natgillin/translations-raw huggingface dataset:
However, all stages of spermatogenesis have been observed in animal.
Vendar so pri živalih opazili vse stopnje spermatogeneze.
In this case, you should contact your doctor as you may need further blood or urine analysis and antibiotics treatment.
V tem primeru morate stopiti v stik s svojim zdravnikom, saj boste morda potrebovali dodatne analize krvi ali urina in zdravljenje z antibiotiki.
Your medical team will decide if you can leave hospital on the evening of your treatment.
Ekipa vaših zdravnikov se bo odločila, ali lahko bolnišnico zapustite v večernih urah po zdravljenju.
In 5 (2.5 %) patients, the infection was considered serious.
Pri 5 (2,5 %) bolnikih je okužba veljala za resno.
No specific dosage recommendation can be given.
Posebnih priporočil za odmerjanje ni mogoče podati.
The targeted zone corresponds to the lobe containing the positive biopsies.
Ciljano območje ustreza režnju, ki vsebuje pozitivne biopsije.
Some cases of hepatotoxicity (1.5 %), such as elevation of transaminases, were also reported.
Poročali so tudi o nekaterih primerih hepatotoksičnosti (1,5 %), kot je povišana raven transaminaz.
Your doctor will also advise what medicines may be substituted where appropriate and when these medicines can be re-started after the VTP procedure.
Vaš zdravnik vam bo tudi svetoval, katera zdravila je mogoče nadomestiti, kjer je to smiselno, in kdaj po postopku VTP je mogoče začeti s ponovnim jemanjem teh zdravil.
• Explain what side effects the Patient might expect and the likelihood of him getting them
• pojasnilo, katere neželene učinke lahko bolnik pričakuje in verjetnost, da se bodo pri njem pojavili.
Do not use after the expiry date which is stated on the shield label after “EXP”.
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na zaščitni nalepki poleg oznake „EXP“.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta.
Co-administration should be done with caution and close monitoring is recommended.
Sočasno dajanje je treba izvesti previdno in priporočljivo je natančno spremljanje.
mpMRI may be used to improve the decision making but not, at present, to replace biopsy.
Za boljše odločanje je mogoče uporabiti mpMRI, ki pa zaenkrat ne more nadomestiti biopsije.
Of the 206 subjects randomised TOOKAD-VTP, 10 did not receive treatment for various reasons including study withdrawal, meeting exclusion criteria, non-compliance and other medical events.
Od 206 oseb, randomiziranih za postopek TOOKAD-VTP, jih 10 ni bilo zdravljenih iz različnih razlogov, med katerimi so umik iz študije, izpolnjevanje pogojev za izključitev, neskladnost in drugi zdravstveni dogodki.
Erectile dysfunction may occur even if radical prostatectomy is avoided.
Erektilna disfunkcija se lahko pojavi, tudi če ni prišlo do radikalne prostatektomije.
In case of bilateral disease (discovered at entry or during follow-up), bilateral treatment was to be applied, either simultaneously or consecutively.
Pri bilateralni bolezni (odkriti ob sprejemu ali med kontrolo) je bilo treba sočasno ali zaporedno uporabiti bilateralno zdravljenje.
Patients meeting indication criteria
Bolniki, ki izpolnjujejo merila indikacije
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Appendix V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
When 48 hours have passed after the procedure, you can resume your normal activities and you can be exposed to direct sunlight.
Ko od postopka mine 48 ur, lahko ponovno začnete opravljati svoje običajne dejavnosti, pri čemer ste lahko izpostavljeni tudi sončni svetlobi.
None of these patients required an operation for incontinence.
Operacije zaradi inkontinence ni potreboval nobeden od teh bolnikov.
ITT population
Populacija ITT
The pharmacokinetic properties of TOOKAD were studied in 42 healthy human male subjects (without photoactivation) and in 70 patients with localised prostate cancer (after photoactivation).
Farmakokinetične lastnosti zdravila TOOKAD so bile preučevane pri 42 zdravih moških (brez fotoaktivacije) in pri 70 bolnikih z lokaliziranim rakom prostate (po fotoaktivaciji).
The treatment is carried out under general anaesthetic (medicines that send you to sleep to prevent pain and discomfort).
Zdravljenje se izvaja pod vplivom splošnih anestetikov (zdravil, ki vas uspavajo, da ne čutite bolečine in nelagodja).
You will be given a general anaesthetic to send you to sleep before the VTP procedure.
Dobili boste splošne anestetike, da boste pred postopkom VTP zaspali.
The injection lasts 10 minutes.
Infuzija traja 10 minut.
Urinary excretion of padeliporfin in healthy human subjects was very low (< 0.2 % of the dose).
Izločanje padeliporfina z urinom pri zdravih moških je bilo zelo majhno (< 0,2 % odmerka).
Simultaneous treatment of both prostate lobes was associated with an inferior outcome in clinical trials and should not be performed.
Sočasno zdravljenje obeh režnjev prostate je bilo v kliničnih študijah povezano s slabšim izidom in se ne sme izvajati.
Only 1 (0.5 %) patient had a severe (Grade 3) urinary incontinence.
Samo 1 (0,5 %) bolnik je imel resno urinsko inkontinenco (3. stopnje).
However, patients weighing more than 115 kg will receive more than 1 mmol potassium.
Vendar bodo bolniki, ki tehtajo več kot 115 kg, prejeli več kot 1 mmol kalija.
Those results were improved at Month 3 and back to baseline values at Month 6, with further improvement until Month 24.
Ti rezultati so se izboljšali v 3. mesecu, nazaj na izhodiščne vrednosti pa so padli v 6. mesecu, pri čemer so se do 24. meseca še izboljšali.
In consequence there is a potential risk of damage to adjacent structures, such as the bladder and/or rectum, and development of a recto-urethral or external fistula.
Zato obstaja potencialno tveganje za poškodbe sosednjih struktur, kot sta mehur in/ali danka, ter razvoj rektouretralne ali zunanje fistule.
Padeliporfin di-potassium is highly bound to human plasma proteins (99 %).
Dikalijev padeliporfin se močno veže na humane plazemske proteine (99 %).
OATP1B1 and OATP1B3 transporters
Prenašalci OATP1B1 in OATP1B3
A secondary objective was to determine the difference between the two arms with regard to the rate of subsequent radical therapy for prostate cancer.
Sekundarni cilj je bil določitev razlike med obema krakoma glede na stopnjo naknadnega radikalnega zdravljena raka prostate.
The VTP procedure is performed under general anaesthetic after rectal preparation.
Postopek VTP se izvaja pod vplivom splošnega anestetika po rektalni pripravi.
This event was not considered to be related to a faulty procedure but rather the pre-existing damage to the internal urethral sphincter from the TURP.
Tega dogodka niso šteli za povezanega z napačnim postopkom, ampak s predhodno poškodbo notranje mišice zapiralke sečnice zaradi TURP.
Difficulties in getting or maintaining an erection
Težave pri doseganju ali vzdrževanju erekcije
Sunscreen creams do not protect against near infra-red light and, therefore, do not provide adequate protection.
Kreme za zaščito pred soncem ne varujejo pred svetlobo z valovno dolžino blizu infrardečega spektra in zato ne zagotavljajo zadostne zaščite.
Check with your doctor about the birth control methods to use and how long to use them for.
Zdravnika povprašajte o oblikah kontracepcije, ki jih lahko uporabite, in o tem, kako dolgo jih uporabljati.
The MAH shall ensure that in each Member State where TOOKAD is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use TOOKAD have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo v vsaki državi članici, v kateri se zdravilo TOOKAD trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali zdravilo TOOKAD, dostop ali prejmejo naslednji izobraževalni paket:
This resolved with a small defect in the visual field.
Težava je bila odpravljena, ostala pa je majhna okvara v vidnem polju.
This may also cause bruising, blood in the urine and/or local pain.
To lahko povzroči tudi podplutbe, kri v urinu in/ali lokalno bolečino.
- The other ingredient is mannitol.
- Druga sestavina je manitol.
In addition to the side effects listed previously, other side effects can occur.
Poleg prej naštetih neželenih učinkov se lahko pojavijo tudi drugi.
Adverse reactions reported are listed below in Table 1 by organ class and frequency.
Neželeni učinki, o katerih so poročali, so našteti v spodnji preglednici 1 glede na klasifikacijo organov in pogostnost.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Pogostnost je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
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)
V vsaki preglednici so predstavljeni tudi rezultati bolnikov, ki izpolnjujejo merila indikacije (bolniki z unilateralnim nizko tveganim lokaliziranim rakom prostate, razen tistih z zelo nizko tveganim rakom prostate).
Taking into account its molecular mass and the very low urinary excretion of the molecule, faecal elimination is the most probable route of elimination in human.
Ob upoštevanju njegove molekulske mase in zelo majhnega izločanja molekul z urinom, je način izločanja, ki je pri ljudeh najverjetnejši, izločanje z blatom.
However, this will be exceeded in patients heavier than 115 kg.
Vendar bo pri bolnikih, težjih od 115 kg, ta količina presežena.
Illumination for photoactivation of TOOKAD
Osvetlitev za fotoaktivacijo zdravila TOOKAD
All of them were mild in intensity.
Vsi ti učinki so bili blagi.
12-48 hours after VTP procedure
12-48 ur po postopku VTP
If you get any of the side effects below, tell your doctor immediately: - Urinary retention (not able to pass urine).
Če se pri vas pojavi kateri koli od spodaj navedenih neželenih učinkov, to takoj sporočite svojemu zdravniku: - Zastajanje urina (nezmožnost uriniranja).
Current or prior treatment for prostate cancer.
Trenutno ali predhodno zdravljenje raka prostate.
This medicine is stored under the responsibility of the specialist.
Za shranjevanje tega zdravila je odgovoren zdravnik specialist.
EU/1/17/1228/002
EU/1/17/1228/001 EU/1/17/1228/002
Patients who have been diagnosed with cholestasis.
Bolniki, pri katerih je bila diagnosticirana holestaza.
TOOKAD is for intravenous use.
Zdravilo TOOKAD je namenjeno intravenski uporabi.
Retreatment of lobes found positive for cancer at 12-months follow-up was allowed.
Dovoljeno je bilo ponovno zdravljenje režnjev, za katere je bilo na kontroli pri 12 mesecih ugotovljeno, da so pozitivni za raka.
Swirl the vial gently for 2 minutes.
Vialo 2 minuti nežno sukajte.
This is normally avoidable by careful planning but should it occur there is a risk of an abnormal connection forming between the rectum and the bladder or skin.
Običajno se je temu mogoče izogniti z natančnim načrtovanjem, če pa kljub temu pride do tega, obstaja tveganje za nastanek nenormalne povezave med danko in mehurjem ali kožo.
This includes sunbeds, bright computer monitor screens (see precautions below), and examination lights from medical equipment.
To vključuje solarije, bleščeče zaslone računalnikov (glejte spodaj navedene previdnostne ukrepe) in luči opreme za medicinske preiskave.
At present TOOKAD-VTP has been shown to defer the need for radical therapy and its associated toxicity.
Zaenkrat so dokazali, da postopek TOOKAD-VTP odloži potrebo po radikalnem zdravljenju in z njim povezano toksičnost.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (pri 2-8 °C).
The following types of medicines may be ones that your doctor will advise you to stop temporarily:
Vrste zdravil, za katere vam zdravnik lahko svetuje, da jih prenehate jemati, so lahko naslednje:
Therefore, the possibility for some in vivo metabolism of padeliporfin cannot be fully excluded.
Zato možnosti za določeno presnovo padeliporfina in vivo ni mogoče v celoti izključiti.
Urinary retention immediately post procedure has been attributed to transient prostatic oedema and generally only short term recatheterisation was required.
Zastajanje urina takoj po postopku je bilo pripisano prehodnemu edemu prostate in v glavnem je bila potrebna le kratkotrajna ponovna kateterizacija.
Additional adverse reactions in the Phase II prostate cancer studies and Special Authorization Extraprostatic necrosis
Dodatni neželeni učinki v študijah raka prostate III. faze in posebno dovoljenje Ekstraprostatična nekroza
In the few days after the VTP procedure some patients may have difficulties (poor stream due to urethral narrowing) or inability to pass urine.
Nekaj dni po postopku VTP imajo lahko nekateri bolniki težave (šibek curek zaradi zoženja sečnice) ali ne morejo urinirati.
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.
Dosedanje informacije o obdobju po postopku VTP, daljšem od dveh let, so omejene, zato podatki o tem, ali je korist postopka TOOKAD-VTP dolgoročna, trenutno niso na voljo.
In case of unilateral disease, focal treatment of one lobe was to be applied.
Pri unilateralni bolezni je bilo treba uporabiti fokalno zdravljenje enega režnja.
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.
Glavna izključitvena merila so bila kakršno koli predhodno ali trenutno zdravljenje raka prostate, kakršen koli kirurški poseg za benigno hipertrofijo prostate, pričakovana življenjska doba manj kot 10 let ter zdravstvena stanja, ki izključujejo uporabo splošne anestezije.
Hepatotoxicity (alanine aminotransferase increased, aspartate aminotransferase increased).
4 Hepatotoksičnost (povišane ravni alanin aminotransferaze, povišane ravni aspartat aminotransferaze).
The safety and efficacy of subsequent radical therapy (surgery or radiotherapy) is uncertain.
Varnost in učinkovitost naknadnega radikalnega zdravljenja (operacije ali obsevanja) nista zagotovljeni.
If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
Če ima bolnik spolne odnose z ženskami, ki lahko zanosijo, mora on in/ali njegova partnerka uporabljati učinkovito obliko kontracepcije za preprečitev zanositve v obdobju 90 dni po postopku
In vitro studies indicate that TOOKAD is unlikely to be an inhibitor of CYP450 enzymes.
Študije in vitro kažejo, da za zdravilo TOOKAD ni verjetno, da bi bilo zaviralec encimov CYP450.
The reconstituted solution is dark.
Rekonstituirana raztopina je temna.
The patient may be discharged in the evening of the same day at the physician's discretion.
Zdravnik lahko po lastni presoji bolnika odpusti zvečer istega dne.
Normally this is just the fat around the prostate and is not important but nearby organs such as the bladder and rectum may potentially be affected.
Običajno gre le za maščobo okrog prostate in za nič pomembnega, vendar so lahko prizadeti bližnji organi, kot sta mehur in danka.
Prior to launch of TOOKAD in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila TOOKAD na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
The final solution concentration is 9.15 mg/mL.
Končna koncentracija raztopine znaša 9,15 mg/ml.
No metabolites of padeliporfin were observed in these studies.
V teh študijah ni bilo opaženih nobenih presnovkov padeliporfina.
In Phase II studies, treatment conditions corresponding to an LDI ≥ 1 were associated with a mean rate of necrosis of the targeted zone at day 7 of 89 % ± 20.75 for unilateral treatment.
faze so bili pogoji zdravljenja, ki so ustrezali indeksu LDI ≥ 1, povezani s srednjo vrednostjo nekroze ciljanega območja, ki je 7. dne znašala 89 % ± 20,75 za unilateralno zdravljenje.
Your doctor may prescribe antibiotics to prevent infection and alpha-blockers (medicines given to prevent difficulties in urinating).
Zdravnik vam lahko predpiše antibiotike za preprečevanje okužbe in zaviralce alfa (zdravila za preprečevanje težav pri uriniranju).
There is limited data on long-term outcomes and on potential consequences of post-TOOKAD local scarring in case of disease progression.
Podatki o dolgoročnih izidih in morebitnih posledicah lokalnega brazgotinjenja po zdravljenju z zdravilom TOOKAD pri napredovanju bolezni so omejeni.
Marketing Authorisation Holder Steba Biotech S.A.
Imetnik dovoljenja za promet z zdravilom Steba Biotech S.A.
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).
starejših od 75 let, zato ni znano, ali pri primerjavi teh starejših bolnikov z bolniki, starimi manj kot 75 let, obstaja razlika (glejte poglavji 4.2 in 5.1).
Elderly No specific posology adjustment is necessary in this population (see section 5.2).
Starejši Pri tej populaciji odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
No data are available in patients with hepatic impairment.
Pri bolnikih z okvaro jeter ni na voljo nobenih podatkov.
Other medicines and TOOKAD
Druga zdravila in zdravilo TOOKAD
In the 24 months of the pivotal European Phase III study, no patients underwent radical radiotherapy post TOOKAD-VTP.
V 24 mesecih ključne evropske študije III. faze noben bolnik po postopku TOOKAD-VTP ni bil radikalno zdravljen z obsevanjem.
This results in transient arterial vasodilatation that triggers the release of the vasoconstrictor, endothelin-1.
Zato pride do prehodne arterijske vazodilatacije, ki sproži sproščanje vazokonstriktorja, endotelina-1.
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 %) bolnikov je doživljalo erektilno disfunkcijo več kot 6 mesecev, vključno s 34 (17,3 %) bolniki, pri katerih erektilna disfunkcija ob koncu študije ni bila odpravljena.
The patient must stay in a dimmed light environment without any direct exposure of the skin and the eyes to daylight.
Bolnik mora ostati v okolju s pridušeno svetlobo, brez kakršne koli neposredne izpostavljenosti kože ali oči dnevni svetlobi.
Poor urinary flow due to urethral stricture developed some months post procedure.
Nezadosten pretok zaradi strikture sečnice se je pojavil nekaj mesecev po postopku.
The median duration was 21 days (4-197).
Srednja vrednost trajanja je znašala 21 dni (4-197).
In certain cases, the bulbar location suggested that the stenosis was caused by urinary catheterisation.
V določenih primerih so izbokline kazale na to, da je stenozo povzročila urinska kateterizacija.
- You experience difficulties in getting or maintaining an erection.
- imate težave pri doseganju ali vzdrževanju erekcije;
T2a, n (%)
T1, n (%) T2a, n (%)
Clinical stages
Klinični stadiji
Longer follow-up will be required to determine whether TOOKAD-VTP will be curative in a proportion of patients.
Za ugotavljanje, ali bo postopek TOOKAD-VTP pri določenem deležu bolnikov kurativen, bo potrebno daljše spremljanje.
Of 58 patients that progressed in the TOOKAD-VTP arm, only 11 underwent radical therapy, 18 patients underwent a second VTP procedure and 29 had not received further treatment at the end of the study.
Od 58 bolnikov, pri katerih je v kraku TOOKAD-VTP bolezen napredovala, jih je bilo le 11 zdravljenih radikalno, 18 jih je bilo zdravljenih z drugim postopkom VTP, 29 pa jih ob koncu študije ni bilo dodatno zdravljenih.
TOOKAD must not be used if: - You are allergic to padeliporfin or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste uporabili zdravilo TOOKAD Ne uporabljajte zdravila TOOKAD: - če ste alergični na padeliporfin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
You may also be required to not take certain medicines for several days after the VTP procedure.
Po postopku VTP bodo od vas morda zahtevali, da več dni ne jemljete določenih zdravil.
In the Active Surveillance arm, the IPSS score slightly worsened over time until Month 24.
V kraku aktivnega opazovanja se je rezultat po 24. mesecu sčasoma rahlo poslabšal.
This is enhanced by RNS-induced endothelial cell apoptosis and initiation of self-propagated tumour cells necrosis through peroxidation of their membrane.
To je še okrepljeno zaradi z RNS inducirane apoptoze endotelijskih celic in sprožitve avtopropagacijske nekroze tumorskih celic s peroksidacijo njihove membrane.
Treatment should not be undertaken in patients where an LDI ≥ 1 cannot be achieved (see section 5.1).
Pri bolnikih, pri katerih ni mogoče doseči indeksa LDI ≥ 1, se zdravljenje ne sme izvajati (glejte poglavje 5.1).
Age (years) Mean (SD) Range: min, max Patients aged > 75 year old, n (%) Unilateral disease, n (%) Bilateral disease, n (%)
Bolniki, stari > 75 let, n (%) Unilateralna bolezen, n (%) Bilateralna bolezen, n (%)
• 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.
• informacije o neželenih učinkih in o verjetnosti, da se bodo ti pojavili, vključno z erektilno disfunkcijo, urinsko inkontinenco, zastajanjem urina/strikturo sečnice ter preobčutljivostjo na svetlobo in nujnostjo upoštevanja pravil za lastno zaščito pred svetlobo 48 ur po postopku.
The median duration was 10 days (1-344).
Srednja vrednost trajanja je znašala 10 dni (1-344).
It should only be used by personnel trained in the VTP procedure.
Uporablja ga lahko le osebje, ki je usposobljeno za postopek VTP.
Urinary incontinence
Urinska inkontinenca
Residual tumour has been found on follow-up biopsy of the treated lobe at 12 and 24 months, usually outside of the treated volume, but occasionally within the area of necrosis.
Pri kontrolni biopsiji zdravljenega režnja je bil po 12 in 24 mesecih odkrit rezidualni tumor, ki je bil običajno zunaj zdravljene prostornine, občasno pa znotraj območja nekroze.
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.
Bolnik lahko gleda televizijo z razdalje dveh metrov, po šestih urah pa lahko uporablja elektronske naprave, kot so pametni telefoni ter tablični in osebni računalniki.
There was a correlation between the total energy delivered and the volume of necrosis observed at day 7.
Obstajala je povezava med skupno dovedeno energijo in prostornino nekroze 7. dne.
Warnings and precautions TOOKAD should only be used by personnel trained in the VTP procedure.
Opozorila in previdnostni ukrepi Zdravilo TOOKAD lahko uporablja le osebje, ki je usposobljeno za postopek VTP.