FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetreksed je indiciran kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice
English: Trometamol (for pH adjustment) Anhydrous citric acid Methionine
Croatian: 6.1 Popis pomoćnih tvari tromeatmol (za podešavanje pH) citratna kiselina, bezvodna metionin voda za injekcije
English: Very common (may affect more than 1 in 10 people) - Low white blood cells - Low haemoglobin level (anaemia) - Low platelet count - Diarrhoea - Vomiting - Pain, redness, swelling or sores in your mouth - Nausea - Loss of appetite - Fatigue (tiredness) - Skin rash, peeling of the skin - Hair loss - Constipation - Loss of sensation - Kidney: abnormal blood tests
Croatian: nizak broj krvnih pločica proljev povraćanje bol, crvenilo, oteklina ili ranice u ustima mučnina gubitak teka umor kožni osip, ljuštenje kože gubitak kose zatvor gubitak osjeta bubrezi: poremećeni rezultati krvnih pretraga
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n=283) and 7.9 months for patients treated with docetaxel (ITT n=288).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III lijeka pemetreksed u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih lijekom ALIMA iznosio je 8,3 mjeseca
English: Cisplatin (N=222)
Croatian: (N = 222)
English: Marketing Authorisation Holder
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Clinically relevant toxicity that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Croatian: U ovu su tablicu uključene sve nuspojave čija je učestalost bila najmanje 5% i za koje je ispitivač procijenio da bi mogle biti povezane s primjenom pemetrekseda i cisplatina.Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih da primaju cisplatin i pemetreksed ubrajaju se: povišene vrijednosti AST-a, povišene vrijednosti ALT-a, infekcija, neutropenijska vrućica, zatajenje bubrega, vrućica, dehidracija, konjuktivitis i smanjen klirens kreatinina.
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended (see section 4.2).
Croatian: < 45 ml/min (vidjeti dio 4.2).
English: Water for injections
Croatian: Ringerovu otopinu za injekcije.
English: N=229 1.23 Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Croatian: Intent-To-Treat [ITT], n=283), a u bolesnika liječenih docetakselom 7,9 mjeseci (ITT populacija, n = 288).
English: The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control.
Croatian: Uobičajena je doza 4 mg jedanput na dan, ali može se smanjiti na 2 mg jedanput na dan kad je bolest pod kontrolom.
English: The results of the three studies after 12 weeks of treatment are as follows:
Croatian: Rezultati tih triju ispitivanja nakon 12 tjedana liječenja:
English: Olumiant must not be used during pregnancy.
Croatian: Olumiant se ne smije uzimati tijekom trudnoće.
English: This overview was last updated in 11-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 11.2018.
English: Further information on Olumiant can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Croatian: Više informacija o lijeku Olumiant nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/olumiant.
English: Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.
Croatian: Lijek Olumiant dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. veljače 2017.
English: What is Olumiant and what is it used for?
Croatian: Što je Olumiant i za što se primjenjuje?
English: What measures are being taken to ensure the safe and effective use of Olumiant?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Olumiant?
English: Olumiant can be used either alone or in combination with the DMARD methotrexate.
Croatian: Olumiant se može primjenjivati samostalno ili u kombinaciji s DMARD-om metotreksat.
English: In one study involving 584 patients, Olumiant was more effective than methotrexate.
Croatian: U ispitivanju kojim je bilo obuhvaćeno 584 bolesnika lijek Olumiant bio je učinkovitiji od metotreksata.
English: Other information about Olumiant
Croatian: Ostale informacije o lijeku Olumiant
English: The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Croatian: Dozu će možda trebati smanjiti i u bolesnika s oštećenom funkcijom bubrega, u bolesnika s povećanim rizikom od infekcija, u onih starijih od 75 godina ili onih koji uzimaju određene druge lijekove.
English: It works by blocking the action of enzymes known as Janus kinases.
Croatian: Djeluje blokiranjem djelovanja enzima Janus kinaze.
English: It is available as tablets to be taken by mouth.
Croatian: Lijek je dostupan u obliku tableta koje se uzimaju kroz usta.
English: Patients will be given a special alert card that summarises the safety information about the medicine.
Croatian: Bolesnici će primiti posebnu karticu s upozorenjima koja sadržava sažetak informacija o sigurnosti primjene lijeka.
English: However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.
Croatian: Međutim, nema podataka o dugoročnoj sigurnosti, a samo navedeni rezultati nisu dostatni da bi se podržala primjena lijeka Olumiant u bolesnika koji nisu prethodno liječeni.
English: Why is Olumiant authorised in the EU?
Croatian: Zašto je lijek Olumiant odobren u EU-u?
English: Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Olumiant 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 Olumiant have also 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 Olumiant nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).
Croatian: Najčešće su nuspojave lijeka Olumiant primijenjenog samostalno ili u kombinaciji s metotreksatom povišena razina kolesterola u krvi, infekcije nosa i grla te mučnina (mogu se pojaviti u 2 ili više osoba od 100).
English: Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Croatian: Liječenje lijekom Olumiant mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa.
English: What are the risks associated with Olumiant?
Croatian: Koji su rizici povezani s lijekom Olumiant?
English: The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients.
Croatian: Tvrtka koja stavlja na tržište lijek Olumiant osigurat će da liječnici za koje se očekuje da će propisivati lijek dobiju informativni paket koji sadržava podatke o rizicima povezanima s lijekom Olumiant, osobito s rizikom od infekcije, i o praćenju bolesnika.
English: The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Croatian: Djelatna tvar lijeka Olumiant je baricitinib, vrsta imunosupresiva (lijek koji smanjuje aktivnost imunosnog sustava).
English: In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given.
Croatian: U pogledu sigurnosti, lijek Olumiant uzima se kroz usta, što znači da nema iste rizike kao DMARD-ovi koji se primjenjuju injekcijom, a to su alergijske reakcije povezane s načinom primjene lijeka.
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Croatian: Ti enzimi imaju važnu ulogu u procesu upale i oštećenja zglobova koji se javljaju u slučaju reumatoidnog artritisa.
English: The Agency also took into account the lack of treatment options for these patients and the fact that Olumiant can be given by mouth is convenient for patients.
Croatian: Agencija je također uzela u obzir nedostatak mogućnosti liječenja tih bolesnika i činjenicu da se Olumiant uzima kroz usta, što je pogodno za bolesnike.
English: Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.
Croatian: Općenito se smatra da je nuspojave lijeka moguće kontrolirati, a uvedeno je i nekoliko mjera za smanjenje rizika povezanih s ovim lijekom, osobito rizika od infekcije.
English: As for all medicines, data on the use of Olumiant is continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Olumiant kontinuirano se prate.
English: An overview of Olumiant and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Olumiant i zašto je odobren u EU-u
English: Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).
Croatian: Olumiant je lijek koji se primjenjuje za liječenje reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova).
English: Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough.
Croatian: Trima ispitivanjima koja su provedena među otprilike 2 500 bolesnika utvrđeno je da Olumiant ublažava simptome kao što su osjetljivost i oticanje zglobova u bolesnika u kojih prethodno primjenjivani DMARD-ovi nisu imali dovoljno dobar učinak.
English: For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Olumiant pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Olumiant has also been studied in patients who had not received previous treatment.
Croatian: Lijek Olumiant ispitivan je i u bolesnika koji nisu prethodno liječeni.
English: The European Medicines Agency decided that Olumiant'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 Olumiant nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Olumiant contains the active substance baricitinib.
Croatian: Olumiant sadržava djelatnu tvar baricitinib.
English: In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo.
Croatian: Tijekom tih ispitivanja primjenom lijeka Olumiant (samostalno ili u kombinaciji s metotreksatom) postignuto je poboljšanje od 20 % ili više, prema standardnom bodovanju simptoma (ACR 20), u većeg broja bolesnika nego primjenom usporednih lijekova i placeba.
English: The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them.
Croatian: Agencija smatra da se lijek Olumiant pokazao učinkovitim u ublažavanju simptoma reumatoidnog artritisa u bolesnika u kojih prethodno primjenjivani DMARD-ovi nisu imali dovoljno dobar učinak ili u bolesnika koji ih ne podnose.
English: It is used in patients with moderate to severe arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs') has not worked well enough or if patients cannot tolerate them.
Croatian: Primjenjuje se u bolesnika s artritisom umjerenog do teškog stupnja ako uobičajeno liječenje antireumaticima koji mijenjaju tijek bolesti (engl. disease-modifying anti-rheumatic drugs, DMARD) nije imalo dovoljno dobar učinak ili ako bolesnici ne podnose te lijekove.
English: How does Olumiant work?
Croatian: Kako djeluje Olumiant?
English: • In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.
Croatian: • među bolesnicima koji su prethodno liječeni vrstom DMARD-a koja se naziva inhibitori TNF-a, u 55 % bolesnika (98 od 177) koji su primali lijek Olumiant postignuto je poboljšanje od najmanje 20 %, u usporedbi sa 27 % bolesnika (48 od 176) koji su primali placebo.
English: What benefits of Olumiant have been shown in studies?
Croatian: Koje su koristi od lijeka Olumiant utvrđene u ispitivanjima?
English: • In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.
Croatian: • među bolesnicima koji su prethodno liječeni metotreksatom, u 70 % bolesnika (339 od 487) koji su uzimali lijek Olumiant postignuto je poboljšanje u pogledu simptoma od najmanje 20 %, u usporedbi sa 61 % bolesnika (202 od 330) koji su primali adalimumab (druga vrsta DMARD-a) i 40 % bolesnika (196 od 488) koji su primali placebo;
English: By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Croatian: Baricitinib ublažuje upalu i druge simptome bolesti blokiranjem enzima.
English: Infections reported with Olumiant treatment also included herpes zoster (shingles).
Croatian: Infekcije zabilježene prilikom primjene lijeka Olumiant obuhvaćaju i herpes zoster.
English: • In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
Croatian: • među bolesnicima koji su prethodno liječeni konvencionalnim DMARD-ovima, u 62 % bolesnika (140 od 227) koji su primali lijek Olumiant postignuto je poboljšanje od najmanje 20 %, u usporedbi s 40 % bolesnika (90 od 228) koji su primali placebo;
English: How is Olumiant used?
Croatian: Kako se Olumiant primjenjuje?
English: For the full list of side effects reported with Olumiant, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene lijeka Olumiant potražite u uputi o lijeku.
English: EMA/CHMP/138741/2015 EMEA/H/C/000563
Croatian: EMA/101950/2015 EMEA/H/C/000563
English: The full EPAR for Aloxi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Aloxi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Aloxi na snazi u Europskoj uniji od 22. ožujka 2005.
English: All of the studies measured the number of patients who did not vomit after receiving chemotherapy.
Croatian: Sva ova ispitivanja izmjerila su broj bolesnika koji nije povraćao nakon primanja kemoterapije.
English: It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Croatian: Dostupan je kao otopina za injekciju (250 mikrograma u 5 ml) i kao kapsule (500 mikrograma).
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Croatian: Ovo znači da sprječava u tijelu vezivanje kemikalije naziva 5-hidroksitriptamin (5HT, poznatu također pod nazivom serotonin) na receptore 5HT3 u crijevima.
English: The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache.
Croatian: Najčešća nuspojava Aloxi (uočena kod više od 10 na 100 bolesnika) je glavobolja.
English: This is a summary of the European public assessment report (EPAR) for Aloxi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aloxi.
English: Aloxi is a medicine that contains the active substance palonosetron.
Croatian: Aloxi je lijek koji sadrži djelatnu tvar palonosetron.
English: What measures are being taken to ensure the safe and effective use of Aloxi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aloxi?
English: Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Croatian: Aloxi, primijenjen u dvije različite doze, uspoređen je s ondansetronom i dolasetronom (drugim lijekovima istoga tipa).
English: In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.
Croatian: Ako se koriste kapsule u odraslih osoba, bolesnik treba uzeti jednu kapsulu jedan sat prije početka kemoterapije.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Croatian: Kada se 5HT vezuje na ove receptore, uobičajeno je da uzrokuje mučninu i povraćanje.
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 Aloxi.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Aloxi.
English: For more information about treatment with Aloxi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Aloxi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Other information about Aloxi
Croatian: Ostale informacije o lijeku Aloxi
English: The active substance in Aloxi, palonosetron, is a ‘5HT3 antagonist'.
Croatian: Djelatna tvar lijeka Aloxi, palonosetron, je "antagonist 5HT3".
English: Aloxi solution for injection was as effective as the comparator medicines.
Croatian: Otopina za injekciju Aloxi je podjednako djelotvorna kao komparatorski lijekovi.
English: The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Croatian: Otopinu za injekciju treba primijeniti zdravstveni djelatnik otprilike 30 minuta prije početka kemoterapije.
English: Aloxi should only be given before chemotherapy.
Croatian: Aloxi se primjenjuje samo prije kemoterapije.
English: By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.
Croatian: Inhibirajući ove receptore, Aloxi sprječava mučninu i povraćanje koje se često pojavljuje nakon kemoterapije.
English: In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting.
Croatian: U ispitivanju koje je istražilo kapsule Aloxi, sve tri doze lijeka Aloxi bile su podjednako djelotvorne kao otopina za injekciju tijekom 24 sata, pri čemu otprilike tri četvrtine bolesnika nije povraćalo.
English: A risk management plan has been developed to ensure that Aloxi is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aloxi.
English: Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Croatian: Aloxi se koristi za sprječavanje mučnine (osjećaja slabosti) i povraćanja uzrokovanog kemoterapijom (lijekovima koji se koriste za liječenje raka).
English: However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Croatian: No, samo doza 500 mikrograma bila je podjednako djelotvorna kao otopina za injekciju tijekom razdoblja od prvih pet dana nakon kemoterapije: otprilike 59% bolesnika koji su primili kapsule od 500 mikrograma ili injekciju nije povraćalo tijekom ovog razdoblja.
English: With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100.
Croatian: U slučaju otopinu za injekciju, omaglica, zatvor i proljev uočeni su kod 1 do 10 osoba na 100.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aloxi, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Aloxi nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Croatian: U djece, otopinu treba primjenjivati infuzijom (dripom) u venu tijekom razdoblja od 15 minuta u dozi od 20 mikrograma po kilogramu tjelesne težine.
English: The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Croatian: Otopina za injekciju koristi se u odraslih osoba i djece u dobi od jednog mjeseca starosti i starijih za kemoterapiju s lijekovima koji su snažni aktivatori mučnine i povraćanja (poput cispatina) ili umjereni aktivatori (poput ciklofosfamida, doksorubicina ili karboplatina).
English: The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Aloxi nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of
Croatian: U slučaju usporedbe s dolasetronom, ove vrijednosti su iznosile 63% za Aloxi (119 bolesnika od 189) i 53% za dolasetron (101 bolesnik od 191).
English: In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms.
Croatian: U odraslih osoba, otopinu treba ubrizgati u venu tijekom 30 sekundi u dozi od 250 mikrograma.