FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Luminity?
Croatian: Što je Luminity?
English: Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
Croatian: U trima ispitivanjima proučavalo se u kojoj mjeri lijek može poboljšati snimke lijeve klijetke uspoređivanjem snimaka ehokardiografijom prije i nakon primjene lijeka Luminity.
English: Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared.
Croatian: Lijek Luminity pokazao se djelotvornim u poboljšanju snimke lijeve klijetke te je u ispitivanjima u kojima je uspoređen s placebom bio djelotvorniji.
English: What benefit has Luminity shown during the studies?
Croatian: Koje su koristi lijeka Luminity dokazane u ispitivanjima?
English: These studies also looked at left ventricle image enhancement.
Croatian: U ispitivanjima se također proučavalo poboljšanje snimke lijeve klijetke.
English: What is Luminity used for?
Croatian: Za što se Luminity koristi?
English: For the full list of all side effects and restrictions with Luminity, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Luminity potražite u uputi o lijeku.
English: How is Luminity used?
Croatian: Kako se Luminity koristi?
English: How has Luminity been studied?
Croatian: Kako je Luminity ispitivan?
English: How does Luminity work?
Croatian: Kako djeluje Luminity?
English: 2 carton pack.
Croatian: Pakiranje s 2 kutije.
English: 40 mg/0.8 ml
Croatian: Veličina pakiranja mg/0,8 ml
English: Immediate Packaging
Croatian: Put primjene Unutarnje pakiranje
English: 1 alcohol pad
Croatian: 1 bočicu
English: Each carton contains: 1 vial + 1 syringe + 1 needle + 1 sterile adapter + 2 alcohol pads
Croatian: 1 sterilni nastavak + 2 jastučića natopljena alkoholom2 napunjene štrcaljke sa štitnikom za iglu + 2 jastučića natopljena alkoholom
English: alcohol pads
Croatian: Doza Farmaceutski oblik
English: 2 pre-filled syringes + 2
Croatian: 1 štrcaljku +
English: 1 pre-filled syringe with needle guard
Croatian: 6 napunjenih štrcaljki sa štitnikom za iglu + 6 jastučića natopljenih alkoholom
English: Solution for injection Subcutaneous use vial (glass)
Croatian: Otopina za injekciju bočica (staklo) 0,8 ml (40 mg/0,8 ml)
English: 90 (3 x 30) capsules
Croatian: 90 (3 x 30) kapsula
English: Further information on Imfinzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Imfinzi možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose is calculated based on the patient's body weight.
Croatian: Doza se računa na temelju tjelesne težine bolesnika.
English: Treatment may be paused or stopped permanently if the patient experiences severe side effects.
Croatian: Liječenje se može prekinuti ili trajno obustaviti ako bolesnik dobije teške nuspojave.
English: What is Imfinzi and what is it used for?
Croatian: Što je Imfinzi i za što se koristi?
English: Treatment should continue for as long as the patient benefits from it or for up to 1 year.
Croatian: Liječenje treba nastaviti sve dok bolesnik ima koristi od terapije ili tijekom godine dana.
English: What measures are being taken to ensure the safe and effective use of Imfinzi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imfinzi?
English: The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs).
Croatian: Najčešća ozbiljna nuspojava (koja se može javiti u do 1 na 10 osoba) jest upala pluća (infekcija pluća).
English: The use of Imfinzi is restricted to patients whose tumours produce PD-L1, since a clear benefit was only shown in this group of patients.
Croatian: Upotreba lijeka Imfinzi ograničena je na bolesnike čiji tumor proizvodi PD-L1 jer je jasna korist dokazana samo u toj skupini bolesnika.
English: For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Imfinzi, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Imfinzi is given as an infusion (drip) into a vein every 2 weeks.
Croatian: Lijek Imfinzi primjenjuje se intravenskom infuzijom (drip) svaka dva tjedna.
English: Other information about Imfinzi
Croatian: Ostale informacije o lijeku Imfinzi
English: By attaching to PDL1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.
Croatian: Vezivanjem na PDL1 i blokiranjem njezina utjecaja, Imfinzi povećava sposobnost imunosnog sustava da napada stanice raka i time uspori napredovanje bolesti.
English: The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash.
Croatian: Najčešće nuspojave lijeka Imfinzi (koje se mogu javiti u više od 1 na 5 osoba) jesu kašalj, infekcije nosa i grla i osip.
English: PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells.
Croatian: PD-L1 djeluje tako da isključuje imunosne stanice koje bi inače napale stanice raka.
English: Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.
Croatian: Imfinzi se izdaje samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Imfinzi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi 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 Imfinzi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Imfinzi are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Imfinzi kontinuirano se prate.
English: In one main study of 713 patients, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo.
Croatian: U jednom glavnom ispitivanju kojim je bilo obuhvaćeno 713 bolesnika, bolesnici koji su uzimali lijek Imfinzi živjeli su u prosjeku oko 17 mjeseci bez pogoršanja bolesti, u usporedbi sa 6 mjeseci u slučaju bolesnika koji primali placebo.
English: Preliminary results also indicated that patients given Imfinzi lived longer overall, compared with patients on placebo, though longer monitoring would be needed to confirm the extent of the benefit.
Croatian: Preliminarni rezultati također su upućivali na to da su bolesnici koji su primali lijek Imfinzi općenito živjeli dulje u usporedbi s bolesnicima koji su primali placebo, iako je potrebno dulje praćenje kako bi se potvrdio opseg koristi.
English: Why is Imfinzi authorised in the EU?
Croatian: Zašto je lijek Imfinzi odobren u EU-u?
English: An overview of Imfinzi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Imfinzi i zašto je odobren u EU-u
English: What are the risks associated with Imfinzi?
Croatian: Koji su rizici povezani s lijekom Imfinzi?
English: Imfinzi is used specifically when the tumour produces a protein known as PD-L1.
Croatian: Imfinzi se osobito upotrebljava kada tumor proizvodi bjelančevinu poznatu pod nazivom PD-L1.
English: Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Croatian: Imfinzi je lijek koji se koristi za liječenje vrste raka pluća koji se naziva rak pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC).
English: Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer).
Croatian: Imfinzi se upotrebljava u odraslih osoba s uznapredovalim rakom koji se ne može ukloniti kirurškim zahvatom, ali kod kojih bolest nije uznapredovala nakon liječenja zračenjem i kemoterapijom temeljenom na platini (lijekovi za liječenje raka).
English: The European Medicines Agency therefore decided that Imfinzi'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 od lijeka Imfinzi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.
Croatian: Smatralo se da se nuspojavama lijeka Imfinzi može upravljati te da je njegov sigurnosni profil prihvatljiv i u skladu sa sigurnosnim profilom sličnih lijekova.
English: The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1' (PD-L1), which is present on the surface of many cancer cells.
Croatian: Djelatna tvar u lijeku Imfinzi, durvalumab, monoklonsko je protutijelo, tj. vrsta bjelančevine osmišljene za prepoznavanje bjelančevine pod nazivom „ligand 1 programirane smrti stanice” (PD-L1) koja je prisutna na površini mnogih stanica raka te za vezivanje na nju.
English: Imfinzi was shown to improve the length of time patients with advanced NSCLC lived without their disease getting worse, and this was considered important for these patients, who have few treatment options.
Croatian: Pokazalo se da lijek Imfinzi produljuje vrijeme tijekom kojeg su bolesnici s unapredovalim NSCLC-om živjeli bez pogoršanja bolesti, što se smatralo važnim za te bolesnike, koji nemaju mnogo mogućnosti liječenja.
English: How does Imfinzi work?
Croatian: Kako djeluje Imfinzi?
English: Imfinzi has been shown to be more effective than placebo (a dummy treatment) at prolonging the time patients with advanced non-small cell lung cancer lived without their disease getting worse.
Croatian: Pokazalo se da je lijek Imfinzi učinkovitiji od placeba (prividno liječenje) u produljenju vremena tijekom kojeg su bolesnici s uznapredovalim rakom pluća nemalih stanica živjeli bez pogoršanja bolesti.
English: What benefits of Imfinzi have been shown in studies?
Croatian: Koje su koristi od lijeka Imfinzi utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Imfinzi, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja za lijek Imfinzi potražite u uputi o lijeku.
English: How is Imfinzi used?
Croatian: Kako se Imfinzi koristi?
English: Imfinzi contains the active substance durvalumab.
Croatian: Imfinzi sadrži djelatnu tvar durvalumab.
English: The safety of the medicine is in line with other similar medicines.
Croatian: Sigurnost primjene lijeka u skladu je s drugim sličnim lijekovima.
English: Further information on Inbrija can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Inbrija.
Croatian: Više informacija o lijeku Inbrija dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Inbrija.
English: The recommended dose is 2 capsules in each ‘off' period up to a maximum of 10 capsules per day.
Croatian: Preporučena doza je dvije kapsule u svakom „off” razdoblju do najviše 10 kapsula na dan.
English: This overview was last updated in 09-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 8. 2019.
English: What is Inbrija and what is it used for?
Croatian: Što je Inbrija i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Inbrija?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Inbrija?
English: Other information about Inbrija
Croatian: Ostale informacije o lijeku Inbrija
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inbrija 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 Inbrija nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: An overview of Inbrija and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Inbrija i zašto je odobren u EU-u
English: The European Medicines Agency therefore decided that Inbrija's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Inbrija nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: What are the risks associated with Inbrija?
Croatian: Koji su rizici povezani s lijekom Inbrija?
English: For more information about using Inbrija, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Inbrija pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Allergic oedema (swelling) and gastrointestinal haemorrhage (bleeding in the gut) have been reported for other medicines containing levodopa.
Croatian: Alergijski edem (oticanje) i gastrointestinalno krvarenje (krvarenje u crijevima) zabilježeni su za druge lijekove koji sadrže levodopu.
English: As for all medicines, data on the use of Inbrija are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Inbrija kontinuirano se prate.
English: Side effects reported with Inbrija are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Inbrija pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The first study involved 226 patients who had 12 weeks of standard treatment with levodopa and a dopa-decarboxylase inhibitor.
Croatian: Prvo je ispitivanje obuhvaćalo 226 bolesnika koji su 12 tjedana liječeni standardnom terapijom levodopom i inhibitorom dopa-dekarboksilaze.
English: Effects were measured using a standard symptom scale known as the unified Parkinson's disease rating scale, UPDRS, part III.
Croatian: Učinci su mjereni putem standardne ljestvice simptoma, poznate kao Jedinstvena ocjenska ljestvica za Parkinsonovu bolest (UPDRS), dio III.
English: Because it is inhaled, Inbrija provides rapid relief of symptoms, which improves patients' quality of life.
Croatian: Budući da se inhalira, lijek Inbrija pruža brzo ublažavanje simptoma, što pomaže u poboljšanju kvalitete života bolesnika.
English: In the second study involving 77 patients who had 4 weeks of standard treatment, patients who took Inbrija during ‘off' periods had an average improvement of 10 points on the scale 10 to 60 minutes later, compared with 3 points for patients taking placebo.
Croatian: U drugom ispitivanju na 77 bolesnika koji su četiri tjedna liječeni standardnom terapijom, bolesnici koji su uzimali lijek Inbrija tijekom „off” razdoblja doživjeli su prosječno poboljšanje od 10 bodova na ljestvici od 10 do 60 minuta kasnije, u usporedbi s bolesnicima koji su uzimali placebo.
English: The most common side effect with Inbrija is cough (which may affect more than 1 in 10 people).
Croatian: Najčešća nuspojava lijeka Inbrija (koja se može javiti u više od 1 na 10 osoba) jest kašalj.
English: In this study, patients who took Inbrija during their ‘off' periods had an average improvement of 10 points on the scale 30 minutes later, compared with 6 points for patients taking placebo (a dummy treatment).
Croatian: U tom su ispitivanju bolesnici, koji su uzimali lijek Inbrija tijekom „off” razdoblja, doživjeli prosječno poboljšanje od 10 bodova na ljestvici 30 minuta kasnije, u usporedbi sa 6 bodova za bolesnike koji su uzimali placebo (prividno liječenje).
English: Of patients treated with Inbrija, 71% reported that their symptoms were improved, compared with 46% of patients on placebo.
Croatian: U bolesnika liječenih lijekom Inbrija u njih 71 % zabilježeno je ublažavanje simptoma, u usporedbi s 46 % bolesnika koji su uzimali placebo.
English: Inbrija contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels, thereby improving the symptoms of the condition.
Croatian: Lijek Inbrija sadrži levodopu koja se u mozgu pretvara u dopamin i pomaže u ponovnoj uspostavi razine dopamina, pri čemu se ublažavaju simptomi bolesti.
English: Other common side effects, which may affect up to 1 in 10 people, are falls, upper respiratory tract infection (nose and throat infection), dyskinesia (difficulty controlling movement) and discoloured sputum (phlegm).
Croatian: Druge česte nuspojave, koje se mogu javiti u najviše 1 do 10 osoba, jesu padovi, infekcije gornjih dišnih puteva (infekcije nosa i grla), diskinezija (poteškoće u kontroliranju pokreta) i promijenjena boja iskašljaja (sluzi).
English: Inbrija is a medicine used to treat adults with Parkinson's disease (a progressive brain disease that causes shaking and muscle stiffness and slows movement).
Croatian: Inbrija je lijek za liječenje odraslih osoba oboljelih od Parkinsonove bolesti (progresivne bolesti mozga koja uzrokuje drhtanje i ukočenost mišića te usporenost pokreta).
English: Two main studies have shown that Inbrija is effective at improving patients' symptoms during ‘off' periods.
Croatian: U dvjema glavnim ispitivanjima pokazalo se da je lijek Inbrija učinkovit u ublažavanju simptoma bolesnika tijekom „off” razdoblja.
English: Why is Inbrija authorised in the EU?
Croatian: Zašto je lijek Inbrija odobren u EU-u?
English: Inbrija is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Croatian: Lijek Inbrija dostupan je u obliku kapsula koje sadrže prašak za inhaliranje i izdaje se samo na recept.
English: Inbrija should be inhaled using the Inbrija inhaler device when the patient recognises the symptoms of an ‘off' period.
Croatian: Lijek Inbrija mora se inhalirati uz pomoć inhalatora Inbrija kada bolesnik prepozna simptome „off” razdoblja.
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika s Parkinsonovom bolešću stanice u mozgu koje proizvode dopamin (neuroprijenosnik važan za kontroliranje pokreta) počinju odumirati, a količina dopamina u mozgu se smanjuje.
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of neuroleptic malignant syndrome or rhabdomyolysis.
Croatian: Ne smiju ga uzimati ni bolesnici koji uzimaju lijekove zvane neselektivni inhibitori monoaminooksidaze (MAO), kao ni bolesnici s malignim neuroleptičkim sindromom ili rabdomiolizom u dosadašnjoj anamnezi.
English: Medicines containing levodopa and a dopa-decarboxylase inhibitor have shown side effects of symptoms like neuroleptic malignant syndrome (a nervous disorder) and rhabdomyolysis (breakdown of muscle fibres).
Croatian: Kod lijekova koji sadrže levodopu i inhibitor dopa-dekarboksilaze utvrđene su nuspojave simptoma poput malignog neuroleptičkog sindroma (poremećaja živčanog sustava) i rabdomiolize (razgradnje mišićnog tkiva).
English: Inbrija contains the active substance levodopa.
Croatian: Lijek Inbrija sadrži djelatnu tvar levodopa.
English: How does Inbrija work?
Croatian: Kako djeluje Inbrija?
English: Studies show that Inbrija is effective at reducing symptoms during ‘off' periods in patients with Parkinson's disease on levodopa/dopa-decarboxylase-inhibitor treatment.
Croatian: Ispitivanja pokazuju da je lijek Inbrija učinkovit u ublažavanju simptoma tijekom „off” razdoblja u bolesnika s Parkinsonovom bolešću tijekom liječenja levodopom / dopa-dekarboksilazom.
English: What benefits of Inbrija have been shown in studies?
Croatian: Koje su koristi od lijeka Inbrija utvrđene u ispitivanjima?
English: Inbrija is used to treat symptoms during ‘off' periods (times when the patient has more difficulty moving about) that occur while the patient is taking their usual treatment of a combination of levodopa and an inhibitor of dopa-decarboxylase.
Croatian: Lijek Inbrija koristi se za ublažavanje simptoma tijekom „off” razdoblja (tijekom kojih se bolesnik teže kreće) koji nastupaju tijekom uzimanja uobičajene terapije bolesnika, odnosno uzimanja levodope i inhibitora dopa-dekarboksilaze.
English: Because Inbrija is inhaled, it can supply extra levodopa (and hence dopamine) quickly when needed during an ‘off' period.
Croatian: Budući da se lijek Inbrija inhalira, njime se prema potrebi omogućuje brža opskrba levodopom (stoga i dopaminom) tijekom „off” razdoblja.
English: Inbrija must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Croatian: Lijek Inbrija ne smiju uzimati bolesnici s glaukomom uskog kuta (poremećajem oka) ili feokromocitom (tumorom nadbubrežne žlijezde).
English: • If you are taking or will be taking paracetamol
Croatian: • Ako uzimate ili ćete uzimati paracetamol
English: Talk to your doctor or pharmacist before taking this medicine:
Croatian: Obratite se svojem liječniku ili ljekarniku prije nego uzmete ovaj lijek:
English: If you had these symptoms prior to treatment with cladribine, tell your doctor about any change in these symptoms.
Croatian: Ako ste imali te simptome prije početka liječenja kladribinom, obavijestite svog liječnika o svim promjenama tih simptoma.
English: The frequency of this side effect is not known (cannot be estimated from the available data).
Croatian: Učestalost ove nuspojave je nepoznata (ne može se procijeniti na temelju dostupnih podataka).
English: Some of these reactions with <product name> have resulted in recurrent symptoms and required a longer period of observation and treatment.
Croatian: Neke od ovih reakcija na <naziv lijeka> su rezultirale rekurentnim simptomima te su zahtijevale dulje razdoblje promatranja i liječenja.
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Croatian: Sve to mogu biti simptomi ozbiljnog i potencijalno smrtonosnog oštećenja mozga poznatog kao progresivna multifokalna leukoencefalopatija (PML).
English: Adopted at the 25-29 September 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 25. - 29. rujna 2017.
English: A negative JCV PCR does not exclude PML.
Croatian: Negativni rezultat metode PCR za JCV ne isključuje PML.
English: Possible side effects [The following adverse drug reaction should be added with a frequency very rare (may affect up to 1 in 10,000 people)]
Croatian: Moguće nuspojave [Sljedeću nuspojavu potrebno je dodati s učestalošću „vrlo rijetko” (mogu se javiti u do 1 na 10 000 osoba)]
English: Patients should be reassured that this is a usually self-limiting consequence of antibiotic treatment of spirochete infections.
Croatian: Bolesnicima je potrebno objasniti da je to obično samoograničavajuća posljedica liječenja infekcije spirohetama antibioticima.
English: Frequency ‘Not known': Jarisch-Herxheimer reaction (see section 4.4)
Croatian: Učestalost „nepoznata”: Jarisch-Herxheimerova reakcija (vidjeti dio 4.4)
English: If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Croatian: Ako se pojavi alergijska reakcija, potrebno je prekinuti uzimanje lijeka i uvesti odgovarajuću terapiju.