FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on other ingredients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti od 40 mg ili 80 mg, tj. zanemarive količine natrija.
English: Very common (49%) 1.2%
Croatian: Vrlo često (49%)
English: Very common (17%) 0.1%
Croatian: Vrlo često (17%)
English: Very common (20%) 0.2%
Croatian: Vrlo često (20%)
English: Median, Months (95% CI)
Croatian: Medijan, mjeseci (95% CI)
English: NC
Croatian: C.
English: Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease ≥ 6 weeks CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
Croatian: Stopa objektivnog odgovora i trajanje odgovora u SŽS-u prema BICR-u za SŽS na temelju verzije 1.1 RECIST kriterija u populaciji u kojoj se mogao ocijeniti odgovor (mjerljive lezije u SŽS-u na početku ispitivanja prema BICR-u) n=30 za TAGRISSO i n=16 za kemoterapiju Temeljeno samo na bolesnicima s odgovorom; trajanje odgovora definiralo se kao vrijeme od datuma prvog dokumentiranog odgovora (potpun ili djelomičan odgovor) do događaja progresije ili smrti; stopa kontrole bolesti definirala se kao udio bolesnika s odgovorom (potpunim ili djelomičnim) ili stabilnom bolešću tijekom ≥ 6 tjedana.
English: Each tablet contains 40 mg osimertinib (as mesylate).
Croatian: Svaka tableta sadrži 40 mg osimertiniba (u obliku osimertinibmesilata).
English: Each tablet contains 80 mg osimertinib (as mesylate).
Croatian: Svaka tableta sadrži 80 mg osimertiniba (u obliku osimertinibmesilata).
English: Very common (33%) 0.1%
Croatian: Vrlo često (33%)
English: Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Croatian: Okrugle, bikonveksne, bež tablete promjera 9 mm, s utisnutom oznakom “AZ” i “40” na jednoj strani i bez oznake na drugoj strani.
English: Patients with a medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies.
Croatian: U klinička ispitivanja nisu bili uključeni bolesnici koji su u anamnezi imali IBP, IBP izazvan liječenjem, pneumonitis uzrokovan zračenjem koji je zahtijevao liječenje steroidima ili bilo kakav dokaz klinički aktivnog IBP-a.
English: Very common (31%) 0.3%
Croatian: Vrlo često (31%)
English: Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies.
Croatian: U ta ispitivanja nisu bili uključeni ni bolesnici s klinički važnim abnormalnostima srčanog ritma i provodljivosti, koji su se mjerili elektrokardiogramom (EKG) u mirovanju (npr. QTc interval dulji od 470 msek).
English: Active substances whose plasma concentrations may be altered by TAGRISSO Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters.
Croatian: Temeljeno na in vitro ispitivanjima, osimertinib je kompetitivni inhibitor BCRP transportera.
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
Croatian: TAGRISSO 40 mg filmom obložene tablete TAGRISSO 80 mg filmom obložene tablete
English: Uncommon (0.9%)
Croatian: Manje često (0,9%)
English: Up to month 9, there were no clinically meaningful differences between the TAGRISSO and EGFR TKI comparator groups in functioning or HRQL.
Croatian: Do 9. mjeseca nisu opažene klinički značajne razlike između skupine koja je primala TAGRISSO i one liječene usporednim inhibitorom tirozin kinaze EGFR-a s obzirom na tjelesnu funkciju ili kvalitetu života vezanu uz zdravlje.
English: What TAGRISSO looks like and contents of the pack TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
Croatian: TAGRISSO 40 mg su okrugle, bikonveksne, bež filmom obložene tablete s oznakom “AZ” i “40” na jednoj strani i bez oznake na drugoj strani.
English: TAGRISSO 40 mg tablets osimertinib
Croatian: TAGRISSO 40 mg tablete osimertinib
English: TAGRISSO 80 mg tablets osimertinib
Croatian: TAGRISSO 80 mg tablete osimertinib
English: Adverse reactions are listed according to system organ class (SOC) in MedDRA.
Croatian: Nuspojave su navedene prema MedDRA-inoj klasifikaciji organskih sustava.
English: Baseline characteristics of the overall study population (AURAex and AURA2) were as follows: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%).
Croatian: Početne karakteristike sveukupne ispitivane populacije (ispitivanja AURAex i AURA2) bile su sljedeće: medijan dobi 63 godine, 13% bolesnika bilo je u dobi
English: Uncommon (0.7%)
Croatian: Manje često (0,7%)
English: A HR<1 favours TAGRISSO
Croatian: HR < 1 i omjer izgleda > 1 govore u prilog lijeku TAGRISSO
English: Very common (35%) 4.1%
Croatian: Vrlo često (35%)
English: HR=Hazard Ratio; CI=confidence interval; NC=non-calculable All efficacy results based on RECIST investigator assessment
Croatian: HR = omjer hazarda; CI = interval pouzdanosti; NI = ne može se izračunati
English: CNS Objective Response Rate and Duration of Response determined by RECIST v1.1 by CNS BICR in the evaluable for response population (CNS measurable lesions at baseline by BICR) n=30 for TAGRISSO and n=16 for Chemotherapy
Croatian: Preživljenje bez progresije bolesti u SŽS-u prema BICR-u za SŽS na temelju verzije 1.1 RECIST kriterija u populaciji svih randomiziranih bolesnika (mjerljive i nemjerljive lezije u SŽS-u na početku ispitivanja prema BICR-u) n=75 za TAGRISSO i n=41 za kemoterapiju HR < 1 ide u korist lijeka TAGRISSO
English: Very common (47%) 0.9%
Croatian: Vrlo često (47%)
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
Croatian: TAGRISSO 40 mg filmom obložene tablete TAGRISSO 80 mg filmom obložene tablete osimertinib
English: Safety findings in the single-arm Phase 2 AURAex and AURA2 studies were generally consistent with those observed in the AURA3 TAGRISSO arm. No additional or unexpected toxicity has been observed and adverse events have been aligned in type, severity and frequency.
Croatian: Sigurnosni nalazi iz ispitivanja faze 2 AURAex i AURA2 s jednom skupinom u načelu su bili u skladu s onima opaženima u skupini liječenoj lijekom TAGRISSO u ispitivanju AURA3.
English: HR (95% CI); P-value
Croatian: HR (95%CI); p-vrijednost
English: Active substances that may decrease osimertinib plasma concentrations In a clinical pharmacokinetic study in patients, the steady-state AUC of osimertinib was reduced by 78% when co-administered with rifampicin (600 mg daily for 21 days).
Croatian: U kliničkom farmakokinetičkom ispitivanju u bolesnika, istodobna primjena rifampicina (600 mg dnevno tijekom 21 dan) smanjila je vrijednost AUC osimertiniba u stanju dinamičke ravnoteže za 78%.
English: NC (16.5, NC)
Croatian: NI (16,5; NI)
English: At the time of the interim analysis of overall survival (25% maturity), a HR of 0.63 favoured TAGRISSO (95% CI:
Croatian: U trenutku provođenja interim analize ukupnog preživljenja (zrelost podataka 25%), omjer hazarda (engl. hazard ratio, HR) od 0,63 išao je u prilog lijeku TAGRISSO (95% CI: 0,45; 0,88; P = 0,0068), koji nije postigao formalnu statističku značajnost.
English: Your doctor may wish to stop TAGRISSO if you get this side effect.
Croatian: Ako dobijete ovu nuspojavu, Vaš liječnik će možda htjeti prekinuti liječenje lijekom TAGRISSO.
English: CNS Progression-free survival
Croatian: Preživljenje bez progresije bolesti u SŽS-u
English: NC (23.7, NC)
Croatian: NI (23,7; NI)
English: A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO Based on an interim analysis with 25% maturity a P-value < 0.0015 was required to achieve statistical significance ORR results by Blinded Independent Central Review (BICR) were consistent with those reported via investigator assessment; ORR by BICR assessment was 78% (95% CI:73, 83) on TAGRISSO and 70% (95% CI:65, 76) on EGFR TKI
Croatian: Blinded Independent Central Review, BICR) bili su u skladu s onima utemeljenima na ocjeni ispitivača; ORR prema BICR-u iznosio je 78% (95% CI: 73; 83) uz TAGRISSO i 70% (95% CI :65; 76) uz usporedni inhibitor tirozin kinaze EGFR-a.
English: Microcrystalline cellulose Low-substituted hydroxypropyl cellulose Sodium stearyl fumarate
Croatian: Nisko supstituirana hidroksipropilceluloza
English: Odds ratio (95% CI); P-value
Croatian: Omjer izgleda (95% CI); p-vrijednost
English: TAGRISSO 40 mg film-coated tablets osimertinib
Croatian: TAGRISSO 40 mg filmom obložene tablete osimertinib
English: TAGRISSO 80 mg film-coated tablets osimertinib
Croatian: TAGRISSO 80 mg filmom obložene tablete osimertinib
English: Duration of Response (DoR)
Croatian: Trajanje odgovora
English: NC (20.5, NC)
Croatian: NI (20,5; NI)
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in FLAURA
Croatian: Tablica 4. Djelotvornost u SŽS-u prema BICR-u u bolesnika iz ispitivanja FLAURA u kojih su oslikavanjem mozga na početku ispitivanja otkrivene metastaze u SŽS-u
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in AURA3
Croatian: Tablica 6. Djelotvornost u SŽS-u prema BICR-u u bolesnika iz ispitivanja AURA3 u kojih su oslikavanjem mozga na početku ispitivanja otkrivene metastaze u SŽS-u
English: HRQL and physical functioning improvement analysis Patients on TAGRISSO had significantly greater chances of achieving a clinically meaningful improvement of greater than or equal to 10 points on the global health status and physical functioning of the EORTC-C30 questionnaire compared with chemotherapy during the study period Odds Ratio (OR) global health status: 2.11, (95% CI 1.24, 3.67, p=0.007); OR physical functioning 2.79 (95% CI 1.50, 5.46, p=0.002).
Croatian: Omjer izgleda (engl. odds ratio, OR) za opće zdravstveno stanje: 2,11 (95% CI: 1,24; 3,67, p=0,007); OR za tjelesnu funkciju: 2,79 (95% CI: 1,50; 5,46, p=0,002).
English: QTc interval prolongation occurs in patients treated with TAGRISSO.
Croatian: U bolesnika liječenih lijekom TAGRISSO dolazi od produljenja QTc intervala.
English: Severe, life-threatening or fatal Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies.
Croatian: U kliničkim ispitivanjima, u bolesnika liječenih lijekom TAGRISSO, zamijećeni su slučajevi teške, po život opasne ili fatalne intersticijske bolesti pluća (IBP) ili nuspojava nalik IBP-u (npr. pneumonitis).
English: How TAGRISSOworks
Croatian: Kako TAGRISSO djeluje
English: Discontinue TAGRISSO (see Section 4.4)
Croatian: Prekinite primjenu lijeka TAGRISSO (vidjeti dio
English: Reporting of side effects
Croatian: Informacije o drugim sastojcima lijeka
English: Diarrhoea
Croatian: TABLETA
English: Median TSST, months (95% CI)
Croatian: Medijan OS-a, mjeseci (95% CI)
English: Lymphocytes decreased
Croatian: Sniženi limfociti
English: The full EPAR for Lusduna can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Lusduna nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lusduna is used once a day at the same time each day.
Croatian: Lijek Lusduna primjenjuje se jedanput na dan, svakog dana u isto vrijeme.
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Croatian: Daje se injekcijom pod kožu u trbuh, bedro ili nadlakticu.
English: This means that Lusduna is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, lijek Lusduna sličan je biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: What is Lusduna and what is it used for?
Croatian: Što je Lusduna i za što se koristi?
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Croatian: Šećerna bolest jest bolest pri kojoj bolesnik ima visoku razinu šećera u krvi zbog toga što tijelo ne može proizvoditi inzulin (šećerna bolest tipa 1) ili zbog toga što tijelo ne proizvodi dovoljno inzulina ili ga ne može djelotvorno koristiti (šećerna bolest tipa 2).
English: Lusduna is a ‘biosimilar medicine'.
Croatian: Lusduna je „biosličan lijek”.
English: The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Croatian: Najčešća nuspojava lijeka Lusduna (koja se može javiti u više od 1 na 10 osoba) jest hipoglikemija (niska razina glukoze u krvi).
English: What measures are being taken to ensure the safe and effective use of Lusduna?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lusduna?
English: This is a summary of the European public assessment report (EPAR) for Lusduna.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Lusduna.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Croatian: Kontrolom razine glukoze u krvi simptomi šećerne bolesti smanjuju se te se tako izbjegavaju komplikacije.
English: Lusduna is a medicine used in patients aged at least 2 years for the treatment of diabetes.
Croatian: Lusduna je lijek koji se primjenjuje u bolesnika u dobi od najmanje dvije godine za liječenje šećerne bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna has been shown to have a comparable quality, safety and effectiveness to Lantus.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Lusduna dokazao usporedivu kakvoću, sigurnosti i učinkovitost kao i lijek Lantus.
English: Because Lusduna is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Croatian: Budući da je lijek Lusduna biosličan lijek, ispitivanja djelotvornosti i sigurnosti nisu bila potrebna jer su djelotvornost i sigurnost već jasno dokazani za inzulin glargin.
English: What are the risks associated with Lusduna?
Croatian: Koji su rizici povezani s lijekom Lusduna?
English: The reference medicine for Lusduna is Lantus.
Croatian: Referentni lijek za lijek Lusduna jest Lantus.
English: In the second study, involving 531 patients with type 2 diabetes, the average reduction in HbA1c was from 8.3 to 7.2% with Lusduna and from 8.4 to 7.2% with Lantus.
Croatian: U drugom ispitivanju koje je uključivalo 531 bolesnika sa šećernom bolesti tipa 2 razina tvari HbA1c u prosjeku je smanjena s 8,3 na 7,2% pri primijeni lijeka Lusduna i s 8,4 na 7,2% pri primjeni lijeka Lantus.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lusduna 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 Lusduna nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Insulin glargine, the active substance in Lusduna, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Croatian: Inzulin glargin, djelatna tvar u lijeku Lusduna, ulazi u krvotok sporije od ljudskog inzulina nakon injektiranja i stoga dulje djeluje.
English: Other information about Lusduna
Croatian: Ostale informacije o lijeku Lusduna
English: It is not intended to provide practical advice on how to use Lusduna.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lusduna.
English: The Committee recommended that Lusduna be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Lusduna.
English: It contains the active substance insulin glargine.
Croatian: Sadržava djelatnu tvar inzulin glargin.
English: In both studies, the main measure of effectiveness was the change after 24 weeks of treatment in the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled.
Croatian: Glavno mjerilo djelotvornosti u oba ispitivanja bila je promjena u razini glikiranog hemoglobina (HbA1c) u krvi, tvari koja upućuje na to koliko je glukoza u krvi kontrolirana, nakon 24 tjedna liječenja.
English: Why is Lusduna approved?
Croatian: Zašto je lijek Lusduna odobren?
English: Extensive laboratory studies comparing Lusduna with Lantus have shown that insulin glargine in Lusduna is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Croatian: Opsežna laboratorijska ispitivanja u kojima je lijek Lusduna uspoređen s lijekom Lantus pokazala su da je inzulin glargin u lijeku Lusduna vrlo sličan onome u lijeku Lantus u pogledu strukture, čistoće i biološke aktivnosti.
English: In the first supportive study, involving 506 patients with type 1 diabetes, the average HbA1c score was reduced from 8.0 to 7.4% with both Lusduna and Lantus.
Croatian: U prvom popratnom ispitivanju koje je uključivalo 506 bolesnika sa šećernom bolesti tipa 1 razina tvari HbA1c u prosjeku je smanjena s 8,0 na 7,4 % pri primijeni lijeka Lusduna i lijeka Lantus.
English: For more information about treatment with Lusduna, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Lusduna pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Lusduna can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.
Croatian: Lijek Lusduna može se također primjenjivati s lijekovima za šećernu bolest koji se uzimaju kroz usta u bolesnika sa šećernom bolesti tipa 2.
English: Lusduna is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Croatian: Lijek Lusduna zamjenski je inzulin koji djeluje na isti način kao inzulin samog tijela i pomaže u tome da glukoza ulazi u stanice iz krvi.
English: What benefits of Lusduna have been shown in studies?
Croatian: Koje su koristi lijeka Lusduna dokazane u ispitivanjima?
English: The dose of Lusduna is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Croatian: Doza lijeka Lusduna prilagođava se pojedinom bolesniku i ovisi o razini glukoze (šećera) u krvi bolesnika i drugim lijekovima koji sadržavaju inzulin koje bolesnik prima.
English: For practical information about using Lusduna, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Lusduna bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Two additional studies showed that Lusduna is absorbed into the body and works on blood glucose in the same way as the reference medicine, Lantus.
Croatian: Dva dodatna ispitivanja pokazala su da se lijek Lusduna apsorbira u tijelo i djeluje na razinu glukoze u krvi na isti način kao referentni lijek Lantus.
English: Lusduna is available in pre-filled disposable pens and can only be obtained with a prescription.
Croatian: Lijek Lusduna dostupan je u napunjenim brizgalicama za jednokratnu uporabu i izdaje se samo na recept.
English: Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Lantus.
English: Lusduna insulin glargine
Croatian: Lusduna inzulin glargin
English: Two supportive studies found that the effectiveness of once-daily Lusduna was comparable to Lantus.
Croatian: Dva popratna ispitivanja pokazala su da je djelotvornost lijeka Lusduna koji se uzima jedanput na dan usporediva s djelotvornošću lijeka Lantus.
English: For the full list of all side effects and restrictions with Lusduna, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Lusduna potražite u uputi o lijeku.
English: How does Lusduna work?
Croatian: Kako djeluje lijek Lusduna?
English: How is Lusduna used?
Croatian: Kako se lijek Lusduna koristi?
English: Further information on Talzenna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/talzenna
Croatian: Više informacija o lijeku Talzenna dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/talzenna
English: What is Talzenna and what is it used for?
Croatian: Što je Talzenna i za što se koristi?
English: Talzenna is available as capsules (1 mg and 0.25 mg) and the recommended dose is 1 mg once a day.
Croatian: Lijek Talzenna dostupan je u obliku kapsula (1 mg i 0,25 mg), a preporučena doza iznosi 1 mg jedanput dnevno.
English: Women must not breastfeed during treatment with Talzenna and for a month after stopping treatment.
Croatian: Žene ne smiju dojiti tijekom liječenja lijekom Talzenna i mjesec dana nakon prestanka liječenja.
English: What measures are being taken to ensure the safe and effective use of Talzenna?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Talzenna?
English: The European Medicines Agency therefore decided that Talzenna'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 Talzenna nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Other information about Talzenna
Croatian: Ostale informacije o lijeku Talzenna
English: Treatment should continue for as long as the patient continues to benefit from it and side effects are tolerable.
Croatian: Liječenje treba trajati sve dok bolesnica ima koristi od liječenja i dok su nuspojave podnošljive.
English: Talzenna contains the active substance talazoparib.
Croatian: Talzenna sadrži djelatnu tvar talazoparib.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talzenna 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 Talzenna nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Side effects reported with Talzenna are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Talzenna pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Talzenna?
Croatian: Koji su rizici povezani s lijekom Talzenna?
English: Patients treated with Talzenna lived on average for 8.6 months without their disease getting worse compared with 5.6 months for patients treated with the doctor's choice of another cancer medicine.
Croatian: Bolesnice liječene lijekom Talzenna u prosjeku su živjele 8,6 mjeseci bez pogoršanja bolesti, u usporedbi s 5,6 mjeseci u bolesnica koje su primale drugi lijek za liječenje raka po izboru liječnika.