FrancophonIA/ELRC3.0 huggingface dataset:
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
Slovenian: • pristope (vključno s postopkom VTP z zdravilom TOOKAD) k zdravljenju raka prostate pri bolniku in morebitne koristi, tveganja in negotovosti postopka VTP z zdravilom TOOKAD: o navedbo, da so informacije o obdobju po postopku TOOKAD -VTP, daljšem od dveh let, omejene ter da podatki o dolgoročni učinkovitosti in varnosti postopka TOOKAD
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 (%)
Slovenian: Drugi razlogid, n (%) Pozitivna biopsija, n (%) Pozitivna biopsija v zdravljenem režnju*, n aRazmerje tveganja (95 % CI) = 3,62 (2,50; 5,26); vrednost p < 0,001 bRazmerje tveganja (95 % CI) = 3,24 (2,41; 4,36); vrednost p < 0,001 cMed 60 bolniki, ki so bili zdravljeni radikalno, je imelo 5 bolnikov biopsijo v 24. mesecu.
English: Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
Slovenian: Uporaba pri bolnikih z nenormalnim strjevanjem krvi Pri bolnikih z nenormalnim strjevanjem krvi lahko zaradi vstavljanja igel, potrebnih za namestitev svetlobnih vlaken, pride do čezmerne krvavitve.
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.
Slovenian: Postopek VTP je bil sestavljen iz 10-minutnega intravenskega injiciranja zdravila TOOKAD v odmerku 4 mg/kg, ki mu je sledilo 22 minut in 15 sekund osvetljevanja z lasersko svetlobo valovne dolžine 753 nm z odmerkom svetlobe, dovedene prek optičnih vlaken, ki znaša 200 J/cm; pri tem so bila uporabljena intersticijska optična vlakna, v prostato vstavljena transperinealno.
English: No in vitro or in vivo studies have been conducted with radiolabelled padeliporfin.
Slovenian: Z radioaktivno označenim padeliporfinom ni bilo izvedenih nobenih študij in vitro ali in vivo.
English: TOOKAD is a medicine that contains padeliporfin (as potassium salt).
Slovenian: Kaj je zdravilo TOOKAD in za kaj ga uporabljamo TOOKAD je zdravilo, ki vsebuje padeliporfin (v obliki kalijeve soli).
English: TOOKAD has no influence on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo TOOKAD nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Possible side effects can occur with TOOKAD and VTP procedure.
Slovenian: Pri zdravilu TOOKAD in postopku VTP se lahko pojavijo možni neželeni učinki.
English: The body weight of patients (range 60-120 kg) presented a minor impact on the TOOKAD pharmacokinetic parameters for doses up to 5 mg/kg of padeliporfin di-potassium.
Slovenian: Na farmakokinetične parametre zdravila TOOKAD je pri odmerkih do 5 mg/kg dikalijevega padeliporfina nekoliko vplivala telesna masa bolnikov (v razponu od 60 kg do 120 kg).
English: Range: min, max Estimated prostate volume (cc) Mean (SD)
Slovenian: Ocenjena prostornina prostate (cc) Srednja vrednost (SD) Razpon: min., maks.
English: Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
Slovenian: 12 Bolečina v prostati (prostatizem, bolezni prostate, fibroza prostate).
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.
Slovenian: Takoj zatem se prostata za 22 minut in 15 sekund osvetli z lasersko svetlobo valovne dolžine 753 nm, ki prihaja iz intersticijskih optičnih vlaken laserske naprave z močjo 150 mW/cm na vlakno, ki dovaja energijo 200 J/cm.
English: Anorectal discomfort (proctalgia, rectal tenesmus).
Slovenian: 2 Nelagoden občutek v anorektalnem predelu (proktalgija, rektalni tenezem).
English: Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Slovenian: Preglednica 4: PCM301 - število radikalno zdravljenih oseb pri 24 mesecih - populacija ITT in bolniki, ki izpolnjujejo merila indikacije
English: - You experience involuntary passing of urine after the VTP procedure.
Slovenian: - se po postopku VTP pojavi nehoteno uriniranje;
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.
Slovenian: Pri bolnikih z anamnezo strikture sečnice ali s težavami pri pretoku urina se po postopku TOOKADVTP lahko poveča tveganje za nezadosten pretok in zastajanje urina.
English: TOOKAD-VTP arm N = 206
Slovenian: Krak TOOKAD-VTP N = 206
English: - A medicine used to treat cardiac arrhythmia (amiodarone).
Slovenian: - zdravilo za zdravljenje glivičnih okužb (griseofulvin); - zdravilo za zdravljenje srčne aritmije (amiodaron).
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),
Slovenian: Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) - Nelagoden občutek v anorektalnem predelu (nelagoden občutek ob anusu in v njem), hemoroidi
English: One patient had Grade 3 prostatitis considered as serious that started 4 days after the VTP procedure, and lasted for 31 days before resolving without sequelae.
Slovenian: Pri enem bolniku je bil prostatitis 3. stopnje ocenjen kot resen, pri čemer se je pojavil 4 dni po postopku VTP in trajal
English: n Mean score (SD) Baseline 179 7.6 (6.09) 185 6.6 (5.30) 71 6.7 (5.69) 73 6.0 (4.34) Day 7 180 14.8 (8.64)
Slovenian: n Srednja vrednost n Srednja vrednost n Srednja vrednost n Srednja vrednost Izhodišče 179 7,6 (6,09) 185 6,6 (5,30) 71 6,7 (5,69) 73 6,0 (4,34) 7. dan 180 14,8 (8,64)
English: Perineal injury and perineal pain occurred in 46 (23.4 %) patients in the controlled Phase III European study.
Slovenian: Poškodba presredka, bolečina v presredku in prostatitis V kontrolirani evropski študiji III. faze so se poškodbe presredka in bolečina v presredku pojavile pri 46 (23,4 %) bolnikih.
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.
Slovenian: TOOKAD 183 mg prašek za raztopino za injiciranje Steklena viala tipa I jantarjeve barve, ki vsebuje 183 mg padeliporfina in je zatesnjena z gumijastim zamaškom, zaščitenim z aluminijasto obrobo, ter pokrita z modrim plastičnim dvižnim pokrovčkom.
English: n Mean score (SD) Baseline 184 18.6 (10.22) 188 20.6 (9.92) 74 18.4 (10.31) 74 20.8 (10.02) Day 7 165 11.5 (10.96)
Slovenian: n Srednja vrednost n Srednja vrednost n Srednja vrednost n Srednja vrednost Izhodišče 184 18,6 (10,22) 188 20,6 (9,92) 74 18,4 (10,31) 74 20,8 (10,02) 7. dan 165 11,5 (10,96)
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
Slovenian: TOOKAD 183 mg prašek za raztopino za injiciranje TOOKAD 366 mg prašek za raztopino za injiciranje
English: Connect an opaque tube to the filter.
Slovenian: Nanj priključite neprosojno cevko.
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.
Slovenian: Pri bolnikih, ki so prejemali intraokularno zdravljenje proti vaskularnemu endotelijskemu rastnemu faktorju VEGF (zdravila, ki se uporabljajo za preprečevanje novih krvnih strdkov), lahko obstaja dodatno tveganje preobčutljivosti oči na svetlobo.
English: Very common side effects (may affect more than 1 in 10 people) - Problems with or pain on passing urine (including pain or discomfort on passing urine, bladder pain, the need to pass urine urgently or more frequently or at night; involuntary passing of urine), - Sexual problems (including difficulty in getting or maintaining an erection, ejaculation failure, loss of desire or pain on intercourse), - Blood in the urine (haematuria), - Perineal injury including bruising in the skin, bruising near where the needles are put into the prostate, pain and tenderness, - Genital pain and discomfort (inflammation of the testicles or the epididymis, pain due to inflammation or fibrosis of the prostate).
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Težave z uriniranjem ali bolečina pri uriniranju (vključno z bolečino ali nelagodnim občutkom med uriniranjem, bolečinami v mehurju, siljenjem na vodo, k pogostejšemu uriniranju ali k uriniranju ponoči, nehoteno uriniranje).
English: Range: min, max
Slovenian: Srednja vrednost (SD) Razpon: min., maks.
English: PSA should be tested every 3 months for first 2 years post VTP and every 6-months thereafter in order to assess PSA dynamics (PSA Doubling Time (DT), PSA velocity).
Slovenian: Za oceno dinamike PSA (podvojitvenega časa PSA in hitrosti PSA) je treba raven PSA preverjati vsake 3 mesece v obdobju prvih dveh let po opravljenem postopku VTP in nato vsakih 6 mesecev.
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
Slovenian: 3. mesec 171 14,7 (10,48) 182 21,0 (9,84) 69 14,3 (10,81) 70 21,7 (9,95) 6. mesec 176 16,1 (9,98) 185 20,4 (9,83) 68 16,9 (9,78) 72 20,6 (9,85) 12. mesec 170 15,1 (10,28) 167 19,9 (10,29) 70 16,7 (10,18) 65 20,4 (10,44) 24. mesec* 159 15,0 (10,70) 152 16,8 (11,17) 62 15,4 (11,11) 54 16,4 (11,10)
English: g g h
Slovenian: Krak AS
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.
Slovenian: TOOKAD 366 mg prašek za raztopino za injiciranje Steklena viala tipa I jantarjeve barve, ki vsebuje 366 mg padeliporfina in je zatesnjena z gumijastim zamaškom, zaščitenim z aluminijasto obrobo, ter pokrita z belim plastičnim dvižnim pokrovčkom.
English: Severe long-term urinary incontinence was observed in a patient who underwent a previous transurethral prostatectomy (TURP).
Slovenian: Pri bolniku, pri katerem je bila predhodno opravljena transuretralna prostatektomija (TURP), so opazili resno dolgotrajno urinsko inkontinenco.
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.
Slovenian: 15 mg/kg dikalijevega padeliporfina je znašal od 0,0245 do 0,088 l/h/kg.
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
Slovenian: 3. mesec 179 9,6 (6,86) 190 7,2 (5,75) 71 8,7 (5,72) 72 6,6 (5,11) 6. mesec 182 7,5 (6,06) 189 6,8 (5,84) 74 6,4 (5,33) 73 6,3 (5,36) 12. mesec 177 7,2 (5,85) 173 7,3 (5,95) 71 5,7 (5,01) 68 7,1 (5,75) 24. mesec* 165 6,6 (5,47) 154 8,2 (6,47) 66 5,5 (5,34) 55 8,6 (6,56)
English: If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
Slovenian: Če imate kakršna koli vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Urethral stenosis
Slovenian: Stenoza sečnice
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).
Slovenian: Pri bolnikih, ki so že prej imeli stenozo, po postopku TOOKAD-VTP obstaja tveganje za poslabšanje stenoze, čeprav so bili takšni bolniki izključeni iz kliničnih študij (glejte poglavje 4.8).
English: Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
Slovenian: Zdravnik lahko po lastni presoji predpiše profilaktične antibiotike in zaviralce alfa.
English: These may be signs of infection in the urinary tract, the prostate or the genital system.
Slovenian: Lahko gre za znake okužbe sečil, prostate ali spolovil.
English: When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
Slovenian: sproži kaskado patofizioloških dogodkov, ki v nekaj dneh povzročijo fokalno nekrozo.
English: - You have a reduced kidney function or if you follow a potassium restricted diet.
Slovenian: - je pri vas prisotno nenormalno strjevanje krvi; - je pri vas prisotno okvarjeno delovanje ledvic ali ste na dieti z nadzorovanim vnosom kalija.
English: Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
Slovenian: Ena škatla zdravila TOOKAD 366 mg prašek za raztopino za injiciranje vsebuje stekleno vialo jantarjeve barve z belim pokrovčkom.
English: Insufficient patients underwent retreatment of the ipsilateral lobe or sequential treatment of the contralateral lobe to determine the efficacy and safety of a second TOOKAD-VTP procedure.
Slovenian: Za določanje učinkovitosti in varnosti ponovne izvedbe postopka TOOKAD-VTP so pri neustreznih bolnikih opravili ponovno zdravljenje režnja na isti strani ali zaporedno zdravljenje režnja na nasprotni strani.
English: TOOKAD 366 mg powder for solution for injection Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Slovenian: TOOKAD 366 mg prašek za raztopino za injiciranje Ena viala vsebuje 366 mg padeliporfina (v obliki dikalijeve soli).
English: Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Slovenian: Preglednica 6: PCM301 - vpliv na erektilno funkcijo (IIEF) - populacija ITT in bolniki, ki izpolnjujejo merila indikacije
English: Perineal injury (post-procedural haematoma, necrosis, perineal haematoma, pelvic haematoma).
Slovenian: 15 Poškodba presredka (hematom, nastal po postopku, nekroza, hematom v presredku, hematom v medenici).
English: Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
Slovenian: 7 Motnje uriniranja (siljenje na vodo, polakiurija, nokturija, zmanjšan pretok urina, napenjanje ob uriniranju).
English: Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Slovenian: Priporočeno odmerjanje zdravila TOOKAD je en sam odmerek padeliporfina 3,66 mg/kg.
English: Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Slovenian: Pustite, da neprosojna brizga brez dodatnega stresanja in premikanja 3 minute miruje v pokončnem položaju, da morebitna pena izgine.
English: Standard handling of syringes should follow.
Slovenian: Nato je treba z brizgami ravnati po standardnem postopku.
English: There is limited biopsy data beyond 2 years after TOOKAD treatment, so long-term efficacy has not been determined.
Slovenian: Spremljanje po postopku TOOKAD-VTP Podatki o biopsiji za obdobje po zdravljenju z zdravilom TOOKAD, daljše od dveh let, so omejeni,
English: TOOKADVTP arm N = 206
Slovenian: Krak TOOKADVTP N = 206
English: Hollow needles are used to insert the fibres into the right place in the prostate.
Slovenian: Za vstavitev vlaken na pravo mesto v prostati se uporabljajo votle igle.
English: TOOKADVTP arm N = 80
Slovenian: Krak TOOKADVTP N = 80
English: Prostatic abscess
Slovenian: občasni absces prostate
English: Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Slovenian: Ena viala zdravila TOOKAD 366 mg vsebuje 366 mg padeliporfina (v obliki kalijeve soli).
English: a a e e
Slovenian: PRILOGA I
English: You may need to stay overnight if you have not fully recovered from the general anaesthetic and depending on your condition.
Slovenian: Če še ne boste popolnoma okrevali od splošne anestezije in glede na vaše stanje, boste morali v bolnišnici morda ostati čez noč.
English: Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Slovenian: Preglednica 3: PCM301 - sočasni primarni opazovani dogodki učinkovitosti - celotna prostata in zdravljeni reženj (ali oba)* - populacija ITT in bolniki, ki izpolnjujejo merila indikacije
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.
Slovenian: Kot je prikazano v preglednici 5, je bilo v študiji PCM301 z mednarodnim vprašalnikom o ocenjevanju simptomov prostate (IPSS - International Prostate Symptoms Score) pri populaciji ITT in bolnikih, ki izpolnjujejo merila indikacije, dokazano zmerno povečanje 7 dni po postopku VTP.
English: Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Slovenian: Ena viala zdravila TOOKAD 183 mg vsebuje 183 mg padeliporfina (v obliki kalijeve soli).
English: TOOKAD should be used with caution in patients with severe hepatic impairment.
Slovenian: Pri bolnikih z resno okvaro jeter je treba zdravilo TOOKAD uporabljati zelo previdno.
English: The equipment should be carefully calibrated and use the treatment guidance software to reduce the risk of clinically significant extraprostatic necrosis.
Slovenian: Za zmanjševanje tveganja klinično pomembne ekstraprostatične nekroze je treba opremo pazljivo umerjati, uporabljati pa je treba tudi programsko opremo za usmerjanje zdravljenja.
English: However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided the precautions against light exposure are stricly followed.
Slovenian: naj bi bilo tveganje povečane fototoksičnosti po pričakovanjih nizko, če so strogo upoštevani previdnostni ukrepi izogibanja svetlobi.
English: Total number of positive cores Mean (SD)
Slovenian: Skupno število pozitivnih stebričkov
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.
Slovenian: ki so se pojavile 35 tednov po postopku VTP in so trajale 35 tednov, posledic pa ni bilo.
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.
Slovenian: Ta zdravila (npr. acenokumarol, varfarin) je treba prenehati jemati vsaj 10 dni pred postopkom VTP z zdravilom TOOKAD.
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.
Slovenian: Antitrombotiki (zdravila, ki zmanjšujejo agregacijo (lepljivost) trombocitov v krvi in strjevanje) Ta zdravila (npr. acetilsalicilna kislina) je treba prenehati jemati vsaj 10 dni pred postopkom VTP z zdravilom TOOKAD in jih znova začeti jemati vsaj 3 dni po postopku.
English: Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Slovenian: Ena viala vsebuje 183 mg padeliporfina (v obliki dikalijeve soli).
English: Table 2: PCM301 - Baseline characteristics by arm for the Intention-To-Treat (ITT) population and patients meeting the indication criteria
Slovenian: Preglednica 2: PCM301 - izhodiščne značilnosti glede na krak za populacijo z namenom zdravljenja (ITT - Intention-To-Treat) in bolnike, ki izpolnjujejo merila indikacije
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih pogosti poškodbe presredka15
English: Follow-up post TOOKAD-VTP
Slovenian: Krak TOOKADVTP
English: This should be taken into consideration (see section 4.4).
Slovenian: 6 mesecev (glejte poglavje 4.8).
English: The vial should rest in an upright position for 3 minutes without further shaking or moving.
Slovenian: Viala mora nato brez dodatnega stresanja in premikanja mirovati v pokončnem položaju 3 minute.
English: You may watch television at a distance of 2 metres and, from 6 hours after the procedure, you may use electronic devices such as smartphones, tablets and computers.
Slovenian: po 6 urah po postopku pa lahko uporabljate elektronske naprave, kot so pametni telefoni ter tablični in osebni računalniki.
English: Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Slovenian: Ena viala vsebuje 366 mg padeliporfina (v obliki dikalijeve soli).
English: Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Slovenian: Ena škatla zdravila TOOKAD 183 mg prašek za raztopino za injiciranje vsebuje stekleno vialo jantarjeve barve z modrim pokrovčkom.
English: Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
Slovenian: Pustite, da viala brez dodatnega stresanja in premikanja 3 minute miruje v pokončnem položaju.
English: Haemorrhoids Anorectal discomfort Abdominal pain Rectal haemorrhage
Slovenian: Bolezni prebavil pogosti hemeroidi nelagoden občutek v anorektalnem predelu2
English: TOOKAD) for the treatment of the type of prostate cancer, potential benefits, risks and uncertainties of VTP with TOOKAD.
Slovenian: • informacije o morebitnih koristih, tveganjih in negotovostih postopka VTP z zdravilom
English: Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Slovenian: Preglednica 5: PCM301 - vpliv na obolevnost zaradi bolezni sečil (IPSS) - populacija ITT in bolniki, ki izpolnjujejo merila indikacije Populacija ITT
English: Some degree of erectile dysfunction is possible soon after the procedure and may last for more than 6 months (see section 4.8).
Slovenian: Določena stopnja erektilne disfunkcije se lahko pojavi kmalu po postopku in lahko traja več kot
English: Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Slovenian: Zdravila, ki lahko povzročajo preobčutljivost na svetlobo: - določeni antibiotiki, ki se uporabljajo za zdravljenje okužb (tetraciklini, sulfonamidi, kinoloni); - določena zdravila za zdravljenje psihiatričnih stanj (fenotiazini); - določena zdravila, ki se uporabljajo pri sladkorni bolezni tipa II (hipoglikemični sulfonamidi); - določena zdravila za visok krvni tlak, edeme, srčno popuščanje ali odpoved ledvic (tiazidni diuretiki);
English: * The treated lobe(s) in the AS arm was defined as the lobe(s) with disease at baseline.
Slovenian: * Zdravljeni reženj v kraku AS je bil v izhodišču opredeljen kot oboleli reženj (če sta bila zdravljena oba, sta bila v kraku AS kot obolela v izhodišču opredeljena oba).