FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Dzuveo
Slovenian: Druge informacije o zdravilu Dzuveo
English: Using a disposable applicator, the healthcare professional should place one tablet under the patient's tongue and leave it to dissolve.
Slovenian: Z uporabo aplikatorja za enkratno uporabo mora zdravstveni delavec postaviti eno tableto pod bolnikov jezik in jo pustiti, da se raztopi.
English: As for all medicines, data on the use of Dzuveo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dzuveo stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dzuveo have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dzuveo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Dzuveo must not be used in patients with serious lung or breathing problems.
Slovenian: Zdravilo Dzuveo se ne sme uporabljati pri bolnikih z resnimi težavami s pljuči ali dihanjem.
English: What benefits of Dzuveo have been shown in studies?
Slovenian: Kakšne koristi zdravila Dzuveo so se pokazale v študijah?
English: It should be given by a healthcare professional experienced in treating pain and in a place (such as a hospital) where the patient can be monitored.
Slovenian: Zdravilo lahko daje samo zdravstveni delavec, ki ima izkušnje z zdravljenjem bolečine, in na kraju (npr. v bolnišnici), kjer je bolnika mogoče opazovati.
English: Why is Dzuveo authorised in the EU?
Slovenian: Zakaj je zdravilo Dzuveo odobreno v EU?
English: The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000.
Slovenian: Najresnejši neželeni učinki sufentanila so hude težave pri dihanju, ki se pojavijo pri približno 6 od 1 000 bolnikov.
English: Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.
Slovenian: V obeh študijah je bila uporabljena lestvica za ocenjevanje bolečine, imenovana SPID12, s katero se spremlja zmanjšanje bolečine v 12 urah.
English: An overview of Dzuveo and why it is authorised in the EU
Slovenian: Pregled zdravila Dzuveo in zakaj je odobreno v EU
English: For more information about using Dzuveo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Dzuveo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Dzuveo and what is it used for?
Slovenian: Kaj je zdravilo Dzuveo in za kaj se uporablja?
English: Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet.
Slovenian: Bolniki deset minut po tem, ko vzamejo tableto, ne smejo jesti ali piti in morajo čim manj govoriti.
English: Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Dzuveo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.
Slovenian: Razlika med zdraviloma je ta, da je zdravilo Dzuveo na voljo v obliki podjezičnih tablet (tablet, ki se raztopijo pod jezikom), referenčno zdravilo pa je raztopina za injiciranje.
English: What are the risks associated with Dzuveo?
Slovenian: Kakšna tveganja so povezana z zdravilom Dzuveo?
English: Dzuveo contains the active substance sufentanil.
Slovenian: Zdravilo Dzuveo vsebuje učinkovino sufentanil.
English: Dzuveo is available as 30 µg sublingual tablets.
Slovenian: Zdravilo Dzuveo je na voljo v obliki 30-µg podjezičnih tablet.
English: The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors.
Slovenian: Učinkovina v zdravilu Dzuveo, sufentanil, je opioid, ki deluje tako, da se veže na receptorje (tarče) v možganih, imenovane μ-opioidni receptorji.
English: Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.
Slovenian: Dzuveo je opioidno protibolečinsko zdravilo, ki se uporablja za zdravljenje zmerne do hude bolečine pri odraslih.
English: In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment).
Slovenian: V prvi študiji s 163 bolniki, pri katerih je bila opravljena abdominalna operacija, se je bolečina pri jemanju zdravila Dzuveo zmanjšala za 26 točk v primerjavi s 13 točkami pri jemanju placeba (zdravila brez učinkovine).
English: In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.
Slovenian: V drugi študiji s 101 bolnikom po operaciji stopala se je bolečina pri dajanju zdravila Dzuveo zmanjšala za približno 6 točk in pri dajanju placeba povečala za približno 7 točk.
English: For the full list of side effects and restrictions with Dzuveo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dzuveo glejte navodilo za uporabo.
English: The side effects seen with Dzuveo are those expected with opioids, and are considered manageable.
Slovenian: Neželeni učinki zdravila Dzuveo so tisti, ki jih pričakujemo pri dajanju opioidov, in veljajo za obvladljive.
English: Two main studies have shown that Dzuveo left to dissolve under the tongue is effective at reducing severe pain following surgeries.
Slovenian: Dve glavni študiji sta pokazali, da zdravilo Dzuveo, ki se da pod jezik, da se raztopi, učinkovito zmanjšuje hudo bolečino po operacijah.
English: Studies show that Dzuveo is effective at reducing severe pain following surgeries.
Slovenian: Študije kažejo, da zdravilo Dzuveo učinkovito zmanjšuje hudo bolečino po operacijah.
English: How does Dzuveo work?
Slovenian: Kako zdravilo Dzuveo deluje?
English: How is Dzuveo used?
Slovenian: Kako se zdravilo Dzuveo uporablja?
English: Dzuveo can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Further information on Cabometyx can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
Slovenian: Več informacij o zdravilu Cabometyx je na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
English: Cabometyx is available as tablets (20, 40 and 60 mg).
Slovenian: Zdravilo Cabometyx je na voljo v obliki tablet (20, 40 in 60 mg).
English: Cabometyx received a marketing authorisation valid throughout the EU on 9 September 2016.
Slovenian: Za zdravilo Cabometyx je bilo 9. septembra 2016 izdano dovoljenje za promet, veljavno po vsej EU.
English: The dose may need to be reduced or treatment stopped temporarily if serious or unacceptable side effects occur.
Slovenian: Odmerek bo morda treba zmanjšati ali zdravljenje začasno prekiniti, če se pojavijo resni ali nesprejemljivi neželeni učinki.
English: The European Medicines Agency therefore decided that Cabometyx's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Cabometyx večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Cabometyx?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cabometyx?
English: The improvement in survival observed is considered significant considering that these patients have poor outcomes and few treatment options available.
Slovenian: Izboljšanje ugotovljenega preživetja se šteje za pomembno glede na to, da imajo ti bolniki slabe izide zdravljenja in je zanje na voljo malo možnosti zdravljenja.
English: As for all medicines, data on the use of Cabometyx are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cabometyx stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabometyx have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cabometyx upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Cabometyx (cabozantinib)
Slovenian: Cabometyx (kabozantinib)
English: These patients have poor outcomes and a high unmet medical need.
Slovenian: Izidi zdravljenja so pri teh bolnikih slabi in imajo veliko neizpolnjeno medicinsko potrebo.
English: Other information about Cabometyx
Slovenian: Druge informacije o zdravilu Cabometyx
English: Why is Cabometyx authorised in the EU?
Slovenian: Zakaj je zdravilo Cabometyx odobreno v EU?
English: It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor'.
Slovenian: Uporablja se pri bolnikih, ki so se predhodno zdravili z vrsto zdravila za zdravljenje raka, ki se imenuje „zaviralec endotelijskega rastnega faktorja v žilah (VEGF)“.
English: By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of the cancer.
Slovenian: Zdravilo z zaviranjem delovanja teh encimov v rakavih celicah zmanjša rast in širjenje raka.
English: For more information about using Cabometyx, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cabometyx glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: These enzymes can be found in certain receptors in cancer cells, where they are involved in activating processes that include cell division and the growth of new blood vessels to supply the cancer.
Slovenian: Ti encimi so prisotni v nekaterih receptorjih v rakavih celicah, v katerih spodbujajo procese, ki vključujejo delitev celic in rast novih žil, ki oskrbujejo raka.
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with renal cell carcinoma are high blood pressure, diarrhoea, nausea (feeling sick), loss of appetite, tiredness, dehydration, hyponatraemia and hypomagnesaemia (low blood levels of sodium and magnesium), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles) and embolism (clot in a blood vessel).
Slovenian: Najpogostejši resni neželeni učinki (opaženi pri več kot 1 osebi od 100) zdravila Cabometyx pri bolnikih s karcinomom ledvičnih celic so visoki krvni tlak, driska, navzeja (slabost), izguba teka, utrujenost, dehidracija, hiponatriemija in hipomagneziemija (nizka raven natrija in magnezija v krvi), sindrom palmarno-plantarne eritrodisestezije (sindrom roka-noga, ki vključuje izpuščaje in odrevenelost dlani in podplatov) ter embolija (strdek v krvnih žilah).
English: An overview of Cabometyx and why it is authorised in the EU
Slovenian: Pregled zdravila Cabometyx in zakaj je odobreno v EU
English: In previously untreated patients with moderate or high risk disease, Cabometyx also provided clinically relevant benefit, delaying the progression of the cancer and the need for other treatments.
Slovenian: Pri predhodno nezdravljenih bolnikih z boleznijo z zmernim ali visokim tveganjem je zdravilo Cabometyx omogočilo tudi klinično pomembno korist, saj je upočasnilo napredovanja raka in odložilo potrebo po drugih zdravilih.
English: It is also used in patients who have not had previous treatment and whose cancer is at moderate or high risk of rapidly getting worse.
Slovenian: Uporablja se tudi pri bolnikih, ki se predhodno niso zdravili in pri katerih obstaja zmerno do visoko tveganje za hitro napredovanje raka.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira delovanje encimov, imenovanih tirozinkinaze.
English: The study involved 157 patients, and compared Cabometyx with another cancer medicine, sunitinib.
Slovenian: Študija je vključevala 157 bolnikov, v njej pa so primerjali zdravilo Cabometyx z drugim zdravilom za zdravljenje raka, sunitinibom.
English: A second main study showed that Cabometyx was effective in adults with previously untreated renal cell carcinoma that was locally advanced or had spread elsewhere in the body.
Slovenian: Druga glavna študija je pokazala, da je zdravilo Cabometyx učinkovito pri odraslih s predhodno nezdravljenim karcinomom ledvičnih celic, ki je napredoval lokalno ali se je razširil na druge dele telesa.
English: Side effects reported with Cabometyx are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cabometyx, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Cabometyx have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cabometyx izkazalo v študijah?
English: In addition, results indicated that patients treated with Cabometyx lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months).
Slovenian: Poleg tega so rezultati pokazali, da so bolniki, ki so se zdravili z zdravilom Cabometyx, na splošno živeli dlje kot bolniki, ki so se zdravili z everolimusom (v povprečju 21,4 meseca v primerjavi s 16,5 meseca).
English: What are the risks associated with Cabometyx?
Slovenian: Kakšna tveganja so povezana z zdravilom Cabometyx?
English: Cabometyx can only be obtained with a prescription and treatment should be started by a doctor who has experience of using cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Cabometyx je le na recept, zdravljenje z njim pa sme uvesti le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: What is Cabometyx and what is it used for?
Slovenian: Kaj je zdravilo Cabometyx in za kaj se uporablja?
English: Results also indicated that Cabometyx helped patients to live longer.
Slovenian: Rezultati so pokazali tudi, da je zdravilo Cabometyx bolnikom pripomoglo k podaljšanju preživetja.
English: Treatment is continued for as long as the patient benefits from it or until side effects become unacceptable.
Slovenian: Zdravljenje je treba nadaljevati, dokler je za bolnika koristno, oziroma do pojava nesprejemljivih neželenih učinkov.
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with hepatocellular carcinoma are hepatic encephalopathy (harmful effects on the brain caused by liver damage), palmar-plantar erythrodysaesthesia syndrome, weakness and diarrhoea.
Slovenian: Najpogostejši resni neželeni učinki (opaženi pri več kot 1 osebi od 100) zdravila Cabometyx pri bolnikih s hepatocelularnim karcinomom so jetrna encefalopatija (škodljivi učinki na možgane, ki jih povzroča poškodba jeter), sindrom palmarno-plantarne eritrodisestezije, šibkost in driska.
English: The side effects of Cabometyx are similar to other tyrosine kinase inhibitors, and they are considered manageable.
Slovenian: Neželeni učinki zdravila Cabometyx so podobni tistim pri drugih zaviralcih tirozinkinaze in veljajo za obvladljive.
English: The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor'.
Slovenian: Zdravilna učinkovina v zdravilu Cabometyx, kabozantinib, je „zaviralec tirozin-kinaze“.
English: For the full list of side effects and restrictions with Cabometyx, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cabometyx glejte navodilo za uporabo.
English: Cabometyx is a cancer medicine used to treat adults with:
Slovenian: Zdravilo Cabometyx se uporablja za zdravljenje raka pri odraslih bolnikih:
English: Patients should not eat for at least two hours before and one hour after taking Cabometyx.
Slovenian: Priporočeni odmerek je 60 mg enkrat na dan. Bolniki ne smejo uživati hrane vsaj dve uri, preden vzamejo zdravilo Cabometyx, in eno uro po tem.
English: One main study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor showed that Cabometyx is effective at prolonging the time patients lived without their disease getting worse (progression-free survival).
Slovenian: Ena glavna študija, ki je vključevala 658 odraslih z napredovalim karcinomom ledvičnih celic, ki se je poslabšal kljub zdravljenju z zaviralcem VEGF, je pokazala, da je zdravilo Cabometyx učinkovito pri podaljševanju obdobja preživetja bolnikov brez poslabšanja bolezni (preživetje brez napredovanja bolezni).
English: One main study involving 707 adults with hepatocellular carcinoma who had already been treated with sorafenib showed that Cabometyx was effective at prolonging how long patients lived (overall survival).
Slovenian: V eni glavni študiji, v katero je bilo vključenih 707 odraslih s hepatocelularnim karcinomom, ki so ga že zdravili s sorafenibom, je bilo ugotovljeno, da zdravilo Cabometyx učinkovito podaljšuje čas preživetja bolnikov (celokupno preživetje).
English: In the study, Cabometyx was compared with placebo (a dummy treatment).
Slovenian: V študiji so zdravilo Cabometyx primerjali s placebom (zdravilom brez učinkovine).
English: In the study, Cabometyx was compared with the cancer medicine everolimus.
Slovenian: V tej študiji so zdravilo Cabometyx primerjali z drugim zdravilom za zdravljenje raka, everolimusom.
English: It is used on its own in patients who have already been treated with the cancer medicine sorafenib.
Slovenian: Uporablja se kot samostojno zdravilo pri bolnikih, ki so se predhodno že zdravili s sorafenibom.
English: Patients treated with Cabometyx lived on average for 10.2 months, compared with 8.0 months in patients who received placebo.
Slovenian: Bolniki, ki so bili zdravljeni z zdravilom Cabometyx, so v povprečju živeli 10,2 meseca, bolniki, ki so prejemali placebo, pa 8,0 meseca.
English: In hepatocellular carcinoma, Cabometyx was shown to prolong survival in patients who had been treated with sorafenib.
Slovenian: Pri hepatocelularnem karcinomu je bilo dokazano, da zdravilo Cabometyx podaljšuje preživetje pri bolnikih, ki so bili zdravljeni s sorafenibom.
English: How does Cabometyx work?
Slovenian: Kako zdravilo Cabometyx deluje?
English: • advanced renal cell carcinoma (a kidney cancer).
Slovenian: • z napredovalim karcinomom ledvičnih celic (rakom ledvic).
English: How is Cabometyx used?
Slovenian: Kako se zdravilo Cabometyx uporablja?
English: Patients treated with Cabometyx lived for an average of 8.6 months without their disease getting worse compared with 5.3 months in those treated with sunitinib.
Slovenian: Bolniki, zdravljeni z zdravilom Cabometyx, so brez poslabšanja bolezni živeli povprečno 8,6 meseca, bolniki, ki so se zdravili s sunitinibom, pa 5,3 meseca.
English: Patients treated with Cabometyx lived for an average of 7.4 months without their disease getting worse compared with 3.8 months in patients treated with everolimus.
Slovenian: Bolniki, zdravljeni z zdravilom Cabometyx, so brez poslabšanja bolezni živeli povprečno 7,4 meseca, bolniki, ki so se zdravili z everolimusom, pa 3,8 meseca.
English: In advanced renal cell carcinoma, Cabometyx was shown to prolong the time previously treated patients lived without their disease getting worse.
Slovenian: Pri napredovalem karcinomu ledvičnih celic je zdravilo Cabometyx podaljšalo čas brez poslabšanja bolezni pri predhodno zdravljenih bolnikih.
English: • hepatocellular carcinoma (a liver cancer).
Slovenian: • s hepatocelularnim karcinomom (rakom jeter).
English: Cabometyx contains the active substance cabozantinib.
Slovenian: Zdravilo Cabometyx vsebuje učinkovino kabozantinib.
English: Whereas
Slovenian: stopnje.
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dexrazoxane-containing medicinal products;
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo deksrazoksan.
English: The majority of studies in adults have been conducted in breast cancer patients.
Slovenian: Večino študij pri odraslih so opravili pri bolnikih z rakom dojke.
English: The CHMP considered that a direct healthcare professional communication should be sent in order to inform adequately on the changes recommended.
Slovenian: CHMP je menil, da je treba poslati neposredno obvestilo za zdravstvene delavce, da bodo ustrezno obveščeni o priporočenih spremembah.
English: Based on the limited data on efficacy in this patient population, and the observed safety concerns, the Committee recommended that the use in children and adolescents up to 18 years of age should be contraindicated.
Slovenian: Na podlagi omejene količine podatkov o učinkovitosti v tej populaciji bolnikov in ugotovljenih varnostnih zadržkov je Odbor priporočil kontraindiciranje uporabe pri otrocih in mladostnikih do 18. leta.
English: In addition, a signal of increased risk of solid tumours was noted.
Slovenian: Poleg tega so ugotovili znake povečanega tveganja čvrstih tumorjev.
English: Overall summary of the scientific evaluation of dexrazoxane-containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo deksrazoksan (glejte Dodatek I)
English: Sub-analysis of these studies also showed a significant reduction of congestive heart failure (CHF) events and a reduction in the severity of CHF events.
Slovenian: Podanalize teh študij so pokazale tudi bistveno zmanjšanje dogodkov kongestivnega srčnega popuščanja (CHF) in zmanjšanje resnosti teh dogodkov.
English: • The Committee also recommended that the ratio of dexrazoxane to doxorubicin should be reduced to take due account of the safety risks observed, including myelosuppression;
Slovenian: • Odbor je tudi priporočil, naj se zmanjša razmerje med deksrazoksanom in doksorubicinom, da se upoštevajo ugotovljena varnostna tveganja, vključno z mielosupresijo.
English: • The Committee considered that use of dexrazoxane in children and adolescents up to 18 years of age is associated with second primary malignancies and should therefore be contraindicated;
Slovenian: • Odbor je menil, da je uporaba deksrazoksana pri otrocih in mladostnikih, mlajših od 18 let, povezana z drugimi primarnimi malignimi tvorbami, zato jo je treba kontraindicirati.
English: • The Committee took into account all available data, including the responses from the MAHs and the conclusion of the SAG Oncology;
Slovenian: • Odbor je upošteval vse razpoložljive podatke, vključno z odgovori imetnikov dovoljenja za promet z zdravili ter zaključkom znanstveno-svetovalne skupine za onkologijo.
English: • The Committee recommended conditions to the marketing authorisation, including a direct healthcare professional communication, the shortening of the PSUR submission cycle to an annual submission and the monitoring of the effectiveness of the risk minimisation measures by means of a drug utilisation study.
Slovenian: • Odbor je priporočil pogoje dovoljenja za promet, vključno z neposrednim obvestilom za zdravstvene delavce, skrajšanjem cikla predložitve PSUR na letno oddajo ter spremljanje učinkovitosti ukrepov za zmanjševanje tveganja v obliki študije o uporabi zdravila.
English: Dexrazoxane is authorised in Europe through mutual recognition (MR), decentralised and national procedures for the prevention of anthracycline (doxorubicin or epirubicin)-induced cardiotoxicity.
Slovenian: Deksrazoksan je v Evropi odobren po postopkih z medsebojnim priznavanjem, decentraliziranih in nacionalnih postopkih za preprečevanje kardiotoksičnosti, povzročene z antraciklini (doksorubicinom ali epirubicinom).