FrancophonIA/ELRC3.0 huggingface dataset:
English: Normally this is just the fat around the prostate and is not important but nearby organs such as the bladder and rectum may potentially be affected.
Slovenian: Običajno gre le za maščobo okrog prostate in za nič pomembnega, vendar so lahko prizadeti bližnji organi, kot sta mehur in danka.
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.
Slovenian: Pred prihodom zdravila TOOKAD na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: The final solution concentration is 9.15 mg/mL.
Slovenian: Končna koncentracija raztopine znaša 9,15 mg/ml.
English: No metabolites of padeliporfin were observed in these studies.
Slovenian: V teh študijah ni bilo opaženih nobenih presnovkov padeliporfina.
English: In Phase II studies, treatment conditions corresponding to an LDI ≥ 1 were associated with a mean rate of necrosis of the targeted zone at day 7 of 89 % ± 20.75 for unilateral treatment.
Slovenian: faze so bili pogoji zdravljenja, ki so ustrezali indeksu LDI ≥ 1, povezani s srednjo vrednostjo nekroze ciljanega območja, ki je 7. dne znašala 89 % ± 20,75 za unilateralno zdravljenje.
English: Your doctor may prescribe antibiotics to prevent infection and alpha-blockers (medicines given to prevent difficulties in urinating).
Slovenian: Zdravnik vam lahko predpiše antibiotike za preprečevanje okužbe in zaviralce alfa (zdravila za preprečevanje težav pri uriniranju).
English: There is limited data on long-term outcomes and on potential consequences of post-TOOKAD local scarring in case of disease progression.
Slovenian: Podatki o dolgoročnih izidih in morebitnih posledicah lokalnega brazgotinjenja po zdravljenju z zdravilom TOOKAD pri napredovanju bolezni so omejeni.
English: Marketing Authorisation Holder Steba Biotech S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom Steba Biotech S.A.
English: Very few patients aged over 75 years were enrolled into studies where pharmacokinetic measurements were taken so it is not known if there is a difference in these older patients compared to patients less than 75 years of age (see sections 4.2 and 5.1).
Slovenian: starejših od 75 let, zato ni znano, ali pri primerjavi teh starejših bolnikov z bolniki, starimi manj kot 75 let, obstaja razlika (glejte poglavji 4.2 in 5.1).
English: Elderly No specific posology adjustment is necessary in this population (see section 5.2).
Slovenian: Starejši Pri tej populaciji odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
English: No data are available in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni na voljo nobenih podatkov.
English: Other medicines and TOOKAD
Slovenian: Druga zdravila in zdravilo TOOKAD
English: In the 24 months of the pivotal European Phase III study, no patients underwent radical radiotherapy post TOOKAD-VTP.
Slovenian: V 24 mesecih ključne evropske študije III. faze noben bolnik po postopku TOOKAD-VTP ni bil radikalno zdravljen z obsevanjem.
English: This results in transient arterial vasodilatation that triggers the release of the vasoconstrictor, endothelin-1.
Slovenian: Zato pride do prehodne arterijske vazodilatacije, ki sproži sproščanje vazokonstriktorja, endotelina-1.
English: 53 (26.9 %) patients experienced erectile dysfunction for more than 6 months, including 34 (17.3 %) patients in whom the erectile dysfunction had not resolved at the end of the study.
Slovenian: 53 (26,9 %) bolnikov je doživljalo erektilno disfunkcijo več kot 6 mesecev, vključno s 34 (17,3 %) bolniki, pri katerih erektilna disfunkcija ob koncu študije ni bila odpravljena.
English: The patient must stay in a dimmed light environment without any direct exposure of the skin and the eyes to daylight.
Slovenian: Bolnik mora ostati v okolju s pridušeno svetlobo, brez kakršne koli neposredne izpostavljenosti kože ali oči dnevni svetlobi.
English: Poor urinary flow due to urethral stricture developed some months post procedure.
Slovenian: Nezadosten pretok zaradi strikture sečnice se je pojavil nekaj mesecev po postopku.
English: The median duration was 21 days (4-197).
Slovenian: Srednja vrednost trajanja je znašala 21 dni (4-197).
English: In certain cases, the bulbar location suggested that the stenosis was caused by urinary catheterisation.
Slovenian: V določenih primerih so izbokline kazale na to, da je stenozo povzročila urinska kateterizacija.
English: - You experience difficulties in getting or maintaining an erection.
Slovenian: - imate težave pri doseganju ali vzdrževanju erekcije;
English: T2a, n (%)
Slovenian: T1, n (%) T2a, n (%)
English: Clinical stages
Slovenian: Klinični stadiji
English: Longer follow-up will be required to determine whether TOOKAD-VTP will be curative in a proportion of patients.
Slovenian: Za ugotavljanje, ali bo postopek TOOKAD-VTP pri določenem deležu bolnikov kurativen, bo potrebno daljše spremljanje.
English: Of 58 patients that progressed in the TOOKAD-VTP arm, only 11 underwent radical therapy, 18 patients underwent a second VTP procedure and 29 had not received further treatment at the end of the study.
Slovenian: Od 58 bolnikov, pri katerih je v kraku TOOKAD-VTP bolezen napredovala, jih je bilo le 11 zdravljenih radikalno, 18 jih je bilo zdravljenih z drugim postopkom VTP, 29 pa jih ob koncu študije ni bilo dodatno zdravljenih.
English: TOOKAD must not be used if: - You are allergic to padeliporfin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TOOKAD Ne uporabljajte zdravila TOOKAD: - če ste alergični na padeliporfin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: You may also be required to not take certain medicines for several days after the VTP procedure.
Slovenian: Po postopku VTP bodo od vas morda zahtevali, da več dni ne jemljete določenih zdravil.
English: In the Active Surveillance arm, the IPSS score slightly worsened over time until Month 24.
Slovenian: V kraku aktivnega opazovanja se je rezultat po 24. mesecu sčasoma rahlo poslabšal.
English: This is enhanced by RNS-induced endothelial cell apoptosis and initiation of self-propagated tumour cells necrosis through peroxidation of their membrane.
Slovenian: To je še okrepljeno zaradi z RNS inducirane apoptoze endotelijskih celic in sprožitve avtopropagacijske nekroze tumorskih celic s peroksidacijo njihove membrane.
English: Treatment should not be undertaken in patients where an LDI ≥ 1 cannot be achieved (see section 5.1).
Slovenian: Pri bolnikih, pri katerih ni mogoče doseči indeksa LDI ≥ 1, se zdravljenje ne sme izvajati (glejte poglavje 5.1).
English: Age (years) Mean (SD) Range: min, max Patients aged > 75 year old, n (%) Unilateral disease, n (%) Bilateral disease, n (%)
Slovenian: Bolniki, stari > 75 let, n (%) Unilateralna bolezen, n (%) Bilateralna bolezen, n (%)
English: • Information on adverse drug reactions and the likelihood of them getting them, including: erectile dysfunction, urinary incontinence, urinary retention/urethral stricture, and photosensitivity and the need to follow the rules to protect themselves against the light after the procedure for 48 hours.
Slovenian: • informacije o neželenih učinkih in o verjetnosti, da se bodo ti pojavili, vključno z erektilno disfunkcijo, urinsko inkontinenco, zastajanjem urina/strikturo sečnice ter preobčutljivostjo na svetlobo in nujnostjo upoštevanja pravil za lastno zaščito pred svetlobo 48 ur po postopku.
English: The median duration was 10 days (1-344).
Slovenian: Srednja vrednost trajanja je znašala 10 dni (1-344).
English: Range: min, max PSA (ng/mL)
Slovenian: PSA (ng/ml)
English: It should only be used by personnel trained in the VTP procedure.
Slovenian: Uporablja ga lahko le osebje, ki je usposobljeno za postopek VTP.
English: Urinary incontinence
Slovenian: Urinska inkontinenca
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.
Slovenian: Pri kontrolni biopsiji zdravljenega režnja je bil po 12 in 24 mesecih odkrit rezidualni tumor, ki je bil običajno zunaj zdravljene prostornine, občasno pa znotraj območja nekroze.
English: The patient may watch television from a distance of 2 metres and, from 6 hours onwards, may use electronic devices such as smartphones, tablets and computers.
Slovenian: Bolnik lahko gleda televizijo z razdalje dveh metrov, po šestih urah pa lahko uporablja elektronske naprave, kot so pametni telefoni ter tablični in osebni računalniki.
English: There was a correlation between the total energy delivered and the volume of necrosis observed at day 7.
Slovenian: Obstajala je povezava med skupno dovedeno energijo in prostornino nekroze 7. dne.
English: Warnings and precautions TOOKAD should only be used by personnel trained in the VTP procedure.
Slovenian: Opozorila in previdnostni ukrepi Zdravilo TOOKAD lahko uporablja le osebje, ki je usposobljeno za postopek VTP.
English: The magnitude of interaction has not been investigated clinically but a transient increase in the plasma concentration of co-administered substrates of OATP1B1 and OATP1B3 cannot be ruled out.
Slovenian: Obseg medsebojnega delovanja ni bil klinično preučevan, vendar prehodnega povečanja plazemske koncentracije sočasno uporabljenih substratov OATP1B1 in OATP1B3 ni mogoče izključiti.
English: An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4).
Slovenian: Prevelik odmerek laserske svetlobe lahko poveča tveganje neželene ekstraprostatične nekroze (glejte poglavje 4.4).
English: First 12 hours after VTP procedure
Slovenian: Prvih 12 ur po postopku VTP
English: Urinary incontinence (urge incontinence, incontinence, stress urinary incontinence).
Slovenian: 8 Urinska inkontinenca (urgentna inkontinenca, inkontinenca, stresna urinska inkontinenca).
English: In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
Slovenian: V evropski študiji III. faze se je pri 25 (12,7 %) bolnikih pojavila urinska inkontinenca (vključno z inkontinenco, stresno urinsko inkontinenco in urgentno inkontinenco).
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).
Slovenian: Če potrebujete dodatno zdravljenje, so informacije o tem, ali postopek TOOKAD-VTP vpliva na rezultate učinkovitosti in varnosti drugih zdravljenj (kot je operacija za odstranitev prostate ali obsevanje), trenutno omejene.
English: The day before and at the beginning of the VTP procedure, a rectal preparation is performed in order to clean the rectum.
Slovenian: En dan pred postopkom VTP in tik pred njim se za čiščenje danke izvede rektalna priprava.
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.
Slovenian: Od 121 bolnikov, pri katerih je v kraku AS bolezen napredovala, jih je bilo 54 zdravljenih radikalno, 67 pa ob koncu študije ni bilo aktivno zdravljenih.
English: In addition, inserting needles into the prostate gland and inserting a urinary catheter for the procedure may be associated with further side effects.
Slovenian: Poleg tega sta vstavljanje igel v prostato in vstavitev urinskega katetra povezana z dodatnimi neželenimi učinki.
English: The Patient information guide about TOOKAD should contain the following key elements:
Slovenian: Vodnik z informacijami za bolnike o zdravilu TOOKAD mora vsebovati naslednje ključne elemente:
English: Additional VTP procedures of the prostate are not recommended.
Slovenian: Dodatni postopki VTP na prostati niso priporočljivi.
English: Rapid consumption of the •NO radicals, by oxygen radicals, leads to the formation of reactive nitrogen species (RNS) (e.g. peroxynitrite), in parallel to arterial constriction.
Slovenian: Radikale •NO hitro konzumirajo radikali kisika, zato se hkrati z zoženjem arterij ustvarijo reaktivne dušikove zvrsti (RNS - reactive nitrogen species) (npr. peroksinitrit).
English: These medicines 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 photosensitising properties.
Slovenian: Ta zdravila je treba prenehati jemati vsaj 10 dni pred postopkom z zdravilom TOOKAD in se jih ne sme jemati vsaj 3 dni po postopku ali pa jih je treba zamenjati z drugimi zdravili brez lastnosti, ki povzročajo preobčutljivost na svetlobo.
English: TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3).
Slovenian: Zdravilo TOOKAD je kontraindicirano pri bolnikih, pri katerih je bila diagnosticirana holestaza (glejte poglavje 4.3).
English: causing local hypoxia that induces the release of nitric oxide (•NO) radicals.
Slovenian: 2), ki povzročijo lokalno hipoksijo, ta pa privede do sprostitve radikalov dušikovega oksida (•NO).
English: After the procedure, you should wear protective goggles and will be kept under medical surveillance for at least 6 hours in a room with reduced light.
Slovenian: Po postopku morate nositi zaščitna očala in ostati pod zdravniškim nadzorom v sobi s pridušeno svetlobo vsaj 6 ur.
English: Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4).
Slovenian: Ponovno zdravljenje istega režnja ali zaporedno zdravljenje režnja prostate na nasprotni strani nista priporočljivi (glejte poglavje 4.4).
English: In addition, impaired deformability is thought to enhance erythrocyte aggregability and formation of blood clots at the interface of the arterial supply (feeding arteries) and tumour microcirculation, results in occlusion of the tumour vasculature.
Slovenian: Poleg tega naj bi okrnjena deformabilnost krepila agregabilnost eritrocitov in nastajanje krvnih strdkov v stičnih oskrbovalnih arterijah, mikrocirkulacija tumorja pa naj bi povzročala zaporo tumorskih žil.
English: This may also cause bruising, haematuria and/or local pain.
Slovenian: To lahko povzroči tudi podplutbe, hematurijo in/ali lokalno bolečino.
English: Healthy subjects have been exposed to doses up to 15 mg/kg of padeliporfin di-potassium (corresponding to 13.73 mg/kg of padeliporfin) without light activation and 23 patients have been treated with 6 mg/kg of padeliporfin di-potassium (corresponding to 5.49 mg/kg of padeliporfin) without significant safety issues.
Slovenian: Zdrave osebe so bile izpostavljene odmerkom dikalijevega padeliporfina do največ 15 mg/kg (kar ustreza 13,73 mg/kg padeliporfina) brez svetlobne aktivacije, 23 bolnikov pa je bilo zdravljenih s 6 mg/kg dikalijevega padeliporfina (kar ustreza 5,49 mg/kg padeliporfina) brez pomembnih varnostnih težav.
English: Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Slovenian: Zdravila, ki preprečujejo ali zmanjšujejo agregacijo trombocitov, se ne smejo uporabljati vsaj 3 dni po postopku.
English: You should wear dark clothes and take care to protect your hands and face from the sun.
Slovenian: Nositi morate temna oblačila in paziti, da roke in obraz zaščitite pred soncem.
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.
Slovenian: Nekatera zdravila (še posebej zdravila, ki povzročajo preobčutljivost na svetlobo ali vplivajo na strjevanje krvi) lahko medsebojno delujejo z zdravilom TOOKAD in jih je pred uporabo zdravila TOOKAD treba prenehati jemati.
English: The solution is administered by intravenous injection over 10 minutes.
Slovenian: Raztopina se daje z intravensko injekcijo v trajanju 10 minut.
English: What TOOKAD looks like and contents of the pack TOOKAD is a dark powder.
Slovenian: Izgled zdravila TOOKAD in vsebina pakiranja Zdravilo TOOKAD je prašek temne barve.
English: In other cases, urethral stenosis may have been a late consequence of TOOKAD-VTP induced necrosis.
Slovenian: V drugih primerih je stenoza sečnice lahko zapoznela posledica nekroze, sprožene s postopkom TOOKAD-VTP.
English: For instructions to healthcare professionals on reconstitution of TOOKAD before injection, see “Reconstitution of the TOOKAD powder for solution for injection”.
Slovenian: Navodila za zdravstvene delavce o rekonstituciji zdravila TOOKAD pred injiciranjem si oglejte v poglavju „Rekonstitucija praška TOOKAD za raztopino za injiciranje“.
English: What you need to know before TOOKAD is used
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TOOKAD 3.
English: VTP procedure
Slovenian: Postopek VTP
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.
Slovenian: Zato je morda treba skozi penis v mehur vstaviti kateter za drenažo urina, ki bo nekaj dni ali tednov ostal na tem mestu.
English: LIST OF EXCIPIENTS Excipient: Mannitol
Slovenian: SEZNAM POMOŽNIH SNOVI pomožna snov: manitol
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.
Slovenian: V ključni evropski študiji III. faze se je zmerna do resna stenoza sečnice pojavila pri 2 (1,0 %) bolnikih v času od 5 do 6 mesecev po postopku.
English: However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4).
Slovenian: Vendar preobčutljivost na svetlobo lahko traja dlje, zato je treba previdnostne ukrepe v zvezi z izogibanjem izpostavljenosti svetlobi upoštevati še dodatnih 24 ur (glejte poglavje 4.4).
English: Sunscreen creams do not protect you against the type of light (near infra-red) that can cause problems after the procedure.
Slovenian: Kreme za zaščito pred soncem ne varujejo pred vrsto svetlobe (z valovno dolžino blizu infrardečega spektra), ki po postopku povzroča težave.
English: Place a 0.22 μm injection filter on the syringe.
Slovenian: Na brizgo namestite injekcijski filter velikosti 0,22 μm.
English: There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
Slovenian: Zdravilo TOOKAD se minimalno izloča skozi ledvice, zato pri bolnikih z okvaro ledvic ni treba prilagoditi odmerka.
English: Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
Slovenian: Aktivacija znotraj osvetljenega ožilja tumorja ustvari kisikove radikale (•OH, O
English: • Explain what the VTP procedure involves, including the need to follow the rules to protect the Patient against light after the procedure for 48 hours, due to the photosensitising effect of TOOKAD and provide a copy of the TOOKAD Package Leaflet to the Patient ahead of the VTP procedure
Slovenian: • razlago, kaj zajema postopek VTP, vključno z nujnostjo upoštevanja pravil za zaščito bolnika pred svetlobo 48 ur po postopku zaradi učinka zdravila TOOKAD, ki povzroča preobčutljivost na svetlobo, in zagotovitev izvoda navodil za uporabo zdravila TOOKAD bolniku pred postopkom VTP.
English: Talk to your doctor or nurse if: - You feel any irritation of the skin or problems with vision or eye irritation after the
Slovenian: Z zdravnikom ali medicinsko sestro se posvetujte, če: - po postopku VTP čutite kakršno koli draženje kože, imate težave z vidom ali čutite draženje oči;
English: In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
Slovenian: V evropski študiji III. faze je 30 (15,2 %) bolnikov doživelo zastajanje urina.
English: Patients in the AS arm were not offered subsequent VTP.
Slovenian: Bolnikom v kraku AS naknadno zdravljenje s postopkom VTP ni bilo ponujeno.
English: Penile swelling (balanoposthitis).
Slovenian: 13 Otekanje penisa (balanopostitis).
English: Only the lobe that contains the cancer will be treated.
Slovenian: Zdravljen bo le reženj, v katerem je rak.
English: The Physician guideline about TOOKAD should contain the following key elements:
Slovenian: Smernice za zdravnike o zdravilu TOOKAD morajo vsebovati naslednje ključne elemente:
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.
Slovenian: Pri enem bolniku, zdravljenem z 2 mg/kg zdravila TOOKAD, so 33 dni po postopku VTP poročali o enem primeru ishemične optične nevropatije 3. stopnje.
English: Excessive extraprostatic necrosis occurred as a result of incorrect calibration of the laser or placement of the light fibres (see section 4.8).
Slovenian: Do čezmerne ekstraprostatične nekroze je prišlo zaradi nepravilnega umerjanja laserja ali namestitve svetlobnih vlaken (glejte poglavje 4.8).
English: The median time to onset of urinary incontinence was 4 days (1-142).
Slovenian: Srednja vrednost časa do nastopa urinske inkontinence je znašala 4 dni (1-142).
English: No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Slovenian: Brez rezultata biopsije, n Osebe, ki so bile zdravljene radikalno, zato biopsija manjka, n (%)
English: For the 48 hours after the procedure you should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Slovenian: Prvih 48 ur po posegu se morate izogibati izpostavljenosti neposredni sončni svetlobi (tudi svetlobi, ki prodira skozi okna) in vsem močnim virom svetlobe v notranjih prostorih in na prostem.
English: Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter je pričakovana povečana in/ali podaljšana izpostavljenost padeliporfinu.
English: Concomitant use of systemic VEGF inhibitors is not recommended with TOOKAD.
Slovenian: Sočasna uporaba sistemskih zaviralcev VEGF z zdravilom TOOKAD ni priporočljiva.
English: Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Slovenian: Do dveh primerov čezmerne ekstraprostatične nekroze brez kliničnih posledic je prišlo zaradi nepravilnega umerjanja laserja.
English: Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Slovenian: Kakršno koli zdravstveno stanje, zaradi katerega dajanje splošnih anestetikov ali invazivni postopki niso mogoči.
English: However, as the procedure includes general anaesthesia, patients should not perform complex tasks like driving or using machines until 24 hours after a general anaesthetic is employed.
Slovenian: Ker pa postopek vključuje splošno anestezijo, bolniki 24 ur po uporabi splošnega anestetika ne smejo izvajati zapletenih opravil, kot sta vožnja ali upravljanje strojev.
English: Patients should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Slovenian: Bolniki se morajo izogibati izpostavljenosti neposredni sončni svetlobi (tudi svetlobi, ki prodira skozi okna) in vsem močnim virom svetlobe v notranjih prostorih in na prostem.