).
English: Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).
Slovenian: Učinkovina baziliksimab je bila zasnovana tako, da se veže na antigen, imenovan CD25, ki je prisoten na površini limfocitov T (vrste belih krvničk, ki sodeluje pri zavrnitvi presajenih organov).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Simulect za zaščito pred akutno zavrnitvijo organa pri de novo alogeni presaditvi ledvice pri odraslih bolnikih in otrocih večje od z njim povezanih tveganj.
English: In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
Slovenian: V tretji študiji je bilo število bolnikov, pri katerih je bilo zdravljenje neuspešno, manjše pri bolnikih, ki so prejemali zdravilo Simulect sočasno s trotirnim zdravljenjem (26 %), kot pri bolnikih, ki so prejemali placebo (40 %).
English: Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Slovenian: Zdravilo Simulect je prašek in vehikel, ki se uporabljata za pripravo raztopine za injiciranje ali infundiranje (vnašanje tekočine v veno po kapljicah).
English: Why has Simulect been approved?
Slovenian: Zakaj je bilo zdravilo Simulect odobreno?
English: For the full list of all side effects reported with Simulect, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Simulect, glejte navodilo za uporabo.
English: Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Slovenian: Zdravilo Simulect se uporablja v kombinaciji z drugimi zdravili, kot so ciklosporin, kortikosteroidi, azatioprin in mofetilmikofenolat, za preprečevanje zavrnitve organov.
English: By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply.
Slovenian: Baziliksimab z vezanjem na CD25 blokira aktivnost interlevkina-2 in tako zmanjša hitrost, s katero se limfociti razmnožujejo.
English: CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
Slovenian: CD25 je receptor za sporočilno molekulo interlevkin-2, ki spodbuja limfocite T k razmnoževanju.
English: In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Slovenian: Pri otrocih so bili neželeni učinki, opaženi pri več kot 20 % bolnikov, okužbe sečil, hipertrihoza (čezmerna poraščenost telesa), rinitis (zamašen nos ter izcedek iz nosu), zvišana telesna temperatura, hipertenzija, okužba zgornjih dihal, virusna okužba, sepsa (okužba krvi) in zapeka.
English: Simulect must not be used during pregnancy or breast-feeding.
Slovenian: Zdravila Simulect ne smejo prejeti nosečnice ali doječe matere.
English: The active substance in Simulect, basiliximab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina v zdravilu Simulect, baziliksimab, je monoklonsko protitelo.
English: All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment).
Slovenian: V vseh treh študijah so učinkovitost zdravila Simulect primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The full EPAR for Simulect can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Simulect je na voljo tukaj.
English: How has Simulect been studied?
Slovenian: Kako je bilo zdravilo Simulect raziskano?
English: What is Simulect used for?
Slovenian: Za kaj se zdravilo Simulect uporablja?
English: How is Simulect used?
Slovenian: Kako se zdravilo Simulect uporablja?
English: It contains the active substance basiliximab.
Slovenian: Zdravilo vsebuje zdravilno učinkovino baziliksimab.
English: What is Simulect?
Slovenian: Kaj je zdravilo Simulect?
English: How does Simulect work?
Slovenian: Kako zdravilo Simulect deluje?
English: This is usually reached within three to five months.
Slovenian: Te ravni so običajno dosežene v treh do petih mesecih.
English: It is available as tablets (500 mg).
Slovenian: Na voljo je v obliki tablet (500 mg).
English: Treatment should continue as long as there is a benefit.
Slovenian: Zdravljenje je treba nadaljevati, dokler ima koristne učinke.
English: Levels above 20 mg/l may cause severe side effects without increasing the medicine's effectiveness.
Slovenian: Ravni nad 20 mg/l lahko povzročijo resne neželene učinke, ne da bi se pri tem povečala učinkovitost zdravila.
English: The recommended starting dose in adults is 2 to 3 g per day, divided into two or three doses, taken with meals containing fatty food.
Slovenian: Priporočeni začetni odmerek za odrasle je 2 do 3 g na dan, razdeljen v dva ali tri odmerke, ki se vzamejo z obroki, ki vsebujejo mastna živila.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lysodren on 28 April 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lysodren, veljavno po vsej Evropski uniji, odobrila dne 28. aprila 2004.
English: If there is no improvement in symptoms after three months of treatment at the optimal dose, treatment should be stopped.
Slovenian: Če izboljšanje simptomov ni opazno po treh mesecih jemanja optimalnega odmerka, je treba zdravljenje prekiniti.
English: The most common side effects with Lysodren (seen in more than 1 patient in 10) are increased blood levels of liver enzymes, cholesterol and triglycerides (a type of fat), leucopenia (low white blood cell counts), prolonged bleeding time, ataxia (difficulty co-ordinating movements), paraesthesia (abnormal sensations like pins and needles), vertigo (a spinning sensation), sleepiness, mucositis (inflammation of the mucous membranes, such as the lining of the mouth), vomiting, diarrhoea, nausea (feeling sick), epigastric discomfort (discomfort around the stomach), skin rash, myasthenia (muscle weakness), adrenal insufficiency (reduced adrenal gland activity), loss of appetite, asthenia (weakness), gynaecomastia (breast enlargement) and confusion.
Slovenian: Najpogostejši neželeni učinki zdravila Lysodren (opaženi pri več kot 1 od 10 bolnikov) so povišane ravni jetrnih encimov, holesterola in trigliceridov (vrste maščob) v krvi, levkopenija (nizke ravni belih krvnih celic), podaljšan čas krvavenja, ataksija (težave pri usklajevanju gibov), parastezija (nenavadni občutki, kot je mravljinčenje), vertigo (vrtoglavica), zaspanost, mukozitis (vnetje sluznic, kot je ustna sluznica), bruhanje, driska, navzeja (slabost), epigastrično neugodje (neugoden občutek okoli želodca), kožni izpuščaji, miastenija (šibkost mišičja), adrenalna insuficienca (zmanjšano delovanje nadledvične žleze), izguba teka, astenija (šibkost), ginekomastija (povečanje dojk) in zmedenost.
English: This is a summary of the European public assessment report (EPAR) for Lysodren.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lysodren.
English: Lysodren mitotane
Slovenian: Lysodren mitotan
English: It may also alter the breakdown of these hormones.
Slovenian: Zdravilo lahko morda spremeni tudi proces razgrajevanja teh hormonov.
English: It should also be used with caution in elderly patients, with frequent monitoring of blood levels.
Slovenian: Previdno ga je treba uporabljati tudi pri starejših bolnikih in obenem redno spremljati njegove ravni v krvi.
English: Treatment with Lysodren should be started and followed by a specialist who has suitable experience.
Slovenian: Zdravljenje z zdravilom Lysodren mora začeti in spremljati specialist z ustreznimi izkušnjami.
English: It is used when the cancer is unresectable (cannot be removed by surgery), is metastatic (has spread to other parts of the body), or has relapsed (returned after treatment).
Slovenian: Uporablja se, kadar je rak neizrezljiv (neodstanljiv s kirurškim posegom), metastatski (se je razširil na druge dele telesa) oziroma relapsiran (se je ponovil po zdravljenju).
English: There was insufficient evidence to support its use as an add-on to other anticancer medicines.
Slovenian: Dokazov, ki bi bili v prid uporabi tega zdravila kot dodatka drugim zdravilom proti raku, je bilo premalo.
English: The studies included over 500 adults and children, who were treated for various lengths of time with mitotane, either alone or in combination with other anticancer medicines.
Slovenian: Študije so vključevale več kot 500 odraslih in otrok, ki so se različno dolgo zdravili z mitotanom kot samostojnim zdravilom ali v kombinaciji z drugimi zdravili proti raku.
English: The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre.
Slovenian: Ravni zdravilne učinkovine v krvi je treba pogosto spremljati, končni odmerek pa mora povzročiti ravni od 14 do 20 mg na liter krvi.
English: Limited information was available on the use of mitotane in children, but overall, the children remained disease free for an average of seven months when taking the medicine.
Slovenian: O uporabi mitotana pri otrocih so na voljo le omejene informacije, vendar se pri otrocih, ki so jemali zdravilo, bolezen v povprečju ni pojavila sedem mesecev.
English: The main measures of effectiveness in the studies included survival time, the reduction in tumour size and the time spent free of the symptoms of the disease.
Slovenian: Glavna merila učinkovitosti v študijah so vključevala čas preživetja, zmanjšanje velikosti tumorja in čas, ko bolniki niso kazali simptomov bolezni.
English: It also reduced the symptoms of the disease, particularly in patients whose cancer was producing high hormone levels.
Slovenian: Zdravilo je prav tako ublažilo simptome bolezni, še zlasti pri bolnikih, pri katerih je rak povzročal visoke ravni hormonov.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Lysodren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Lysodren je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Lysodren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lysodren preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: When this area develops cancer, levels of these hormones can increase, causing the symptoms of the disease.
Slovenian: Če se rak razvije v tem predelu, se lahko ravni teh hormonov povečajo, kar povzroči simptome bolezni.
English: There is limited information on the use of Lysodren in children, but a daily starting dose of 1.5 to 3.5 g per square metre body surface area (calculated using the child's height and weight) is recommended.
Slovenian: Informacije o zdravljenju otrok z zdravilom Lysodren so omejene, vendar pa se priporoča začetni dnevni odmerek 1,5 do 3,5 g na kvadratni meter telesne površine (izračunane na podlagi otrokove višine in telesne mase).
English: Lysodren is a medicine that contains the active substance mitotane.
Slovenian: Lysodren je zdravilo, ki vsebuje zdravilno učinkovino mitotan.
English: It presented the results of 220 studies published since 1990 on the use of the medicine in unresectable, metastatic adrenal cortical carcinoma.
Slovenian: Predstavila je rezultate 220 objavljenih študij, ki so jih o uporabi zdravila pri neizrezljivem metastatskem karcinomu skorje nadledvične žleze, opravili od leta 1990.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lysodren.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Lysodren, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about Lysodren
Slovenian: Druge informacije o zdravilu Lysodren
English: Patients who take Lysodren should receive the ‘Lysodren patient card' that they should carry with them in case of emergency, to inform healthcare professionals (such as doctors and nurses) that they are taking the medicine.
Slovenian: Bolniki, ki jemljejo zdravilo Lysodren, bi morali prejeti „kartico za bolnike“, ki jo morajo nositi s seboj zaradi morebitnih nujnih primerov, v katerih bo kartica zdravstvene delavce (kot so zdravniki in medicinske sestre) opozorila, da bolnik jemlje to zdravilo.
English: Together, these effects reduce the levels of the hormones in the body, improving the symptoms of the disease.
Slovenian: Ti učinki skupaj zmanjšajo ravni hormonov v telesu in ublažijo simptome bolezni.
English: Lysodren is not recommended for use in patients with severe liver or kidney problems, and it should be used with caution in those with mild or moderate liver or kidney problems.
Slovenian: Uporaba zdravila Lysodren ni priporočljiva pri bolnikih s hudimi težavami z jetri ali ledvicami, pri bolnikih z blagimi ali zmernimi težavami z jetri ali ledvicami pa ga je treba uporabljati previdno.
English: What benefit has Lysodren shown during the studies?
Slovenian: Kakšne koristi je zdravilo Lysodren izkazalo med študijami?
English: Since the active substance in Lysodren, mitotane, is a well-established medicine that has been used in the treatment of adrenal cortical carcinoma in Europe since 1959, the company presented information from the published literature to support its application for Lysodren.
Slovenian: Ker je zdravilna učinkovina zdravila Lysodren, mitotan, dobro uveljavljeno zdravilo, ki se za zdravljenje karcinoma skorje nadledvične žleze v Evropi uporablja že od leta 1959, je družba v podporo svoji vlogi za zdravilo Lysodren predložila informacije iz objavljene literature.
English: The full EPAR for Lysodren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lysodren je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lysodren must not be used in people who are hypersensitive (allergic) to mitotane or any of the other ingredients.
Slovenian: Zdravila Lysodren ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) mitotan ali katero koli drugo sestavino zdravila.
English: Because the number of patients with adrenal cortical carcinoma is low, the disease is considered ‘rare', and Lysodren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 June
Slovenian: Ker je bolnikov s karcinomom skorje nadledvične žleze malo, velja ta bolezen za redko, zato je bilo zdravilo Lysodren dne 12. junija 2002 določeno kot „zdravilo sirota” (zdravilo za zdravljenje redkih boleznih).
English: It must not be used in patients who are breast-feeding or who are taking spironolactone (a diuretic).
Slovenian: Ne smejo ga uporabljati bolnice, ki dojijo, ali bolniki, ki jemljejo spironolakton (diuretik)
English: Overall, the studies suggested that Lysodren could provide a benefit in patients with advanced adrenal cortical carcinoma, by increasing survival times (by over five years in a few cases) and causing shrinkage or stabilisation of tumour size in 20 to 30% of patients.
Slovenian: Študije so pokazale, da je zdravilo Lysodren lahko koristno pri podaljšanju časa preživetja (v nekaterih primerih za več kot pet let) bolnikov z napredovalim karcinomom skorje nadledvične žleze in pri krčenju ali stabilizaciji velikosti tumorja pri 20 do 30 % bolnikov.
English: The Committee recommended that Lysodren be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Lysodren odobri dovoljenje za promet.
English: What is the risk associated with Lysodren?
Slovenian: Kakšna tveganja so povezana z zdravilom Lysodren?
English: The CHMP decided that Lysodren's benefits are greater than its risks for the treatment of advanced adrenal cortical carcinoma, but noted that the effect of Lysodren has not been established in adrenal cortical carcinoma that is not producing high levels of steroid hormones.
Slovenian: CHMP je zaključil, da so koristi zdravila Lysodren pri zdravljenju napredovalega karcinoma skorje nadledvične žleze večje od z njim povezanih tveganj, vendar je hkrati opomnil, da učinki zdravila Lysodren pri karcinomu skorje nadledvične žleze, ki ne tvori visokih ravni steroidnih hormonov, niso bili ugotovljeni.
English: For the full list of all side effects reported with Lysodren, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lysodren, glejte navodilo za uporabo.
English: The active substance in Lysodren, mitotane, is thought to work by preventing cells in the adrenal gland from working properly, by damaging their mitochondria (the energy-producing components), reducing the production of some steroid hormones.
Slovenian: Zdravilna učinkovina zdravila Lysodren, mitotan, naj bi s poškodovanjem mitohondrijev (delov celic, ki proizvajajo energijo) celic nadledvične žleze preprečevala njihovo pravilno delovanje in se tem zmanjša tvorjenje nekaterih steroidnih hormonov.
English: Lysodren is used to treat the symptoms of advanced adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).
Slovenian: Zdravilo Lysodren se uporablja za zdravljenje napredovalega karcinoma skorje nadledvične žleze (raka zunanje plasti nadledvične žleze).
English: Why has Lysodren been approved?
Slovenian: Zakaj je bilo zdravilo Lysodren odobreno?
English: The dose may be reduced or treatment interrupted if the patient experiences side effects.
Slovenian: Če se pri bolniku pojavijo neželeni učinki, se lahko odmerek zniža ali zdravljenje prekine.
English: The cortex of the adrenal gland produces steroid hormones.
Slovenian: V skorji nadledvične žleze nastajajo steroidni hormoni.
English: How has Lysodren been studied?
Slovenian: Kako je bilo zdravilo Lysodren raziskano?
English: What is Lysodren used for?
Slovenian: Za kaj se zdravilo Lysodren uporablja?
English: How does Lysodren work?
Slovenian: Kako zdravilo Lysodren deluje?
English: What is Lysodren?
Slovenian: Kaj je zdravilo Lysodren?
English: How is Lysodren used?
Slovenian: Kako se zdravilo Lysodren uporablja?
English: A starting dose of 4 to 6 g per day can be used in patients who need urgent control of Cushing's syndrome (a set of symptoms of adrenal gland cancer caused by high hormone levels).
Slovenian: Pri bolnikih, ki potrebujejo nujni nadzor nad Cushingovim sindromom (skupek simptomov, ki se pojavijo pri raku nadledvične žleze in jih povzročajo visoke ravni hormonov), lahko začetni dnevni odmerek znaša 4 do 6 g. Odmerek se prilagaja postopoma, dokler ni dosežen optimalni odmerek, pri katerem so rezultati najboljši, ne da bi se pojavili nesprejemljivi neželeni učinki.
English: This overview was last updated in 11-2018.
Slovenian: Pregled je bil nazadnje posodobljen 11-2018.
English: The tablets should be taken at the same time every day and consistently with or without food.
Slovenian: Tablete je treba jemati vsak dan ob istem času in dosledno s hrano ali brez nje.
English: Further information on Afinitor can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Afinitor.
Slovenian: Nadaljnje informacije o zdravilu Afinitor so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Afinitor.
English: Afinitor received a marketing authorisation valid throughout the EU on 03 August 2009.
Slovenian: Zdravilo Afinitor je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 3. avgusta 2009.
English: The European Medicines Agency decided that Afinitor's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Afinitor večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Afinitor
Slovenian: Druge informacije o zdravilu Afinitor
English: What measures are being taken to ensure the safe and effective use of Afinitor?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Afinitor?
English: Doses need to be reduced for patients with liver problems.
Slovenian: Odmerke je treba zmanjšati pri bolnikih s težavami z jetri.
English: This slows down the growth and spread of the cancer.
Slovenian: Zaradi tega se rast in širjenje tumorja upočasnita.
English: As for all medicines, data on the use of Afinitor are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Afinitor stalno spremljajo.
English: What benefits of Afinitor have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Afinitor izkazalo v študijah?
English: It is used when the cancer is metastatic (has spread to other parts of the body) or when it cannot be surgically removed;
Slovenian: Uporablja se, kadar je rak metastaziral (se razširil v druge dele telesa) ali ko ga ni mogoče kirurško odstraniti;
English: The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects.
Slovenian: Zdravnik lahko zmanjša odmerek ali prekine zdravljenje za krajše obdobje pri bolnikih s hudimi ali neznosnimi neželenimi učinki.
English: Why is Afinitor authorised in the EU?
Slovenian: Zakaj je zdravilo Afinitor odobreno v EU?
English: What are the risks associated with Afinitor?
Slovenian: Kakšna tveganja so povezana z zdravilom Afinitor?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afinitor have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Afinitor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.