natgillin/translations-raw huggingface dataset:
Unspecific adverse events probably linked to the general anaesthesia were also observed: transient global amnesia, bradycardia, sinus arrhythmia, atrial fibrillation, hypotension, bronchospasm, pharyngeal inflammation, respiratory tract congestion, nausea, vomiting, constipation, pyrexia, procedural hypotension.
Nespecifični štetni događaji vjerojatno povezani s općom anestezijom također su uočeni: prolazna opća amnezija, bradikardija, sinusna aritmija, fibrilacija atrija, hipotenzija, bronhospazam, faringealna upala, kongestija respiratornog sustava, mučnina, povraćanje, konstipacija, vrućica, proceduralna hipotenzija.
For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Za upute o rekonstituciji lijeka TOOKAD prije primjene vidjeti dio 6.6.
The median time to onset of urinary incontinence was 4 days (1-142).
Medijan vremena do pojave urinarne inkontinencije iznosio je 4 dana (1 - 142).
Excessive extraprostatic necrosis occurred as a result of incorrect calibration of the laser or placement of the light fibres (see section 4.8).
Prekomjerna izvanprostatna nekroza koja se pojavila kao posljedica nepravilne kalibracije lasera ili nepravilnog postavljanja svjetlosnih vlakana (vidjeti dio 4.8).
Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation.
Zabilježen je jedan slučaj minimalne epitelne degeneracije sjemenovoda u mužjaka pri visokoj dozi s vakuolacijom.
Anticoagulants and antiplatelet agents
Antikoagulansi i antitrombocitni lijekovi
Its volume is measured after prostate delineation using the treatment guidance software.
Volumen se mjeri nakon delineacije prostate uporabom terapijskog vodiča kao programske podrške.
First 12 hours after VTP procedure
Prvih 12 sati nakon VTP terapije
Once it has been given, TOOKAD has to be activated by laser light shone along a fibre that targets the light onto the cancer.
Nakon ubrizgavanja, TOOKAD se aktivira laserskim svjetlom duž vlakna kojima se svjetlost cilja na rak.
TOOKAD is restricted to hospital use only.
Uporaba lijeka TOOKAD ograničena je isključivo na bolničku primjenu.
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.
Ipak, budući da postupak uključuje opću anesteziju, bolesnik ne smije izvoditi složene radnje poput upravljanja vozilom ili rada sa strojevima do 24 sata nakon primitka opće anestezije.
If you feel skin or eye discomfort while in hospital, you must tell your doctor or nurse so the level of lighting can be reduced and extra care can be taken to protect you from artificial and natural light.
Ako osjetite nelagodu na koži ili u očima za vrijeme boravka u bolnici, potrebno je obavijestiti liječnika ili medicinsku sestre tako da smanje razinu osvjetljenja i zaštite Vas od umjetnog i prirodnog svjetla.
In other cases, urethral stenosis may have been a late consequence of TOOKAD-VTP induced necrosis.
U ostalim slučajevima uretralna stenoza može biti kasna posljedica nekroze izazvane
This medicinal product contains potassium and in general the dose (3.66 mg/kg) will be less than 1 mmol (39 mg) i.e. essentially ‘potassium free'.
Ovaj lijek sadrži kalij i općenito, doza (3,66 mg/kg) sadrži manje od 1 mmol (39 mg), tj. zanemarive količine kalija.
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.
Ipak, budući da postupak uključuje opću anesteziju, ne smiju se izvoditi složene radnje poput upravljanja vozilom ili rada sa strojevima do 24 sata nakon primitka opće anestezije.
Submission of final study results:
Podnošenje konačnih rezultata
After reconstitution with a 5 % glucose solution in its vial, the chemical and physical stability of TOOKAD has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Nakon rekonstitucije s 5 %-tnom otopinom glukoze u svojoj bočici, kemijska i fizikalna stabilnost lijeka TOOKAD dokazana je tijekom 8 sati na temperaturi od 15 °C - 25 °C i na 5 °C ± 3 °C.
This medicine is stored under the responsibility of the specialist.
Za čuvanje ovog lijeka su odgovorni specijalisti.
Patients in the AS arm were not offered subsequent VTP.
Bolesnicima u skupini AS nije ponuđena sljedeća VTP terapija.
If the patient must go outdoors during daylight hours, he should wear protective clothes and high protection goggles to shield his skin and eyes.
Ako bolesnik mora izići na danju svjetlost, trebao bi nositi zaštitnu odjeću i zaštitne naočale kako bi zaštitio kožu i oči.
This medicine contains potassium.
Ovaj lijek sadrži kalij.
Padeliporfin has not been tested for reproductive toxicity and fertility.
Nije ispitan učinak padeliporfina vezano uz reproduktivnu toksičnost i plodnost.
7 Place du Théâtre L-2613 Luxembourg Luxembourg
L-2613 Luxembourg
If it is not possible to stop a photosensitising medicinal product (such as amiodarone), the patient should be advised that increased sensitivity to sunlight may occur and they may need to protect themselves from direct light exposure for a longer period (see section 4.2).
Ako nije moguće prestati uzimati fotosenzibilizirajući lijek (kao što je amiodaron), bolesnika treba upozoriti na moguću povećanu osjetljivost na sunčevu svjetlost i na potrebu zaštite od izravnog izlaganja svjetlosti na dulje vrijeme (vidjeti dio 4.2).
It is not expected that a delay in clotting will reduce the effectiveness of the TOOKAD-VTP treatment ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure (see section 4.5).
Ne očekuje se da će sporije zgrušavanje umanjiti učinkovitost liječenja TOOKADVTP terapijom; ipak, preporučuje se prestanak uzimanja lijekova koji utječu na zgrušavanje krvi prije i odmah nakon VTP postupka (vidjeti dio 4.5).
Urinary incontinence (urge incontinence, incontinence, stress urinary incontinence).
8 Urinarna inkontinencija (urgentna inkontinencija, inkontinencija, stres inkontinencija).
The patient may go outdoors during daylight hours but only in shaded areas or when it is overcast.
Bolesnik smije izaći na danju svjetlost, ali samo u zasjenjena područja ili kad je oblačno.
Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Trenutačno pogoršanje rektalne upale bolesti crijeva (vidjeti dio 4.4).
A urinary fistula has occurred in one case due to incorrect fibre placement.
Zabilježen je jedan slučaj urinarne fistule do koje je došlo zbog nepravilnog postavljanja vlakna.
The risk of sphincter damage can be minimised by careful planning of the fibre placement using the treatment guidance software.
Rizik od oštećenja sfinktera može se minimizirati pažljivim planiranjem postavljanja vlakana korištenjem terapijskog vodiča u obliku programske podrške.
One case of external urethral fistula occurred due to fibre misplacement (see section 4.4).
Jedan slučaj vanjske uretralne fistule dogodio se zbog pogrešnog postavljanja vlakana (vidjeti dio 4.4).
AS arm N = 78
AS skupina N = 78
In the Phase III European study, 60 (30.5 %) of patients in the TOOKAD-VTP arm experienced erectile dysfunction and 16 (8.1 %) experienced ejaculation failure.
U europskom ispitivanju faze III, 60 (30,5 %) bolesnika u skupini TOOKAD-VTP imalo je erektilnu disfunkciju, a 16 (8,1 %) bolesnika imalo je nemogućnost ejakulacije.
Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%)
Progresija na Gleason ≥ 4 49 (23,8) 91 (44,0) 19 (23,8) Broj ispitanika s progresijom u liječenom režnju* u 24. mjesecu, n
If you have received prior VEGF therapy, you should take particular care to protect your eyes from light for 48 hours post TOOKAD injection.
Ako ste ranije primili anti-VEGF terapiju, trebate posebno zaštititi oči od svjetlosti tijekom 48 sati od injiciranja lijeka TOOKAD.
- You are having an exacerbation of rectal inflammatory bowel disease.
- ako imate pogoršanje rektalne upalne bolesti crijeva;
Effects of covariates on pharmacokinetic properties The effects of age, weight and race were investigated in healthy volunteers and patients.
U zdravih dobrovoljaca i bolesnika istražili su se učinci dobi, težine i rase.
How TOOKAD is used
Kako se TOOKAD primjenjuje
4.4 Special warnings and precautions for use
4.4 Posebna upozorenja i mjere opreza pri uporabi Lokalizacija tumora
In the Phase III European study, 20 (10.2 %) patients in the TOOKAD-VTP arm experienced genito-urinary infection.
europskom ispitivanju faze III, 20 (10,2 %) bolesnika u skupini TOOKAD-VTP imalo je infekciju genitalno-urinarnog sustava.
Urethral stenosis Urinary incontinence
Uretralna stenoza Urinarna inkontinencija8
If the patient reports discomfort to the skin or eyes during hospitalisation, reduce the level of lighting and take extra care to shield the patient from artificial and natural light.
Ako bolesnik prijavi nelagodu u području kože ili očiju tijekom hospitalizacije, potrebno je sniziti razinu osvjetljenja i zaštititi bolesnika od umjetnog i prirodnog svjetla.
The chemical and physical stability of TOOKAD after reconstitution with 5 % glucose solution, in its vial, has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Kemijska i fizikalna stabilnost lijeka TOOKAD nakon rekonstitucije s 5 %-tnom otopinom glukoze, u svojoj bočici, dokazana je tijekom 8 sati na temperaturi od 15 °C - 25 °C i na 5 °C ± 3 °C.
Standard handling of syringes should follow.
Potrebno je slijediti uobičajeno rukovanje štrcaljkama.
In healthy human male subjects, the Cmax was shown to be linear from 1.25 mg/kg to 15 mg/kg of padeliporfin di-potassium, covering the therapeutic range.
U zdravih muških ispitanika, pokazalo se da je Cmax linearan u rasponu doza od 1,25 mg/kg do 15 mg/kg padeliporfindikalija, što pokriva terapijski raspon.
You should wear dark clothes and take care to protect your hands and face from the sun.
Treba nositi tamniju odjeću i paziti na izlaganje ruku i lica suncu.
In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
U europskom ispitivanju faze III, 30 (15,2 %) bolesnika imalo je urinarnu retenciju.
Table 2 gives baseline characteristics by arm.
Tablica 2. prikazuje početne značajke po skupinama.
This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental (see section 4.2).
To treba uzeti u obzir u bolesnika sa smanjenom bubrežnom funkcijom ili bolesnika na dijeti s ograničenim unosom kalija u kojih se porast kalija u serumu smatra štetnim (vidjeti dio 4.2).
The reconstituted solution is dark.
Rekonstituirana je otopina tamna.
Hollow needles are used to insert the fibres into the right place in the prostate.
Šupljim iglama umeću se vlakna na pravo mjesto u prostati.
Abnormal clotting is not expected to affect how well the treatment works ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure.
Ne očekuje se da će abnormalno zgrušavanje utjecati na djelotvornost liječenja; ipak, preporučuje se prestanak uzimanja lijekova koji utječu na zgrušavanje krvi prije i odmah nakon VTP terapije.
Transfer the contents of the vial into an opaque syringe.
Prebacite sadržaj bočice u neprozirnu štrcaljku.
Urethral stenosis
Uretralna stenoza
The vial should rest in an upright position for 3 minutes without further shaking or moving.
Bočicu treba ostaviti u uspravnom položaju 3 minute bez daljnjeg mućkanja ili pomicanja.
There is limited biopsy data beyond 2 years after TOOKAD treatment, so long-term efficacy has not been determined.
Daljnje praćenje nakon primjene postupka TOOKAD-VTP Biopsijski podaci nakon dvije godine od liječenja lijekom TOOKAD su ograničeni, tako da nije utvrđena dugoročna djelotvornost.
There is limited clinical information on overdose involving TOOKAD.
Kliničke su informacije o predoziranju lijekom TOOKAD ograničene.
Prostatic abscess
Apsces prostate
VTP procedure.
TOOKAD-VTP postupkom.
The vial should then be swirled gently for 2 minutes.
Bočica se nakon toga nježno vrti 2 minute.
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).
In vitro ispitivanja pokazuju da TOOKAD ne inhibira P-gp, OAT1, OAT3, OCT2, OCT1, BCRP i BSEP, ali može inhibirati transportere OATP1B1 i OATP1B3 (vidjeti dio 4.5).
TOOKAD-VTP arm N = 80
TOOKAD-VTP skupina N = 80
Patients who have received prior VEGF therapy should take particular care to protect the eyes from light for 48 hours post TOOKAD injection.
Bolesnici koji su prethodno primili VEGF terapiju trebaju posebno zaštititi oči od svjetlosti tijekom 48 sati nakon injiciranja lijeka TOOKAD.
Following TOOKAD VTP, patients should undergo digital rectal examination (DRE) and have their serum PSA monitored, including an assessment of PSA dynamics (PSA doubling time and PSA velocity).
Nakon TOOKAD-VTP terapije bolesnici trebaju biti podvrgnuti digitalnom rektalnom pregledu (engl. digital rectal examination, DRE) uz praćenje PSA u serumu, uključujući procjenu dinamike vrijednosti PSA (vrijeme udvostručenja vrijednosti PSA i brzina porasta vrijednosti PSA).
Do not use after the expiry date which is stated on the shield label after “EXP”.
Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP.
Male sexual dysfunction (erectile dysfunction, ejaculation failure, dyspareunia, ejaculation disorder, hypospermia, painful ejaculation, retrograde ejaculation, sexual dysfunction, semen volume decreased).
10 Seksualna disfunkcija muškaraca (erektilna disfunkcija, nemogućnost ejakulacije, dispareunija, poremećaj ejakulacije, hipospermija, bolna ejakulacija, retrogradna ejakulacija, seksualna disfunkcija, smanjen volumen sjemena).
Back pain (intervertebral disc protrusion).
5 Bol u leđima (protruzija intervertebralnog diska).
During the procedure, the number and the length of the optical fibres are selected depending on the shape and the size of the prostate and the optical fibres are positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Tijekom postupka broj i duljina optičkih vlakana odabiru se ovisno o obliku i veličini prostate i optička vlakna smještaju se transperinealno u prostatu uz ultrazvučno usmjeravanje kako bi se postigao indeks gustoće svjetlosti (engl.
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 (%)
aOmjer rizika (95 % CI) = 3,62 (2,50; 5,26) ; p vrijednost < 0,001 bOmjer rizika (95 % CI) = 3,24 (2,41; 4,36) ; p vrijednost < 0,001 cMeđu 60 bolesnika koji su podvrgnuti radikalnoj terapiji, 5 bolesnika podvrgnuto je biopsiji u 24. mjesecu dPrimjerice: povlačenje iz sudjelovanja u ispitivanju, medicinski razlog, odbijanje ispitanika eOmjer rizika (95 % CI) = 4,39 (2,18; 8,83) ; p vrijednosti < 0,001 fOmjer rizika (95 % CI) = 4,61 (2,60; 8,16) ; p vrijednost < 0,001 B: Razlika u stopi neuspjeha liječenja povezanog s opaženom progresijom bolesti Broj ispitanika s progresijom u 24. mjesecu, n (%)
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 as well as further characterise the long term safety of TOOKAD, the MAH should submit the results of a randomised phase 3 study in patients with localised prostate cancer compared to active surveillance (7-year follow-up study including in an depth biopsy study) (PCM301 FU5).
(PAES): Kako bi se dodatno istražila dugoročna djelotvornost lijeka TOOKAD i njegov utjecaj na progresiju bolesti, uključujući moguć utjecaj na djelotvornost sljedeće radikalne terapije u bolesnika s rakom prostate niskog rizika, kao i kako bi se dodatno okarakterizirala dugoročna sigurnost lijeka TOOKAD, nositelj odobrenja treba podnijeti rezultate randomiziranog ispitivanja faze III u bolesnika s lokaliziranim rakom prostate u usporedbi s aktivnim nadzorom (7-godišnje ispitivanje praćenja uključujući ispitivanje dubinske biopsije) (PCM301 FU5).
• 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
• informaciju o mogućim koristima, rizicima i dvojbama oko VTP terapije s lijekom TOOKAD, uključujući: dvojbe u vezi s dugotrajnom koristi primjene lijeka TOOKAD; dvojbe u vezi s dugoročnom sigurnošću lijeka TOOKAD i djelotvornosti/sigurnosti daljnjih nužnih tretmana poput radikalne prostatektomije;
You will not have to store this medicine.
Kako se TOOKAD čuva Nećete morati čuvati ovaj lijek.
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.
Antikoagulansi i lijekovi koji smanjuju agregaciju trombocita (npr. acetilsalicilatna kiselina) trebaju se prestati uzimati najmanje 10 dana prije postupka s lijekom TOOKAD.
The main exclusion criteria were any prior or current treatment for prostate cancer, any surgical intervention for benign prostatic hypertrophy, life expectancy less than 10 years, medical conditions which preclude the use of general anaesthesia.
Glavni kriterij isključivanja iz ispitivanja bilo je prijašnje ili trenutačno liječenje raka prostate, svaka kirurška intervencija benigne hipertrofije prostate, očekivani životni vijek manji od 10 godina,
Check with your doctor about the birth control methods to use and how long to use them for.
Savjetujte se s liječnikom o načinima kontracepcije i trajanju zaštite.
Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
Na temelju analiza populacijske farmakokinetike, procijenjeni poluvijek iznosi 1,19 h ± 0,08 pri 4 mg/kg padeliporfindikalija.
No data are available in patients with hepatic impairment.
Nema podataka o bolesnicima s oštećenjem funkcije jetre.
This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental.
To treba uzeti u obzir u bolesnika sa smanjenom bubrežnom funkcijom ili bolesnika na dijeti s ograničenim unosom kalija u kojih se porast kalija u serumu smatra štetnim.
In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Općenito, doza lijeka TOOKAD sadrži manje od 1 mmol (39 mg) kalija, tj. zanemarive količine kalija.
1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
Jedan ml rekonstituirane otopine sadrži 9,15 mg padeliporfina.
PHARMACEUTICAL FORM Powder for solution for injection.
OBLIK Prašak za otopinu za injekciju.
Active inflammatory bowel disease
Aktivna upalna bolest crijeva
Fibres to carry the laser light are inserted into the prostate gland by using hollow needles.
Vlakna koja pronose lasersku svjetlost umeću se u prostatu uporabom šupljih igala.
The TOOKAD-VTP procedure is contraindicated in patients with any previous prostatic interventions where the internal urinary sphincter may have been damaged, including transurethral resection of the prostate (TURP) for benign prostatic hypertrophy (see section 4.3).
TOOKAD-VTP postupak kontraindiciran je u bolesnika s bilo kakvim prijašnjim intervencijama na prostati gdje postoji mogućnost oštećenja unutarnjeg urinarnog sfinktera, uključujući transuretralnu resekciju prostate (TURP) kod benigne hipertrofije prostate
TOOKAD is activated immediately after injection by shining light through the fibres from a connected laser device.
Odmah nakon injiciranja TOOKAD se aktivira svjetlošću koja dolazi kroz vlakna iz spojenog laserskog uređaja.
The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of padeliporfin, including photosensitivity, and also information on the existing therapeutic approaches (including VTP with
Cilj edukacijskog programa jest povećati svijest i pružiti informaciju o znakovima i simptomima određenih važnih identificiranih rizika padeliporfina, uključujući fotoosjetljivost, te informaciju o postojećim terapijskim pristupima (uključujući VTP s lijekom TOOKAD) za liječenje vrste raka prostate, mogućim koristima, rizicima i dvojbama oko VTP terapije lijekom TOOKAD.
Moderate/higher risk prostate cancer was defined as any of the following: > 3 cores definitively positive for cancer; Gleason primary or secondary pattern ≥ 4; at least 1 cancer core length > 5 mm; PSA > 10 ng/mL in 3 consecutive measures; T3 prostate cancer; metastasis; prostate cancer-related death.
Rak prostate umjerenog/višeg rizika bio je definiran bilo kojim od sljedećih kriterija: > 3 cilindra konačno pozitivna na rak; primarni ili sekundarni obrazac na Gleason skali ≥ 4; najmanje jedan cilindar pozitivan na rak duljine > 5 mm; vrijednost PSA > 10 ng/ml tijekom 3 uzastopna mjerenja; rak prostate stadija T3; metastaze; smrt uzrokovana rakom prostate.
Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Zbog neispravne kalibracije lasera dogodila su se dva slučaja prekomjerne izvanprostatne nekroze bez kliničkih posljedica.
Adverse reactions reported are listed below in Table 1 by organ class and frequency.
Tablični popis nuspojava Prijavljene nuspojave navedene su u nastavku u tablici 1. prema organskim sustavima i učestalosti.
Blood lactate dehydrogenase increased Blood triglyceride increased Gamma-glutamyltransferase increased Blood cholesterol increased Blood creatine phosphokinase increased Blood potassium decreased Low density lipoprotein increased Neutrophil count increased PSA increased
Povišena razina triglicerida u krvi Povišena razina gama-glutamiltransferaze Povišena razina kolesterola u krvi Povišena razina kreatin-fosfokinaze u krvi Snižena razina kalija u krvi
In addition to the side effects listed previously, other side effects can occur.
Uz navedene nuspojave, mogu se pojaviti još neke.
Anorectal discomfort (proctalgia, rectal tenesmus).
2 Anorektalna nelagoda (proktalgija, rektalni tenezam).
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.
Te lijekove (npr. acetilsalicilatnu kiselinu) treba prestati uzimati najmanje 10 dana prije VTP terapije lijekom TOOKAD i ponovno ih nastaviti uzimati barem 3 dana nakon terapije.
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.
Urinarna retencija / uretralna striktura Bolesnici s anamnezom uretralne strikture ili s problemima urinarnog protoka mogu biti pod povećanim rizikom slabijeg protoka i urinarne retencije nakon primjene TOOKAD-VTP postupka.
Table 1: Summary of adverse reactions considered related to TOOKAD and/or the study device and/or the study procedure in the pooled safety analysis (N=398)
Tablica 1.: Sažetak nuspojava iz objedinjene analize sigurnosti (N=398) koje se smatraju povezanima s lijekom TOOKAD i/ili uređajima i/ili postupkom iz ispitivanja