natgillin/translations-raw huggingface dataset:
Prostatitis occurred in 7 (3.6 %) patients in the controlled Phase III European study. 
Prostatitis se pojavio u 7 (3,6 %) bolesnika u kontroliranom europskom ispitivanju faze III.
Padeliporfin is retained within the vascular system. 
Padeliporfin se zadržava u krvožilnom sustavu.
• Explain what side effects the Patient might expect and the likelihood of him getting them 
• Objašnjenje koje nuspojave bolesnik može očekivati i vjerojatnost dobivanja tih nuspojava.
Place a 0.22 μm injection filter on the syringe. 
Stavite injekcijski filtar od 0,22 μm na štrcaljku.
There was no significant correlation between the percentage of prostate necrosis on Day 7 MRI and the likelihood of a negative prostate biopsy at follow-up. 
Nije bilo značajne korelacije između postotka nekroze prostate na MR-u 7. dana i vjerojatnosti negativnog nalaza biopsije prostate u daljnjem praćenju.
LIST OF EXCIPIENTS Excipient: Mannitol 
POPIS POMOĆNIH TVARI Pomoćna tvar: manitol
53 (26.9 %) patients experienced erectile dysfunction for more than 6 months, including 34 (17.3 %) patients in whom the erectile dysfunction had not resolved at the end of the study. 
53 (26,9 %) bolesnika imala su erektilnu disfunkciju dulje od 6 mjeseci, uključujući 34 (17,3 %) bolesnika u kojih erektilna disfunkcija nije prestala do završetka ispitivanja.
Urinary retention immediately post procedure has been attributed to transient prostatic oedema and generally only short term recatheterisation was required. 
Urinarna retencija nastala odmah nakon postupka pridodaje se privremenom edemu prostate i općenito je potrebna samo kratkotrajna rekateterizacija.
The median duration was 10 days (1-344). 
Medijan trajanja iznosio je 10 dana (1 - 344).
The final solution concentration is 9.15 mg/mL. 
Konačna koncentracija otopine iznosi 9,15 mg/ml.
TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3). 
TOOKAD je kontraindiciran u bolesnika s dijagnozom kolestaze (vidjeti dio 4.3).
- You experience difficulties in getting or maintaining an erection. 
- ako imate poteškoća u postizanju ili održavanju erekcije;
Rapid consumption of the •NO radicals, by oxygen radicals, leads to the formation of reactive nitrogen species (RNS) (e.g. peroxynitrite), in parallel to arterial constriction. 
Brza potrošnja radikala •NO putem radikala kisika dovodi do stvaranja reaktivnih dušikovih spojeva (npr. peroksinitrita), istodobno sa konstrikcijom arterija.
The median duration was 21 days (4-197). 
Medijan trajanja iznosio je 21 dan (4 - 197).
The equipment should be carefully calibrated and use the treatment guidance software to reduce the risk of clinically significant extraprostatic necrosis. 
Oprema mora biti pažljivo kalibrirana i potrebno se koristiti terapijskim vodičem u obliku programske podrške kako bi se smanjio rizik nastanka klinički značajne izvanprostatne nekroze.
Warnings and precautions TOOKAD should only be used by personnel trained in the VTP procedure. 
Upozorenja i mjere opreza TOOKAD smije upotrebljavati samo osoblje osposobljeno za primjenu VTP terapije.
In addition, impaired deformability is thought to enhance erythrocyte aggregability and formation of blood clots at the interface of the arterial supply (feeding arteries) and tumour microcirculation, results in occlusion of the tumour vasculature. 
Uz to, smatra se da promijenjena deformabilnost poboljšava agregaciju eritrocita i stvaranje krvnih ugrušaka na granici između opskrbnih arterija (hranidbene arterije) i tumorske mikrocirkulacije, što rezultira okluzijom krvnih žila tumora.
An LDI ≥ 1 appeared to be associated with a greater volume of necrosis on Day 7 MRI and greater share of patients with negative biopsy at 6 months compared with an LDI < 1 (see section 4.2). 
LDI ≥ 1 pokazao se povezan s većim volumenom nekroze na MR-u 7. dana i s većim udjelom bolesnika s negativnim nalazom biopsije nakon 6 mjeseci u usporedbi s LDI < 1 (vidjeti dio 4.2).
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. 
Tjelesna težina bolesnika (raspon od 60 do 120 kg) predstavljala je manji utjecaj na farmakokinetičke parametre lijeka TOOKAD za doze padeliporfindikalija do 5 mg/kg.
Therefore, the possibility for some in vivo metabolism of padeliporfin cannot be fully excluded. 
Stoga se ne može potpuno isključiti mogućnost in vivo metabolizma padeliporfina.
• Information on adverse drug reactions and the likelihood of them getting them, including: erectile dysfunction, urinary incontinence, urinary retention/urethral stricture, and photosensitivity and the need to follow the rules to protect themselves against the light after the procedure for 48 hours. 
• informaciju o nuspojavama i vjerojatnosti njihovog pojavljivanja, uključujući: erektilnu disfunkciju, urinarnu inkontinenciju, urinarnu retenciju/uretralnu strikturu i fotoosjetljivost, te potrebu poštivanja pravila radi zaštite od svjetlosti idućih 48 sati nakon postupka.
Co-administration should be done with caution and close monitoring is recommended. 
Istodobna primjena se mora odvijati uz mjere opreza i preporučuje se pažljivo praćenje bolesnika.
• Patient information guide • Physician guideline 
• Vodič za bolesnike • Vodič za liječnike
12-48 hours after VTP procedure 
12 - 48 sati nakon VTP terapije
An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4). 
Prekomjerna doza laserskog svjetla može povećati rizik od neželjene izvanprostatne nekroze (vidjeti dio 4.4).
mpMRI may be used to improve the decision making but not, at present, to replace biopsy. 
Može se obaviti MR pregled u svrhu lakšeg donošenja odluke, ali još uvijek ne i kao zamjena za biopsiju.
Clinical stages 
Klinički stadij
This may also cause bruising, blood in the urine and/or local pain. 
To također može uzrokovati pojavu modrica, krvi u urinu i/ili lokalizirane boli.
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. 
Kod nedovoljnog broja bolesnika je uslijedilo ponovno liječenje ipsilateralnog režnja ili uzastopno liječenje kontralateralnog režnja da bi se mogla utvrditi djelotvornosti i sigurnosti druge TOOKADVTP terapije.
You must remain under reduced light conditions, without exposing your skin and your eyes to daylight. 
Morate ostati pod prigušenim svjetlom i ne izlagati kožu i oči danjem svjetlu.
After the procedure, you should wear protective goggles and will be kept under medical surveillance for at least 6 hours in a room with reduced light. 
Nakon postupka treba nositi zaštitne naočale i ostati pod liječničkim nadzorom najmanje 6 sati u prostoriji s prigušenim svjetlom.
Padeliporfin was shown to be cytotoxic in the presence of UVA irradiation (in vitro) and considered phototoxic in the guinea pig (in vivo). 
Padeliporfin se pokazao citotoksičnim u prisutnosti UVA zračenja (in vitro) i smatra se fototoksičnim u zamoraca (in vivo).
The patient may watch television from a distance of 2 metres and, from 6 hours onwards, may use electronic devices such as smartphones, tablets and computers. 
Bolesnik smije gledati televiziju s udaljenosti od 2 metra i nakon 6 sati upotrebljavati elektroničke uređaje poput pametnog mobitela, tableta i računala.
These medicines should be stopped at least 10 days before the procedure with TOOKAD, and for at least 3 days after the procedure, or replaced by other treatments without photosensitising properties. 
Te lijekove treba prestati uzimati najmanje 10 dana prije postupka liječenja lijekom TOOKAD i najmanje 3 dana nakon postupka ili ih treba zamijeniti drugim lijekovima bez fotosenzibilizirajućih svojstava.
When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days. 
Pri aktivaciji laserskim svjetlom valne duljine 753 nm padeliporfin pokreće kaskadu patofizioloških događaja koji dovode do fokalne nekroze unutar nekoliko dana.
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). 
TOOKAD-VTP smije se primijeniti samo nakon pažljive kliničke procjene bolesnika s anamnezom aktivne rektalne upalne bolesti crijeva ili bilo kojeg stanja koje može povećati rizik od stvaranja rektouretralne fistule (vidjeti dio 4.3).
Number of subjects who initiated a radical treatment, n (%) 
Broj ispitanika koji su započeli s radikalnim liječenjem, n (%)
In addition, inserting needles into the prostate gland and inserting a urinary catheter for the procedure may be associated with further side effects. 
Uz to, umetanje igala u prostatu i umetanje urinarnog katetera tijekom postupka mogu biti povezani s daljnjim nuspojavama.
Surgical procedure repeated Contusion 
Ponovljen kirurški postupak Kontuzija
To date information beyond two years after VTP procedure is limited and so, at this time, data are currently not available to know whether the benefit of TOOKAD-VTP is long-lasting. 
Za sada su informacije o razdoblju nakon dvije godine od VTP terapije ograničene i stoga, u ovom trenutku, podaci o dugotrajnoj koristi liječenja TOOKAD-VTP terapijom nisu dostupni.
This includes sunbeds, bright computer monitor screens and medical examination lights, such as ophthalmoscopes, otoscopes and endoscopy equipment, for 48 hours following the VTP procedure. 
To obuhvaća solarije, jarke računalne zaslone i medicinska osvjetljenja pri pregledu kao što su oftalmoskopska, otoskopska i endoskopska oprema tijekom 48 sati nakon primjene VTP terapije.
In the few days after the VTP procedure some patients may have difficulties (poor stream due to urethral narrowing) or inability to pass urine. 
Nekoliko dana nakon VTP terapije neki bolesnici mogu imati poteškoće pri mokrenju (slab mlaz zbog suženja mokraćne cijevi) ili nemogućnost mokrenja.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
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. 
Upotrebljava se za liječenje odraslih muškaraca s niskorizičnim lokaliziranim rakom prostate u samo jednom režnju uporabom tehnike pod nazivom vaskularno ciljana fotodinamička terapija (engl.
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. 
Dopušteno je gledati televizor s udaljenosti od 2 metra i nakon 6 sati poslije postupka upotrebljavati elektroničke uređaje poput pametnog mobitela, tableta i računala.
Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4). 
Ne preporučuje se ponovno liječenje istog režnja ili uzastopno liječenje kontralateralnog režnja prostate (vidjeti dio 4.4).
However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4). 
Ipak, moguće je produljenje fotoosjetljivosti i trebaju se poduzeti mjere zaštite od izlaganja svjetlosti dodatna 24 sata (vidjeti dio 4.4).
causing local hypoxia that induces the release of nitric oxide (•NO) radicals. 
2 ) i uzrokuje lokalnu hipoksiju koja potiče otpuštanje radikala dušikovog oksida (•NO).
Healthy subjects have been exposed to doses up to 15 mg/kg of padeliporfin di-potassium (corresponding to 13.73 mg/kg of padeliporfin) without light activation and 23 patients have been treated with 6 mg/kg of padeliporfin di-potassium (corresponding to 5.49 mg/kg of padeliporfin) without significant safety issues. 
Zdravi ispitanici bili su izloženi dozama do 15 mg/kg padeliporfindikalija (što odgovara dozi od 13,73 mg/kg padeliporfina) bez svjetlosne aktivacije, a 23 bolesnika liječena su dozom od 6 mg/kg padeliporfindikalija (što odgovara dozi od 5,49 mg/kg padeliporfina) bez značajnih sigurnosnih problema.
The patient must stay in a dimmed light environment without any direct exposure of the skin and the eyes to daylight. 
Bolesnik mora ostati u prostoriji s prigušenim svjetlom bez izravnog izlaganja kože i očiju dnevnom svjetlu.
The patient should wear protective goggles and be kept under medical surveillance for at least 6 hours in a room with dimmed light. 
Bolesnik treba nositi zaštitne naočale i ostati pod liječničkim nadzorom barem 6 sati u prostoriji s prigušenim svjetlom.
The LDI corresponds to the ratio of the cumulative length of illuminated fibre tips (cm) to the volume (cc) of the targeted zone to be treated. 
LDI (indeks gustoće svjetlosti) odgovara omjeru kumulativne duljine osvijetljenih vrhova vlakana (cm) i volumenu (cm3) ciljane zone koja se liječi.
The recommended dose of TOOKAD is one single dose of 3.66 mg per kg of body weight, injected into a vein. 
Preporučena doza lijeka TOOKAD je jedna doza od 3,66 mg po kilogramu tjelesne težine, injicirano u venu.
The most frequently reported adverse reactions in the Phase II and III clinical studies were urinary and reproductive system disorders: dysuria (25.1 %), erectile dysfunction (21.1 %), haematuria (19.6 %), perineal pain/haematoma (15.3 %), urinary retention (13.3 %), micturition urgency (9.0 %), pollakiuria (7.3 %), urinary tract infection (5.5 %), incontinence (5.3 %) and ejaculation failure 
Najčešće prijavljene nuspojave u kliničkim ispitivanjima faze II i faze III bili su poremećaji urinarnog i reproduktivnog sustava: dizurija (25,1 %), erektilna disfunkcija (21,1 %), hematurija (19,6 %), perinealna bol / hematomi (15,3 %), urinarna retencija (13,3 %), urgencija (9,0 %), polakizurija (7,3 %), infekcija urinarnog trakta (5,5 %), inkontinencija (5,3 %) i nemogućnost ejakulacije (5,0 %).
Any medical condition that precludes the administration of a general anaesthetic or invasive procedures. 
Svako medicinsko stanje koje isključuje primjenu opće anestezije ili invazivnih postupaka.
Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure. 
Lijekovi koji sprječavaju ili smanjuju agregaciju trombocita ne smiju se uzimati najmanje 3 dana nakon postupka.
Concomitant use of systemic VEGF inhibitors is not recommended with TOOKAD. 
Ne preporučuje se istodobna uporaba sistemskih VEGF inhibitora s lijekom TOOKAD.
No in vitro or in vivo studies have been conducted with radiolabelled padeliporfin. 
Ni in vitro ni in vivo ispitivanja nisu provedena s radioaktivno označenim padeliporfinom.
Radical therapy post VTP procedure 
Radikalna terapija nakon VTP postupka
Penile swelling (balanoposthitis). 
13 Oticanje penisa (balanopostitis).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom planu upravljanja rizikom (RMP), koji se nalazi u modulu 1.8.2. odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMPa.
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. 
U ispitivanju provedenom u Latinskoj Americi prijavljen je jedan ozbiljan štetan događaj apscesa prostate u bolesnika koji je podvrgnut unilateralnom VTP postupku.
If you have had an active inflammatory bowel disease or any condition that may increase the risk of causing abnormal connection between the rectum and the urethra (recto-urethral fistula), the treatment should be given only after careful evaluation. 
Ako ste bolovali od aktivne upalne bolesti crijeva ili bilo kojeg stanja koje može povećati rizik od stvaranja abnormalnih veza između rektuma (završnog dijela crijeva) i mokraćne cijevi (rektouretralna fistula), liječenje se vrši isključivo nakon pažljive procjene.
Treatment should not be undertaken in patients where an LDI ≥ 1 cannot be achieved (see section 5.1). 
Kod bolesnika kod kojih nije moguće postići LDI ≥ 1, liječenje se ne bi trebalo izvoditi (vidjeti dio 5.1).
Your doctor may prescribe antibiotics to prevent infection and alpha-blockers (medicines given to prevent difficulties in urinating). 
Liječnik može propisati antibiotike za sprječavanje infekcije i alfa blokatore (lijekove za sprječavanje poteškoća pri mokrenju).
Only use light bulbs with a maximum power of 60 watts (for an incandescent light bulb) or 6 watts (for LED lights), or 12 watts (for fluorescent low-energy lights). 
Smiju se upotrebljavati samo žarulje sa žarnom niti snage od najviše 60 vata (za žarulje sa žarnom niti) ili 6 vati (za LED žarulje), ili 12 vati (za fluorescentnu niskoenergetsku rasvjetu).
White blood cell count increased 
Povećan broj bijelih krvnih zrnaca
If it is not possible to stop a photosensitising medicine (such as amiodarone), increased sensitivity may occur, you may need to protect yourself from direct light exposure for a longer period. 
Ako nije moguće prestati uzimati fotosenzibilizirajuće lijekove (poput amiodarona), može doći do pojačane osjetljivosti i tada može biti potrebno zaštititi se od izlaganja izravnom svjetlu dulje vremena.
Antiplatelet agents (medicines that decrease platelet aggregation (stickiness) in the blood and reduce clotting) 
Antitrombocitni lijekovi (lijekovi koji smanjuju nakupljanje (lijepljenje) trombocita u krvi i smanjuju zgrušavanje)
The magnitude of interaction has not been investigated clinically but a transient increase in the plasma concentration of co-administered substrates of OATP1B1 and OATP1B3 cannot be ruled out. 
Značaj interakcija nije klinički ispitan, ali se ne može isključiti privremeno povećanje koncentracije u plazmi istodobno primijenjenih supstrata OATP1B1 i OATP1B3.
Haematoma Hypertension 
Hematom Hipertenzija
In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7. 
U bolesnika s lokaliziranim rakom prostate koji su primili TOOKAD-VTP terapiju, nekroza se uočila oslikavanjem magnetskom rezonancijom 7. dan.
However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided these patients strictly follow the precautions against light exposure. 
Ipak, kratko djelovanje lijeka TOOKAD znači da se očekuje niži rizik pojačane fototoksičnosti pod uvjetom da bolesnici strogo slijede mjere opreza vezane uz izlaganje svjetlosti.
The safety and efficacy of subsequent radical therapy (surgery or radiotherapy) is uncertain. 
Sigurnost i djelotvornost radikalne terapije (operacije ili zračenja) koja slijedi nakon VTP-a nije jasna.
You may go outdoors during daylight hours but only in shaded areas or when it is overcast. 
Dopušten je izlazak na danju svjetlost, ali samo u zasjenjena područja ili kad je oblačno.
This is enhanced by RNS-induced endothelial cell apoptosis and initiation of self-propagated tumour cells necrosis through peroxidation of their membrane. 
To je pojačano apoptozom endotelnih stanica induciranom reaktivnim dušikovim spojevima i inicijacijom nekroze tumorskih stanica koja se sama širi putem peroksidacije njihove membrane.
Very few patients aged over 75 years were enrolled into studies where pharmacokinetic measurements were taken so it is not known if there is a difference in these older patients compared to patients less than 75 years of age (see sections 4.2 and 5.1). 
Starija populacija Veoma je malen broj bolesnika starijih od 75 godina bio uključen u ispitivanja s farmakokinetičkim mjerenjima, tako da nije poznato postoji li razlika između starijih bolesnika i onih mlađih od 75 godina
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). 
PSA treba se određivati svaka 3 mjeseca prve 2 godine nakon VTP terapije i svakih 6 mjeseci nakon toga kako bi se procijenila dinamika vrijednosti PSA (vrijeme udvostručenja vrijednosti PSA, brzina porasta vrijednosti PSA).
When the analysis was restricted to patients that underwent unilateral VTP, 33 (16.8 %) patients experienced erectile dysfunction for more than 6 months, including 17 (8.6 %) patients in whom the erectile dysfunction had not resolved at the end of the study. 
Kad je analiza bila ograničena na bolesnike koji su podvrgnuti unilateralnom VTP-u, 33 (16,8 %) bolesnika imalo je erektilnu disfunkciju dulje od 6 mjeseci, uključujući 17 (8,6 %) bolesnika u kojih erektilna disfunkcija nije prestala do završetka ispitivanja.
This may also cause bruising, haematuria and/or local pain. 
To također može uzrokovati pojavu modrica, hematurije i/ili lokalnu bol.
See also under “Other medicines and TOOKAD” for photosensitizing medicines. 
Pogledajte dio „Drugi lijekovi i TOOKAD” u vezi s fotosenzibilizirajućim lijekovima.
Due to the photosensitising properties of TOOKAD, the content of the vial should then be transferred into an opaque syringe that should be held in an upright position for 3 minutes to ensure any foam disappears. 
Zbog fotosenzibilizirajućih svojstava lijeka TOOKAD sadržaj bočice treba premjestiti u neprozirnu štrcaljku koju treba držati u uspravnom položaju 3 minute kako bi nestala pjena.
Reconstitution of the TOOKAD powder for solution for injection The solution must be prepared in a dimmed-light environment due to the photosensitizing properties of the medicine. 
Rekonstitucija TOOKAD praška za otopinu za injekciju Otopina se mora pripremati u okruženju prigušenog svjetla zbog fotosenzibilizirajućih svojstava lijeka.
AS involved serial absolute PSA measurements and ultrasound-guided prostatic biospy at 12 and 24 months. 
Aktivno praćenje (AS) je uključivalo serijska apsolutna mjerenja vrijednosti PSA i ultrazvučno vođenu biopsiju prostate nakon 12 i 24 mjeseca.
The median time to onset of urinary retention was 3 days (1-417). 
Medijan vremena do pojave urinarne retencije iznosio je 3 dana (1 - 417).
• Explain what the VTP procedure involves, including the need to follow the rules to protect the Patient against light after the procedure for 48 hours, due to the photosensitising effect of TOOKAD and provide a copy of the TOOKAD Package Leaflet to the Patient ahead of the VTP procedure 
• Objašnjenje o tome što VTP terapija obuhvaća, uključujući potrebu za poštivanjem pravila radi zaštite bolesnika od svjetlosti nakon postupka idućih 48 sati zbog fotosenzibilizirajućeg učinka lijeka TOOKAD i osiguravanje primjerka upute o lijeku TOOKAD bolesniku prije provedbe VTP postupka.
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. 
Jedan bolesnik imao je prostatitis 3. stupnja koji se smatrao ozbiljnim i koji je započeo 4 dana nakon VTP postupka, i trajao je 31 dan prije nego što se povukao bez posljedica.
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).