FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Tagrisso and what is it used for?
Slovenian: Kaj je zdravilo Tagrisso in za kaj se uporablja?
English: In two studies involving 411 previously treated patients who had T790 mutations, the overall response rates (the proportion of patients whose tumours shrank) with Tagrisso was 66% and the average length of time the response lasted was 12.5 months.
Slovenian: V dveh študijah, ki sta vključevali 411 bolnikov z mutacijami T790, ki so se predhodno zdravili, je bil skupni odziv (delež bolnikov, pri katerih se je tumor zmanjšal) po zdravljenju z zdravilom Tagrisso 66 %, povprečna doba tega odziva pa je bila 12,5 meseca.
English: What are the risks associated with Tagrisso?
Slovenian: Kakšna tveganja so povezana z zdravilom Tagrisso?
English: Finally, in a study of 556 patients with activating mutations, patients taking Tagrisso as a first treatment lived for 18.9 months without their disease getting worse compared with 10.2 months in patients receiving treatment with other medicines (either erlotinib or gefitinib).
Slovenian: V študiji s 556 bolniki z aktivirajočimi mutacijami so bolniki, ki so jemali zdravilo Tagrisso kot prvo zdravljenje, živeli 18,9 meseca, ne da bi se njihova bolezen poslabšala, v primerjavi z 10,2 meseca pri bolnikih, ki so prejemali zdravljenje z drugim zdravilom (erlotinibom ali gefitinibom).
English: The active substance in Tagrisso, osimertinib, is a type of cancer medicine called tyrosine kinase inhibitor.
Slovenian: Učinkovina zdravila Tagrisso, osimertinib, je vrsta zdravila za zdravljenje raka, imenovana zaviralec tirozin kinaze.
English: Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression).
Slovenian: Zdravilo Tagrisso se ne sme uporabljati skupaj s šentjanževko (pripravkom rastlinskega izvora, namenjenim za zdravljenje depresije).
English: By blocking EGFR, osimertinib helps to reduce the growth and spread of the cancer.
Slovenian: Z zaviranjem EGFR osimertinib pripomore k manjši rasti in širjenju raka.
English: A third study in 419 previously treated patients with T790 mutations looked mainly at how effective Tagrisso was at preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC).
Slovenian: V tretji študiji so pri 419 bolnikih z mutacijami T790, ki so se predhodno zdravili, proučevali predvsem, kako učinkovito je zdravilo Tagrisso pri preprečevanju slabšanja raka v primerjavi s kemoterapijo na osnovi platine (standardnim zdravljenjem za nedrobnocelični rak pljuč).
English: Tagrisso is medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread.
Slovenian: Zdravilo Tagrisso se uporablja za zdravljenje pljučnega raka, imenovanega nedrobnocelični rak pljuč, ko je ta že napredoval ali se je razširil.
English: Tagrisso has been shown in studies to be effective at shrinking tumors in patients with these mutations and at slowing down the worsening of the cancer.
Slovenian: Zdravilo Tagrisso se je v študijah izkazalo za učinkovito pri zmanjševanju tumorjev pri bolnikih s temi mutacijami in upočasnjevanju slabšanja raka.
English: For the full list of restrictions and side effects with Tagrisso, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov pri uporabi zdravila Tagrisso glejte navodilo za uporabo.
English: How does Tagrisso work?
Slovenian: Kako zdravilo Tagrisso deluje?
English: How is Tagrisso used?
Slovenian: Kako se zdravilo Tagrisso uporablja?
English: Tagrisso has been shown to be effective at shrinking tumours in patients with NSCLC and at slowing down the worsening of the cancer.
Slovenian: Zdravilo Tagrisso se je izkazalo za učinkovito pri zmanjševanju tumorjev pri bolnikih z nedrobnoceličnim rakom pljuč in pri upočasnjevanju slabšanja raka.
English: The results were as follows:
Slovenian: Rezultati so bili naslednji:
English: Further information on Steglatro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Steglatro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patient should start with one 5 mg tablet once a day in the morning.
Slovenian: Bolnik mora zdravljenje začeti z eno 5-miligramsko tableto enkrat na dan zjutraj.
English: What measures are being taken to ensure the safe and effective use of Steglatro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Steglatro?
English: Steglatro is available as tablets (5 and 15mg).
Slovenian: Zdravilo Steglatro je na voljo v obliki tablet (5 in 15 mg).
English: The European Medicines Agency concluded that Steglatro‘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 Steglatro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglatro 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 Steglatro upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Rare cases of diabetic ketoacidosis, a serious condition where the patient has very high blood acid levels, may occur in up to 1 in 1,000 patients.
Slovenian: Redki primeri diabetične ketoacidoze, resnega stanja, pri katerem ima bolnik zelo visoko vrednost kisline v krvi, se lahko pojavijo pri največ 1 od 1 000 bolnikov.
English: Why is Steglatro authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Steglatro odobreno v EU?
English: The result is a high level of glucose in the blood.
Slovenian: Posledica je visoka vrednost glukoze v krvi.
English: As for all medicines, data on the use of Steglatro is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Steglatro stalno spremljajo.
English: What are the risks associated with Steglatro?
Slovenian: Kakšna tveganja so povezana z zdravilom Steglatro?
English: The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of treatment.
Slovenian: V študijah so proučevali predvsem učinke na vrednost HbA1c (kazalnik glukoze v krvi) po šestih mesecih ali enem letu zdravljenja.
English: An overview of Steglatro and why it is authorised in the EU
Slovenian: Pregled zdravila Steglatro in zakaj je odobreno v EU
English: Side effects reported with Steglatro are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Steglatro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Steglatro have been shown in studies?
Slovenian: Kakšne koristi zdravila Steglatro so se pokazale v študijah?
English: What is Steglatro and what is it used for?
Slovenian: Kaj je zdravilo Steglatro in za kaj se uporablja?
English: At the start of the studies, patients' HbA1c was above 7 percentage points.
Slovenian: Na začetku študij je bila vrednost HbA1c pri bolnikih višja od sedem odstotkov.
English: Other information about Steglatro
Slovenian: Druge informacije o zdravilu Steglatro
English: A lower dose of ertugliflozin 5 mg was less effective.
Slovenian: Nižji, 5-miligramski odmerek ertugliflozina je bil manj učinkovit;
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri telo ne tvori dovolj insulina za uravnavanje vrednosti glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
English: Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.
Slovenian: Zdravilo Steglatro se lahko uporablja v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni ali pri bolnikih, ki ne morejo jemati metformina.
English: The most common side effects with Steglatro (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Slovenian: Najpogostejši neželeni učinki zdravila Steglatro (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glivične okužbe nožnice in druge okužbe ženskih spolovil.
English: Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be started in such patients.
Slovenian: Zdravilo Steglatro pri bolnikih z zmerno okvaro ledvic ni enako učinkovito in se zato zdravljenje z njim pri teh bolnikih ne sme uvesti.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Slovenian: Ta učinek povzroči z zaviranjem beljakovine v ledvicah (imenovane SGLT2), ki normalno privzema glukozo iz ledvic v kri.
English: For the full list of side effects and restrictions with Steglatro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Steglatro, glejte navodilo za uporabo.
English: The active substance in Steglatro, ertugliflozin, helps to lower blood glucose by making the patient pass out glucose in the urine.
Slovenian: Zdravilna učinkovina v zdravilu Steglatro, ertugliflozin, pomaga znižati vrednost glukoze v krvi tako, da pripomore k temu, da se glukoza iz bolnikovega telesa izloča z urinom.
English: Several studies in around 4,800 patients with type 2 diabetes have shown that ertugliflozin helps lower glucose levels on its own and in combination with other diabetes medicine.
Slovenian: Več študij pri okoli 4 800 bolnikih s sladkorno boleznijo tipa 2 je pokazalo, da ertugliflozin pomaga znižati vrednost glukoze v krvi pri samostojni uporabi in v kombinaciji z drugim zdravilom za zdravljenje sladkorne bolezni.
English: The data from this study showed that the effect of ertugliflozin reduces when the kidneys do not work properly.
Slovenian: Podatki iz te študije so pokazali, da je učinek ertugliflozina pri slabšem delovanju ledvic manjši.
English: Steglatro contains the active substance ertugliflozin.
Slovenian: Zdravilo Steglatro vsebuje zdravilno učinkovino ertugliflozin.
English: • A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo.
Slovenian: • peta študija je pokazala, da je bil dodatek ertugliflozina kombinaciji sitagliptina in metformina učinkovitejši od placeba.
English: • A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride.
Slovenian: • tretja študija je pokazala, da je bila kombinacija ertugliflozina v 15-miligramskem odmerku in metformina približno enako učinkovita kot kombinacija metformina in drugega zdravila za zdravljenje sladkorne bolezni, glimepirida.
English: • A second study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo was added to metformin.
Slovenian: • druga študija je pokazala, da je pri bolnikih, ki so jemali kombinacijo ertugliflozina in metformina, vrednost HbA1c padla za približno 0,8 odstotne točke, v primerjavi z zmanjšanjem za 0,03 odstotne točke, kadar so metforminu dodali placebo;
English: Studies showed that Steglatro helps lower glucose levels on its own and in combination with other diabetes medicines.
Slovenian: Študije so pokazale, da zdravilo Steglatro pomaga zmanjšati vrednost glukoze pri samostojni uporabi in v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni.
English: • A sixth study found that adding the combination of ertugliflozin and sitagliptin to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Slovenian: • šesta študija je pokazala, da je bil dodatek kombinacije ertugliflozina in sitagliptina dieti in telesni vadbi precej učinkovitejši od placeba, pri čemer je pri kombinaciji ertugliflozina in sitagliptina vrednost HbA1c padla za od 1,6 do 1,7 odstotne točke, pri placebu pa za 0,4 odstotne točke;
English: • A fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin, another diabetes medicine, with HbA1c levels falling by around 1 point with both treatments.
Slovenian: • četrta študija je pokazala, da je bil pri bolnikih, ki so jemali metformin, dodatek ertugliflozina enako učinkovit kot dodatek sitagliptina, drugega zdravila za zdravljenje sladkorne bolezni, pri čemer je vrednost HbA1c pri obeh načinih zdravljenja padla za približno eno odstotno točko.
English: • A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment.
Slovenian: • sedma študija je pokazala, da ertugliflozin pri bolnikih z zmerno okvaro ledvic ni učinkovitejši od placeba.
English: HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Slovenian: Vrednost HbA1c je pri zdravljenju z ertugliflozinom padla za 0,6 odstotne točke, pri zdravljenju z glimepiridom pa za 0,7 odstotne točke.
English: Steglatro is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes together with diet and exercise.
Slovenian: Steglatro je zdravilo, ki se poleg diete in telesne vadbe uporablja za nadzor vrednosti glukoze (sladkorja) v krvi pri odraslih s sladkorno boleznijo tipa 2.
English: In addition, Steglatro can help some patients lose weight.
Slovenian: Poleg tega lahko nekaterim bolnikom pomaga izgubiti telesno maso.
English: How is Steglatro used?
Slovenian: Kako se zdravilo Steglatro uporablja?
English: • A study of ertugliflozin on its own, showed that levels of HbA1c (a measure of blood glucose) fell by between 0.8 points and 1 point in patients who took the medicine compared with a rise of 0.2 points in patients receiving placebo (a dummy treatment).
Slovenian: • študija samostojne uporabe ertugliflozina je pokazala, da je vrednost HbA1c (kazalnika glukoze v krvi) pri bolnikih, ki so jemali to zdravilo, padla za od 0,8 do 1 odstotne točke, pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine), pa je padla za 0,2 odstotne točke;
English: HbA1c levels fell by between 0.8 and 0.9 points when ertugliflozin was added, compared with a fall of 0.1 with placebo.
Slovenian: Vrednost HbA1c je pri dodatku ertugliflozina padla za od 0,8 do 0,9 odstotne točke, pri dodatku placeba pa za 0,1 odstotne točke;
English: How does Steglatro work?
Slovenian: Kako zdravilo Steglatro deluje?
English: If the patients' glucose level is still too high the dose can be increased to 15 mg once a day.
Slovenian: Če je vrednost glukoze pri bolniku še vedno previsoka, se lahko odmerek poveča na 15 mg enkrat na dan. Za več informacij glede uporabe zdravila Steglatro glejte navodilo za uporabo ali se posvetujete z zdravnikom ali farmacevtom.
English: Finally, in addition to lowering glucose levels, studies showed that ertugliflozin can help patients reduce bodyweight.
Slovenian: Študije pa so pokazale tudi, da lahko ertugliflozin poleg znižanja ravni glukoze bolnikom pomaga tudi zmanjšati telesno maso.
English: HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
Slovenian: Pri dodatku obeh zdravil metforminu je vrednost HbA1c padla še za nadaljnje pol odstotne točke;
English: Steglatro can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: This summary was last updated in 06-2014.
Slovenian: Povzetek je bil nazadnje posodobljen 6-2014.
English: Nausea is more common in women than in men.
Slovenian: Slabost je pogostejša pri ženskah kot pri moških.
English: What measures are being taken to ensure the safe and effective use of Xyrem?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xyrem?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem on 13 October 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xyrem, veljavno po vsej Evropski uniji, izdala 13. oktobra 2005.
English: The precise way in which it works is not known, but it is thought to attach to receptor molecules on the surface of some cells in the brain.
Slovenian: Natančen način njegovega delovanja ni znan, vendar se najverjetneje veže na receptorske molekule na površini nekaterih celic v možganih.
English: This improves the symptoms of narcolepsy.
Slovenian: To izboljša simptome narkolepsije.
English: The second dose is taken 2.5 to 4 hours later.
Slovenian: Drugi odmerek se vzame 2,5 do 4 ure pozneje.
English: Other information about Xyrem:
Slovenian: Druge informacije o zdravilu Xyrem:
English: The full EPAR for Xyrem 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 Xyrem je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Xyrem sodium oxybate
Slovenian: Xyrem natrijev oksibat
English: This leads to changes in the activity of the brain, bringing about ‘delta' (slow) brain waves and night-time sleep.
Slovenian: To povzroči spremembe aktivnosti možganov ter pospeši „delta“ (počasne) možganske valove in nočni spanec.
English: Xyrem was more effective than placebo in reducing symptoms.
Slovenian: Zdravilo Xyrem je bilo pri zmanjševanju simptomov učinkovitejše od placeba.
English: The dose is then adjusted at one- to two-week intervals depending on the patient's response.
Slovenian: Odmerek se nato prilagaja v eno- do dvotedenskih intervalih, odvisno od bolnikovega odziva.
English: The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.
Slovenian: Podatki, zbrani s študijami fibromialgije, niso podprli uporabe zdravila Xyrem pri tej bolezni evropske populacije.
English: The medicine can only be obtained with a special prescription.
Slovenian: Izdaja zdravilo je le na poseben recept.
English: Cataplexy can sometimes cause a patient to collapse.
Slovenian: Katapleksija lahko včasih povzroči, da se bolnik zgrudi.
English: Xyrem can also cause respiratory depression (inhibition of breathing).
Slovenian: Zdravilo Xyrem lahko povzroči tudi respiratorno depresijo (oteženo dihanje).
English: The main measure of effectiveness was the change in daytime sleepiness.
Slovenian: Glavno merilo učinkovitosti je bila sprememba dnevne zaspanosti.
English: This document is a summary of the European Public Assessment Report (EPAR) for Xyrem.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xyrem.
English: The study measured the number of cataplexy attacks over two weeks.
Slovenian: V študiji so merili število kataplektičnih napadov v obdobju dveh tednov.
English: What benefit has Xyrem shown during the studies?
Slovenian: Kakšne koristi je zdravilo Xyrem izkazalo med študijami?
English: The first dose of the day is taken at bedtime, at least two to three hours after food.
Slovenian: Prvi dnevni odmerek se vzame pred spanjem, najmanj dve do tri ure po obroku.
English: Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Slovenian: Katapleksija je simptom narkolepsije, ki se kaže kot nenadna mišična šibkost kot odgovor na čustveno reakcijo, kot so na primer jeza, strah, veselje, smeh ali presenečenje.
English: Narcolepsy is a sleep disorder that causes excessive daytime sleepiness.
Slovenian: Narkolepsija je motnja spanja, ki povzroča prekomerno dnevno zaspanost.
English: A risk management plan has been developed to ensure that Xyrem is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Xyrem je bil pripravljen načrt obvladovanja tveganj.
English: Patients taking Xyrem should avoid alcohol, as it can increase Xyrem's effects.
Slovenian: Bolniki, ki jemljejo zdravilo Xyrem, se morajo izogibati alkoholu, saj lahko ta poveča učinke zdravila Xyrem.
English: The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Slovenian: Učinke zdravila Xyrem pri narkolepsiji in katapleksiji so proučevali v štirih študijah s 707 bolniki.
English: For more information about treatment with Xyrem, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xyrem preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Both doses should be prepared at the same time before the patient goes to bed.
Slovenian: Oba odmerka je treba pripraviti hkrati, preden bolnik leže zvečer k počitku.
English: Although the 9-g dose was the most effective, it was linked to high levels of side effects, so the Committee recommended a starting dose of 4.5 g per day.
Slovenian: Čeprav je bil 9-gramski odmerek najbolj učinkovit, je bil povezan z mnogimi neželenimi učinki, zato je odbor priporočil začetni odmerek 4,5 g dnevno.
English: Xyrem is an oral solution that contains the active substance sodium oxybate (500 mg/ml).
Slovenian: Zdravilo Xyrem je peroralna raztopina, ki vsebuje zdravilno učinkovino natrijev oksibat (500 mg/ml).
English: Fibromyalgia is a disease of unknown origin causing long-lasting, widespread pain and painful responses to touch.
Slovenian: Fibromialgija je bolezen neznanega izvora, ki povzroča dolgotrajno razširjeno bolečino in bolečino ob dotiku.
English: The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.
Slovenian: Družba, ki izdeluje zdravilo Xyrem, bo čim bolj zmanjšala tveganje za zlorabo zdravila Xyrem, tako da bo zdravstvenim delavcem in bolnikom priskrbela izobraževalno gradivo, strogo nadzorovala distribucijo zdravila in spremljala njegovo uporabo.
English: The main measure of effectiveness was based on reduction of pain severity and improvement in function.
Slovenian: Glavno merilo učinkovitosti je bilo ublažitev bolečine in izboljšanje zmogljivosti.
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 Xyrem.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Before taking the medicine, the patient should dissolve the dose in water to make up a drink.
Slovenian: Pred jemanjem zdravila mora bolnik odmerek raztopiti v vodi, da dobi napitek.
English: The effects of Xyrem have also been studied in fibromyalgia patients with moderate to severe symptoms in two short-term (12-week) studies in 1,121 patients, and one long-term (up to nine months) study in 560 patients.
Slovenian: Učinke zdravila Xyrem so proučevali tudi pri 1 121 bolnikih s fibromialgijo z zmernimi do hudimi simptomi v dveh kratkotrajnih (12-tedenskih) študijah in v eni dolgoročni študiji (do devet mesecev) pri 560 bolnikih.