FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use after the expiry date which is stated on the shield label after “EXP”.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP.
English: Male sexual dysfunction (erectile dysfunction, ejaculation failure, dyspareunia, ejaculation disorder, hypospermia, painful ejaculation, retrograde ejaculation, sexual dysfunction, semen volume decreased).
Croatian: 10 Seksualna disfunkcija muškaraca (erektilna disfunkcija, nemogućnost ejakulacije, dispareunija, poremećaj ejakulacije, hipospermija, bolna ejakulacija, retrogradna ejakulacija, seksualna disfunkcija, smanjen volumen sjemena).
English: Back pain (intervertebral disc protrusion).
Croatian: 5 Bol u leđima (protruzija intervertebralnog diska).
English: During the procedure, the number and the length of the optical fibres are selected depending on the shape and the size of the prostate and the optical fibres are positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Croatian: Tijekom postupka broj i duljina optičkih vlakana odabiru se ovisno o obliku i veličini prostate i optička vlakna smještaju se transperinealno u prostatu uz ultrazvučno usmjeravanje kako bi se postigao indeks gustoće svjetlosti (engl.
English: Other reasons d, n (%) Positive biopsy, n (%) Positive biopsy in the treated lobe*, n (%) Risk Ratio (95% CI) = 3.62 (2.50 ; 5.26) ; p value < 0.001 Risk Ratio (95% CI) = 3.24 (2.41 ; 4.36) ; p value < 0.001 Among the 60 patients who had radical therapy, 5 patients had a Month 24 biopsy For example: study withdrawal, medical reason, subject refusal Risk Ratio (95% CI) = 4.39 (2.18 ; 8.83) ; p value < 0.001 Risk Ratio (95% CI) = 4.61 (2.60 ; 8.16) ; p value < 0.001 B: Difference in rate of treatment failure associated with observed progression of disease Number of subjects progressed at Month 24, n (%)
Croatian: aOmjer rizika (95 % CI) = 3,62 (2,50; 5,26) ; p vrijednost < 0,001 bOmjer rizika (95 % CI) = 3,24 (2,41; 4,36) ; p vrijednost < 0,001 cMeđu 60 bolesnika koji su podvrgnuti radikalnoj terapiji, 5 bolesnika podvrgnuto je biopsiji u 24. mjesecu dPrimjerice: povlačenje iz sudjelovanja u ispitivanju, medicinski razlog, odbijanje ispitanika eOmjer rizika (95 % CI) = 4,39 (2,18; 8,83) ; p vrijednosti < 0,001 fOmjer rizika (95 % CI) = 4,61 (2,60; 8,16) ; p vrijednost < 0,001 B: Razlika u stopi neuspjeha liječenja povezanog s opaženom progresijom bolesti Broj ispitanika s progresijom u 24. mjesecu, n (%)
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 as well as further characterise the long term safety of TOOKAD, the MAH should submit the results of a randomised phase 3 study in patients with localised prostate cancer compared to active surveillance (7-year follow-up study including in an depth biopsy study) (PCM301 FU5).
Croatian: (PAES): Kako bi se dodatno istražila dugoročna djelotvornost lijeka TOOKAD i njegov utjecaj na progresiju bolesti, uključujući moguć utjecaj na djelotvornost sljedeće radikalne terapije u bolesnika s rakom prostate niskog rizika, kao i kako bi se dodatno okarakterizirala dugoročna sigurnost lijeka TOOKAD, nositelj odobrenja treba podnijeti rezultate randomiziranog ispitivanja faze III u bolesnika s lokaliziranim rakom prostate u usporedbi s aktivnim nadzorom (7-godišnje ispitivanje praćenja uključujući ispitivanje dubinske biopsije) (PCM301 FU5).
English: • Information on the potential benefits, risks and uncertainties of VTP with TOOKAD, including: uncertainties on long-lasting benefit of TOOKAD; uncertainties on long-term safety of TOOKAD and efficacy/safety of any further treatments required such as radical prostatectomy
Croatian: • informaciju o mogućim koristima, rizicima i dvojbama oko VTP terapije s lijekom TOOKAD, uključujući: dvojbe u vezi s dugotrajnom koristi primjene lijeka TOOKAD; dvojbe u vezi s dugoročnom sigurnošću lijeka TOOKAD i djelotvornosti/sigurnosti daljnjih nužnih tretmana poput radikalne prostatektomije;
English: You will not have to store this medicine.
Croatian: Kako se TOOKAD čuva Nećete morati čuvati ovaj lijek.
English: Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.
Croatian: Antikoagulansi i lijekovi koji smanjuju agregaciju trombocita (npr. acetilsalicilatna kiselina) trebaju se prestati uzimati najmanje 10 dana prije postupka s lijekom TOOKAD.
English: The main exclusion criteria were any prior or current treatment for prostate cancer, any surgical intervention for benign prostatic hypertrophy, life expectancy less than 10 years, medical conditions which preclude the use of general anaesthesia.
Croatian: Glavni kriterij isključivanja iz ispitivanja bilo je prijašnje ili trenutačno liječenje raka prostate, svaka kirurška intervencija benigne hipertrofije prostate, očekivani životni vijek manji od 10 godina,
English: Check with your doctor about the birth control methods to use and how long to use them for.
Croatian: Savjetujte se s liječnikom o načinima kontracepcije i trajanju zaštite.
English: Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
Croatian: Na temelju analiza populacijske farmakokinetike, procijenjeni poluvijek iznosi 1,19 h ± 0,08 pri 4 mg/kg padeliporfindikalija.
English: No data are available in patients with hepatic impairment.
Croatian: Nema podataka o bolesnicima s oštećenjem funkcije jetre.
English: This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental.
Croatian: To treba uzeti u obzir u bolesnika sa smanjenom bubrežnom funkcijom ili bolesnika na dijeti s ograničenim unosom kalija u kojih se porast kalija u serumu smatra štetnim.
English: In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Croatian: Općenito, doza lijeka TOOKAD sadrži manje od 1 mmol (39 mg) kalija, tj. zanemarive količine kalija.
English: 1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
Croatian: Jedan ml rekonstituirane otopine sadrži 9,15 mg padeliporfina.
English: PHARMACEUTICAL FORM Powder for solution for injection.
Croatian: OBLIK Prašak za otopinu za injekciju.
English: Active inflammatory bowel disease
Croatian: Aktivna upalna bolest crijeva
English: Fibres to carry the laser light are inserted into the prostate gland by using hollow needles.
Croatian: Vlakna koja pronose lasersku svjetlost umeću se u prostatu uporabom šupljih igala.
English: The TOOKAD-VTP procedure is contraindicated in patients with any previous prostatic interventions where the internal urinary sphincter may have been damaged, including transurethral resection of the prostate (TURP) for benign prostatic hypertrophy (see section 4.3).
Croatian: TOOKAD-VTP postupak kontraindiciran je u bolesnika s bilo kakvim prijašnjim intervencijama na prostati gdje postoji mogućnost oštećenja unutarnjeg urinarnog sfinktera, uključujući transuretralnu resekciju prostate (TURP) kod benigne hipertrofije prostate
English: TOOKAD is activated immediately after injection by shining light through the fibres from a connected laser device.
Croatian: Odmah nakon injiciranja TOOKAD se aktivira svjetlošću koja dolazi kroz vlakna iz spojenog laserskog uređaja.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of padeliporfin, including photosensitivity, and also information on the existing therapeutic approaches (including VTP with
Croatian: Cilj edukacijskog programa jest povećati svijest i pružiti informaciju o znakovima i simptomima određenih važnih identificiranih rizika padeliporfina, uključujući fotoosjetljivost, te informaciju o postojećim terapijskim pristupima (uključujući VTP s lijekom TOOKAD) za liječenje vrste raka prostate, mogućim koristima, rizicima i dvojbama oko VTP terapije lijekom TOOKAD.
English: Moderate/higher risk prostate cancer was defined as any of the following: > 3 cores definitively positive for cancer; Gleason primary or secondary pattern ≥ 4; at least 1 cancer core length > 5 mm; PSA > 10 ng/mL in 3 consecutive measures; T3 prostate cancer; metastasis; prostate cancer-related death.
Croatian: Rak prostate umjerenog/višeg rizika bio je definiran bilo kojim od sljedećih kriterija: > 3 cilindra konačno pozitivna na rak; primarni ili sekundarni obrazac na Gleason skali ≥ 4; najmanje jedan cilindar pozitivan na rak duljine > 5 mm; vrijednost PSA > 10 ng/ml tijekom 3 uzastopna mjerenja; rak prostate stadija T3; metastaze; smrt uzrokovana rakom prostate.
English: Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Croatian: Zbog neispravne kalibracije lasera dogodila su se dva slučaja prekomjerne izvanprostatne nekroze bez kliničkih posljedica.
English: Adverse reactions reported are listed below in Table 1 by organ class and frequency.
Croatian: Tablični popis nuspojava Prijavljene nuspojave navedene su u nastavku u tablici 1. prema organskim sustavima i učestalosti.
English: Blood lactate dehydrogenase increased Blood triglyceride increased Gamma-glutamyltransferase increased Blood cholesterol increased Blood creatine phosphokinase increased Blood potassium decreased Low density lipoprotein increased Neutrophil count increased PSA increased
Croatian: Povišena razina triglicerida u krvi Povišena razina gama-glutamiltransferaze Povišena razina kolesterola u krvi Povišena razina kreatin-fosfokinaze u krvi Snižena razina kalija u krvi
English: In addition to the side effects listed previously, other side effects can occur.
Croatian: Uz navedene nuspojave, mogu se pojaviti još neke.
English: Anorectal discomfort (proctalgia, rectal tenesmus).
Croatian: 2 Anorektalna nelagoda (proktalgija, rektalni tenezam).
English: These medicines (e.g. acetylsalicylic acid) should be stopped at least 10 days before the VTP procedure with TOOKAD and re-started at least 3 days after the procedure.
Croatian: Te lijekove (npr. acetilsalicilatnu kiselinu) treba prestati uzimati najmanje 10 dana prije VTP terapije lijekom TOOKAD i ponovno ih nastaviti uzimati barem 3 dana nakon terapije.
English: Patients with a history of urethral stricture or with urinary flow problems may be at increased risk of poor flow and urinary retention post the TOOKAD-VTP procedure.
Croatian: Urinarna retencija / uretralna striktura Bolesnici s anamnezom uretralne strikture ili s problemima urinarnog protoka mogu biti pod povećanim rizikom slabijeg protoka i urinarne retencije nakon primjene TOOKAD-VTP postupka.
English: Table 1: Summary of adverse reactions considered related to TOOKAD and/or the study device and/or the study procedure in the pooled safety analysis (N=398)
Croatian: Tablica 1.: Sažetak nuspojava iz objedinjene analize sigurnosti (N=398) koje se smatraju povezanima s lijekom TOOKAD i/ili uređajima i/ili postupkom iz ispitivanja
English: Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
Croatian: 11 Genitalna bol (bol u penisu, bol u testisima, bol u skrotumu, neinfektivni orhitis, upala spermatičnog voda, genitalna kontuzija).
English: Short-term urinary incontinence has been observed and may result from urinary tract infection or from urgency caused by irritation to the urethra from the procedure.
Croatian: Uočena je kratkotrajna urinarna inkontinencija (nevoljno istjecanje mokraće) koja može nastati zbog infekcije mokraćnog sustava ili zbog neizdržive potrebe za mokrenjem izazvane iritacijom mokraćne cijevi tijekom postupka.
English: In case you need to go out during the day, you must wear protective clothing and high-protection goggles to shield your skin and eyes.
Croatian: U slučaju izlaska na danje svjetlo nužno je nositi zaštitnu odjeću i sunčane naočale visoke zaštite kako bi se koža i oči zaštitili.
English: Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
Croatian: U periprostatskom masnom tkivu može doći do izvanprostatne nekroze koja nije povezana s kliničkim simptomima.
English: The pivotal open-label Phase III study (PCM301), conducted in 10 European countries, randomised 413 patients to TOOKAD-VTP arm or AS arm.
Croatian: U pivotalnom otvorenom ispitivanju faze III (PCM301), provedenom u 10 europskih zemalja, 413 bolesnika je randomizirano u skupinu za liječenje postupkom TOOKAD-VTP ili u skupinu AS (engl.active surveillance, aktivno praćenje).
English: n Mean score (SD)
Croatian: n Srednja vrijednost bodova (SD)
English: In vitro studies predict that TOOKAD at therapeutic concentrations is unlikely to inhibit cytochrome P450 enzymes but could inhibit OATP1B1 and OATP1B3 transporters (see section 5.2).
Croatian: Na temelju ispitivanja in vitro malo je vjerojatno da TOOKAD u terapijskim koncentracijama inhibira enzime citokroma P450, ali može inhibirati transportere OATP1B1 i OATP1B3 (vidjeti dio 5.2).
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu čuvajte u originalnoj kutiji radi zaštite od svjetlosti.
English: Medicinal products which have potential photosensitising effects (such as tetracyclines, sulphonamides, quinolones, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin or amiodarone) should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.
Croatian: fenotiazini, hipoglikemici iz skupine sulfonilureja, tiazidski diuretici, grizeofulvin ili amiodaron) trebaju se prestati uzimati najmanje 10 dana prije postupka s lijekom TOOKAD i najmanje 3 dana nakon postupka ili ih treba zamijeniti drugim lijekovima bez fotosenzibilizirajućih svojstava.
English: If you have a history of a narrowing of the urethra or urinary flow problems, treatment may increase the risk of poor flow and urinary retention.
Croatian: Ako u povijesti bolesti imate suženje mokraćne cijevi ili probleme s protokom mokraće, liječenje može povećati rizik od slabog protoka i zadržavanja mokraće.
English: The results of the population PK study showed that age, race, health status and markers of hepatic function were unlikely to have a substantial and biologically significant impact on the pharmacokinetics of TOOKAD.
Croatian: zdravstveno stanje i markeri jetrene funkcije mogu imati znatan i biološki značajan utjecaj na farmakokinetiku lijeka TOOKAD.
English: It should only be used by personnel trained in the VTP procedure.
Croatian: Smije ga upotrebljavati samo osoblje osposobljeno za primjenu VTP terapije.
English: Muscular and connective tissue disorders
Croatian: Poremećaji mišićnog i vezivnog tkiva
English: Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Croatian: Postoji rizik fotoosjetljivosti kože i očiju prilikom izlaganja svjetlosti nakon TOOKAD-VTP terapije.
English: It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure.
Croatian: Smije ga primjenjivati samo osoblje osposobljeno za provođenje postupka vaskularno ciljane fotodinamičke terapije (engl.
English: In vitro studies indicate that TOOKAD is unlikely to be a substrate of OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 or BSEP hepatic uptake transporters.
Croatian: In vitro ispitivanja upućuju na to da nije vjerojatno da je lijek TOOKAD supstrat transportera unosa u jetru: OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 ili BSEP.
English: A similar mean distribution volume was seen in patients with localised prostate cancer treated with 2 and 4 mg/kg of padeliporfin di-potassium (0.09-0.10 L/kg respectively).
Croatian: Sličan prosječan volumen distribucije viđen je u bolesnika s lokaliziranim rakom prostate liječenih s 2 i 4 mg/kg padeliporfindikalija (0,09-0,10 l/kg, ovisno o doziranju).
English: The solution is administered by intravenous injection over 10 minutes.
Croatian: Osvjetljavanje za fotoaktivaciju lijeka TOOKAD Otopina se primjenjuje intravenskom injekcijom u trajanju od 10 minuta.
English: Table 3 describes the co-primary efficacy endpoints in the whole prostate gland and in the treated lobe (ITT population and patients meeting the indication criteria).
Croatian: Tablica 3. opisuje koprimarne mjere ishoda djelotvornosti u cijeloj prostati i u liječenom režnju (ITT populacija i bolesnici koji ispunjavaju kriterije indikacije).
English: Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
Croatian: 12 Bol u prostati (prostatizam, poremećaji prostate, fibroza prostate).
English: TOOKAD is locally activated immediately after injection by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm over 22 minutes 15 seconds.
Croatian: TOOKAD se odmah nakon ubrizgavanja lokalno aktivira laserskom svjetlošću od 753 nm putem intersticijalnih optičkih vlakana iz laserskog uređaja pri snazi vlakana od 150 mW/cm, uz dostavljanje energije od 200 J/cm tijekom 22 minute i 15 sekundi.
English: - Fever, pain and swelling in the area of the operation might occur after the procedure.
Croatian: - nakon postupka može doći do vrućice, boli i oticanja područja operacije.
English: Follow-up post TOOKAD-VTP
Croatian: TOOKAD-VTP
English: The main inclusion criteria were low-risk prostate cancer with Gleason 3 + 3 prostate adenocarcinoma as a maximum, two to three cores positive for cancer and a maximum cancer core length of 5 mm in any core (at least 3 mm for patients with only one positive core), clinical stage up to T2a, PSA ≤ 10 ng/mL, prostate volume equal or greater than 25 cc and less than 70 cc.
Croatian: Glavni kriteriji za uključivanje u ispitivanje bili su rak prostate niskog rizika s maksimalnim zbrojem Gleason skale 3 + 3 za adenokarcinom prostate, dva do tri cilindra pozitivna na rak, dobivena biopsijom širokom iglom, s najvećom duljinom od 5 mm u bilo kojem od cilindara (najmanje 3 mm za bolesnike sa samo jednim pozitivnim cilindrom), klinički stadij do T2a, PSA ≤ 10 ng/ml, volumen prostate jednak ili veći od 25 cm3 i manji od 70 cm3.
English: TOOKAD 366 mg powder for solution for injection Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a white plastic flip-off cap, containing 366 mg padeliporfin.
Croatian: TOOKAD 366 mg prašak za otopinu za injekciju Bočica od smeđeg stakla tipa I, zatvorena gumenim čepom i aluminijskom brtvom te prekrivena bijelim plastičnim poklopcem, koja sadrži 366 mg padeliporfina.
English: TOOKAD 183 mg powder for solution for injection Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a blue plastic flip-off cap, containing 183 mg padeliporfin.
Croatian: TOOKAD 183 mg prašak za otopinu za injekciju Bočica od smeđeg stakla tipa I, zatvorena gumenim čepom i aluminijskom brtvom te prekrivena plavim plastičnim poklopcem, koja sadrži 183 mg padeliporfina.
English: Negative biopsy in the treated lobe*, n (%)
Croatian: Pozitivni nalazi biopsije u liječenom režnju*, n (%)
English: What you need to know before TOOKAD is used
Croatian: Što morate znati prije primjene lijeka TOOKAD 3.
English: TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
Croatian: TOOKAD se priprema rekonstitucijom praška za otopinu za injekciju s: - 20 ml 5 %-tne otopine glukoze za TOOKAD 183 mg, - 40 ml 5 %-tne otopine glukoze za TOOKAD 366 mg.
English: AS arm N = 207
Croatian: AS skupina N = 207
English: Range: min, max
Croatian: Srednja vrijednost (SD) Raspon: min, maks
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV TOOKAD 183 mg prašak za otopinu za injekciju Jedna bočica sadrži 183 mg padeliporfina (u obliku dikalijeve soli).
English: What TOOKAD contains - The active substance is padeliporfin.
Croatian: Sadržaj pakiranja i druge informacije Što TOOKAD sadrži - Djelatna tvar je padeliporfin.
English: Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Croatian: Ostavite neprozirnu štrcaljku u uspravnom položaju 3 minute dok pjena ne nestane.
English: Use in patients on a controlled potassium diet
Croatian: Uporaba u bolesnika na dijeti s ograničenim unosom kalija
English: * The treated lobe(s) in the AS arm was defined as the lobe(s) with disease at baseline.
Croatian: * Liječeni režanj(evi) u AS skupini definirani su kao režanj(evi) s bolesti na početku ispitivanja.
English: Then the prostate is illuminated immediately for 22 minutes 15 seconds by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm.
Croatian: Zatim se prostata smjesta osvjetljava tijekom 22 minute i 15 sekundi laserskom svjetlošću od 753 nm putem intersticijskih optičkih vlakana iz laserskog uređaja pri snazi od 150 mW/cm vlakna, proizvodeći energiju od 200
English: Use in patients with abnormal clotting
Croatian: Uporaba u bolesnika s abnormalnim zgrušavanjem krvi
English: Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
Croatian: Liječnik može propisati profilaktički antibiotike i alfa blokatore.
English: No patients with light-sensitive conditions such as porphyria, a history of sensitivity to sunlight or a history of photosensitive dermatitis have received TOOKAD in clinical studies.
Croatian: U kliničkim ispitivanjima bolesnici s fotoosjetljivim stanjima poput porfirije ili bolesnici koji u povijesti bolesti imaju osjetljivost na sunčevu svjetlost ili fotodermatitis nisu primili lijek TOOKAD.
English: Reconstitute the solution by adding: - for TOOKAD 183 mg: 20 mL of a 5 % glucose solution in the vial containing the powder; - for TOOKAD 366 mg: 40 mL of a 5 % glucose solution in the vial containing the powder.
Croatian: - za TOOKAD 183 mg: 20 ml 5 %-tne otopine glukoze u bočicu s praškom; - za TOOKAD 366 mg: 40 ml 5 %-tne otopine glukoze u bočicu s praškom
English: Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
Croatian: 1 Infekcija genitalno-urinarnog sustava (infekcija urinarnog sustava, orhitis, epididimitis, cistitis).
English: Patients with abnormal clotting may bleed excessively from the insertion of the needles required to position the fibres that guide the laser light.
Croatian: Bolesnici s poremećajem zgrušavanja krvi mogu imati pretjerano krvarenje zbog ubadanja igala u svrhu smještanja vlakana koja vode lasersku svjetlost.
English: Perineal injury (post-procedural haematoma, necrosis, perineal haematoma, pelvic haematoma).
Croatian: 15 Perinealna ozljeda (postoperativni hematom, nekroza, perinealni hematom, zdjelični hematom).
English: A similar mean clearance range was seen in patients with localised prostate cancer treated with 4 mg/kg and 2 mg/kg of padeliporfin di-potassium (0.04-0.06 L/h/kg respectively).
Croatian: Sličan raspon prosječnog klirensa uočen je u bolesnika s lokaliziranim rakom prostate liječenima s 4 mg/kg i 2 mg/kg padeliporfindikalija (0,04 - 0,06 l/h/kg, ovisno o doziranju).
English: Simultaneous treatment of both prostate lobes was associated with an inferior outcome in clinical trials and should not be performed.
Croatian: U kliničkim ispitivanjima uočen je nepovoljniji ishod nakon istodobnog liječenja obaju režnjeva prostate i stoga se takvo liječenje ne smije izvoditi.