FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant CTC toxicity of any grade that was reported in ≥1% and ≤5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i  5% bolesnika randomiziranih da primaju pemetreksed ubrajaju se: neutropenijska vrućica, infekcija, snižen broj trombocita, proljev, konstipacija, alopecija, pruritus/svrbež, vrućica (bez neutropenije), površinske bolesti oka (uključujući konjunktivitis), pojačano suzenje, omaglica i motorička neuropatija.
English: Haemoglobin decreased 33.0* Neutrophils/Granulocyte s decreased
Croatian: Poremećaji krvi i limfnog sustava vrlo često snižen hemoglobin 33,0* snižen broj neutrofila/ granulocita snižen broj leukocita snižen broj trombocita
English: Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Croatian: Pemetrexed Krka je u kombinaciji s cisplatinom indiciran za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N=481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI=0.56-0.88, p=0.002).
Croatian: Medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N = 481) bio je 15,5 mjeseci u skupini koja je primala pemetreksed i 10,3 mjeseca u skupini koja je primala placebo, omjer hazarda = 0,70 (95% CI = 0,56-0,88, p = 0,002).
English: **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Croatian: ** Za sve stupnjeve toksičnosti vidjeti CTC NCI (v2.0; NCI 1998).
English: From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio = 0.78, 95% CI=0.64-0.96).
Croatian: Medijan OS od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78, 95% CI = 0,64-0,96).
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Pemetrexed Krka 500 mg prašak za koncentrat za otopinu za infuziju Bočice od 500 mg rekonstituirajte s 20 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Pemetrexed Krka 500 mg: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetrexed Krka 500 mg: Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Pemetrexed Krka 100 mg prašak za koncentrat za otopinu za infuziju Bočice od 100 mg rekonstituirajte s 4,2 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Pemetrexed (N=265)
Croatian: Pemetreksed (N=265)
English: Overall response rate** (95% CI)
Croatian: Log rank p-vrijednost* Stopa ukupnog odgovora ** (95% CI)
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetrexed Krka 500 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Krka 100 mg prašak za koncentrat za otopinu za infuziju Pemetrexed Krka 500 mg prašak za koncentrat za otopinu za infuziju
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetrexed Krka 100 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Pemetrexed/Cisplati n (N=839)
Croatian: Pemetreksed/Cisplatin (N=839)
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 100 mg rekonstituirajte s 4,2 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: A multi-centre, 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 [ITT] population N=283) and 7.9 months for patients treated with docetaxel (ITT N=288).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III pemetrekseda u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih pemetreksedom iznosio je 8,3 mjeseca (populacija svih uključenih bolesnika, engl.
English: Grade toxicity
Croatian: Toksičnos t stupnja
English: Table 1 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Haematologic toxicities
Croatian: Tablica 1 - Tablica za prilagodbu doze lijeka Pemetrexed Krka (u monoterapiji ili u kombinaciji) i cisplatina - hematološka toksičnost Najniži ABN < 500/mm
English: Side effects with Pemetrexed Krka may include:
Croatian: Moguće nuspojave lijeka Pemetrexed Krka su:
English: pemetrexed/ Cisplatin (N=168)
Croatian: Pemetreksed/ cisplatin (N=168)
English: 9 l/m2.
Croatian: Pemetreksed o, 0,7
English: Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 500 mg rekonstituirajte s 20 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: PFS Time (Months)
Croatian: Vrijenie PFS-a (mjeseci)
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Krka 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Grade 34 toxicity
Croatian: Toksičnost stupnja 3
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Krka 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Time to treatment failure (months) (95% CI)
Croatian: Medijan ukupnog preživljenja (mjeseci) (95% CI)
English: The median OS for the overall population (N=663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p=0.01192).
Croatian: Medijan ukupnog preživljenja za ukupnu populaciju (N = 663) iznosio je 13,4 mjeseci u skupini koja je primala pemetreksed i 10,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,79
English: Pemetrexed Krka 500 mg powder for concentrate pemetrexed
Croatian: Pemetrexed Krka 500 mg prašak za koncentrat pemetreksed i.v.
English: OS Time (Months)
Croatian: Vrijeme pre±ivljenja (mjeseci)
English: Pemetrexed Krka 100 mg powder for concentrate pemetrexed
Croatian: Pemetrexed Krka 100 mg prašak za koncentrat pemetreksed i.v.
English: Pemetrexed Krka as single agent
Croatian: Pemetrexed Krka u monoterapiji
English: Oesophagitis/radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed:
Croatian: Tijekom kliničkih ispitivanja pemetrekseda ezofagitis/radijacijski ezofagitis je prijavljen manje često.
English: CTC
Croatian: FARMACEUTSKI
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8
Croatian: U bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N=430, neovisno procijenjena populacija), medijan PFS-a bio je 4,4 mjeseci u skupini koja je primala pemetreksed te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,47 (95% CI = 0,37-0,60, p = 0,00001).
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single agent in 64 chemonaive patients with malignant pleural mesothelioma.
Croatian: U 64 bolesnika s malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju pemetreksed je ispitan u dozi od 500 mg/m2 u monoterapiji.
English: months for the placebo arm, hazard ratio = 0.47 (95% CI=0.37-0.60, p=0.00001).
Croatian: (95% CI = 0,65-0,95, p = 0,01192).
English: Hepatobiliary Common SGPT (ALT) elevation disorders
Croatian: Poremećaji jetre i žuči često povišene vrijednosti ALT-a (SGPT-a) povišene vrijednosti AST-a (SGOT-a)
English: This overview was last updated in November 2018.
Croatian: Pregled informacija posljednji je put ažuriran u 11. 2018.
English: Loxicom received a marketing authorisation valid throughout the EU on 10 February 2009.
Croatian: Loxicom je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 10. veljače 2009.
English: Loxicom (meloxicam)
Croatian: Loxicom (meloksikam)
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su VMP-a bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari i stoga se očekuje da imaju isti učinak.
English: For the 20 mg/ml solution for injection the meat withdrawal period is five days, and for the 50 mg/ml oral paste it is three days.
Croatian: Za 20 mg/ml otopinu za injekciju razdoblje karencije za meso iznosi pet dana, dok za 50 mg/ml oralne paste iznosi tri dana.
English: Loxicom is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Croatian: Loxicom je protuupalni lijek koji se primjenjuje u goveda, svinja, konja, pasa i mačaka.
English: Why is Loxicom authorised in the EU?
Croatian: Zašto je Loxicom odobren u EU-u?
English: This means that Loxicom contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Croatian: To znači da Loxicom sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni VMP” koji je već odobren u Europskoj uniji (EU) pod nazivom Metacam.
English: As for every medicine, the company provided studies on the quality of Loxicom.
Croatian: Kao i za svaki VMP, tvrtka je dostavila ispitivanja o kvaliteti VMP-a Loxicom.
English: What are the benefits and risks of Loxicom?
Croatian: Koje su koristi i rizici od VMP-a Loxicom?
English: Further information on Loxicom can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/loxicom.
Croatian: Više informacija o VMP-u Loxicom nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/loxicom Informacije o referentnom VMP-u također se nalaze na internetskim stranicama Agencije.
English: What is Loxicom and what is it used for?
Croatian: Što je Loxicom i za što se primjenjuje?
English: Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances (toxins).
Croatian: Septikemija i toksemija stanja su u kojima bakterija kruži u krvi i proizvodi štetne tvari (otrove).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Loxicom has been shown to have comparable quality and to be bioequivalent to Metacam.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da Loxicom posjeduje usporedivu kakvoću te da je bioekvivalentan VMP-u Metacam.
English: Other information about Loxicom
Croatian: Ostale informacije o VMP-u Loxicom
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje blokiranjem enzima ciklooksigenaze koji je uključen u proizvodnju prostaglandina.
English: An overview of Loxicom and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Loxicom i zašto je odobren u EU-u
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Loxicom.
Croatian: Ispitivanja omjera koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim VMP-om Metacam i stoga ih nije potrebno ponavljati za VMP Loxicom.
English: Loxicom contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Loxicom sadrži meloksikam, koji pripada skupini lijekova zvanih nesteroidni protuupalni lijekovi (NSAID).
English: It can be used with oral re-hydration therapy (fluids given by mouth to restore water levels in the body) to reduce diarrhoea in calves of over one week of age and young, non-lactating cattle.
Croatian: Može se primjenjivati u kombinaciji s oralnom rehidracijskom terapijom (tekućine koje se daju na usta kako bi se obnovila razina vode u organizmu) radi smanjenja proljeva u teladi starije od tjedan dana i mladih goveda koja nisu u laktaciji.
English: For meat the withdrawal period is five days.
Croatian: Razdoblje karencije za meso iznosi pet dana.
English: Loxicom is available as an oral (taken by mouth) suspension, oral paste, chewable tablets and a solution for injection.
Croatian: Loxicom je dostupan u obliku oralne suspenzije (koja se daje na usta), oralne paste, tableta za žvakanje i otopine za injekciju.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanja koja su pokazala da je VMP „bioekvivalentan” referentnom VMP-u.
English: As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Croatian: S obzirom na to da su prostaglandini tvari koje potiču upalu, bol, eksudaciju (tekućinu koja curi iz krvnih žila tijekom upale) i vrućicu, meloksikam smanjuje te znakove bolesti.
English: In cattle, Loxicom is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Croatian: U goveda se VMP Loxicom primjenjuje zajedno s odgovarajućom antibiotskom terapijom radi smanjenja znakova akutne respiratorne infekcije (infekcije pluća i dišnih putova).
English: In pigs, Loxicom is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move that are not caused by an infection) and to support together with appropriate antibiotic therapy the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Croatian: U svinja se VMP Loxicom primjenjuje u slučaju neinfektivnih poremećaja lokomotornog sustava (bolesti koje utječu na sposobnost kretanja, koje nisu uzrokovane infekcijom) radi smanjenja simptoma hromosti i upale, te kao potporna terapija uz prikladnu antibiotsku terapiju u liječenju bolesti koje se mogu javiti nakon prasenja (okota) poput puerperalne septikemije i toksemije (sindrom mastitismetritis-agalakcija).
English: Loxicom can only be obtained with a prescription.
Croatian: Loxicom se izdaje samo na veterinarski recept.
English: Therefore, the Agency's view was that, as for Metacam, the benefit of Loxicom outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je mišljenje Agencije da korist od VMP-a Loxicom, kao i od VMP-a Metacam, nadmašuje utvrđeni rizik te da može biti odobren za primjenu u Europskoj uniji.
English: Because Loxicom is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Loxicom generički VMP te je bioekvivalentan referentnom VMP-u, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: Loxicom contains the active substance meloxicam and is a ‘generic medicine'.
Croatian: Loxicom sadržava djelatnu tvar meloksikam te je „generički lijek”.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Loxicom, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava kao i u uputi o VMP-u Loxicom nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For further information about using Loxicom, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Dodatne informacije o primjeni VMP-a Loxicom pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: In horses, Loxicom is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Croatian: U konja se VMP Loxicom primjenjuje za ublažavanje bolova povezanih s kolikama (abdominalnom boli) te za ublažavanje upale i bolova u akutnih i kroničnih mišićno-koštanih poremećaja.
English: In dogs, Loxicom is used to reduce pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Croatian: U pasa se VMP Loxicom primjenjuje za ublažavanje boli i upale nakon ortopedskog zahvata (primjerice operacije nakon frakture) i kirurškog zahvata na mekanom tkivu.
English: In cats, Loxicom is used to reduce pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Croatian: U mačaka se VMP Loxicom primjenjuje za smanjenje postoperativne boli i upale nakon ovariohisterektomije (operacija sterilizacije), ortopedskih i manjih kirurških zahvata na mekanom tkivu.
English: How has Loxicom been studied?
Croatian: Kako je Loxicom ispitivan?
English: How does Loxicom work?
Croatian: Kako djeluje Loxicom?
English: Moreover, it is used to lessen inflammation and pain in musculoskeletal disorders.
Croatian: Nadalje, primjenjuje se za ublažavanje upale i bolova u akutnih i kroničnih mišićno-koštanih poremećaja.
English: It can be used to relieve pain following dehorning in calves and to support the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Croatian: Može se primjenjivati u kombinaciji s antibioticima za ublažavanje postoperativnih bolova nakon odrožnjavanja teladi i kao potporna terapija za liječenje akutnog mastitisa (upala vimena).
English: How is Loxicom used?
Croatian: Kako se Loxicom primjenjuje?
English: Moreover, it is used to lessen pain and inflammation in musculo-skeletal disorders.
Croatian: Nadalje, primjenjuje se za olakšavanje boli i upale u akutnih i kroničnih mišićno-koštanih poremećaja.
English: h-4197-AA-en
Croatian: h-4197-AA-hr
English: The average length of response was 8.3 months.
Croatian: Prosječna duljina odgovora iznosila je 8,3 mjeseca.
English: The recommended dose is 450 mg (3 capsules) once a day taken with food at the same time each day.
Croatian: Preporučena doza je 450 mg (3 kapsule) jednom dnevno uz hranu u isto vrijeme svakog dana.
English: Further information on Zykadia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Zykadia možete naći na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was switched to full marketing authorisation on 26 July 2017.
Croatian: To je odobrenje pretvoreno u potpuno odobrenje za stavljanje lijeka u promet 26. srpnja 2017.
English: The presence of genetic defects affecting ALK (‘ALK-positive' status) has to be confirmed in advance by appropriate methods.
Croatian: Prisutnost genetskog nedostatka koji utječe na ALK (status „pozitivan na ALK”) mora se unaprijed potvrditi odgovarajućim metodama.
English: In the second study, the overall response rate was 41% (57 of 140 patients) and the average length of response was 10.6 months.
Croatian: U drugom ispitivanju ukupna stopa odgovora iznosila je 41 % (57 od 140 bolesnika), a prosječno trajanje odgovora bilo je 10,6 mjeseci.
English: What is Zykadia and what is it used for?
Croatian: Što je Zykadia i za što se koristi?
English: In two of these studies, involving 303 patients, the medicine was not compared with any other treatment.
Croatian: U dvama od tih ispitivanja, u kojima je sudjelovalo 303 bolesnika, lijek nije uspoređen ni s jednom drugom terapijom.
English: The European Medicines Agency therefore decided that Zykadia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Zykadia nadmašuju s njim povezane rizike i preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: What measures are being taken to ensure the safe and effective use of Zykadia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zykadia?
English: Zykadia was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Croatian: Za lijek Zykadia prvotno je izdano „uvjetno odobrenje” jer su se očekivali dodatni podatci o lijeku.
English: Other information about Zykadia
Croatian: Ostale informacije o lijeku Zykadia
English: Response to treatment was assessed using body scans and standardised criteria used for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Croatian: Odgovor na terapiju ocijenjen je pomoću snimki tijela i standardiziranih kriterija koji se primjenjuju za solidne tumore, pri čemu se potpunim odgovorom smatra slučaj kada bolesnik nema preostalih znakova raka.
English: The most common side effects with Zykadia (which may affect 1 or more people in 10) are diarrhoea, nausea (feeling sick), vomiting, tiredness, abnormal liver tests, abdominal (belly) pain, decreased appetite, weight loss, constipation, rash, increases in the level of a waste product called creatinine in the blood (a possible sign of kidney problems), oesophageal disorder (problems affecting the food pipe) and anaemia (low levels of red blood cells).
Croatian: Najčešće nuspojave lijeka Zykadia (koje se mogu javiti u 1 ili više osoba na 10) jesu proljev, mučnina, povraćanje, umor, abnormalni jetreni testovi, abdominalna bol (bol u trbuhu), smanjeni apetit, gubitak težine, zatvor, osip, povišene razine otpadnog proizvoda naziva kreatinin u krvi (mogući znak problema s bubrezima), ezofagealni poremećaj (problemi koji zahvaćaju jednjak) i anemija (mali broj crvenih krvnih stanica).