natgillin/translations-raw huggingface dataset:
Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
11 Genitalna bol (bol u penisu, bol u testisima, bol u skrotumu, neinfektivni orhitis, upala spermatičnog voda, genitalna kontuzija).
Short-term urinary incontinence has been observed and may result from urinary tract infection or from urgency caused by irritation to the urethra from the procedure.
Uočena je kratkotrajna urinarna inkontinencija (nevoljno istjecanje mokraće) koja može nastati zbog infekcije mokraćnog sustava ili zbog neizdržive potrebe za mokrenjem izazvane iritacijom mokraćne cijevi tijekom postupka.
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.
U slučaju izlaska na danje svjetlo nužno je nositi zaštitnu odjeću i sunčane naočale visoke zaštite kako bi se koža i oči zaštitili.
Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
U periprostatskom masnom tkivu može doći do izvanprostatne nekroze koja nije povezana s kliničkim simptomima.
The pivotal open-label Phase III study (PCM301), conducted in 10 European countries, randomised 413 patients to TOOKAD-VTP arm or AS arm.
U pivotalnom otvorenom ispitivanju faze III (PCM301), provedenom u 10 europskih zemalja, 413 bolesnika je randomizirano u skupinu za liječenje postupkom TOOKAD-VTP ili u skupinu AS (engl.active surveillance, aktivno praćenje).
n Mean score (SD)
n Srednja vrijednost bodova (SD)
In vitro studies predict that TOOKAD at therapeutic concentrations is unlikely to inhibit cytochrome P450 enzymes but could inhibit OATP1B1 and OATP1B3 transporters (see section 5.2).
Na temelju ispitivanja in vitro malo je vjerojatno da TOOKAD u terapijskim koncentracijama inhibira enzime citokroma P450, ali može inhibirati transportere OATP1B1 i OATP1B3 (vidjeti dio 5.2).
Keep the vial in the outer carton in order to protect from light.
Bočicu čuvajte u originalnoj kutiji radi zaštite od svjetlosti.
Medicinal products which have potential photosensitising effects (such as tetracyclines, sulphonamides, quinolones, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin or amiodarone) should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.
fenotiazini, hipoglikemici iz skupine sulfonilureja, tiazidski diuretici, grizeofulvin ili amiodaron) trebaju se prestati uzimati najmanje 10 dana prije postupka s lijekom TOOKAD i najmanje 3 dana nakon postupka ili ih treba zamijeniti drugim lijekovima bez fotosenzibilizirajućih svojstava.
If you have a history of a narrowing of the urethra or urinary flow problems, treatment may increase the risk of poor flow and urinary retention.
Ako u povijesti bolesti imate suženje mokraćne cijevi ili probleme s protokom mokraće, liječenje može povećati rizik od slabog protoka i zadržavanja mokraće.
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.
zdravstveno stanje i markeri jetrene funkcije mogu imati znatan i biološki značajan utjecaj na farmakokinetiku lijeka TOOKAD.
It should only be used by personnel trained in the VTP procedure.
Smije ga upotrebljavati samo osoblje osposobljeno za primjenu VTP terapije.
Muscular and connective tissue disorders
Poremećaji mišićnog i vezivnog tkiva
Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Postoji rizik fotoosjetljivosti kože i očiju prilikom izlaganja svjetlosti nakon TOOKAD-VTP terapije.
It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure.
Smije ga primjenjivati samo osoblje osposobljeno za provođenje postupka vaskularno ciljane fotodinamičke terapije (engl.
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.
In vitro ispitivanja upućuju na to da nije vjerojatno da je lijek TOOKAD supstrat transportera unosa u jetru: OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 ili BSEP.
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).
Sličan prosječan volumen distribucije viđen je u bolesnika s lokaliziranim rakom prostate liječenih s 2 i 4 mg/kg padeliporfindikalija (0,09-0,10 l/kg, ovisno o doziranju).
The solution is administered by intravenous injection over 10 minutes.
Osvjetljavanje za fotoaktivaciju lijeka TOOKAD Otopina se primjenjuje intravenskom injekcijom u trajanju od 10 minuta.
Table 3 describes the co-primary efficacy endpoints in the whole prostate gland and in the treated lobe (ITT population and patients meeting the indication criteria).
Tablica 3. opisuje koprimarne mjere ishoda djelotvornosti u cijeloj prostati i u liječenom režnju (ITT populacija i bolesnici koji ispunjavaju kriterije indikacije).
Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
12 Bol u prostati (prostatizam, poremećaji prostate, fibroza prostate).
TOOKAD is locally activated immediately after injection by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm over 22 minutes 15 seconds.
TOOKAD se odmah nakon ubrizgavanja lokalno aktivira laserskom svjetlošću od 753 nm putem intersticijalnih optičkih vlakana iz laserskog uređaja pri snazi vlakana od 150 mW/cm, uz dostavljanje energije od 200 J/cm tijekom 22 minute i 15 sekundi.
- Fever, pain and swelling in the area of the operation might occur after the procedure.
- nakon postupka može doći do vrućice, boli i oticanja područja operacije.
Follow-up post TOOKAD-VTP
TOOKAD-VTP
The main inclusion criteria were low-risk prostate cancer with Gleason 3 + 3 prostate adenocarcinoma as a maximum, two to three cores positive for cancer and a maximum cancer core length of 5 mm in any core (at least 3 mm for patients with only one positive core), clinical stage up to T2a, PSA ≤ 10 ng/mL, prostate volume equal or greater than 25 cc and less than 70 cc.
Glavni kriteriji za uključivanje u ispitivanje bili su rak prostate niskog rizika s maksimalnim zbrojem Gleason skale 3 + 3 za adenokarcinom prostate, dva do tri cilindra pozitivna na rak, dobivena biopsijom širokom iglom, s najvećom duljinom od 5 mm u bilo kojem od cilindara (najmanje 3 mm za bolesnike sa samo jednim pozitivnim cilindrom), klinički stadij do T2a, PSA ≤ 10 ng/ml, volumen prostate jednak ili veći od 25 cm3 i manji od 70 cm3.
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 prašak za otopinu za injekciju Bočica od smeđeg stakla tipa I, zatvorena gumenim čepom i aluminijskom brtvom te prekrivena bijelim plastičnim poklopcem, koja sadrži 366 mg padeliporfina.
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 prašak za otopinu za injekciju Bočica od smeđeg stakla tipa I, zatvorena gumenim čepom i aluminijskom brtvom te prekrivena plavim plastičnim poklopcem, koja sadrži 183 mg padeliporfina.
Negative biopsy in the treated lobe*, n (%)
Pozitivni nalazi biopsije u liječenom režnju*, n (%)
What you need to know before TOOKAD is used
Što morate znati prije primjene lijeka TOOKAD 3.
TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
TOOKAD se priprema rekonstitucijom praška za otopinu za injekciju s: - 20 ml 5 %-tne otopine glukoze za TOOKAD 183 mg, - 40 ml 5 %-tne otopine glukoze za TOOKAD 366 mg.
AS arm N = 207
AS skupina N = 207
Range: min, max
Srednja vrijednost (SD) Raspon: min, maks
QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
KVALITATIVNI I KVANTITATIVNI SASTAV TOOKAD 183 mg prašak za otopinu za injekciju Jedna bočica sadrži 183 mg padeliporfina (u obliku dikalijeve soli).
What TOOKAD contains - The active substance is padeliporfin.
Sadržaj pakiranja i druge informacije Što TOOKAD sadrži - Djelatna tvar je padeliporfin.
Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Ostavite neprozirnu štrcaljku u uspravnom položaju 3 minute dok pjena ne nestane.
Use in patients on a controlled potassium diet
Uporaba u bolesnika na dijeti s ograničenim unosom kalija
* The treated lobe(s) in the AS arm was defined as the lobe(s) with disease at baseline.
* Liječeni režanj(evi) u AS skupini definirani su kao režanj(evi) s bolesti na početku ispitivanja.
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.
Zatim se prostata smjesta osvjetljava tijekom 22 minute i 15 sekundi laserskom svjetlošću od 753 nm putem intersticijskih optičkih vlakana iz laserskog uređaja pri snazi od 150 mW/cm vlakna, proizvodeći energiju od 200
Use in patients with abnormal clotting
Uporaba u bolesnika s abnormalnim zgrušavanjem krvi
Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
Liječnik može propisati profilaktički antibiotike i alfa blokatore.
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.
U kliničkim ispitivanjima bolesnici s fotoosjetljivim stanjima poput porfirije ili bolesnici koji u povijesti bolesti imaju osjetljivost na sunčevu svjetlost ili fotodermatitis nisu primili lijek TOOKAD.
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.
- za TOOKAD 183 mg: 20 ml 5 %-tne otopine glukoze u bočicu s praškom; - za TOOKAD 366 mg: 40 ml 5 %-tne otopine glukoze u bočicu s praškom
Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
1 Infekcija genitalno-urinarnog sustava (infekcija urinarnog sustava, orhitis, epididimitis, cistitis).
Patients with abnormal clotting may bleed excessively from the insertion of the needles required to position the fibres that guide the laser light.
Bolesnici s poremećajem zgrušavanja krvi mogu imati pretjerano krvarenje zbog ubadanja igala u svrhu smještanja vlakana koja vode lasersku svjetlost.
Perineal injury (post-procedural haematoma, necrosis, perineal haematoma, pelvic haematoma).
15 Perinealna ozljeda (postoperativni hematom, nekroza, perinealni hematom, zdjelični hematom).
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).
Sličan raspon prosječnog klirensa uočen je u bolesnika s lokaliziranim rakom prostate liječenima s 4 mg/kg i 2 mg/kg padeliporfindikalija (0,04 - 0,06 l/h/kg, ovisno o doziranju).
Simultaneous treatment of both prostate lobes was associated with an inferior outcome in clinical trials and should not be performed.
U kliničkim ispitivanjima uočen je nepovoljniji ishod nakon istodobnog liječenja obaju režnjeva prostate i stoga se takvo liječenje ne smije izvoditi.
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.
(tj. imaju GS >6, >3 pozitivna cilindra ili bilo koji zaseban cilindar duljine >5mm) trebaju primiti preporuku za radikalnu terapiju.
You will be given a general anaesthetic to send you to sleep before the VTP procedure.
Prije VTP terapije dobit ćete opću anesteziju kako bi Vas se uspavalo.
Abnormal clotting (fibrin D dimer increased, aPTT prolonged, INR increased).
14 Abnormalno zgrušavanje (povišena razina fibrinskih D dimera, produljen aPTT, povišen INR).
Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Lijekovi s mogućim fotosenzibilizirajućim učinkom: - neki antibiotici za liječenje infekcije (tetraciklini, sulfonamidi, kinoloni); - neki lijekovi za liječenje psihijatrijskih stanja (fenotiazini); - neki lijekovi za liječenje dijabetesa tipa 2 (hipoglikemijski sulfonamidi);
No patients with photosensitive dermatitis, skin conditions such as porphyria or a history of sensitivity to sunlight have received TOOKAD in clinical studies.
U kliničkim ispitivanjima bolesnici s fotoosjetljivim dermatitisom te kožnim oboljenjima poput porfirije ili s anamnezom osjetljivosti na sunčevu svjetlost nisu primili lijek TOOKAD.
Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
U bolesnika s abnormalnim zgrušavanjem krvi može doći do pretjeranog krvarenja zbog ubadanja igala u svrhu smještanja svjetlosnih vlakana.
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.
VTP terapija sastojala se od i.v. injiciranja 4 mg/kg lijeka TOOKAD tijekom 10 minuta, nakon čega je slijedilo osvijetljavanje laserskom svjetlošću od 753 nm vlaknima od 200 J/cm tijekom 22 minute i 15 sekundi uz uporabu intersticijalnih optičkih vlakana, umetnutih transperinealno u prostatu.
In each table are also presented the results of patients meeting the indication criteria (patients with unilateral low-risk localised prostate cancer excluded the very low-risk)
(bolesnici s unilateralnim lokaliziranim rakom prostate niskog rizika, isključujući vrlo niskog rizika)
Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Doziranje Preporučeno doziranje lijeka TOOKAD je jedna doza od 3,66 mg/kg padeliporfina.
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 padeliporfindikalija u rasponu je od 0,0245 do 0,088 l/h/kg.
- A medicine used to treat cardiac arrhythmia (amiodarone).
- lijek za liječenje gljivičnih infekcija (grizeofulvin); - lijek za liječenje nepravilnog srčanog ritma (amiodaron).
TOOKAD should be used with caution in patients with severe hepatic impairment.
Savjetuje se oprez pri primjeni lijeka TOOKAD u bolesnika s teškim oštećenjem funkcije jetre.
A: Rate of absence of definite cancer based on histology at 24 months Negative biopsy, n (%)
A: Stopa izostanka potvrđenog raka na temelju histologije nakon 24 mjeseca
Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Tablica 4.: PCM301 - Broj ispitanika s radikalnim liječenjem nakon 24 mjeseca - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije Karakteristika
The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Drugi lijekovi koji mogu biti u interakciji s lijekom TOOKAD Uporaba lijekova poput repaglinida, atorvastatina, pitavastatina, pravastatina, rosuvastatina, simvastatina, bosentana, gliburida treba se izbjegavati na dan primjene lijeka TOOKAD i najmanje 24 sata nakon primjene.
Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment.
U bolesnika s oštećenjem funkcije jetre očekuje se povećana i/ili produljena izloženost padeliporfinu.
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.
Preporučuje se obaviti digitalni rektalni pregled (DRE) barem jednom godišnje, te češće ako je pregled klinički opravdan.
Reproductive system and breast disorders
Poremećaji reproduktivnoga sustava i dojki
VTP procedure
VTP terapija
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 radikalne terapije u bolesnika s rakom prostate niskog rizika (isključujući vrlo niskog rizika), kao i kako bi se dodatno okarakterizirala dugoročna sigurnost lijeka TOOKAD, nositelj odobrenja treba provesti i podnijeti rezultate dugoročnog opservacijskog ispitivanja kohorti u bolesnika s unilateralnim lokaliziranim rakom prostate niskog rizika liječenih TOOKAD-VTP terapijom (CLIN1501 PCM401).
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/1/17/1228/001
Only the lobe that contains the cancer will be treated.
Liječi se samo režanj zahvaćen rakom.
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.
Jedan bolesnik imao je perinealnu bol 3. stupnja koja je započela 35 tjedana nakon VTP
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.
International Indeks of Erectile Function, IIEF-15) pokazuju značajan pad, 7 dana nakon VTP terapije, nakon kojeg je uslijedilo poboljšanje sljedećih mjeseci do 24. mjeseca, u ITT populaciji i u bolesnika koji ispunjavaju kriterije indikacije.
• Information on the existing therapeutic approaches (including VTP with TOOKAD) for the treatment of the type of prostate cancer
Vodič za bolesnike o lijeku TOOKAD treba sadržavati sljedeće ključne elemente: • informaciju o postojećim terapijskim pristupima (uključujući VTP s lijekom TOOKAD) za liječenje vrste raka prostate;
Genito-urinary infections
Infekcije genitalno-urinarnog sustava
OATP1B1 and OATP1B3 transporters
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Transporteri OATP1B1 i OATP1B3
During the procedure, the optical fibres are selected and positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Tijekom postupka optička vlakna odabiru se i smještaju transperinealno u prostatu uz kontrolu ultrazvukom kako bi se postigao indeks gustoće svjetlosti
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte uputu o lijeku.
The patient may be discharged in the evening of the same day at the physician's discretion.
Na temelju liječničke procjene, bolesnik se može otpustiti iz bolnice uvečer na dan postupka.
Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity
Hemartroza Mišićno-koštana bol Bol u udovima
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.
Fototoksičnost 33 dana nakon VTP postupka prijavljen je jedan slučaj ishemijske optičke neuropatije 3. stupnja u bolesnika liječenog dozom 2 mg/kg lijeka TOOKAD.
AS arm n Mean score (SD)
AS skupina n Srednja vrijednost bodova (SD)
- Certain medicines used for hypertension, oedema, heart failure or renal failure (thiazide diuretics).
- neki lijekovi za visoki krvni tlak, oticanje, zatajenje srca ili zatajenje bubrega (tiazidski diuretici);
Prostatitis Genital pain Prostatic pain
Prostatitis Genitalna bol11
If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
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
7. dan 165 11,5 (10,96) Nije primjenjivo 68 10,1 (10,82) Nije primjenjivo 3. mjesec 171 14,7 (10,48) 182 21,0 (9,84) 69 14,3 (10,81) 70 21,7 (9,95) 6. mjesec 176 16,1 (9,98) 185 20,4 (9,83) 68 16,9 (9,78) 72 20,6 (9,85) 12. mjesec 170 15,1 (10,28) 167 19,9 (10,29) 70 16,7 (10,18) 65 20,4 (10,44)
TOOKADVTP arm N = 80
TOOKADVTP skupina N = 80
Some degree of erectile dysfunction is possible soon after the procedure and may last for more than 6 months (see section 4.8).
Određen stupanj erektilne disfunkcije moguć je ubrzo nakon postupka i može trajati više od 6 mjeseci
Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
Jedna kutija lijeka TOOKAD 366 mg prašak za otopinu za injekciju sadrži smeđu staklenu bočicu s bijelim zatvaračem.
Nervous system disorders
Poremećaji mokraćnog sustava
TOOKADVTP arm N = 206
TOOKADVTP skupina N = 206
Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
Bočicu je potrebno ostaviti da miruje u uspravnom položaju 3 minute bez daljnjeg mućkanja pomicanja.
Urinary incontinence
Urinarna inkontinencija
TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
TOOKAD 183 mg prašak za otopinu za injekciju TOOKAD 366 mg prašak za otopinu za injekciju
Store in the outer carton in order to protect it from light.
Bočicu čuvati u originalnoj kutiji radi zaštite od svjetlosti.
Abdominal discomfort Abnormal faeces Diarrhoea
Abdominalna nelagoda Abnormalna stolica Proljev
g g h
J/cm.
Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Tablica 5.: PCM301 - Učinak na urinarno pobolijevanje (IPSS) - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
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
7. dan 180 14,8 (8,64) Nije primjenjivo 72 14,2 (8,89) Nije primjenjivo 3. mjesec 179 9,6 (6,86) 190 7,2 (5,75) 71 8,7 (5,72) 72 6,6 (5,11) 6. mjesec 182 7,5 (6,06) 189 6,8 (5,84) 74 6,4 (5,33) 73 6,3 (5,36) 12. mjesec 177 7,2 (5,85) 173 7,3 (5,95) 71 5,7 (5,01) 68 7,1 (5,75)
This required urethral dilatation (see section 4.4).
To je zahtijevalo uretralnu dilataciju (vidjeti dio
Perineal pain (pelvic pain).
9 Perinealna bol (bol u zdjelici).
Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Jedna bočica lijeka TOOKAD 183 mg sadrži 183 mg padeliporfina (u obliku kalijeve soli).