FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of positive biopsies, patients who exceed the threshold for low risk disease (i.e. have GS > 6, > 3 positive cores or any single core length > 5mm) should receive a treatment recommendation for radical therapy.
Croatian: (tj. imaju GS >6, >3 pozitivna cilindra ili bilo koji zaseban cilindar duljine >5mm) trebaju primiti preporuku za radikalnu terapiju.
English: You will be given a general anaesthetic to send you to sleep before the VTP procedure.
Croatian: Prije VTP terapije dobit ćete opću anesteziju kako bi Vas se uspavalo.
English: Abnormal clotting (fibrin D dimer increased, aPTT prolonged, INR increased).
Croatian: 14 Abnormalno zgrušavanje (povišena razina fibrinskih D dimera, produljen aPTT, povišen INR).
English: Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Croatian: Lijekovi s mogućim fotosenzibilizirajućim učinkom: - neki antibiotici za liječenje infekcije (tetraciklini, sulfonamidi, kinoloni); - neki lijekovi za liječenje psihijatrijskih stanja (fenotiazini); - neki lijekovi za liječenje dijabetesa tipa 2 (hipoglikemijski sulfonamidi);
English: No patients with photosensitive dermatitis, skin conditions such as porphyria or a history of sensitivity to sunlight have received TOOKAD in clinical studies.
Croatian: U kliničkim ispitivanjima bolesnici s fotoosjetljivim dermatitisom te kožnim oboljenjima poput porfirije ili s anamnezom osjetljivosti na sunčevu svjetlost nisu primili lijek TOOKAD.
English: Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
Croatian: U bolesnika s abnormalnim zgrušavanjem krvi može doći do pretjeranog krvarenja zbog ubadanja igala u svrhu smještanja svjetlosnih vlakana.
English: The VTP procedure consisted of a 10 minutes IV injection of 4 mg/kg of TOOKAD followed by 22 minutes 15 seconds of illumination with 753 nm laser light at 200 J/cm of fibre delivered using interstitial optical fibres, inserted transperineally into the prostate gland.
Croatian: VTP terapija sastojala se od i.v. injiciranja 4 mg/kg lijeka TOOKAD tijekom 10 minuta, nakon čega je slijedilo osvijetljavanje laserskom svjetlošću od 753 nm vlaknima od 200 J/cm tijekom 22 minute i 15 sekundi uz uporabu intersticijalnih optičkih vlakana, umetnutih transperinealno u prostatu.
English: In each table are also presented the results of patients meeting the indication criteria (patients with unilateral low-risk localised prostate cancer excluded the very low-risk)
Croatian: (bolesnici s unilateralnim lokaliziranim rakom prostate niskog rizika, isključujući vrlo niskog rizika)
English: Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Croatian: Doziranje Preporučeno doziranje lijeka TOOKAD je jedna doza od 3,66 mg/kg padeliporfina.
English: Clearance of padeliporfin di-potassium in healthy male subjects treated from 1.25 mg/kg up to 15 mg/kg of padeliporfin di-potassium ranged from 0.0245 to 0.088 L/h/kg.
Croatian: 15 mg/kg padeliporfindikalija u rasponu je od 0,0245 do 0,088 l/h/kg.
English: - A medicine used to treat cardiac arrhythmia (amiodarone).
Croatian: - lijek za liječenje gljivičnih infekcija (grizeofulvin); - lijek za liječenje nepravilnog srčanog ritma (amiodaron).
English: TOOKAD should be used with caution in patients with severe hepatic impairment.
Croatian: Savjetuje se oprez pri primjeni lijeka TOOKAD u bolesnika s teškim oštećenjem funkcije jetre.
English: A: Rate of absence of definite cancer based on histology at 24 months Negative biopsy, n (%)
Croatian: A: Stopa izostanka potvrđenog raka na temelju histologije nakon 24 mjeseca
English: Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Croatian: Tablica 4.: PCM301 - Broj ispitanika s radikalnim liječenjem nakon 24 mjeseca - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije Karakteristika
English: The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Croatian: Drugi lijekovi koji mogu biti u interakciji s lijekom TOOKAD Uporaba lijekova poput repaglinida, atorvastatina, pitavastatina, pravastatina, rosuvastatina, simvastatina, bosentana, gliburida treba se izbjegavati na dan primjene lijeka TOOKAD i najmanje 24 sata nakon primjene.
English: Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment.
Croatian: U bolesnika s oštećenjem funkcije jetre očekuje se povećana i/ili produljena izloženost padeliporfinu.
English: Digital Rectal Examination (DRE) is recommended to be performed at least once a year and more often if clinically justified.Routine biopsy is recommended at 2-4 years and 7 years post VTP, with additional biopsies based on clinical/ PSA assessment.
Croatian: Preporučuje se obaviti digitalni rektalni pregled (DRE) barem jednom godišnje, te češće ako je pregled klinički opravdan.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnoga sustava i dojki
English: VTP procedure
Croatian: VTP terapija
English: Post-authorisation efficacy study (PAES): In order to further investigate long-term efficacy of TOOKAD and its impact on disease progression including potential impact on the efficacy of subsequent radical therapy in patients with low risk prostate cancer (excluding very low risk) as well as further characterise the long term safety of TOOKAD, the MAH should conduct and submit the results of a long-term observational cohort study of patients with unilateral low risk localised prostate cancer treated with TOOKAD VTP (CLIN1501 PCM401).
Croatian: Do datuma radikalne terapije u bolesnika s rakom prostate niskog rizika (isključujući vrlo niskog rizika), kao i kako bi se dodatno okarakterizirala dugoročna sigurnost lijeka TOOKAD, nositelj odobrenja treba provesti i podnijeti rezultate dugoročnog opservacijskog ispitivanja kohorti u bolesnika s unilateralnim lokaliziranim rakom prostate niskog rizika liječenih TOOKAD-VTP terapijom (CLIN1501 PCM401).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/1/17/1228/001
English: Only the lobe that contains the cancer will be treated.
Croatian: Liječi se samo režanj zahvaćen rakom.
English: One patient had Grade 3 perineal pain that started 35 weeks after the VTP procedure, and lasted for about 35 weeks before resolving without sequelae.
Croatian: Jedan bolesnik imao je perinealnu bol 3. stupnja koja je započela 35 tjedana nakon VTP
English: As shown in Table 6, in the VTP arm of PCM301 study, erectile function domain scores of the 15-question International Index of Erectile Function (IIEF-15) questionnaire showed a marked decrease, 7 days after the VTP procedure followed by a subsequent improvement in the following months up to Month 24, in the ITT population and in patients meeting the indication criteria.
Croatian: International Indeks of Erectile Function, IIEF-15) pokazuju značajan pad, 7 dana nakon VTP terapije, nakon kojeg je uslijedilo poboljšanje sljedećih mjeseci do 24. mjeseca, u ITT populaciji i u bolesnika koji ispunjavaju kriterije indikacije.
English: • Information on the existing therapeutic approaches (including VTP with TOOKAD) for the treatment of the type of prostate cancer
Croatian: Vodič za bolesnike o lijeku TOOKAD treba sadržavati sljedeće ključne elemente: • informaciju o postojećim terapijskim pristupima (uključujući VTP s lijekom TOOKAD) za liječenje vrste raka prostate;
English: Genito-urinary infections
Croatian: Infekcije genitalno-urinarnog sustava
English: OATP1B1 and OATP1B3 transporters
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Transporteri OATP1B1 i OATP1B3
English: During the procedure, the optical fibres are selected and positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Croatian: Tijekom postupka optička vlakna odabiru se i smještaju transperinealno u prostatu uz kontrolu ultrazvukom kako bi se postigao indeks gustoće svjetlosti
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte uputu o lijeku.
English: The patient may be discharged in the evening of the same day at the physician's discretion.
Croatian: Na temelju liječničke procjene, bolesnik se može otpustiti iz bolnice uvečer na dan postupka.
English: Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity
Croatian: Hemartroza Mišićno-koštana bol Bol u udovima
English: In a patient treated at 2 mg/kg of TOOKAD, one case of Grade 3 ischaemic optic neuropathy was reported 33 days after the VTP procedure.
Croatian: Fototoksičnost 33 dana nakon VTP postupka prijavljen je jedan slučaj ishemijske optičke neuropatije 3. stupnja u bolesnika liječenog dozom 2 mg/kg lijeka TOOKAD.
English: AS arm n Mean score (SD)
Croatian: AS skupina n Srednja vrijednost bodova (SD)
English: - Certain medicines used for hypertension, oedema, heart failure or renal failure (thiazide diuretics).
Croatian: - neki lijekovi za visoki krvni tlak, oticanje, zatajenje srca ili zatajenje bubrega (tiazidski diuretici);
English: Prostatitis Genital pain Prostatic pain
Croatian: Prostatitis Genitalna bol11
English: If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Month 3 171 14.7 (10.48) 182 21.0 (9.84) 69 14.3 (10.81) 70 21.7 (9.95) Month 6 176 16.1 (9.98) 185 20.4 (9.83) 68 16.9 (9.78) 72 20.6 (9.85) Month 12 170 15.1 (10.28) 167 19.9 (10.29) 70 16.7 (10.18) 65 20.4 (10.44) Month 24* 159 15.0 (10.70) 152 16.8 (11.17) 62 15.4 (11.11) 54 16.4 (11.10) *Scores at Month 24 include patients who underwent radical therapy
Croatian: 7. dan 165 11,5 (10,96) Nije primjenjivo 68 10,1 (10,82) Nije primjenjivo 3. mjesec 171 14,7 (10,48) 182 21,0 (9,84) 69 14,3 (10,81) 70 21,7 (9,95) 6. mjesec 176 16,1 (9,98) 185 20,4 (9,83) 68 16,9 (9,78) 72 20,6 (9,85) 12. mjesec 170 15,1 (10,28) 167 19,9 (10,29) 70 16,7 (10,18) 65 20,4 (10,44)
English: TOOKADVTP arm N = 80
Croatian: TOOKADVTP skupina N = 80
English: Some degree of erectile dysfunction is possible soon after the procedure and may last for more than 6 months (see section 4.8).
Croatian: Određen stupanj erektilne disfunkcije moguć je ubrzo nakon postupka i može trajati više od 6 mjeseci
English: Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
Croatian: Jedna kutija lijeka TOOKAD 366 mg prašak za otopinu za injekciju sadrži smeđu staklenu bočicu s bijelim zatvaračem.
English: Nervous system disorders
Croatian: Poremećaji mokraćnog sustava
English: TOOKADVTP arm N = 206
Croatian: TOOKADVTP skupina N = 206
English: Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
Croatian: Bočicu je potrebno ostaviti da miruje u uspravnom položaju 3 minute bez daljnjeg mućkanja pomicanja.
English: Urinary incontinence
Croatian: Urinarna inkontinencija
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
Croatian: TOOKAD 183 mg prašak za otopinu za injekciju TOOKAD 366 mg prašak za otopinu za injekciju
English: Store in the outer carton in order to protect it from light.
Croatian: Bočicu čuvati u originalnoj kutiji radi zaštite od svjetlosti.
English: Abdominal discomfort Abnormal faeces Diarrhoea
Croatian: Abdominalna nelagoda Abnormalna stolica Proljev
English: g g h
Croatian: J/cm.
English: Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Croatian: Tablica 5.: PCM301 - Učinak na urinarno pobolijevanje (IPSS) - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
English: Month 3 179 9.6 (6.86) 190 7.2 (5.75) 71 8.7 (5.72) 72 6.6 (5.11) Month 6 182 7.5 (6.06) 189 6.8 (5.84) 74 6.4 (5.33) 73 6.3 (5.36) Month 12 177 7.2 (5.85) 173 7.3 (5.95) 71 5.7 (5.01) 68 7.1 (5.75) Month 24* 165 6.6 (5.47) 154 8.2 (6.47) 66 5.5 (5.34) 55 8.6 (6.56) *Scores at Month 24 include patients who underwent radical therapy
Croatian: 7. dan 180 14,8 (8,64) Nije primjenjivo 72 14,2 (8,89) Nije primjenjivo 3. mjesec 179 9,6 (6,86) 190 7,2 (5,75) 71 8,7 (5,72) 72 6,6 (5,11) 6. mjesec 182 7,5 (6,06) 189 6,8 (5,84) 74 6,4 (5,33) 73 6,3 (5,36) 12. mjesec 177 7,2 (5,85) 173 7,3 (5,95) 71 5,7 (5,01) 68 7,1 (5,75)
English: This required urethral dilatation (see section 4.4).
Croatian: To je zahtijevalo uretralnu dilataciju (vidjeti dio
English: Perineal pain (pelvic pain).
Croatian: 9 Perinealna bol (bol u zdjelici).
English: Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Croatian: Jedna bočica lijeka TOOKAD 183 mg sadrži 183 mg padeliporfina (u obliku kalijeve soli).
English: Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
Croatian: 7 Poremećaji mokrenja (urgencija, polakizurija, nokturija, smanjen protok urina, napinjanje pri mokrenju).
English: - General and musculoskeletal pain (muscle/bony pain, pain in the end of the limbs, back pain or bleeding into the joints), - Haematospermia (presence of blood in the ejaculate), - High blood pressure, - Increases in blood lipids, lactate dehydrogenase increased, white blood cell increased, creatine phosphokinase increased, potassium decreased, prostatic specific antigen (PSA) increased, - Skin reaction, erythema (reddening), rash, dryness, pruritus, depigmentation, - Abnormal blood tests related to coagulation, - Discomfort in the abdominal region, - Fatigue (tiredness).
Croatian: - visok krvni tlak, - povišeni lipidi u krvi, povišena laktat-dehidrogenaza, povišene bijele krvne stanice, povišena kreatin-fosfokinaza, snižena razina kalija, povišen antigen specifičan za prostatu (PSA),
English: Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Croatian: Jedna bočica lijeka TOOKAD 366 mg sadrži 366 mg padeliporfina (u obliku kalijeve soli).
English: • The approaches (including VTP with TOOKAD) for the treatment of his prostate cancer and the potential benefits, risks and uncertainties of VTP with TOOKAD: o To state that information beyond two years after the TOOKAD -VTP procedure is limited and consequently, data on the long-term efficacy and safety of TOOKADVTP are currently not available o Information on the efficacy/safety of any subsequent treatments required, such as radical prostatectomy, is currently lacking
Croatian: Vodič za liječnike o lijeku TOOKAD trebaju sadržavati sljedeće ključne elemente: • Pristupe (uključujući VTP s lijekom TOOKAD) liječenju raka prostate i moguće koristi, rizike i dvojbe oko VTP terapije lijekom TOOKAD; o informaciju da su podaci nakon dvije godine od TOOKAD-VTP postupka ograničeni i posljedično, podaci o dugoročnoj djelotvornosti i sigurnosti TOOKAD-VTP terapije trenutačno nisu dostupni.
English: In healthy human male subjects, the mean volume of distribution ranged from 0.064-0.279 L/kg, for posologies from 1.25 to 15 mg/kg of padeliporfin di-potassium indicating distribution into extracellular fluid.
Croatian: 0,279 l/kg, za doziranja od 1,25 to 15 mg/kg padeliporfindikalija, što upućuje na distribuciju u izvanstaničnu tekućinu.
English: Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Croatian: Tablica 6.: PCM301 - Učinak na erektilnu funkciju (IIEF) - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
English: There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
Croatian: U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze zbog minimalnog izlučivanja lijeka TOOKAD putem bubrega.
English: An injection filter of 0.22 µm and an opaque tubing should be used to administer the medicinal product to the patient.
Croatian: Za primjenu lijeka bolesniku potrebno je koristiti injekcijski filtar od 0,22 µm i neprozirne cjevčice.
English: Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Croatian: Jedna kutija lijeka TOOKAD 183 mg prašak za otopinu za injekciju sadrži smeđu staklenu bočicu s plavim zatvaračem.
English: Photosensitisers
Croatian: Fotoosjetljivost
English: Patients on a controlled potassium diet
Croatian: Bolesnici na dijeti s ograničenim unosom kalija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1228/002
English: The study had two co-primary endpoints for TOOKAD-VTP in comparison to AS: - A: The rate of absence of definite cancer based on histology at 24 months, - B: The difference in rate of treatment failure associated with observed progression of disease from low to moderate or higher risk prostate cancer.
Croatian: - B: razlika u stopi neuspjeha liječenja povezanog s opaženom progresijom bolesti od raka prostate niskog do umjerenog ili višeg rizika.
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF (medicines used to prevent new blood vessel growth) therapy.
Croatian: U bolesnika koji su primili intraokularnu anti-VEGF terapiju (lijekovi za sprječavanje rasta novih krvnih žila) može postojati dodatni rizik fotoosjetljivosti očiju.
English: Each mL of the resulting solution will contain 9.15 mg of padeliporfin.
Croatian: Jedan ml dobivene otopine sadržava 9,15 mg padeliporfina.
English: TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm
Croatian: - Gleason zbrojem ≤ 6, na temelju biopsijskih strategija visoke rezolucije, - PSA ≤ 10 ng/ml, - 3 cilindra pozitivna na rak, dobivena biopsijom širokom iglom (engl. core biopsy) s najvećom duljinom od 5 mm u bilo kojem od cilindara ili 1 - 2 cilindra pozitivna na rak pri čemu u bilo kojem od cilindara ≥ 50 % sačinjava rak ili gustoćom PSA ≥ 0,15 ng/ml/cm3.
English: Back pain
Croatian: Bol u leđima5
English: Range: min, max Estimated prostate volume (cc) Mean (SD)
Croatian: Ukupan broj pozitivnih cilindara Srednja vrijednost (SD) Raspon: min, maks Procijenjen volumen prostate (cm3) Srednja vrijednost (SD) Raspon: min, maks PSA (ng/ml)
English: Anticoagulants (medicines that prevent the blood from clotting) These medicines (e.g. acenocoumarol, warfarin) should be stopped at least 10 days before the VTP procedure with TOOKAD.
Croatian: Ovi lijekovi (npr. acenokumarol, varfarin) trebaju se prestati uzimati barem 10 dana prije VTP terapije s lijekom TOOKAD.
English: Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Croatian: 6 Dizurija (bol u mjehuru, spazam mjehura, hipertonični mjehur, uretralni spazam, bol u urinarnom sustavu).
English: Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Croatian: Tablica 3.: PCM301 - Koprimarne mjere ishoda djelotvornosti - cijela prostata i liječeni režanj(evi)* - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
English: Very common Perineal pain Male sexual dysfunction
Croatian: Perinealna bol9 Seksualna disfunkcija muškaraca10
English: TOOKAD-VTP arm
Croatian: TOOKAD-VTP skupina
English: Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Croatian: Jedna bočica sadrži 366 mg padeliporfina (u obliku dikalijeve soli).
English: Number of subjects who initiated a radical treatment after progression, n (%)
Croatian: Broj ispitanika koji su započeli s radikalnim liječenjem nakon progresije,
English: Dysuria
Croatian: Doza
English: No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Croatian: Ostali razlozid, n (%) Pozitivan nalaz biopsije, n
English: Hepatotoxicity
Croatian: Hepatotoksičnost4
English: Planning of optical fibre positioning should be performed at the beginning of the procedure using the treatment guidance software.
Croatian: U početku postupka potrebno je uporabom terapijskog vodiča u obliku programske podrške izvršiti planiranje smještanja optičkih vlakana.
English: Effect on urinary morbidity (IPSS) and erectile function (IIEF) following TOOKAD-VTP As shown in Table 5, in PCM301 study, the International Prostate Symptoms Score (IPSS) showed, a moderate increase 7 days after the VTP procedure, in both the ITT population and in patients meeting the indication criteria.
Croatian: International Prostate Symptoms Score, IPSS) pokazao je umjeren rast 7 dana nakon VTP terapije, i u ITT populaciji i u bolesnika koji ispunjavaju kriterije indikacije.
English: Hepatic impairment
Croatian: Afektivni poremećaj
English: Although they were excluded from the clinical trials, there is a potential risk of increased stenosis post the TOOKAD-VTP procedure in patients with pre-existing stenosis (see section 4.8).
Croatian: TOOKAD-VTP postupka u bolesnika s od prije postojećim stenozama (vidjeti dio 4.8).
English: - You experience involuntary passing of urine after the VTP procedure.
Croatian: - ako Vam se javi nekontrolirano mokrenje nakon VTP terapije;
English: What TOOKAD is and what it is used for What you need to know before TOOKAD is used How TOOKAD is used
Croatian: Što morate znati prije primjene lijeka TOOKAD TOOKAD se ne smije primjenjivati:
English: Rectal haemorrhage (anal haemorrhage).
Croatian: 3 Rektalna hemoragija (analna hemoragija).
English: Post-procedural urine leak Procedural pain Post-procedural discharge Fall
Croatian: Istjecanje urina nakon postupka Bol tijekom postupka Iscjedak nakon postupka Pad
English: Sciatica
Croatian: Astenija
English: Genital haemorrhage Penile swelling Prostatic haemorrhage Testicular swelling
Croatian: Hemoragija prostate Oticanje testisa
English: Common side effects (may affect up to 1 in 10 people) - Anorectal discomfort (discomfort near the anus and just inside the anus), haemorrhoids (piles),
Croatian: - Anorektalna nelagoda (nelagoda u području anusa i neposredno unutar anusa), hemoroidi,
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
Croatian: U bolesnika koji su primili intraokularnu anti-VEGF terapiju postoji dodatni rizik fotoosjetljivosti očiju.
English: Problem associated with the urethra
Croatian: Poteškoće u vezi s mokraćnom cijevi
English: Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
Croatian: 39 (50,0)j gPrilagođen omjer hazarda (95 % CI) = 0,34 (0,24; 0,46) ; p vrijednost ≤ 0,001 hPrilagođen omjer hazarda (95 % CI) = 0,31 (0,20; 0,50) ; p vrijednosti ≤ 0,001 iPrilagođen omjer hazarda (95 % CI) = 0,17 (0,12; 0,27) ; p vrijednost ≤ 0,001 jPrilagođen omjer hazarda (95 % CI) = 0,11 (0,05; 0,25) ; p vrijednost ≤ 0,001
English: Abnormal clotting
Croatian: Abnormalno zgrušavanje
English: Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
Croatian: uključujući transuretralnu resekciju prostate (TURP) zbog benigne hipertrofije prostate.
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
Croatian: TOOKAD 183 mg prašak za otopinu za injekciju padeliporfin