natgillin/translations-raw huggingface dataset:
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.
Obseg medsebojnega delovanja ni bil klinično preučevan, vendar prehodnega povečanja plazemske koncentracije sočasno uporabljenih substratov OATP1B1 in OATP1B3 ni mogoče izključiti.
An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4).
Prevelik odmerek laserske svetlobe lahko poveča tveganje neželene ekstraprostatične nekroze (glejte poglavje 4.4).
First 12 hours after VTP procedure
Prvih 12 ur po postopku VTP
Urinary incontinence (urge incontinence, incontinence, stress urinary incontinence).
8 Urinska inkontinenca (urgentna inkontinenca, inkontinenca, stresna urinska inkontinenca).
In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
V evropski študiji III. faze se je pri 25 (12,7 %) bolnikih pojavila urinska inkontinenca (vključno z inkontinenco, stresno urinsko inkontinenco in urgentno inkontinenco).
If you do require further treatment, at the moment, there is limited information on whether TOOKAD-VTP affects the efficacy and safety results of other treatments (such as surgery to remove the prostate or radiotherapy).
Če potrebujete dodatno zdravljenje, so informacije o tem, ali postopek TOOKAD-VTP vpliva na rezultate učinkovitosti in varnosti drugih zdravljenj (kot je operacija za odstranitev prostate ali obsevanje), trenutno omejene.
The day before and at the beginning of the VTP procedure, a rectal preparation is performed in order to clean the rectum.
En dan pred postopkom VTP in tik pred njim se za čiščenje danke izvede rektalna priprava.
Of 121 patients that progressed in the AS arm, 54 underwent radical therapy and 67 had not received any active treatment at the end of the study.
Od 121 bolnikov, pri katerih je v kraku AS bolezen napredovala, jih je bilo 54 zdravljenih radikalno, 67 pa ob koncu študije ni bilo aktivno zdravljenih.
In addition, inserting needles into the prostate gland and inserting a urinary catheter for the procedure may be associated with further side effects.
Poleg tega sta vstavljanje igel v prostato in vstavitev urinskega katetra povezana z dodatnimi neželenimi učinki.
The Patient information guide about TOOKAD should contain the following key elements:
Vodnik z informacijami za bolnike o zdravilu TOOKAD mora vsebovati naslednje ključne elemente:
Additional VTP procedures of the prostate are not recommended.
Dodatni postopki VTP na prostati niso priporočljivi.
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.
Radikale •NO hitro konzumirajo radikali kisika, zato se hkrati z zoženjem arterij ustvarijo reaktivne dušikove zvrsti (RNS - reactive nitrogen species) (npr. peroksinitrit).
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.
Ta zdravila je treba prenehati jemati vsaj 10 dni pred postopkom z zdravilom TOOKAD in se jih ne sme jemati vsaj 3 dni po postopku ali pa jih je treba zamenjati z drugimi zdravili brez lastnosti, ki povzročajo preobčutljivost na svetlobo.
TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3).
Zdravilo TOOKAD je kontraindicirano pri bolnikih, pri katerih je bila diagnosticirana holestaza (glejte poglavje 4.3).
causing local hypoxia that induces the release of nitric oxide (•NO) radicals.
2), ki povzročijo lokalno hipoksijo, ta pa privede do sprostitve radikalov dušikovega oksida (•NO).
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.
Po postopku morate nositi zaščitna očala in ostati pod zdravniškim nadzorom v sobi s pridušeno svetlobo vsaj 6 ur.
Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4).
Ponovno zdravljenje istega režnja ali zaporedno zdravljenje režnja prostate na nasprotni strani nista priporočljivi (glejte poglavje 4.4).
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.
Poleg tega naj bi okrnjena deformabilnost krepila agregabilnost eritrocitov in nastajanje krvnih strdkov v stičnih oskrbovalnih arterijah, mikrocirkulacija tumorja pa naj bi povzročala zaporo tumorskih žil.
This may also cause bruising, haematuria and/or local pain.
To lahko povzroči tudi podplutbe, hematurijo in/ali lokalno bolečino.
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.
Zdrave osebe so bile izpostavljene odmerkom dikalijevega padeliporfina do največ 15 mg/kg (kar ustreza 13,73 mg/kg padeliporfina) brez svetlobne aktivacije, 23 bolnikov pa je bilo zdravljenih s 6 mg/kg dikalijevega padeliporfina (kar ustreza 5,49 mg/kg padeliporfina) brez pomembnih varnostnih težav.
Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Zdravila, ki preprečujejo ali zmanjšujejo agregacijo trombocitov, se ne smejo uporabljati vsaj 3 dni po postopku.
You should wear dark clothes and take care to protect your hands and face from the sun.
Nositi morate temna oblačila in paziti, da roke in obraz zaščitite pred soncem.
Some medicines (in particular any medicines that are photosensitising or that affect blood clotting) may interact with TOOKAD and should be stopped before using TOOKAD.
Nekatera zdravila (še posebej zdravila, ki povzročajo preobčutljivost na svetlobo ali vplivajo na strjevanje krvi) lahko medsebojno delujejo z zdravilom TOOKAD in jih je pred uporabo zdravila TOOKAD treba prenehati jemati.
The solution is administered by intravenous injection over 10 minutes.
Raztopina se daje z intravensko injekcijo v trajanju 10 minut.
What TOOKAD looks like and contents of the pack TOOKAD is a dark powder.
Izgled zdravila TOOKAD in vsebina pakiranja Zdravilo TOOKAD je prašek temne barve.
In other cases, urethral stenosis may have been a late consequence of TOOKAD-VTP induced necrosis.
V drugih primerih je stenoza sečnice lahko zapoznela posledica nekroze, sprožene s postopkom TOOKAD-VTP.
For instructions to healthcare professionals on reconstitution of TOOKAD before injection, see “Reconstitution of the TOOKAD powder for solution for injection”.
Navodila za zdravstvene delavce o rekonstituciji zdravila TOOKAD pred injiciranjem si oglejte v poglavju „Rekonstitucija praška TOOKAD za raztopino za injiciranje“.
What you need to know before TOOKAD is used
Kaj morate vedeti, preden boste uporabili zdravilo TOOKAD 3.
VTP procedure
Postopek VTP
This may necessitate inserting a catheter inside your bladder through the penis and the catheter will remain in place for a few days or weeks to drain the urine.
Zato je morda treba skozi penis v mehur vstaviti kateter za drenažo urina, ki bo nekaj dni ali tednov ostal na tem mestu.
LIST OF EXCIPIENTS Excipient: Mannitol
SEZNAM POMOŽNIH SNOVI pomožna snov: manitol
In the pivotal Phase III European study, moderate or severe urethral stenosis developed in 2 (1.0 %) patients 5 to 6 months post-procedure.
V ključni evropski študiji III. faze se je zmerna do resna stenoza sečnice pojavila pri 2 (1,0 %) bolnikih v času od 5 do 6 mesecev po postopku.
However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4).
Vendar preobčutljivost na svetlobo lahko traja dlje, zato je treba previdnostne ukrepe v zvezi z izogibanjem izpostavljenosti svetlobi upoštevati še dodatnih 24 ur (glejte poglavje 4.4).
Sunscreen creams do not protect you against the type of light (near infra-red) that can cause problems after the procedure.
Kreme za zaščito pred soncem ne varujejo pred vrsto svetlobe (z valovno dolžino blizu infrardečega spektra), ki po postopku povzroča težave.
Place a 0.22 μm injection filter on the syringe.
Na brizgo namestite injekcijski filter velikosti 0,22 μm.
There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
Zdravilo TOOKAD se minimalno izloča skozi ledvice, zato pri bolnikih z okvaro ledvic ni treba prilagoditi odmerka.
Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
Aktivacija znotraj osvetljenega ožilja tumorja ustvari kisikove radikale (•OH, O
• 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
• razlago, kaj zajema postopek VTP, vključno z nujnostjo upoštevanja pravil za zaščito bolnika pred svetlobo 48 ur po postopku zaradi učinka zdravila TOOKAD, ki povzroča preobčutljivost na svetlobo, in zagotovitev izvoda navodil za uporabo zdravila TOOKAD bolniku pred postopkom VTP.
Talk to your doctor or nurse if: - You feel any irritation of the skin or problems with vision or eye irritation after the
Z zdravnikom ali medicinsko sestro se posvetujte, če: - po postopku VTP čutite kakršno koli draženje kože, imate težave z vidom ali čutite draženje oči;
In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
V evropski študiji III. faze je 30 (15,2 %) bolnikov doživelo zastajanje urina.
Patients in the AS arm were not offered subsequent VTP.
Bolnikom v kraku AS naknadno zdravljenje s postopkom VTP ni bilo ponujeno.
Penile swelling (balanoposthitis).
13 Otekanje penisa (balanopostitis).
Only the lobe that contains the cancer will be treated.
Zdravljen bo le reženj, v katerem je rak.
The Physician guideline about TOOKAD should contain the following key elements:
Smernice za zdravnike o zdravilu TOOKAD morajo vsebovati naslednje ključne elemente:
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.
Pri enem bolniku, zdravljenem z 2 mg/kg zdravila TOOKAD, so 33 dni po postopku VTP poročali o enem primeru ishemične optične nevropatije 3. stopnje.
Excessive extraprostatic necrosis occurred as a result of incorrect calibration of the laser or placement of the light fibres (see section 4.8).
Do čezmerne ekstraprostatične nekroze je prišlo zaradi nepravilnega umerjanja laserja ali namestitve svetlobnih vlaken (glejte poglavje 4.8).
The median time to onset of urinary incontinence was 4 days (1-142).
Srednja vrednost časa do nastopa urinske inkontinence je znašala 4 dni (1-142).
No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Brez rezultata biopsije, n Osebe, ki so bile zdravljene radikalno, zato biopsija manjka, n (%)
For the 48 hours after the procedure you should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Prvih 48 ur po posegu se morate izogibati izpostavljenosti neposredni sončni svetlobi (tudi svetlobi, ki prodira skozi okna) in vsem močnim virom svetlobe v notranjih prostorih in na prostem.
Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment.
Pri bolnikih z okvaro jeter je pričakovana povečana in/ali podaljšana izpostavljenost padeliporfinu.
Concomitant use of systemic VEGF inhibitors is not recommended with TOOKAD.
Sočasna uporaba sistemskih zaviralcev VEGF z zdravilom TOOKAD ni priporočljiva.
Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Do dveh primerov čezmerne ekstraprostatične nekroze brez kliničnih posledic je prišlo zaradi nepravilnega umerjanja laserja.
Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Kakršno koli zdravstveno stanje, zaradi katerega dajanje splošnih anestetikov ali invazivni postopki niso mogoči.
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.
Ker pa postopek vključuje splošno anestezijo, bolniki 24 ur po uporabi splošnega anestetika ne smejo izvajati zapletenih opravil, kot sta vožnja ali upravljanje strojev.
Patients should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Bolniki se morajo izogibati izpostavljenosti neposredni sončni svetlobi (tudi svetlobi, ki prodira skozi okna) in vsem močnim virom svetlobe v notranjih prostorih in na prostem.
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.
Med postopkom se število in dolžina optičnih vlaken izbereta glede na obliko in velikost prostate, s pomočjo ultrazvočnega usmerjanja pa se optična vlakna transperinealno namestijo v prostato, tako da se v ciljnem tkivu doseže indeks gostote svetlobe (LDI - Light Density Index) ≥ 1.
The reconstituted solution for infusion is dark.
Rekonstituirana raztopina za infundiranje je temna.
For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila TOOKAD pred dajanjem glejte poglavje 6.6.
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).
Po opravljenem postopku TOOKAD-VTP je treba pri bolnikih izvesti digitalni rektalni pregled (DRE - Digital Rectal Examination), spremljati pa je treba tudi njihovo raven PSA v serumu, vključno z oceno dinamike PSA (podvojitveni čas PSA in hitrost PSA).
Number of subjects who initiated a radical treatment, n (%)
Število oseb, ki je začelo radikalno zdravljenje, n (%)
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.
V evropski študiji III. faze je 60 (30,5 %) bolnikov v kraku TOOKAD-VTP doživelo erektilno disfunkcijo, 16 (8,1 %) pa neuspešno ejakulacijo.
Limited information is available regarding the safety and efficacy of radical prostatectomy after TOOKAD-VTP.
Informacije o varnosti in učinkovitosti radikalne prostatektomije po postopku TOOKAD-VTP, ki so na voljo, so omejene.
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.
Rezultati farmakokinetične študije populacije so pokazali, da znaten in pomemben vpliv starosti, rase, zdravstvenega stanja in označevalcev jetrne funkcije na farmakokinetiko zdravila TOOKAD ni verjeten.
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.
Če čutite nelagodje na koži ali v očeh med bivanjem v bolnišnici, morate to povedati zdravniku ali medicinski sestri, da bo mogoče svetlobo pridušiti in še posebej paziti na to, da boste zaščiteni tako pred umetno kot tudi naravno svetlobo.
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.
Ko je bila analiza omejena na bolnike, pri katerih je bil opravljen unilateralni postopek VTP, je 33 (16,8 %) bolnikov doživljalo erektilno disfunkcijo več kot 6 mesecev, vključno s 17 (8,6 %) bolniki, pri katerih erektilna disfunkcija ob koncu študije ni bila odpravljena.
Some difficulties in getting or maintaining an erection is possible soon after the procedure and may last for more than 6 months.
Kmalu po postopku so možne določene težave pri doseganju ali vzdrževanju erekcije, ki lahko trajajo več kot 6 mesecev.
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).
Uporabljate lahko le sijalke z močjo največ 60 vatov (pri žarnicah), 6 vatov (pri lučeh LED) ali 12 vatov (pri fluorescentnih nizkoenergijskih lučeh).
In 18 patients the adverse event resolved with a median duration of 63.5 days (1-360), and the adverse event was still ongoing at the end of the study for 7 patients.
Pri 18 bolnikih je srednja vrednost trajanja časa do odprave neželenega učinka znašala 63,5 dni (1-360), pri 7 bolnikih pa je bil ob koncu študije ta še vedno prisoten.
- 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).
- je bila pri vas prisotna aktivna vnetna črevesna bolezen ali kakršno koli stanje, ki lahko poveča tveganje za nastanek nenormalne povezave med danko in sečnico (rektouretralna fistula);
What TOOKAD is and what it is used for
Kaj je zdravilo TOOKAD in za kaj ga uporabljamo 2.
All patients had Gleason score ≤ 3 + 3 at baseline.
Ocena po Gleasonu je bila v izhodišču pri vseh bolnikih ≤ 3 + 3.
AS involved serial absolute PSA measurements and ultrasound-guided prostatic biospy at 12 and 24 months.
Aktivno opazovanje je vključevalo zaporedne meritve absolutne PSA in ultrazvočno vodeno biopsijo prostate pri 12 in 24 mesecih.
Padeliporfin has not been tested for reproductive toxicity and fertility.
Preskušanje padeliporfina glede vpliva na sposobnost razmnoževanja in plodnosti ni bilo izvedeno.
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.
Če morate podnevi oditi ven, morate nositi zaščitna oblačila in očala z visoko zaščito, da boste zavarovali svojo kožo in oči.
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)
TOOKAD in/ali metodo študije in/ali postopkom študije v zbirni analizi varnosti (N = 398) Organski sistem
TOOKAD is restricted to hospital use only.
Uporaba zdravila TOOKAD je omejena le na bolnišnice.
5 years
6 ur.
You may go outdoors during daylight hours but only in shaded areas or when it is overcast.
Podnevi lahko odidete ven le na senčna območja ali takrat, ko je oblačno.
Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
Na podlagi analize popPK znaša ocenjena razpolovna doba 1,19 h ± 0,08 pri 4 mg/kg dikalijevega padeliporfina.
In some cases pain relief was required for perineal pain or anorectal discomfort.
V nekaterih primerih je bilo za bolečino v presredku ali nelagoden občutek v anorektalnem predelu potrebno lajšanje bolečin.
Before treatment, the tumour must be accurately located and confirmed as unilateral using high-resolution biopsy strategies based on current best practice, such as multi-parametric MRI-based strategies or template-based biopsy procedures.
Pred zdravljenjem je treba s strategijami biopsije z visoko ločljivostjo, ki temeljijo na obstoječih dobrih praksah, kot so multiparametrične strategije na podlagi MRI ali postopki biopsije na podlagi predloge, natančno določiti mesto tumorja in ga potrditi kot unilateralnega.
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.
Zaradi lastnosti zdravila TOOKAD, ki povzročajo preobčutljivost na svetlobo, je treba vsebino viale nato prenesti v neprosojno brizgo, ki mora 3 minute stati v pokončnem položaju, da morebitna pena izgine.
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.
Rekonstituirajte raztopino tako, da dodate: - za zdravilo TOOKAD 183 mg: 20 ml 5-odstotne raztopine glukoze v vialo, ki vsebuje prašek; - za zdravilo TOOKAD 366 mg: 40 ml 5-odstotne raztopine glukoze v vialo, ki vsebuje prašek.
The most common infections are orchitis, epididymitis and urinary tract infections including cystitis.
Okužbe spolovil in sečil Najpogostejše okužbe so orhitis, epididimitis in okužbe sečil, vključno s cistitisom.
In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7.
Pri bolnikih z lokaliziranim rakom prostate, pri katerih je bil izveden postopek TOOKAD-VTP, so z napravo za magnetnoresonančno slikanje (MRI - Magnetic Resonance Imaging) 7. dan opazili nekrozo.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje 1 viala
In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
T3, pozitivnih robovih in impotenci.
TOOKAD is administered as part of focal VTP.
Zdravilo TOOKAD se daje kot del fokalnega zdravljenja s postopkom VTP.
The pivotal open-label Phase III study (PCM301), conducted in 10 European countries, randomised 413 patients to TOOKAD-VTP arm or AS arm.
Ključna odprta študija III. faze (PCM301), ki je bila izvedena v 10 evropskih državah, je randomizirala 413 bolnikov v krak TOOKAD-VTP ali krak z aktivnim spremljanjem (AS - Active Surveillance).
If the patient must go outdoors during daylight hours, he should wear protective clothes and high protection goggles to shield his skin and eyes.
Če mora bolnik podnevi oditi ven, mora nositi zaščitna oblačila in očala z visoko stopnjo zaščite, da zavaruje svojo kožo in oči.
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).
Če prenehanje uporabe zdravil, ki povzročajo preobčutljivost na svetlobo (kot je amiodaron), ni mogoče, je treba bolniku povedati, da lahko pride do povečane občutljivosti na svetlobo in da se bo moral morda dlje časa varovati pred izpostavljenostjo neposredni svetlobi (glejte poglavje 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).
Ni pričakovati, da bi zamik pri strjevanju krvi zmanjšal učinkovitost zdravljenja s postopkom TOOKAD-VTP, vendar zdravil, ki vplivajo na strjevanje, ni priporočljivo dajati pred postopkom VTP in takoj po njem (glejte poglavje 4.5).
Because the fibres that carry the light have to be inserted in such a way that the whole of the lobe of the prostate gland gets exposed, it is possible that some damage may occur outside of the prostate.
Tveganje poškodb v bližini prostate Ker morajo biti vlakna, ki prenašajo svetlobo, vstavljena na tak način, da pride do izpostavljenosti celotnega režnja prostate, lahko zunaj prostate pride do določenih poškodb.
1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
1 ml rekonstituirane raztopine vsebuje 9,15 mg padeliporfina.