FrancophonIA/ELRC3.0 huggingface dataset:
English: Use in women of childbearing potential/Contraception in males and females Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.4).
Croatian: Liječenje lijekom Opsumit smije se započeti u žena reproduktivne dobi samo kada je potvrđeno da nisu trudne, kada su primile odgovarajući savjet o kontracepciji te primjenjuju pouzdanu metodu kontracepcije (vidjeti dijelove 4.3 i 4.4).
English: Be sure to discuss any questions you may have with your doctor.
Croatian: Pobrinite se da od svog liječnika dobijete odgovor na sva pitanja.
English: 4.7 Effects on ability to drive and use machines Macitentan has minor influence on the ability to drive and use machines.
Croatian: Macitentan malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • yellowing of your skin or the whites of your eyes (jaundice)
Croatian: • žutilo kože i bjeloočnica (žuticu) • tamno obojanu mokraću
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/893/001
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean leucocyte count from baseline of 0.7 × 109/L versus no change in placebo-treated patients.
Croatian: U dvostruko slijepom ispitivanju u bolesnika s PAH-om, macitentan od 10 mg povezan je s padom prosječnog broja leukocita u odnosu na početne vrijednosti od 0,7 × 109/L naspram izostanka promjene u bolesnika liječenih placebom.
English: • Nasopharyngitis (inflammation of the throat and nasal passages)
Croatian: • nazofaringitis (upala grla i nosa)
English: The safety of macitentan has been evaluated in a long-term placebo-controlled trial of 742 patients with symptomatic PAH.
Croatian: Sigurnost macitentana procijenjena je u dugoročnom placebom kontroliranom ispitivanju sa
English: • If it is possible you could become pregnant, use a reliable form of birth control (contraception)
Croatian: • Ako postoji mogućnost da zatrudnite, koristite pouzdanu metodu kontracepcije dok uzimate lijek Opsumit.
English: You will need blood tests, as indicated by your doctor:
Croatian: Trebat ćete krvne pretrage, kako to navodi Vaš liječnik: Vaš liječnik će provesti krvne pretrage prije početka liječenja lijekom Opsumit i tijekom liječenja kako bi ispitao:
English: If you notice any of these signs, tell your doctor.
Croatian: • bljedilo kože Ako primijetite bilo koji od navedenih znakova, obavijestite svog liječnika.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg tablets macitentan
Croatian: NAZIV LIJEKA Opsumit 10 mg tablete macitentan
English: prostanoid initiation n (%)
Croatian: Početak liječenja i.v./s.c. prostanoidom n (%)
English: The number of deaths of all causes up to EOS on macitentan 10 mg was 35 versus 44 on placebo (HR 0.77; 97.5% CI: 0.46 to 1.28).
Croatian: naspram 44 u skupini koja je primala placebo (HR 0,77; 97,5% CI 0,46 do 1,28).
English: Anaemia, haemoglobin decrease5
Croatian: Vrlo često anemija, snižene vrijednosti hemoglobina5
English: • St. John's Wort (an herbal preparation used to treat depression),
Croatian: • gospina trava (biljni pripravak koji se koristi za liječenje depresije),
English: Due to the high degree of protein binding of macitentan, dialysis is unlikely to be effective.
Croatian: Nije vjerojatno da će dijaliza biti djelotvorna zbog visokog stupnja vezivanja macitentana.
English: • The Summary of Product Characteristics for Opsumit;
Croatian: • Sažetak opisa svojstava lijeka za Opsumit;
English: Opsumit contains lactose, lecithin from soya and sodium Opsumit contains a sugar called lactose.
Croatian: Opsumit sadrži šećer zvan laktoza.
English: Magnesium stearate (E572)
Croatian: natrijev škroboglikolat (vrsta A) povidon K-30 magnezijev stearat (E572) polisorbat 80 (E433)
English: The pharmacokinetics of macitentan and its active metabolite were not affected by warfarin.
Croatian: Varfarin nije utjecao na farmakokinetiku macitentana i njegovog aktivnog metabolita.
English: Influenza
Croatian: Često influenca
English: Logrank p-value
Croatian: Logrank pvrijednost
English: • Thrombocytopenia (decreased blood platelet counts)
Croatian: • trombocitopenija (snižene vrijednosti trombocita)
English: • pallor
Croatian: • mučninu
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets
Croatian: NAZIV LIJEKA Opsumit 10 mg filmom obložene tablete
English: Excipients
Croatian: Trombociti
English: Evaluation of 6MWD by functional class resulted in a placebo-corrected mean increase from baseline to Month 6 in FC III/IV patients of 37 meters (97.5% CI: 5 to 69) and in FC I/II of 12 meters (97.5% CI: −8 to 33).
Croatian: od 37 metara (97,5% CI 5 do 69) te u funkcionalnoj skupini I/II od 12 metara (97,5% CI -8 do 33).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg macitentan
Croatian: Jedna filmom obložena tableta sadrži 10 mg macitentana
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets macitentan
Croatian: NAZIV LIJEKA Opsumit 10 mg filmom obložene tablete macitentan
English: • phenytoin (a medicine used to treat seizures),
Croatian: • fenitoin (lijek za liječenje epileptičkih napadaja),
English: Opsumit contains soya bean lecithin.
Croatian: Opsumit sadrži laktozu, sojin lecitin i natrij
English: Thrombocytopenia7
Croatian: Ketokonazol:
English: 6 White blood cells
Croatian: 6 Leukociti
English: How to store Opsumit 6.
Croatian: Moguće nuspojave 5. Kako čuvati Opsumit
English: Treatment centre: ____________________________________ Name of prescribing doctor: ___________________________ Phone number of prescribing doctor: _____________________
Croatian: Telefonski broj liječnika propisivača:
English: You need to use a reliable form of birth control (contraception) while you are taking Opsumit.
Croatian: Za vrijeme liječenja lijekom Opsumit morate koristiti pouzdanu metodu kontracepcije.
English: OTHER
Croatian: Nakon
English: Hepatobiliary disorders
Croatian: Hemodinamske mjere ishoda
English: Nasopharyngitis
Croatian: SERAPHIN
English: Soya bean lecithin (E322)
Croatian: Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171) talk (E553b) sojin lecitin (E322) ksantan guma (E415)
English: This procedure usually takes 3-4 hours.
Croatian: Ovaj postupak obično traje 3-4 sata.
English: Some have resulted in hospitalization.
Croatian: Neke su rezultirale hospitalizacijom.
English: It is very important that you arrive on time for your appointments.
Croatian: Vrlo je važno da dođete točno na vrijeme na Vaš zakazani termin.
English: It should not be given to children or adolescents under the age of 18 years.
Croatian: Ne smije se davati djeci ili adolescentima mlađim od 18 godina.
English: This will allow quick identification of new safety information.
Croatian: To će omogućiti brzu identifikaciju novih podataka o sigurnosti.
English: In the insulated container 18 hours.
Croatian: U izoliranom spremniku 18 sati.
English: <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Croatian: <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: You will be monitored before and during the infusion.
Croatian: Biti ćete pod nadzorom prije i tijekom infuzije.
English: Abbreviations: CI = confidence interval.
Croatian: Kratice: CI = interval pouzdanosti.
English: Your doctor may decide that Provenge is not suitable for you due to one or more of these conditions.
Croatian: Vaš liječnik može odlučiti da Provenge nije prikladan za Vas zbog jednog ili više od ovih stanja.
English: Missed treatment
Croatian: Propušteni tretman
English: To provide data from the observational US-based registry (PROCEED, Study P10-3)
Croatian: Dostavljanje podataka iz opažajnog registra iz SAD-a (PROCEED, ispitivanje P10-3)
English: If this happens, do not drive or use any tools or machines until you feel better.
Croatian: U tom slučaju, nemojte voziti ili koristiti alate ili strojeve sve dok se ne budete osjećali bolje.
English: The clinical significance is uncertain.
Croatian: Kliničko značenje nije jasno.
English: What Provenge is and what it is used for
Croatian: Što je Provenge i za što se koristi
English: On the first day of the infusion, Provenge may cause infusion-related reactions such as:
Croatian: Na prvi dan infuzije, Provenge može uzrokovati infuzijski vezane reakcije, kao što su:
English: NL-6229 EV, Maastricht The Netherlands
Croatian: NL-6229 EV, Maastricht Nizozemska
English: Patients should be advised of this possibility prior to initiating treatment.
Croatian: Bolesnike je potrebno upozoriti na tu mogućnost prije početka liječenja.
English: Tell the doctor or nurse if you do not feel well during the infusion.
Croatian: Obavijestite liječnika ili medicinsku sestru ako se ne osjećate dobro tijekom infuzije.
English: Do not throw away any medicines via wastewater.
Croatian: Nemojte nikada nikakve lijekove bacati u otpadne vode.
English: Do not refrigerate or freeze the container.
Croatian: Nemojte odlagati u hladnjak niti zamrzavati spremnik.
English: Microbiological testing
Croatian: Mikrobiološka ispitivanja
English: Some patients developed infection, including sepsis.
Croatian: Neki su bolesnici razvili infekcije, uključujući i sepsu.
English: This includes any possible side effects not listed in this leaflet.
Croatian: To uključuje i sve moguće nuspojave koje nisu navedene u ovoj uputi.
English: You may also be given other medicines if needed.
Croatian: Također Vam prema potrebi mogu dati druge lijekove.
English: No data are available for these patients.
Croatian: Nema dostupnih podataka za takve bolesnike.
English: The educational material for healthcare professionals will include the following key elements:
Croatian: Edukacijski materijal za zdravstvene djelatnike mora sadržavati sljedeće ključne elemente:
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: To uključuje lijekove dobivene bez recepta i biljne lijekove.
English: The medicinal product should be used immediately.
Croatian: Lijek se mora primijeniti odmah.
English: Overall survival Median, months (95% CI) Hazard ratio (95% CI)
Croatian: Ukupno preživljenje Medijan, mjeseci (95% CI) Omjer rizika (95% CI)
English: The doses of paracetamol and antihistamine given should be in accordance with local practice.
Croatian: Doze paracetamola i antihistaminika trebaju biti u skladu s lokalnom praksom.
English: If you experience any of the following side effects several days after the infusion, contact a doctor immediately:
Croatian: Ako primijetite bilo koju od sljedećih nuspojava unutar nekoliko dana nakon infuzije, odmah se obratite liječniku:
English: The incidence of severe reactions was greater following the second infusion (2.1% vs. 0.8% following the first infusion), and decreased to 1.3% following the third infusion.
Croatian: Incidencija teških reakcija bila je veća nakon druge infuzije (2,1% u odnosu na 0,8% nakon prve infuzije), a smanjena na 1,3% nakon treće infuzije.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Croatian: Farmakoterapijska skupina: Imunostimulatori, drugi imunostimulatori, ATC kod: L03AX17.
English: Your doctor or nurse will confirm that your details (name and date of birth) correspond to the details provided with the Provenge container.
Croatian: Vaš liječnik ili medicinska sestra će potvrditi da Vaši podaci (ime, prezime i datum rođenja) odgovaraju podacima na spremniku lijeka Provenge.
English: This peripheral delivery system is commonly used in clinical practice for the transfusion of blood components.
Croatian: Ovaj periferni sustav obično se koristi u kliničkoj praksi za transfuziju krvnih pripravaka.
English: Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili ćete uzimati ikakve druge lijekove.
English: A cell filter should not be used.
Croatian: Stanični filter ne smije se koristiti.
English: This test will determine whether you have enough blood cells to allow the leukapheresis procedure to be safely carried out.
Croatian: Ovim će se testom odrediti imate li dovoljno krvnih stanica koje omogućuju sigurno provođenje postupka leukafereze.
English: This procedure will take 3 to 4 hours (see section “Steps before Provenge treatment” below).
Croatian: Ovaj postupak će potrajati 3 do 4 sata (vidjeti dio "Koraci prije primjene lijeka Provenge" u nastavku).
English: Your treatment will involve at least 6 visits to the cell collection site and/or clinic.
Croatian: Vaše liječenje će uključivati najmanje 6 dolazaka u ustanovu u kojoj će prikupljati stanice i/ili kliniku.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Croatian: Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na web stranici Europske agencije za lijekove.
English: Other medicines and Provenge
Croatian: Drugi lijekovi i Provenge
English: In case of using premedication, the status of the patient and possible contraindications/interactions should be taken into account.
Croatian: U slučaju primjene premedikacije, potrebno je uzeti u obzir opće stanje bolesnika i moguće kontraindikacije/interakcije.
English: In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate.
Croatian: U 95,1% bolesnika koji su prijavili akutne infuzijske reakcije, one su bile blage ili umjerene.
English: Do not remove the top insulated lid and do not open the insulated box until both of the following have occurred:
Croatian: Nemojte uklanjati gornji izolirani poklopac niti otvarati izoliranu kutiju sve dok oba uvjeta nisu zadovoljena:
English: Table 2 Summary of overall survival (all patients as randomized) IMPACT
Croatian: Tablica 2 Sažetak ukupnog preživljenja (svi randomizirani bolesnici) IMPACT
English: Patients should be advised not to drive or use machines if they experience these symptoms following their infusion.
Croatian: Bolesnike je potrebno savjetovati da ne voze ili upravljaju strojevima ukoliko primijete ove simptome nakon primljene infuzije.
English: In such cases, if your doctor decides that the course of treatment should be continued, he or she will arrange for another collection of your blood cells (leukapheresis) and the manufacturing process will be repeated (see information on leukapheresis in section 3).
Croatian: U takvim slučajevima, ako Vaš liječnik odluči da je liječenje potrebno nastaviti, on ili ona će organizirati novi postupak prikupljanja Vaših krvnih stanica (leukafereza) i postupak proizvodnje lijeka će se ponoviti (vidjeti informacije o leukaferezi u dijelu 3).
English: Provenge should be infused intravenously over a period of approximately 60 minutes.
Croatian: Provenge je potrebno primijenjivati intravenski tijekom otprilike 60 minuta.
English: This involves a procedure called leukapheresis, which consists of extracting white blood cells from your blood, usually from the veins in your arms.
Croatian: Ovo uključuje postupak koji se zove leukafereza koji se sastoji od izdvajanja bijelih krvnih stanica iz Vaše krvi, obično iz vena ruku.
English: The primary endpoint was overall survival.
Croatian: Primarni ishod bilo je ukupno preživljenje.
English: You will have to have this procedure on at least 3 occasions approximately 3 days before each of your 3 Provenge infusion treatments.
Croatian: Ovaj postupak ćete morati proći najmanje 3 puta otprilike 3 dana prije svake od Vaše 3 infuzije lijeka Provenge.
English: • A heart condition including blocked blood vessels which could lead to a heart attack
Croatian: • bolest srca uključujući začepljenje krvnih žila, koja bi mogla dovesti do srčanog udara
English: The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Croatian: Medijan dobi iznosio je 71 godinu, 90% bolesnika bili su bijelci, a u svih je očekivano trajanje života iznosilo najmanje 6 mjeseci.
English: Educational material for patients and/or carers to explain:
Croatian: U edukacijskom materijalu za bolesnike i/ili skrbnike mora se objasniti:
English: Practical information for medical or healthcare professionals on handling and administration of Provenge dispersion for infusion
Croatian: Praktične informacije za medicinske ili zdravstvene djelatnike za rukovanje i primjenu Provenge disperzije za infuziju
English: What Provenge contains
Croatian: Što Provenge sadrži
English: These patients should be closely monitored for signs and symptoms of infection.
Croatian: Takve bolesnike potrebno je pažljivo pratiti radi pojave znakova i simptoma infekcije.
English: Overall survival was not a study endpoint but a pre-specified analysis.
Croatian: Ukupno preživljenje nije bilo ishod ispitivanja, već je korišteno kao prethodna analiza.
English: This will be added to your Patient Alert Card that you should bring to each appointment.
Croatian: Ti će podaci biti dodani u Vašu karticu s upozorenjima za bolesnika koju trebate donijeti pri svakom dolasku.
English: What to check prior to infusion
Croatian: Što provjeriti prije primjene infuzije
English: Conventional reproductive and development toxicity studies are not considered relevant given the nature and the intended clinical use of this autologous cell therapy product.
Croatian: Uobičajena toksikološka ispitivanja reproduktivne i razvojne toksičnosti ne smatraju se relevantnima s obzirom na prirodu i primarnu kliničku namjenu ovog pripravka za autolognu primjenu.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja ta će izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: • not enough of the right type of cells to manufacture the medicine.
Croatian: • nedovoljan broj odgovarajućih stanica za proizvodnju lijeka.
English: It consists of immune cells (part of your body's natural defense system) taken from your own blood (also called autologous immune cells).
Croatian: Sastoji se od imunoloških stanica (dio Vašeg vlastitog obrambenog sustava) koje su dobivene iz Vaše krvi (zovu se i autologne stanice imunološkog sustava).
English: The final (7-day incubation) sterility test results will not be available at the time of infusion.
Croatian: Konačni (nakon 7 dana inkubacije) rezultati ispitivanja sterilnosti neće biti dostupni u vrijeme infuzije.
English: Citrate is generally the preferred anticoagulant used during leukapheresis and can result in hypocalcaemia.
Croatian: Citrat je uobičajeni antikoagulans koji se primjenjuje tijekom leukafereze i koji može dovesti do hipokalcemije.
English: • Only one of the 2 spike ports should be used and should not be opened prior to administration in order to avoid contamination.
Croatian: • Potrebno je koristiti samo jedan od 2 otvora za iglu na vrećici, koji se ne smije otvoriti prije primjene infuzije kako bi se izbjegla kontaminacija.
English: Provenge can only be administered by a doctor or nurse who has been trained in using this medicine.
Croatian: Provenge mogu primijenjivati samo liječnik ili medicinska sestra obučeni za uporabu ovog lijeka.
English: It is important that you read the entire content of this procedure prior to administering Provenge.
Croatian: Važno je pročitati cijeli sadržaj ovih uputa prije primjene lijeka Provenge.
English: As it has to be given to you shortly after it has been manufactured, the final sterility results may not always be available before you are given your infusion of Provenge.
Croatian: Budući da ga morate primiti ubrzo nakon što je proizveden, konačni rezultati ispitivanja sterilnosti neće uvijek biti dostupni prije nego što primite infuziju lijeka Provenge.
English: Do not use a cell filter for infusion.
Croatian: Nemojte koristiti stanični filter za infuziju.
English: Additionally, there is the small possibility/risk of transmitting infectious viruses to a patient if he is not the intended recipient of the product.
Croatian: Također postoji mala mogućnost/rizik od prenošenja zaraznih virusa na bolesnika kojem proizvod prvotno nije bio namijenjen.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu putem nacionalnog sustava za prijavu navedenog u Dodatku V.
English: After removal from the insulated container
Croatian: Nakon vađenja iz izoliranog spremnika
English: A total of 512 patients were randomised in a 2:1 ratio to receive Provenge (n=341) or control (n=171).
Croatian: Ukupno je 512 bolesnika randomizirano u omjeru 2:1 za primanje lijeka Provenge (n = 341) ili kontrolnu skupinu (n = 171).
English: For patients with cardiovascular disease or those at risk for cardiac ischaemia, physicians should consider observing patients for at least 60 minutes following each infusion with vital signs taken at 30 minutes and 60 minutes following the infusion.
Croatian: Bolesnike s kardiovaskularnim bolestima ili one s rizikom od srčane ishemije, liječnici bi trebali promatrati najmanje 60 minuta nakon svake infuzije te mjeriti vitalne znakove 30 minuta i 60 minuta nakon infuzije.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na aktivne tvari ili na bilo koju od pomoćnih tvari navedenih u dijelu 6.1.
English: Following randomization, patients from both treatment groups underwent a series of 3 leukapheresis procedures (at approximately 2 week intervals, range 1 to 15 weeks).
Croatian: Nakon randomizacije, bolesnici iz obje skupine ispitanika podvrgnuti su nizu od 3 leukafereze (u intervalima od otprilike 2 tjedna, raspon od 1 do 15 tjedana).
English: It is recommended that the minimum interval between leukapheresis procedures should not be less than 2 weeks.
Croatian: Preporuča se minimalni interval između dva postupka leukafereze od najmanje 2 tjedna.
English: Provenge is manufactured specifically for you using your own blood and must not be used in anyone else.
Croatian: Provenge je proizveden isključivo za Vas, koristeći Vašu krv i ne smije se primijeniti nekom drugom.
English: The efficacy and safety of Provenge in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were studied in three similar Phase III, randomised, double-blind, controlled, multicentre trials: D9902B (IMPACT), D9901, and D9902A.
Croatian: Djelotvornost i sigurnost lijeka Provenge u bolesnika s asimptomatskim ili minimalno simptomatskim metastatskim rakom prostate rezistentnim na kastraciju ispitivana je u tri slična, randomizirana, dvostruko slijepa, kontrolirana, multicentrična ispitivanja faze III: D9902B (IMPACT), D9901 i D9902A.
English: Provenge is designed to stimulate the immune system.
Croatian: Provenge je napravljen kako bi stimulirao imunološki sustav.
English: After removal from the insulated container, Provenge should be used immediately.
Croatian: Nakon vađenja iz izoliranog spremnika, Provenge je potrebno primijeniti odmah.
English: Thirty-five percent of patients had undergone radical prostatectomy, 54% had received local radiotherapy, and 82% had received combined androgen blockade.
Croatian: U 35% bolesnika učinjena je radikalna prostatektomija, 54% je primilo lokalnu radioterapiju, a 82% totalnu androgenu blokadu.
English: Patients did not require opioid analgesics for pain management and the majority had not received prior chemotherapy.
Croatian: U bolesnika nije bila potrebna primjena opioidnih analgetika za liječenje boli, a većina njih prethodno nije primala kemoterapiju.