FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Med postopkom se število in dolžina optičnih vlaken izbereta glede na obliko in velikost prostate, s pomočjo ultrazvočnega usmerjanja pa se optična vlakna transperinealno namestijo v prostato, tako da se v ciljnem tkivu doseže indeks gostote svetlobe (LDI - Light Density Index) ≥ 1.
English: The reconstituted solution for infusion is dark.
Slovenian: Rekonstituirana raztopina za infundiranje je temna.
English: For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila TOOKAD pred dajanjem glejte poglavje 6.6.
English: Following TOOKAD VTP, patients should undergo digital rectal examination (DRE) and have their serum PSA monitored, including an assessment of PSA dynamics (PSA doubling time and PSA velocity).
Slovenian: Po opravljenem postopku TOOKAD-VTP je treba pri bolnikih izvesti digitalni rektalni pregled (DRE - Digital Rectal Examination), spremljati pa je treba tudi njihovo raven PSA v serumu, vključno z oceno dinamike PSA (podvojitveni čas PSA in hitrost PSA).
English: Number of subjects who initiated a radical treatment, n (%)
Slovenian: Število oseb, ki je začelo radikalno zdravljenje, n (%)
English: In the Phase III European study, 60 (30.5 %) of patients in the TOOKAD-VTP arm experienced erectile dysfunction and 16 (8.1 %) experienced ejaculation failure.
Slovenian: V evropski študiji III. faze je 60 (30,5 %) bolnikov v kraku TOOKAD-VTP doživelo erektilno disfunkcijo, 16 (8,1 %) pa neuspešno ejakulacijo.
English: Limited information is available regarding the safety and efficacy of radical prostatectomy after TOOKAD-VTP.
Slovenian: Informacije o varnosti in učinkovitosti radikalne prostatektomije po postopku TOOKAD-VTP, ki so na voljo, so omejene.
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.
Slovenian: Rezultati farmakokinetične študije populacije so pokazali, da znaten in pomemben vpliv starosti, rase, zdravstvenega stanja in označevalcev jetrne funkcije na farmakokinetiko zdravila TOOKAD ni verjeten.
English: If you feel skin or eye discomfort while in hospital, you must tell your doctor or nurse so the level of lighting can be reduced and extra care can be taken to protect you from artificial and natural light.
Slovenian: Če čutite nelagodje na koži ali v očeh med bivanjem v bolnišnici, morate to povedati zdravniku ali medicinski sestri, da bo mogoče svetlobo pridušiti in še posebej paziti na to, da boste zaščiteni tako pred umetno kot tudi naravno svetlobo.
English: When the analysis was restricted to patients that underwent unilateral VTP, 33 (16.8 %) patients experienced erectile dysfunction for more than 6 months, including 17 (8.6 %) patients in whom the erectile dysfunction had not resolved at the end of the study.
Slovenian: Ko je bila analiza omejena na bolnike, pri katerih je bil opravljen unilateralni postopek VTP, je 33 (16,8 %) bolnikov doživljalo erektilno disfunkcijo več kot 6 mesecev, vključno s 17 (8,6 %) bolniki, pri katerih erektilna disfunkcija ob koncu študije ni bila odpravljena.
English: Some difficulties in getting or maintaining an erection is possible soon after the procedure and may last for more than 6 months.
Slovenian: Kmalu po postopku so možne določene težave pri doseganju ali vzdrževanju erekcije, ki lahko trajajo več kot 6 mesecev.
English: Only use light bulbs with a maximum power of 60 watts (for an incandescent light bulb) or 6 watts (for LED lights), or 12 watts (for fluorescent low-energy lights).
Slovenian: Uporabljate lahko le sijalke z močjo največ 60 vatov (pri žarnicah), 6 vatov (pri lučeh LED) ali 12 vatov (pri fluorescentnih nizkoenergijskih lučeh).
English: In 18 patients the adverse event resolved with a median duration of 63.5 days (1-360), and the adverse event was still ongoing at the end of the study for 7 patients.
Slovenian: Pri 18 bolnikih je srednja vrednost trajanja časa do odprave neželenega učinka znašala 63,5 dni (1-360), pri 7 bolnikih pa je bil ob koncu študije ta še vedno prisoten.
English: - You have had an active inflammatory bowel disease or any condition that may increase the risk of causing abnormal connection between the rectum and the urethra (recto-urethral fistula).
Slovenian: - je bila pri vas prisotna aktivna vnetna črevesna bolezen ali kakršno koli stanje, ki lahko poveča tveganje za nastanek nenormalne povezave med danko in sečnico (rektouretralna fistula);
English: What TOOKAD is and what it is used for
Slovenian: Kaj je zdravilo TOOKAD in za kaj ga uporabljamo 2.
English: All patients had Gleason score ≤ 3 + 3 at baseline.
Slovenian: Ocena po Gleasonu je bila v izhodišču pri vseh bolnikih ≤ 3 + 3.
English: AS involved serial absolute PSA measurements and ultrasound-guided prostatic biospy at 12 and 24 months.
Slovenian: Aktivno opazovanje je vključevalo zaporedne meritve absolutne PSA in ultrazvočno vodeno biopsijo prostate pri 12 in 24 mesecih.
English: Padeliporfin has not been tested for reproductive toxicity and fertility.
Slovenian: Preskušanje padeliporfina glede vpliva na sposobnost razmnoževanja in plodnosti ni bilo izvedeno.
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.
Slovenian: Če morate podnevi oditi ven, morate nositi zaščitna oblačila in očala z visoko zaščito, da boste zavarovali svojo kožo in oči.
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)
Slovenian: TOOKAD in/ali metodo študije in/ali postopkom študije v zbirni analizi varnosti (N = 398) Organski sistem
English: TOOKAD is restricted to hospital use only.
Slovenian: Uporaba zdravila TOOKAD je omejena le na bolnišnice.
English: 5 years
Slovenian: 6 ur.
English: You may go outdoors during daylight hours but only in shaded areas or when it is overcast.
Slovenian: Podnevi lahko odidete ven le na senčna območja ali takrat, ko je oblačno.
English: Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
Slovenian: Na podlagi analize popPK znaša ocenjena razpolovna doba 1,19 h ± 0,08 pri 4 mg/kg dikalijevega padeliporfina.
English: In some cases pain relief was required for perineal pain or anorectal discomfort.
Slovenian: V nekaterih primerih je bilo za bolečino v presredku ali nelagoden občutek v anorektalnem predelu potrebno lajšanje bolečin.
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.
Slovenian: Pred zdravljenjem je treba s strategijami biopsije z visoko ločljivostjo, ki temeljijo na obstoječih dobrih praksah, kot so multiparametrične strategije na podlagi MRI ali postopki biopsije na podlagi predloge, natančno določiti mesto tumorja in ga potrditi kot unilateralnega.
English: Due to the photosensitising properties of TOOKAD, the content of the vial should then be transferred into an opaque syringe that should be held in an upright position for 3 minutes to ensure any foam disappears.
Slovenian: Zaradi lastnosti zdravila TOOKAD, ki povzročajo preobčutljivost na svetlobo, je treba vsebino viale nato prenesti v neprosojno brizgo, ki mora 3 minute stati v pokončnem položaju, da morebitna pena izgine.
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.
Slovenian: Rekonstituirajte raztopino tako, da dodate: - za zdravilo TOOKAD 183 mg: 20 ml 5-odstotne raztopine glukoze v vialo, ki vsebuje prašek; - za zdravilo TOOKAD 366 mg: 40 ml 5-odstotne raztopine glukoze v vialo, ki vsebuje prašek.
English: The most common infections are orchitis, epididymitis and urinary tract infections including cystitis.
Slovenian: Okužbe spolovil in sečil Najpogostejše okužbe so orhitis, epididimitis in okužbe sečil, vključno s cistitisom.
English: In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7.
Slovenian: Pri bolnikih z lokaliziranim rakom prostate, pri katerih je bil izveden postopek TOOKAD-VTP, so z napravo za magnetnoresonančno slikanje (MRI - Magnetic Resonance Imaging) 7. dan opazili nekrozo.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje 1 viala
English: In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
Slovenian: T3, pozitivnih robovih in impotenci.
English: TOOKAD is administered as part of focal VTP.
Slovenian: Zdravilo TOOKAD se daje kot del fokalnega zdravljenja s postopkom VTP.
English: The pivotal open-label Phase III study (PCM301), conducted in 10 European countries, randomised 413 patients to TOOKAD-VTP arm or AS arm.
Slovenian: Ključna odprta študija III. faze (PCM301), ki je bila izvedena v 10 evropskih državah, je randomizirala 413 bolnikov v krak TOOKAD-VTP ali krak z aktivnim spremljanjem (AS - Active Surveillance).
English: If the patient must go outdoors during daylight hours, he should wear protective clothes and high protection goggles to shield his skin and eyes.
Slovenian: Če mora bolnik podnevi oditi ven, mora nositi zaščitna oblačila in očala z visoko stopnjo zaščite, da zavaruje svojo kožo in oči.
English: If it is not possible to stop a photosensitising medicinal product (such as amiodarone), the patient should be advised that increased sensitivity to sunlight may occur and they may need to protect themselves from direct light exposure for a longer period (see section 4.2).
Slovenian: Če prenehanje uporabe zdravil, ki povzročajo preobčutljivost na svetlobo (kot je amiodaron), ni mogoče, je treba bolniku povedati, da lahko pride do povečane občutljivosti na svetlobo in da se bo moral morda dlje časa varovati pred izpostavljenostjo neposredni svetlobi (glejte poglavje 4.2).
English: It is not expected that a delay in clotting will reduce the effectiveness of the TOOKAD-VTP treatment ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure (see section 4.5).
Slovenian: Ni pričakovati, da bi zamik pri strjevanju krvi zmanjšal učinkovitost zdravljenja s postopkom TOOKAD-VTP, vendar zdravil, ki vplivajo na strjevanje, ni priporočljivo dajati pred postopkom VTP in takoj po njem (glejte poglavje 4.5).
English: Because the fibres that carry the light have to be inserted in such a way that the whole of the lobe of the prostate gland gets exposed, it is possible that some damage may occur outside of the prostate.
Slovenian: Tveganje poškodb v bližini prostate Ker morajo biti vlakna, ki prenašajo svetlobo, vstavljena na tak način, da pride do izpostavljenosti celotnega režnja prostate, lahko zunaj prostate pride do določenih poškodb.
English: 1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
Slovenian: 1 ml rekonstituirane raztopine vsebuje 9,15 mg padeliporfina.
English: A urinary fistula has occurred in one case due to incorrect fibre placement.
Slovenian: V enem primeru se je zaradi nepravilne namestitve vlaken pojavila urinska fistula.
English: Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
Slovenian: Ekstraprostatična nekroza V periprostatični maščobi se lahko pojavi ekstraprostatična nekroza, ki ni povezana s kliničnimi simptomi.
English: • Information on the existing therapeutic approaches (including VTP with TOOKAD) for the treatment of the type of prostate cancer
Slovenian: • informacije o obstoječih terapevtskih pristopih (vključno o postopku VTP z zdravilom
English: Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Slovenian: Trenutno poslabšanje rektalne vnetne črevesne bolezni (glejte poglavje 4.4).
English: The most frequently reported adverse reactions in the Phase II and III clinical studies were urinary and reproductive system disorders: dysuria (25.1 %), erectile dysfunction (21.1 %), haematuria (19.6 %), perineal pain/haematoma (15.3 %), urinary retention (13.3 %), micturition urgency (9.0 %), pollakiuria (7.3 %), urinary tract infection (5.5 %), incontinence (5.3 %) and ejaculation failure
Slovenian: in III. faze, so bile bolezni ledvic in sečil ter motnje reprodukcije: disurija (25,1 %), erektilna disfunkcija (21,1 %), hematurija (19,6 %), bolečina/hematom v presredku (15,3 %), zadrževanje urina (13,3 %), siljenje na vodo (9,0 %), polakiurija (7,3 %), okužba sečil (5,5 %), inkontinenca (5,3 %) in neuspešna ejakulacija
English: He should wear dark clothes and take care when exposing hands and face to the sun.
Slovenian: Nositi mora temna oblačila in biti pazljiv pri izpostavljanju rok in obraza soncu.
English: Transfer the contents of the vial into an opaque syringe.
Slovenian: Vsebino viale prenesite v neprosojno brizgo.
English: It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure.
Slovenian: Zdravilo lahko uporablja le osebje, ki je usposobljeno za postopek žilno ciljanega fotodinamičnega zdravljenja (VTP -Vascular-Targeted
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.
Slovenian: Pri pozitivnih biopsijah je treba bolnikom, pri katerih je presežen prag za nizko tvegano bolezen (npr. pri katerih je GS > 6 in pri katerih je število pozitivnih stebričkov > 3 ali pa je dolžina katerega koli posameznega stebrička >5 mm), priporočiti radikalno zdravljenje.
English: 7 Place du Théâtre L-2613 Luxembourg Luxembourg
Slovenian: L-2613 Luxembourg
English: This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental (see section 4.2).
Slovenian: To je treba upoštevati pri bolnikih z okvarjenim delovanjem ledvic ali pri bolnikih, ki so na dieti z nadzorovanim vnosom kalija, pri katerih bi povečanje kalija v serumu veljalo za škodljivo (glejte poglavje 4.2).
English: c
Slovenian: Z
English: If the patient reports discomfort to the skin or eyes during hospitalisation, reduce the level of lighting and take extra care to shield the patient from artificial and natural light.
Slovenian: Če bolnik med hospitalizacijo poroča o nelagodnih občutkih na koži ali v očeh, zmanjšajte osvetljenost ter posebej pazite na to, da bolnika zaščitite tako pred umetno kot tudi naravno svetlobo.
English: However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided these patients strictly follow the precautions against light exposure.
Slovenian: Toda zaradi kratkotrajnega delovanja zdravila TOOKAD naj bi bilo tveganje povečane fototoksičnosti po pričakovanjih nizko, če ti bolniki strogo upoštevajo previdnostne ukrepe izogibanja svetlobi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: The risk of sphincter damage can be minimised by careful planning of the fibre placement using the treatment guidance software.
Slovenian: Tveganje za poškodbe mišice zapiralke je mogoče zmanjšati s pazljivim načrtovanjem namestitve vlaken s programsko opremo za usmerjanje zdravljenja.
English: Abnormal clotting is not expected to affect how well the treatment works ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure.
Slovenian: Ni pričakovati, da bi nenormalno strjevanje krvi vplivalo na to, kako dobro deluje zdravljenje, vendar zdravil, ki vplivajo na strjevanje, ni priporočljivo jemati pred postopkom VTP in takoj po njem.
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.
Slovenian: Kakršni koli predhodni posegi na prostati, pri katerih bi se lahko poškodovala notranja mišica zapiralka sečnice, vključno s transuretralno resekcijo prostate (TURP - Trans-Urethral Resection of the Prostate) pri benigni hipertrofiji prostate.
English: There was no significant correlation between the percentage of prostate necrosis on Day 7 MRI and the likelihood of a negative prostate biopsy at follow-up.
Slovenian: Med odstotkom nekroze prostate, ugotovljene z MRI 7. dne, in verjetnostjo negativne biopsije prostate ob kontroli ni bilo pomembne korelacije.
English: An LDI ≥ 1 appeared to be associated with a greater volume of necrosis on Day 7 MRI and greater share of patients with negative biopsy at 6 months compared with an LDI < 1 (see section 4.2).
Slovenian: Indeks LDI ≥ 1 se je v primerjavi z indeksom LDI < 1 zdel povezan z večjo prostornino nekroze, ugotovljeno z MRI 7. dne, in z večjim deležem bolnikov z negativno biopsijo po 6 mesecih (glejte poglavje 4.2).
English: The patient can return to normal activity and tolerate direct sunlight 48 hours after the procedure.
Slovenian: Bolnik se lahko vrne k običajnim dejavnostim in prenaša neposredno sončno svetlobo, ko preteče
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD07
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za fotodinamično terapijo in terapijo z obsevanjem z vidnim delom elektromagnetnega valovanja, koda ATC: L01XD07
English: Radical therapy post VTP procedure
Slovenian: Radikalno zdravljenje po postopku VTP
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).
Slovenian: Postopek TOOKAD-VTP je kontraindiciran pri bolnikih s kakršnimi koli predhodnimi posegi na prostati, pri katerih je bila notranja mišica zapiralka sečnice morda poškodovana, vključno s transuretralno resekcijo prostate (TURP) zaradi benigne hipertrofije prostate (glejte poglavje 4.3).
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.
Slovenian: Kot je prikazano v preglednici 6, so v kraku VTP študije PCM301 rezultati s področja erektilne disfunkcije, pridobljeni iz 15 vprašanj mednarodnega indeksa erektilne funkcije (IIEF-15International Index of Erectile Function), v populaciji ITT in pri bolnikih, ki izpolnjujejo merila indikacije, 7 dni po postopku VTP pokazali jasno zmanjšanje, ki mu je v naslednjih mesecih do 24. meseca sledilo izboljšanje.
English: There is limited clinical information on overdose involving TOOKAD.
Slovenian: O prevelikem odmerjanju v povezavi z zdravilom TOOKAD obstajajo omejene informacije.
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.
Slovenian: Da preprečite zanositev partnerke, morate vi ali vaša partnerka ali pa oba 90 dni po postopku VTP uporabljati učinkovito obliko kontracepcije.
English: Effects of covariates on pharmacokinetic properties The effects of age, weight and race were investigated in healthy volunteers and patients.
Slovenian: Pri zdravih prostovoljcih in bolnikih so bili preučevani vplivi starosti, mase in rase.
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.
Slovenian: Zmerno/visoko tvegani rak prostate je bil opredeljen kot kar koli od naslednjega: > 3 stebrički, ki so zagotovo pozitivni za raka; primarni ali sekundarni vzorec po Gleasonu ≥ 4; vsaj 1 dolžina stebrička rakastega tkiva > 5 mm; PSA > 10 ng/ml pri treh zaporednih meritvah; rak prostate T3; metastaza; smrt, povezana z rakom prostate.
English: There is no relevant use of TOOKAD in the paediatric population in the treatment of low-risk localised prostate cancer.
Slovenian: Uporabe zdravila TOOKAD za zdravljenje nizko tveganega raka prostate pri pediatrični populaciji ni relevantna.
English: Anticoagulants and antiplatelet agents
Slovenian: Antikoagulanti in antitrombotiki
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.
Slovenian: To je treba upoštevati pri bolnikih z okvarjenim delovanjem ledvic ali bolnikih, ki so na dieti z nadzorovanim vnosom kalija, pri katerih bi povečanje kalija v serumu lahko bilo škodljivo.
English: In assessing overall tolerability by Month 24, post enrolment patients who underwent a radical therapy were also counted in the scoring of prostate symptoms and erectile function.
Slovenian: Pri ocenjevanju splošnega prenašanja do 24. meseca so bili v ocenjevanje simptomov prostate in erektilne funkcije všteti tudi bolniki po vključitvi v študijo, ki so bili zdravljeni radikalno.
English: Minimal metabolism of padeliporfin was observed in in vitro metabolism studies in human liver microsomes and S9 fractions.
Slovenian: V študijah presnove in vitro v humanih jetrnih mikrosomih in frakcijah S9 je bila opažena minimalna presnova padeliporfina.
English: The patient may go outdoors during daylight hours but only in shaded areas or when it is overcast.
Slovenian: Bolnik se lahko podnevi zadržuje zunaj, vendar le v senci ali takrat, ko je oblačno.
English: In healthy human male subjects, the Cmax was shown to be linear from 1.25 mg/kg to 15 mg/kg of padeliporfin di-potassium, covering the therapeutic range.
Slovenian: Pri zdravih moških je bilo dokazano, da je vrednost Cmax linearna od 1,25 mg/kg do 15 mg/kg dikalijevega padeliporfina, kar zajema terapevtski razpon.
English: Its volume is measured after prostate delineation using the treatment guidance software.
Slovenian: Njegova prostornina se izmeri po zamejitvi prostate s programsko opremo za usmerjanje zdravljenja.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje
English: If it is not possible to stop a photosensitising medicine (such as amiodarone), increased sensitivity may occur, you may need to protect yourself from direct light exposure for a longer period.
Slovenian: Če prenehanje uporabe zdravil, ki povzročajo preobčutljivost na svetlobo (kot je amiodaron), ni mogoče, lahko pride do povečane občutljivosti in morda se boste morali dlje časa varovati pred izpostavljenostjo neposredni svetlobi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1228/001
English: Number of subjects who initiated a radical treatment after progression, n (%)
Slovenian: Število oseb, ki je začelo radikalno zdravljenje po napredovanju bolezni, n (%)