FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Tagrisso, osimertinib, is a type of cancer medicine called tyrosine kinase inhibitor.
Croatian: Djelatna tvar u lijeku Tagrisso, osimertinib, vrsta je lijeka za liječenje raka pod nazivom inhibitor tirozin kinaze.
English: An overview of Tagrisso and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Tagrisso i zašto je odobren u EU-u
English: As for all medicines, data on the use of Tagrisso are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Tagrisso kontinuirano se prate.
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).
Croatian: Naposljetku, u ispitivanju 556 bolesnika s aktivirajućim mutacijama, bolesnici koji su uzimali lijek Tagrisso kao prvu terapiju živjeli su 18,9 mjeseci bez pogoršanja bolesti u usporedbi s 10,2 mjeseca u bolesnika koji su liječeni drugim lijekovima (erlotinib ili gefitinib).
English: Why is Tagrisso authorised in the EU?
Croatian: Zašto je lijek Tagrisso odobren u EU-u?
English: For more information about using Tagrisso, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Tagrisso pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
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).
Croatian: Treće ispitivanje na 419 prethodno liječenih bolesnika s mutacijama T790 uglavnom je bilo usredotočeno na djelotvornost lijeka Tagrisso u sprječavanju pogoršanja raka, pri čemu je uspoređen s kemoterapijom temeljenom na platini (standardno liječenje raka pluća nemalih stanica).
English: What are the risks associated with Tagrisso?
Croatian: Koji su rizici povezani s lijekom Tagrisso?
English: Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression).
Croatian: Tagrisso se ne smije koristiti zajedno s gospinom travom (biljnim pripravkom za liječenje depresije).
English: How is Tagrisso used?
Croatian: Kako se Tagrisso koristi?
English: How does Tagrisso work?
Croatian: Kako djeluje Tagrisso?
English: What benefits of Tagrisso have been shown in studies?
Croatian: Koje su koristi od lijeka Tagrisso utvrđene u ispitivanjima?
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.
Croatian: Lijek Tagrisso pokazao se djelotvornim u smanjenju tumora u bolesnika s tim mutacijama i u usporavanju pogoršanja raka.
English: For the full list of restrictions and side effects with Tagrisso, see the package leaflet.
Croatian: Potpuni popis ograničenja i nuspojava zabilježenih pri primjeni lijeka Tagrisso potražite u uputi o lijeku.
English: Tagrisso has been shown to be effective at shrinking tumours in patients with NSCLC and at slowing down the worsening of the cancer.
Croatian: Lijek Tagrisso pokazao se djelotvornim u smanjenju tumora u bolesnika s rakom pluća nemalih stanica i u usporavanju pogoršanja raka.
English: The results were as follows:
Croatian: Rezultati su bili sljedeći:
English: Further information on Steglatro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Steglatro nalazi se na internetskim stranicama 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.
Croatian: Bolesnik mora početi s jednom tabletom od 5 mg jedanput na dan ujutro.
English: Steglatro is available as tablets (5 and 15mg).
Croatian: Steglatro je dostupan u obliku tableta (od 5 i 15 mg).
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.
Croatian: Najčešće nuspojave lijeka Steglatro (koje se mogu javiti u više od 1 na 10 osoba) jesu gljivične infekcije vagine i druge infekcije ženskog reproduktivnog sustava.
English: What measures are being taken to ensure the safe and effective use of Steglatro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Steglatro?
English: If the patients' glucose level is still too high the dose can be increased to 15 mg once a day.
Croatian: Ako je razina šećera u krvi bolesnika još uvijek previsoka, doza se može povećati na 15 mg jedanput na dan.
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.
Croatian: Rijetki slučajevi dijabetičke ketoacidoze, ozbiljnog stanja kod kojeg bolesnik ima vrlo visoke razine kiseline u krvi, mogu se pojaviti u do 1 na 1 000 bolesnika.
English: In addition, Steglatro can help some patients lose weight.
Croatian: Osim toga, Steglatro može pomoći nekim bolesnicima pri gubitku težine.
English: For more information about using Steglatro, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Steglatro pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: What is Steglatro and what is it used for?
Croatian: Što je Steglatro i za što se koristi?
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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Steglatro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: A lower dose of ertugliflozin 5 mg was less effective.
Croatian: Niža doza ertugliflozina, 5 mg, bila je manje učinkovita.
English: The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of treatment.
Croatian: U ispitivanjima su se uglavnom promatrali učinci na razine HbA1c (pokazatelj razine šećera u krvi) nakon 6 mjeseci ili jedne godine liječenja.
English: Why is Steglatro authorised in the EU?
Croatian: Zašto je lijek Steglatro odobren u EU-u?
English: Side effects reported with Steglatro are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Steglatro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The data from this study showed that the effect of ertugliflozin reduces when the kidneys do not work properly.
Croatian: Podaci iz ovog ispitivanja pokazali su da se učinak ertugliflozina smanjuje kada bubrezi ne rade pravilno.
English: The result is a high level of glucose in the blood.
Croatian: To dovodi do visoke razine šećera u krvi.
English: What are the risks associated with Steglatro?
Croatian: Koji su rizici povezani s lijekom Steglatro?
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.
Croatian: Šećerna bolest tipa 2 bolest je kod koje tijelo ne proizvodi dovoljno inzulina za kontrolu razine šećera u krvi ili ga tijelo ne može učinkovito iskoristiti.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Croatian: To se postiže blokiranjem proteina u bubrezima (pod nazivom SGLT2) koji u normalnim okolnostima vraća šećer iz bubrega u krv.
English: Other information about Steglatro
Croatian: Ostale informacije o lijeku Steglatro
English: Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be started in such patients.
Croatian: Steglatro nije toliko učinkovit u bolesnika s umjerenim oštećenjem bubrega pa ga stoga takvi bolesnici ni ne smiju početi uzimati.
English: Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.
Croatian: Steglatro se može uzimati u kombinaciji s drugim lijekovima protiv šećerne bolesti ili samostalno ako bolesnici ne mogu uzimati metformin.
English: An overview of Steglatro and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Steglatro i zašto je odobren u EU-u
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.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Steglatro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Steglatro can only be obtained with a prescription.
Croatian: Steglatro se izdaje samo na recept.
English: As for all medicines, data on the use of Steglatro is continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Steglatro kontinuirano se prate.
English: • A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment.
Croatian: • Sedmo ispitivanje pokazalo je da ertugliflozin nije bio učinkovitiji od placeba u bolesnika s umjerenim oštećenjem bubrega.
English: HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Croatian: Razine HbA1c snizile su se za 0,6 bodova uz ertugliflozin i 0,7 bodova uz glimepirid.
English: • A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo.
Croatian: • U petom ispitivanju ustanovljeno je da je dodavanje ertugliflozina kombinaciji sitagliptina i metformina bilo učinkovitije nego placebo.
English: At the start of the studies, patients' HbA1c was above 7 percentage points.
Croatian: Na početku ispitivanja vrijednost HbA1c u bolesnika iznosila je više od 7 postotnih bodova.
English: Steglatro contains the active substance ertugliflozin.
Croatian: Steglatro sadrži djelatnu tvar ertugliflozin.
English: HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
Croatian: Razine HbA1c snizile su se za dodatnih 0,5 bodova kada su metforminu dodana oba lijeka.
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.
Croatian: Nekoliko ispitivanja koja su obuhvatila oko 4 800 bolesnika sa šećernom bolesti tipa 2 pokazalo je da ertugliflozin pomaže sniziti razine šećera kada se uzima kao jedini lijek te u kombinaciji s drugim lijekovima protiv šećerne bolesti.
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.
Croatian: • U šestom je ispitivanju ustanovljeno da je kombinacija ertugliflozina i sitagliptina kao dopuna dijeti i tjelovježbi bila mnogo učinkovitija nego placebo, pri čemu su se razine HbA1c snizile između 1,6 i 1,7 bodova s kombinacijom ertugliflozina i sitagliptina, a 0,4 boda uz placebo.
English: Studies showed that Steglatro helps lower glucose levels on its own and in combination with other diabetes medicines.
Croatian: Ispitivanja su pokazala da Steglatro pomaže sniziti razine šećera kada se uzima sam te u kombinaciji s drugim lijekovima protiv šećerne bolesti.
English: The active substance in Steglatro, ertugliflozin, helps to lower blood glucose by making the patient pass out glucose in the urine.
Croatian: Djelatna tvar lijeka Steglatro, ertugliflozin, pomaže sniziti šećer u krvi bolesnika tako što potiče izlučivanje šećera mokraćom.
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.
Croatian: Razine HbA1c snizile su se između 0,8 i 0,9 bodova kada je dodan ertugliflozin, u usporedbi sa smanjenjem od 0,1 uz placebo.
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.
Croatian: • Treće je ispitivanje pokazalo da je kombinacija ertugliflozina u dozi od 15 mg i metformina bila otprilike jednako učinkovita kao i kombinacija metformina i glimepirida, još jednog lijeka protiv šećerne bolesti.
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.
Croatian: • U četvrtom ispitivanju pokazalo se da je u bolesnika koji su uzimali metformin dodavanje ertugliflozina bilo jednako učinkovito kao i dodavanje sitagliptina, još jednog lijeka protiv šećerne bolesti, s tim da su se razine HbA1c snizile za otprilike 1 bod uz obje terapije.
English: Finally, in addition to lowering glucose levels, studies showed that ertugliflozin can help patients reduce bodyweight.
Croatian: Konačno, ispitivanja su pokazala da ertugliflozin, osim što smanjuje razine šećera, može pomoći bolesnicima smanjiti tjelesnu težinu.
English: How does Steglatro work?
Croatian: Kako djeluje Steglatro?
English: How is Steglatro used?
Croatian: Kako se Steglatro koristi?
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.
Croatian: • U drugom je ispitivanju ustanovljeno da su se u bolesnika koji su uzimali kombinaciju ertugliflozina i metformina razine HbA1c smanjile za oko 0,8 bodova, dok je to smanjenje iznosilo samo 0,03 kada je metforminu dodan placebo.
English: Steglatro is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes together with diet and exercise.
Croatian: Steglatro je lijek kojim se, uz dijetalnu prehranu i tjelovježbu, kontrolira šećer (glukoza) u krvi u odraslih osoba sa šećernom bolesti tipa 2.
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).
Croatian: • Ispitivanje djelovanja samo ertugliflozina pokazalo je da su se u bolesnika koji su uzimali lijek razine HbA1c (pokazatelj razine šećera u krvi) smanjile između 0,8 bodova i 1 boda, dok je u bolesnika koji su primali placebo (prividno liječenje) zabilježen porast od 0,2 boda.
English: For the full list of side effects and restrictions with Steglatro, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Steglatro potražite u uputi o lijeku.
English: What benefits of Steglatro have been shown in studies?
Croatian: Koje su koristi lijeka Steglatro utvrđene u ispitivanjima?
English: Nausea is more common in women than in men.
Croatian: Mučnina je češća kod žena nego kod muškaraca.
English: Xyrem can also cause respiratory depression (inhibition of breathing).
Croatian: Xyrem također može uzrokovati depresiju disanja (inhibiciju disanja).
English: Both doses should be prepared at the same time before the patient goes to bed.
Croatian: Obje doze treba pripremiti u isto vrijeme prije nego bolesnik pođe na spavanje.
English: This summary was last updated in 06-2014.
Croatian: Sažetak je posljednji put ažuriran: 06.2014.
English: This improves the symptoms of narcolepsy.
Croatian: To poboljšava simptome narkolepsije.
English: Xyrem sodium oxybate
Croatian: Xyrem natrijev oksibat
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.
Croatian: Točan način djelovanja nije poznat ali smatra se da se vezuje na molekule receptora na površini nekih stanica u mozgu.
English: The second dose is taken 2.5 to 4 hours later.
Croatian: Druga se doza uzima 2,5 do 4 sata kasnije.
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.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku Xyrem (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.
Croatian: Podaci dobiveni u ispitivanjima fibromijalgije nisu podržali upotrebu lijeka Xyrem u ovom stanju kod europske populacije bolesnika.
English: The main measure of effectiveness was based on reduction of pain severity and improvement in function.
Croatian: Glavna mjera učinkovitosti temeljila se na smanjenju težine boli i poboljšanju funkcije.
English: Other information about Xyrem:
Croatian: Ostale informacije o lijeku Xyrem:
English: What measures are being taken to ensure the safe and effective use of Xyrem?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xyrem?
English: This leads to changes in the activity of the brain, bringing about ‘delta' (slow) brain waves and night-time sleep.
Croatian: To uzrokuje promjene u aktivnosti mozga, aktivira „delta” (spore) valove u mozgu i dovodi do noćnog sna.
English: Cataplexy can sometimes cause a patient to collapse.
Croatian: Katapleksija može ponekad uzrokovati da bolesnik kolabira.
English: Xyrem is an oral solution that contains the active substance sodium oxybate (500 mg/ml).
Croatian: Xyrem je oralna otopina koja sadrži djelatnu tvar natrijev oksibat (500 mg/ml).
English: When taken at bedtime, Xyrem increases deep sleep and increases the amount of time spent asleep at night, whilst reducing the number of sleeping periods during the day.
Croatian: Kad se uzima u vrijeme spavanja Xyrem povećava duboki san i povećava količinu vremena koje provedemo spavajući dok istovremeno smanjuje razdoblja spavanja tijekom dana.
English: The medicine can only be obtained with a special prescription.
Croatian: Ovaj se lijek izdaje samo na poseban recept.
English: Patients taking Xyrem should avoid alcohol, as it can increase Xyrem's effects.
Croatian: Bolesnici koji uzimaju Xyrem moraju izbjegavati alkohol jer može pojačati učinke Xyrema.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem on 13 October 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Xyrem vrijedi na prostoru Europske unije od 13. listopada 2005.
English: Xyrem is used to treat adults who have narcolepsy with cataplexy.
Croatian: Xyrem se koristi za liječenje odraslih koji imaju narkolepsiju s katapleksijom.
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.
Croatian: Katapleksija je simptom narkolepsije koji uključuje iznenadnu slabost mišića na emocionalnu reakciju poput ljutnje, straha, radosti, smijeha ili iznenađenja.
English: This document is a summary of the European Public Assessment Report (EPAR) for Xyrem.
Croatian: Ovo je sažetak Europskog javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Xyrem.
English: The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Croatian: Učinci lijeka Xyrem u narkolepsiji i katapleksiji proučavani su kod 707 bolesnika u četiri ispitivanja.
English: The study measured the number of cataplexy attacks over two weeks.
Croatian: Ispitivanje je mjerilo broj napadaja katapleksije tijekom dva tjedna.
English: Xyrem is supplied with a measuring device and a cup.
Croatian: Xyrem se isporučuje s mjernim uređajem i šalicom.
English: The main measure of effectiveness was the change in daytime sleepiness.
Croatian: Glavna mjera djelotvornosti bila je promjena u pospanosti tijekom dana.
English: Before taking the medicine, the patient should dissolve the dose in water to make up a drink.
Croatian: Prije uzimanja lijeka, bolesnik treba otopiti dozu u vodi za piće.
English: The first dose of the day is taken at bedtime, at least two to three hours after food.
Croatian: Prva doza lijeka uzima se u vrijeme spavanja, barem dva do tri sata nakon obroka.
English: Xyrem was more effective than placebo in reducing symptoms.
Croatian: Xyrem se u redukciji simptoma pokazao djelotvornijim od placeba.
English: The dose is then adjusted at one- to two-week intervals depending on the patient's response.
Croatian: Doza se potom prilagođava intervalima od jednog do dva tjedna ovisno o bolesnikovom odgovoru.
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.
Croatian: Učinci lijeka Xyrem također su proučavani u bolesnika s fibromijalgijom s umjerenim do teškim simptomima u dva kratkoročna (12 tjedna) ispitivanja kod 1 121 bolesnika i jednom dugotrajnom ispitivanju (do devet mjeseci) kod 560 bolesnika.
English: Narcolepsy is a sleep disorder that causes excessive daytime sleepiness.
Croatian: Narkolepsija je poremećaj sna koji uzrokuje prekomjernu pospanost tijekom dana.
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.
Croatian: Iako se doza od 9 g pokazala najučinkovitijom, bila je povezana s visokim razinama nuspojava tako da je Povjerenstvo preporučilo početnu dozu od 4,5 g po danu.
English: A risk management plan has been developed to ensure that Xyrem is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Xyrem.
English: In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared with a fall of 4.3 per week in the patients taking placebo.
Croatian: U prvom ispitivanju, dnevna doza od 9 g smanjila je broj napadaja katapleksije za 16,1 (od 23,5 do 8,7) po tjednu, u usporedbi s padom od 4,3 po tjednu u bolesnika koji uzimaju placebo.
English: Xyrem must not be used in patients with major depression, in patients with ‘succinic semialdehyde dehydrogenase deficiency' (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures).
Croatian: Xyrem se ne smije koristiti u bolesnika s velikim depresivnim poremećajem, u bolesnika s „deficijencijom sukcinat-semialdehid-dehidrogenaze” (rijetke metaboličke bolesti) ili u bolesnika liječenih opioidima (kao što su neki analgetici) ili barbituratima (kao što su neki anestetici i lijekovi za sprječavanje napadaja).
English: Patients who have problems with their kidneys should consider a low sodium diet.
Croatian: Bolesnici koji imaju problema s bubrezima moraju razmotriti dijetu s niskim sadržajem soli.
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.
Croatian: Tvrtka koja proizvodi lijek Xyrem smanjit će rizik od zloupotrebe lijeka dostavljanjem dodatnih edukacijskih materijala zdravstvenim djelatnicima i bolesnicima, strogom kontrolom distribucije lijeka i praćenjem njegove upotrebe.
English: Fibromyalgia is a disease of unknown origin causing long-lasting, widespread pain and painful responses to touch.
Croatian: Fibromijalgija je bolest nepoznatog podrijetla koja uzrokuje dugotrajnu, raširenu bol i bolne reakcije na dodir.