natgillin/translations-raw huggingface dataset:
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.
V kliničnih študijah noben bolnik, pri katerem je bilo prisotno stanje preobčutljivosti na svetlobo, kot je porfirija, ali pa je imel anamnezo občutljivosti na sončno svetlobo ali anamnezo fotosenzitivnega dermatitisa, ni prejemal zdravila TOOKAD.
An injection filter of 0.22 µm and an opaque tubing should be used to administer the medicinal product to the patient.
Za dajanje zdravila bolniku je treba uporabiti injekcijski filter velikosti 0,22 µm in neprosojno cevko.
Negative biopsy in the treated lobe*, n (%)
Negativna biopsija v zdravljenem režnju*, n
However, as the procedure includes general anaesthesia, you should not perform complex tasks like driving or using machines until 24 hours after a general anaesthetic is used.
Ker pa postopek vključuje splošno anestezijo, 24 ur po uporabi splošnega anestetika ne smete izvajati zapletenih opravil, kot sta vožnja ali upravljanje strojev.
Pregnancy and breast-feeding TOOKAD is not indicated for the treatment of women.
Zdravilo TOOKAD ni indicirano za zdravljenje žensk.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
TOOKAD is activated immediately after injection by shining light through the fibres from a connected laser device.
Zdravilo TOOKAD je takoj po injiciranju aktivirano s svetlobo, ki prihaja iz priključene laserske naprave in sveti skozi vlakna.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo TOOKAD nima vpliva na sposobnost vožnje in upravljanja strojev.
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.
Študije in vitro kažejo, da za zdravilo TOOKAD ni verjetno, da bi bilo substrat prenašalcev jetrnega privzema OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 ali BSEP.
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).
Podobna srednja vrednost razpona očistka je bila opažena pri bolnikih z lokaliziranim rakom prostate, ki so bili zdravljeni s 4 mg/kg in 2 mg/kg dikalijevega padeliporfina (oziroma 0,04-0,06 l/h/kg).
Patients who have received prior VEGF therapy should take particular care to protect the eyes from light for 48 hours post TOOKAD injection.
Bolniki, ki so bili predhodno zdravljeni proti VEGF, morajo 48 ur po vbrizganju zdravila TOOKAD še posebej skrbno varovati oči pred svetlobo.
60 watts or equivalent (i.e. 6 watts for LED lights, 12 watts for fluorescent low-energy lights).
Uporablja lahko le žarnice z močjo največ 60 vatov ali enakovredno močjo (tj. 6 vatov pri lučeh LED, 12 vatov pri fluorescentnih nizkoenergijskih lučeh).
Post-authorisation efficacy study (PAES): In order to further investigate long-term efficacy of TOOKAD and its impact on disease progression including potential impact on the efficacy of subsequent radical therapy in patients with low risk prostate cancer (excluding very low risk) as well as further characterise the long term safety of TOOKAD, the MAH should conduct and submit the results of a long-term observational cohort study of patients with unilateral low risk localised prostate cancer treated with TOOKAD VTP (CLIN1501 PCM401).
Do datuma raziskovanje dolgoročne učinkovitosti zdravila TOOKAD in njegovega vpliva na napredovanje bolezni, vključno z morebitnim vplivom na učinkovitost naknadnega radikalnega zdravljenja pri bolnikih z nizko tveganim rakom prostate (brez bolnikov z zelo nizkim tveganjem), in dodatno opredelitev dolgoročne varnosti zdravila TOOKAD mora imetnik dovoljenja za promet z zdravilom izvesti dolgoročno opazovalno kohortno študijo bolnikov z unilateralnim, nizko tveganim lokaliziranim rakom prostate, zdravljenim s postopkom TOOKAD VTP (CLIN1501 PCM401), in predložiti njene rezultate.
Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation.
Pri enem od samcev z vakuolizacijo, ki je prejemal visok odmerek, je bila zabeležena tudi minimalna degeneracija semenskega epitelija.
TOOKAD-VTP should only be administered after careful clinical evaluation, to patients with a history of active rectal inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation (see section 4.3).
Postopek TOOKAD-VTP se lahko pri bolnikih z anamnezo aktivne rektalne vnetne črevesne bolezni ali katere koli bolezni, ki lahko poveča tveganje za nastanek rektouretralne fistule, uporabi le po temeljiti klinični oceni (glejte poglavje 4.3).
No patients with photosensitive dermatitis, skin conditions such as porphyria or a history of sensitivity to sunlight have received TOOKAD in clinical studies.
V kliničnih študijah noben bolnik, pri katerem je bil prisoten fotosenzitivni dermatitis ali kožne bolezni, kot je porfirija, ali pa je imel anamnezo občutljivosti na sončno svetlobo, ni prejel zdravila TOOKAD.
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).
Podobna srednja vrednost prostornine porazdelitve je bila opažena pri bolnikih z lokaliziranim rakom prostate, ki so bili zdravljeni z 2 in 4 mg/kg dikalijevega padeliporfina (oziroma 0,09-0,10 l/kg).
In vitro studies indicate that TOOKAD does not inhibit P-gp, OAT1, OAT3, OCT2, OCT1, BCRP and BSEP but it could inhibit both OATP1B1 and OATP1B3 transporters (see section 4.5).
Študije in vitro kažejo, da zdravilo TOOKAD ne zavira P-gp, OAT1, OAT3, OCT2, OCT1, BCRP in BSEP, lahko pa bi zaviralo prenašalce OATP1B1 in OATP1B3 (glejte poglavje 4.5).
A: Rate of absence of definite cancer based on histology at 24 months Negative biopsy, n (%)
A: Stopnja odsotnosti očitnega raka na podlagi histologije pri 24 mesecih
If you have received prior VEGF therapy, you should take particular care to protect your eyes from light for 48 hours post TOOKAD injection.
Če ste predhodno zdravili zaradi VEGF, morate 48 ur po vbrizganju zdravila TOOKAD še posebej skrbno varovati oči pred svetlobo.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Lokalizacija tumorja
Once it has been given, TOOKAD has to be activated by laser light shone along a fibre that targets the light onto the cancer.
Ko je zdravilo TOOKAD vneseno, ga je treba aktivirati z lasersko svetlobo, ki sije vzdolž vlakna, to pa jo usmerja v rakasto tkivo.
Urinary retention/urethral stricture
Zastajanje urina/striktura sečnice
Urethral stenosis Urinary incontinence
pogosti stenoza sečnice urinska inkontinenca8
It is important that all patients follow the light precautions below for 48 hours post-procedure to minimize the risk of damage to the skin and eyes.
Za zmanjšanje tveganja poškodb kože in oči je pomembno, da vsi bolniki v 48 urah po postopku upoštevajo spodaj navedene previdnostne ukrepe v zvezi s svetlobo.
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.
Z uporabo antikoagulantnih zdravil in zdravil, ki zmanjšujejo agregacijo trombocitov (npr. acetilsalicilne kisline), je treba prenehati 10 dni pred postopkom z zdravilom TOOKAD.
One serious adverse event of prostatic abscess which was considered severe was reported in the study performed in Latin America in a patient who had a unilateral VTP procedure.
Absces prostate V študiji, izvedeni v Južni Ameriki, so pri bolniku, pri katerem je bil izveden unilateralni postopek VTP, poročali o enem hudem neželenem učinku abscesa prostate, ki je bil ocenjen kot resen.
Digital Rectal Examination (DRE) is recommended to be performed at least once a year and more often if clinically justified.Routine biopsy is recommended at 2-4 years and 7 years post VTP, with additional biopsies based on clinical/ PSA assessment.
Dve do štiri leta in sedem let po postopku VTP je priporočljiva rutinska biopsija, na podlagi klinične ocene/ocene PSA pa še dodatne biopsije.
The recommended dose of TOOKAD is one single dose of 3.66 mg per kg of body weight, injected into a vein.
Priporočeni odmerek zdravila TOOKAD je en sam odmerek, vbrizgan v veno, ki znaša 3,66 mg na kg telesne mase.
• 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
TOOKAD, vključno z negotovostmi dolgoročnih koristi zdravila TOOKAD, negotovostmi dolgoročne varnosti zdravila TOOKAD in varnosti/učinkovitosti morebitnih nadaljnjih potrebnih zdravljenj, kot je radikalna prostatektomija;
It is used to treat adult men who have low-risk, localised prostate cancer in only one lobe, using a technique called Vascular-Targeted Photodynamic (VTP) therapy.
Uporablja se za zdravljenje odraslih moških, ki imajo nizko tvegani, lokalizirani rak prostate samo v enem režnju, s postopkom,
In the Phase III European study, 20 (10.2 %) patients in the TOOKAD-VTP arm experienced genito-urinary infection.
III. faze je 20 (10,2 %) bolnikov v kraku TOOKAD-VTP doživelo okužbo sečil.
TOOKAD-VTP arm N = 80
Krak TOOKAD-VTP N = 80
Libido decreased Affective disorder Encopresis
Psihiatrične motnje občasni zmanjšan libido afektivna motnja enkopreza
AS arm N = 207
Krak AS N = 207
Prostatitis occurred in 7 (3.6 %) patients in the controlled Phase III European study.
V kontrolirani evropski študiji III. faze se je prostatitis pojavil pri 7 (3,6 %) bolnikih.
• 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
• 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
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 (%)
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.
Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
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.
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.
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.
No in vitro or in vivo studies have been conducted with radiolabelled padeliporfin.
Z radioaktivno označenim padeliporfinom ni bilo izvedenih nobenih študij in vitro ali in vivo.
TOOKAD is a medicine that contains padeliporfin (as potassium salt).
Kaj je zdravilo TOOKAD in za kaj ga uporabljamo TOOKAD je zdravilo, ki vsebuje padeliporfin (v obliki kalijeve soli).
TOOKAD has no influence on the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo TOOKAD nima vpliva na sposobnost vožnje in upravljanja strojev.
Possible side effects can occur with TOOKAD and VTP procedure.
Pri zdravilu TOOKAD in postopku VTP se lahko pojavijo možni neželeni učinki.
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.
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).
Range: min, max Estimated prostate volume (cc) Mean (SD)
Ocenjena prostornina prostate (cc) Srednja vrednost (SD) Razpon: min., maks.
Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
12 Bolečina v prostati (prostatizem, bolezni prostate, fibroza prostate).
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.
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.
Anorectal discomfort (proctalgia, rectal tenesmus).
2 Nelagoden občutek v anorektalnem predelu (proktalgija, rektalni tenezem).
Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Preglednica 4: PCM301 - število radikalno zdravljenih oseb pri 24 mesecih - populacija ITT in bolniki, ki izpolnjujejo merila indikacije
- You experience involuntary passing of urine after the VTP procedure.
- se po postopku VTP pojavi nehoteno uriniranje;
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.
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.
TOOKAD-VTP arm N = 206
Krak TOOKAD-VTP N = 206
- A medicine used to treat cardiac arrhythmia (amiodarone).
- zdravilo za zdravljenje glivičnih okužb (griseofulvin); - zdravilo za zdravljenje srčne aritmije (amiodaron).
Common side effects (may affect up to 1 in 10 people) - Anorectal discomfort (discomfort near the anus and just inside the anus), haemorrhoids (piles),
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) - Nelagoden občutek v anorektalnem predelu (nelagoden občutek ob anusu in v njem), hemoroidi
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.
Pri enem bolniku je bil prostatitis 3. stopnje ocenjen kot resen, pri čemer se je pojavil 4 dni po postopku VTP in trajal
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)
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)
Perineal injury and perineal pain occurred in 46 (23.4 %) patients in the controlled Phase III European study.
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.
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.
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.
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)
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)
TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
TOOKAD 183 mg prašek za raztopino za injiciranje TOOKAD 366 mg prašek za raztopino za injiciranje
Connect an opaque tube to the filter.
Nanj priključite neprosojno cevko.
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.
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.
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).
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).
Range: min, max
Srednja vrednost (SD) Razpon: min., maks.
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).
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.
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
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)
g g h
Krak AS
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.
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.
Severe long-term urinary incontinence was observed in a patient who underwent a previous transurethral prostatectomy (TURP).
Pri bolniku, pri katerem je bila predhodno opravljena transuretralna prostatektomija (TURP), so opazili resno dolgotrajno urinsko inkontinenco.
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.
15 mg/kg dikalijevega padeliporfina je znašal od 0,0245 do 0,088 l/h/kg.
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
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)
If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
Če imate kakršna koli vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Urethral stenosis
Stenoza sečnice
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).
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).
Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
Zdravnik lahko po lastni presoji predpiše profilaktične antibiotike in zaviralce alfa.
These may be signs of infection in the urinary tract, the prostate or the genital system.
Lahko gre za znake okužbe sečil, prostate ali spolovil.
When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
sproži kaskado patofizioloških dogodkov, ki v nekaj dneh povzročijo fokalno nekrozo.
- You have a reduced kidney function or if you follow a potassium restricted diet.
- je pri vas prisotno nenormalno strjevanje krvi; - je pri vas prisotno okvarjeno delovanje ledvic ali ste na dieti z nadzorovanim vnosom kalija.
Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
Ena škatla zdravila TOOKAD 366 mg prašek za raztopino za injiciranje vsebuje stekleno vialo jantarjeve barve z belim pokrovčkom.
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.
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.
TOOKAD 366 mg powder for solution for injection Each vial contains 366 mg of padeliporfin (as di-potassium salt).
TOOKAD 366 mg prašek za raztopino za injiciranje Ena viala vsebuje 366 mg padeliporfina (v obliki dikalijeve soli).
Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Preglednica 6: PCM301 - vpliv na erektilno funkcijo (IIEF) - populacija ITT in bolniki, ki izpolnjujejo merila indikacije