FrancophonIA/ELRC3.0 huggingface dataset:
English: The new evidence provided by marketing authorisation holders including evidence from new casecontrol studies and retrospective studies add to the evidence of an increased risk with diclofenac
Croatian: Novi dokazi koje su ustupili nositelji odobrenja za stavljanje lijeka u promet, uključujući i dokaze iz novih kontroliranih istraživanja i retrospektivnih ispitivanja, nadopunjuju dokaz povećanog rizika povezanog s diklofenakom u usporedbi s ostalim NSAR lijekovima, te da je rizik povezan s diklofenakom sličan riziku povezanom s koksibima.
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Croatian: • PRAC je zaključio da lijekovi koji sadrže diklofenak moraju biti kontraindicirani za uporabu u bolesnika s utvrđenom zastojnom srčanom insufijencijom (NYHA II-IV), ishemijskom srčanom bolešću, perifernom arterijskom bolešću i/ili cerebrovaskularnom bolešću kako bi zadržali povoljnu ravnotežu koristi i rizika s obzirom na trenutno dostupne sigurnosne podatke.
English: This is very rare.
Croatian: To je vrlo rijetko.
English: The case resolved within three days.
Croatian: Slučaj se povukao unutar tri dana.
English: These infections are usually easily treated.
Croatian: Te se infekcije obično jednostavno liječe.
English: Children and adolescents This medicine should not be given to children and adolescents less than 18 years of age.
Croatian: Lijek se ne smije davati djeci i adolescentima mlađima od 18 godina.
English: The condition gets better on its own or with treatment of the infection.
Croatian: Stanje se poboljša samo od sebe ili uz liječenje infekcije.
English: If your partner becomes pregnant within three months of your treatment, you must immediately tell your doctor.
Croatian: Ako vaša partnerica zatrudni unutar tri mjeseca od Vašeg liječenja, morate odmah javiti svome liječniku.
English: The following terms represent a group of related events that describes a medical condition rather than a single event.
Croatian: Pojmovi u nastavku predstavljaju skupinu povezanih događaja koji više opisuju medicinsko stanje nego zasebni događaj.
English: The injection lasts 10 minutes.
Croatian: Injiciranje traje 10 minuta.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koji se dobivaju bez recepta.
English: None of these patients required an operation for incontinence.
Croatian: Nijednom bolesniku nije bila potrebna operacija zbog inkontinencije.
English: The following types of medicines may be ones that your doctor will advise you to stop temporarily:
Croatian: Za sljedeće vrste lijekova liječnik će Vam možda savjetovati da ih privremeno prekinete uzimati:
English: This should be taken into consideration (see section 4.4).
Croatian: To treba uzeti u obzir (vidjeti dio 4.4).
English: Your medical team will decide if you can leave hospital on the evening of your treatment.
Croatian: Vaš liječnički tim odlučuje o tome hoćete li napustiti bolnicu uvečer nakon tretmana.
English: Phase III Study (PCM301)
Croatian: Ispitivanje faze III (PCM301)
English: Some cases of hepatotoxicity (1.5 %), such as elevation of transaminases, were also reported.
Croatian: Prijavljeni su i neki slučajevi hepatotoksičnosti (1,5 %) poput povećanja transaminaza.
English: You may need to stay overnight if you have not fully recovered from the general anaesthetic and depending on your condition.
Croatian: Možda ćete morati ostati u bolnici preko noći ako se niste u potpunosti oporavili od opće anestezije i ako to Vaše stanje zahtijeva.
English: However, this will be exceeded in patients heavier than 115 kg.
Croatian: Međutim, to će biti prekoračeno u bolesnika težine veće od 115 kg.
English: The activated medicine then causes the death of the cancer cells.
Croatian: Aktivirani lijek zatim uzrokuje smrt stanica raka.
English: In 5 (2.5 %) patients, the infection was considered serious.
Croatian: U 5 (2,5 %) bolesnika infekcija se smatrala ozbiljnom.
English: Erectile dysfunction may occur even if radical prostatectomy is avoided.
Croatian: Do erektilne disfunkcije može doći čak i ako se izbjegne radikalna prostatektomija.
English: No specific dosage recommendation can be given.
Croatian: Ne može se dati posebna preporuka o doziranju.
English: However, all stages of spermatogenesis have been observed in animal.
Croatian: Ipak, sve faze spermatogeneze ispitane su na životinjama.
English: In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
Croatian: U malim kirurškim nizovima postoje izvješća o tumorima T3, pozitivnim marginama i impotenciji.
English: You may also be required to not take certain medicines for several days after the VTP procedure.
Croatian: Od Vas se može tražiti da ne uzimate određene lijekove nekoliko dana nakon VTP terapije.
English: Other medicines and TOOKAD
Croatian: Drugi lijekovi i TOOKAD
English: All of them were mild in intensity.
Croatian: Sve su nuspojave bile blagog intenziteta.
English: Steba Biotech S.A. 7 Place du Théâtre L-2613 Luxembourg Luxembourg
Croatian: Steba Biotech S.A. 7 Place du Théâtre L-2613 Luxembourg Luksemburg
English: Urinary excretion of padeliporfin in healthy human subjects was very low (< 0.2 % of the dose).
Croatian: Izlučivanje padeliporfina putem urina u zdravih ispitanika bilo je veoma nisko (< 0,2 % doze).
English: All these changes were considered to be incidental and probably related to the intravenous administration procedure.
Croatian: Sve te promjene smatraju se sporadičnima i vjerojatno vezanima uz postupak intravenske primjene.
English: See section 4.5 for interactions with photosensitizing medicinal products.
Croatian: Vidjeti dio 4.5 za interakcije s fotosenzibilizirajućim lijekovima.
English: At present TOOKAD-VTP has been shown to defer the need for radical therapy and its associated toxicity.
Croatian: Trenutačno je TOOKAD-VTP pokazao da odgađa potrebu za radikalnom terapijom i s njom povezanom toksičnosti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije ili toksičnosti ponovljenih doza.
English: This resolved with a small defect in the visual field.
Croatian: To se povuklo s malim oštećenjem u vidnom polju.
English: Those results were improved at Month 3 and back to baseline values at Month 6, with further improvement until Month 24.
Croatian: Ti su se rezultati poboljšali u 3. mjesecu i vratili se na početne vrijednosti u.6. mjesecu, s daljnjim poboljšanjem do 24. mjeseca.
English: In case of bilateral disease (discovered at entry or during follow-up), bilateral treatment was to be applied, either simultaneously or consecutively.
Croatian: (otkrivene po ulasku u ispitivanje ili tijekom praćenja) bila je primijenjena bilateralna terapija, ili istodobno ili uzastopno.
English: Some difficulties in getting or maintaining an erection is possible soon after the procedure and may last for more than 6 months.
Croatian: Određene poteškoće u postizanju ili održavanju erekcije moguće su ubrzo nakon postupka i mogu trajati više od 6 mjeseci.
English: - The other ingredient is mannitol.
Croatian: - Drugi sastojak je manitol.
English: The pharmacokinetic properties of TOOKAD were studied in 42 healthy human male subjects (without photoactivation) and in 70 patients with localised prostate cancer (after photoactivation).
Croatian: Farmakokinetička svojstva lijeka TOOKAD ispitivala su se u 42 zdrava muška ispitanika (bez fotoaktivacije) i u 70 bolesnika s lokaliziranim rakom prostate (nakon fotoaktivacije).
English: The following information is intended for the specialist only.
Croatian: Informacija u nastavku namijenjena je samo specijalistu.
English: In case of unilateral disease, focal treatment of one lobe was to be applied.
Croatian: U slučaju unilateralne bolesti treba primijeniti fokalnu terapiju jednog režnja.
English: Difficulties in getting or maintaining an erection
Croatian: Poteškoće u postizanju ili održavanju erekcije
English: The powder is a dark lyophilisate.
Croatian: Prašak je tamni liofilizat.
English: Marketing Authorisation Holder Steba Biotech S.A.
Croatian: Nositelj odobrenja za stavljanje u promet Steba Biotech S.A.
English: The day before and at the beginning of the VTP procedure, a rectal preparation is performed in order to clean the rectum.
Croatian: Dan prije i na početku VTP terapije obavlja se rektalna priprema kako bi se rektum očistio.
English: The targeted zone corresponds to the lobe containing the positive biopsies.
Croatian: Ciljana zona odgovara režnju s pozitivnim biopsijama.
English: Taking into account its molecular mass and the very low urinary excretion of the molecule, faecal elimination is the most probable route of elimination in human.
Croatian: Uzimajući u obzir molekularnu masu i veoma ograničeno urinarno izlučivanje molekule, eliminacija putem fecesa najvjerojatniji je put eliminacije u ljudi.
English: When 48 hours have passed after the procedure, you can resume your normal activities and you can be exposed to direct sunlight.
Croatian: Nakon 48 sati od postupka možete se vratiti uobičajenim aktivnostima i izložiti izravnoj sunčevoj svjetlosti.
English: Sunscreen creams do not protect against near infra-red light and, therefore, do not provide adequate protection.
Croatian: Zaštitne kreme za sunčanje ne štite od infracrvenog zračenja i stoga ne osiguravaju prikladnu zaštitu.
English: Only 1 (0.5 %) patient had a severe (Grade 3) urinary incontinence.
Croatian: Samo 1 (0,5 %) bolesnik imao je tešku (3. stupanj) urinarnu inkontinenciju.
English: Prior to launch of TOOKAD in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka TOOKAD u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet (MAH) mora dogovoriti sadržaj i oblik edukacijskog programa, uključujući sredstva komunikacije, distribucijske načine i bilo kakve druge aspekte programa, s nacionalnim nadležnim tijelom.
English: In this case, you should contact your doctor as you may need further blood or urine analysis and antibiotics treatment.
Croatian: U tom slučaju trebate se javiti liječniku zbog moguće potrebe za daljnjim pretragama krvi ili urina i liječenja antibioticima.
English: What TOOKAD is and what it is used for
Croatian: Što je TOOKAD i za što se koristi
English: The VTP procedure is performed under general anaesthetic after rectal preparation.
Croatian: VTP postupak izvodi se pod općom anestezijom nakon pripreme rektuma.
English: Connect an opaque tube to the filter.
Croatian: Spojite neprozirnu cijev na filtar.
English: In consequence there is a potential risk of damage to adjacent structures, such as the bladder and/or rectum, and development of a recto-urethral or external fistula.
Croatian: Posljedično, postoji potencijalni rizik od oštećenja susjednih struktura poput mjehura i/ili rektuma, te razvoja rektouretralnih ili vanjskih fistula.
English: This may necessitate inserting a catheter inside your bladder through the penis and the catheter will remain in place for a few days or weeks to drain the urine.
Croatian: To može zahtijevati umetanje katetera u mjehur kroz penis, koji će ostati nekoliko dana ili tjedana kako bi se odvodio urin.
English: What TOOKAD looks like and contents of the pack TOOKAD is a dark powder.
Croatian: Kako TOOKAD izgleda i sadržaj pakiranja TOOKAD je tamni prašak.
English: Limited information is available regarding the safety and efficacy of radical prostatectomy after TOOKAD-VTP.
Croatian: Dostupne su ograničene informacije o sigurnosti i djelotvornosti radikalne prostatektomije nakon TOOKAD-VTP-a.
English: There was a correlation between the total energy delivered and the volume of necrosis observed at day 7.
Croatian: Postojala je korelacija između ukupne dostavljene energije i volumena nekroze uočenog 7. dan.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Croatian: Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često
English: Your doctor will also advise what medicines may be substituted where appropriate and when these medicines can be re-started after the VTP procedure.
Croatian: Liječnik će Vas savjetovati koji se lijekovi mogu nadomjestiti drugima i kad se ponovno može započeti s njihovim uzimanjem nakon VTP terapije.
English: A secondary objective was to determine the difference between the two arms with regard to the rate of subsequent radical therapy for prostate cancer.
Croatian: Sekundarni cilj bio je odrediti razliku između dviju skupina s obzirom na stopu sljedeće radikalne terapije raka prostate.
English: Eye irritation Photophobia
Croatian: Iritacija oka Fotofobija
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se lijek odmah ne upotrijebi, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika.
English: Illumination for photoactivation of TOOKAD
Croatian: Osvjetljavanje za fotoaktivaciju lijeka TOOKAD
English: These may be signs of infection in the urinary tract, the prostate or the genital system.
Croatian: To mogu biti znakovi infekcije mokraćnog sustava, prostate ili spolnog sustava.
English: Of the 206 subjects randomised TOOKAD-VTP, 10 did not receive treatment for various reasons including study withdrawal, meeting exclusion criteria, non-compliance and other medical events.
Croatian: Od 206 randomiziranih ispitanika za postupak TOOKAD-VTP, njih 10 nije primilo liječenje iz raznih razloga, uključujući povlačenje iz sudjelovanja u ispitivanju, ispunjavanje kriterija za isključivanje,
English: Elderly No specific posology adjustment is necessary in this population (see section 5.2).
Croatian: Nije potrebna posebna prilagodba doziranja u toj populaciji (vidjeti dio 5.2).
English: This is normally avoidable by careful planning but should it occur there is a risk of an abnormal connection forming between the rectum and the bladder or skin.
Croatian: To se obično izbjegne pažljivim planiranjem, ali ako se ipak dogodi, postoji rizik od stvaranja abnormalnog spoja između rektuma i mjehura ili kože.
English: Before treatment, the tumour must be accurately located and confirmed as unilateral using high-resolution biopsy strategies based on current best practice, such as multi-parametric MRI-based strategies or template-based biopsy procedures.
Croatian: Prije liječenja tumor se mora točno locirati i potvrditi kao unilateralan uporabom biopsijskih strategija visoke rezolucije na temelju trenutačno najbolje prakse, kao što su multi-parametarske strategije koje se temelje na MR-u ili postupci biopsije prema predlošku (engl. template-based)
English: Hepatotoxicity (alanine aminotransferase increased, aspartate aminotransferase increased).
Croatian: 4 Hepatotoksičnost (povišena razina alanin-aminotransferaze, povišena razina aspartat aminotransferaze).
English: Talk to your doctor or nurse if: - You feel any irritation of the skin or problems with vision or eye irritation after the
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako: - osjećate iritaciju kože ili probleme s vidom ili iritaciju oka nakon VTP terapije;
English: It is important that all patients follow the light precautions below for 48 hours post-procedure to minimize the risk of damage to the skin and eyes.
Croatian: Važno je da svi bolesnici slijede niže navedene mjere opreza vezane uz svjetlost u razdoblju od 48 sati nakon primjene postupka kako bi se minimizirao rizik od oštećenja kože i očiju.
English: The patient can return to normal activity and tolerate direct sunlight 48 hours after the procedure.
Croatian: Bolesnik se smije vratiti uobičajenim aktivnostima i podnositi izravnu sunčevu svjetlost 48 sati nakon postupka.
English: Residual tumour has been found on follow-up biopsy of the treated lobe at 12 and 24 months, usually outside of the treated volume, but occasionally within the area of necrosis.
Croatian: Rezidualni tumor nađen je na biopsijama u sklopu praćenja liječenog režnja nakon 12 i 24 mjeseca, obično izvan liječenog volumena, ali povremeno unutar područja nekroze.
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD07
Croatian: Farmakoterapijska skupina: Senzibilizatori koji se koriste u fotodinamičkoj terapiji/terapiji zračenjem, ATK oznaka: L01XD07
English: The treatment is carried out under general anaesthetic (medicines that send you to sleep to prevent pain and discomfort).
Croatian: Liječenje se provodi pod općom anestezijom (lijekovima koji uspavaju bolesnika kako bi izbjegao osjećaj boli i nelagode).
English: Perineal injury, perineal pain and prostatitis
Croatian: Perinealna ozljeda, perinealna bol i prostatitis
English: There is limited data on long-term outcomes and on potential consequences of post-TOOKAD local scarring in case of disease progression.
Croatian: Postoje ograničeni podaci o dugoročnim ishodima i o mogućim posljedicama stvaranja lokalnih ožiljaka nakon uporabe lijeka TOOKAD u slučaju progresije bolesti.
English: Poor urinary flow due to urethral stricture developed some months post procedure.
Croatian: Slab urinarni protok izazvan uretralnom strikturom razvio se nekoliko mjeseci nakon postupka.
English: Skin depigmentation Skin reaction
Croatian: Depigmentacija kože Kožna reakcija
English: In some cases pain relief was required for perineal pain or anorectal discomfort.
Croatian: U nekim slučajevima tražili su se analgetici za perinealnu bol ili anorektalnu nelagodu.
English: • Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide.
Croatian: • Objašnjenje postupka kao i relevantnih rezultata djelotvornosti i sigurnosti lijeka TOOKAD uz pomoć jednostavnih prikaza uključenih u vodič za bolesnike.
English: TOOKAD has no influence on the ability to drive or use machines.
Croatian: TOOKAD ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Padeliporfin di-potassium is highly bound to human plasma proteins (99 %).
Croatian: Padeliporfindikalij se u visokoj mjeri veže proteine ljudske plazme (99 %).
English: Minimal metabolism of padeliporfin was observed in in vitro metabolism studies in human liver microsomes and S9 fractions.
Croatian: Minimalan metabolizam padeliporfina uočen je u ispitivanjima metabolizma in vitro u mikrosomima ljudske jetre i S9 frakcijama jetre.
English: The MAH shall ensure that in each Member State where TOOKAD is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use TOOKAD have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da u svakoj državi članici gdje je TOOKAD u prometu, svi zdravstveni radnici i bolesnici/njegovatelji od kojih se očekuje propisivanje i primjena lijeka TOOKAD imaju pristup/dobiju sljedeći edukacijski paket:
English: Current or prior treatment for prostate cancer.
Croatian: Trenutno ili prijašnje liječenje raka prostate.
English: Retreatment of lobes found positive for cancer at 12-months follow-up was allowed.
Croatian: Bilo je dozvoljeno ponovno liječenje režnjeva pozitivnih na rak tijekom 12mjesečnog praćenja.
English: See also under “Other medicines and TOOKAD” for the effects of anticoagulants and antiplatelet medicines.
Croatian: Pogledajte i dio „Drugi lijekovi i TOOKAD” za učinak antikoagulansa i antitrombocitnih lijekova.
English: If you do require further treatment, at the moment, there is limited information on whether TOOKAD-VTP affects the efficacy and safety results of other treatments (such as surgery to remove the prostate or radiotherapy).
Croatian: Ako Vam je potrebno daljnje liječenje, u ovom trenutku postoje ograničene informacije o tome utječe li TOOKAD-VTP terapija na djelotvornost i sigurnost ostalih oblika liječenja (poput operacije uklanjanja prostate ili zračenja).
English: Additional adverse reactions in the Phase II prostate cancer studies and Special Authorization Extraprostatic necrosis
Croatian: Dodatne nuspojave iz ispitivanja faze II raka prostate i posebnih odobrenja Izvanprostatna nekroza
English: In the pivotal Phase III European study, moderate or severe urethral stenosis developed in 2 (1.0 %) patients 5 to 6 months post-procedure.
Croatian: U pivotalnom europskom ispitivanju faze III, umjerena ili teška uretralna stenoza razvila se u 2 (1,0 %) bolesnika 5 do 6 mjeseci nakon postupka.
English: Sunscreen creams do not protect you against the type of light (near infra-red) that can cause problems after the procedure.
Croatian: Zaštitne kreme za sunčanje ne štite od određenog tipa svjetlosti (oko infracrvenog spektra) koja može izazvati probleme nakon postupka.
English: Risk of damage near the prostate gland
Croatian: Rizik od oštećenja u blizini žlijezde prostate
English: You or your partner or both should use an effective form of birth control to prevent your partner getting pregnant for 90 days after the VTP procedure.
Croatian: Vi ili Vaša partnerica ili oboje morate upotrebljavati učinkovit oblik kontracepcije kako bi se spriječilo začeće tijekom 90 dana od dana VTP terapije.
English: Patients meeting indication criteria
Croatian: Bolesnici koji ispunjavaju kriterije indikacije
English: This includes sunbeds, bright computer monitor screens (see precautions below), and examination lights from medical equipment.
Croatian: To uključuje solarije, svijetle računalne zaslone (vidjeti mjere opreza u nastavku) i svjetla za pregled u sklopu medicinske opreme.
English: ITT population
Croatian: ITT populacija
English: In vitro studies indicate that TOOKAD is unlikely to be an inhibitor of CYP450 enzymes.
Croatian: In vitro ispitivanja pokazuju da je malo vjerojatno da TOOKAD može biti inhibitor enzima CYP450.
English: In the 24 months of the pivotal European Phase III study, no patients underwent radical radiotherapy post TOOKAD-VTP.
Croatian: Tijekom 24 mjeseca pivotalnog europskog ispitivanja faze III nijedan bolesnik nije bio podvrgnut radikalnom zračenju nakon TOOKAD-VTP terapije.
English: There is no relevant use of TOOKAD in the paediatric population in the treatment of low-risk localised prostate cancer.
Croatian: Nema relevantne primjene lijeka TOOKAD u pedijatrijskoj populaciji u liječenju lokaliziranoga raka prostate niskog rizika.
English: Patients who have been diagnosed with cholestasis.
Croatian: Bolesnici kojima je dijagnosticirana kolestaza.
English: Of 121 patients that progressed in the AS arm, 54 underwent radical therapy and 67 had not received any active treatment at the end of the study.
Croatian: Od 121 bolesnika s progresijom u skupini AS, njih 54 podvrgnuto je radikalnoj terapiji, a 67 nije primilo nikakvo aktivno liječenje na kraju ispitivanja.
English: Some medicines (in particular any medicines that are photosensitising or that affect blood clotting) may interact with TOOKAD and should be stopped before using TOOKAD.
Croatian: Neki lijekovi (posebno fotosenzibilizirajući lijekovi ili lijekovi koji djeluju na zgrušavanje krvi) mogu biti u interakciji s lijekom TOOKAD i treba prestati s njihovom primjenom prije uporabe lijeka TOOKAD.
English: TOOKAD is for intravenous use.
Croatian: TOOKAD je namijenjen za intravensku primjenu.