FrancophonIA/ELRC3.0 huggingface dataset:
English: It was stated that the patient had been exposed to more light than permitted for the trial.
Slovenian: Izjavili so, da je bil bolnik bolj izpostavljen svetlobi, kot je bilo dovoljeno v preskušanju.
English: Pack sizes: 1, 2 and 10 bottles.
Slovenian: Velikosti pakiranj: 1, 2 in 10 steklenic.
English: Do not use this medicine if you are pregnant.
Slovenian: Tega zdravila ne uporabljajte, če ste noseči.
English: The training course will take place at qualified training centres using qualified trainers.
Slovenian: Izobraževalni tečaj bo opravljen v kvalificiranem izobraževalnem centru, vodili pa ga bodo kvalificirani predavatelji.
English: The safety and efficacy of Gliolan in children and adolescents aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Gliolan pri otrocih in mladostnikih, starih od 0 do 18 let, še nista bili dokazani.
English: Long-term in vivo carcinogenicity studies have not been conducted.
Slovenian: Dolgoročnih študij kancerogenosti in vivo niso opravili.
English: Five minutes after administration, the baseline values had been reached again.
Slovenian: Pet minut po odmerjanju so bile znova dosežene izhodiščne vrednosti.
English: • if you are allergic to 5-ALA or porphyrins.
Slovenian: • če ste alergični na 5-ALA ali porfirine;
English: − A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the medicinal product.
Slovenian: − izobraževalni tečaj za nevrokirurge, katerega namen je zmanjševanje tveganja in podpiranje varne in učinkovite uporabe zdravila.
English: It is not known whether this medicine enters breast milk.
Slovenian: Ni znano, ali to zdravilo lahko prehaja v materino mleko.
English: In this case, anaesthesia and surgery must be postponed for at least 2 hours, if possible.
Slovenian: V takem primeru je treba anestezijo in kirurški poseg prestaviti za vsaj 2 uri, če je mogoče.
English: No significant increase in overall survival has been observed in this trial; however, it was not powered to detect such a difference.
Slovenian: V tej študiji niso opazili povečanega skupnega preživetja, vendar preskušanje ni bilo oblikovano za določanje te razlike.
English: The difference was statistically significant using the chi-square test (p=0.015).
Slovenian: Razlika je bila pri testu hi-kvadrat statistično pomembna (p = 0,015).
English: The influence of food has not been investigated because this medicinal product is generally given on empty stomach prior to induction of anaesthesia.
Slovenian: Vpliva hrane niso raziskovali, ker se to zdravilo na splošno uporablja na prazen želodec pred indukcijo anestezije.
English: It is not known whether Gliolan will harm an unborn baby.
Slovenian: Ni znano, ali zdravilo Gliolan škoduje nerojenemu otroku.
English: However, considering the therapeutic indication, a single oral treatment with 5-ALA might not be related to any serious potential carcinogenic risk.
Slovenian: Vendar pa, glede na terapevtske indikacije, enkratna peroralna uporaba 5-ALA verjetno ni povezana s kakršnim koli resnim potencialnim kancerogenim tveganjem.
English: If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anaesthesia.
Slovenian: Če ste pozabili vzeti zdravilo v tem časovnem obdobju, ga ni priporočeno vzeti tik pred začetkom anestezije.
English: This medicine is a powder that must be first mixed with drinking water before use.
Slovenian: To zdravilo je prašek, ki ga je treba pred uporabo raztopiti v pitni vodi.
English: Therefore this medicine is not recommended in this age group.
Slovenian: Zato uporaba tega zdravila pri tej starostni skupini ni priporočena.
English: The changes will completely resolve within a few weeks.
Slovenian: V nekaj tednih se popolnoma povrnejo na izhodiščne vrednosti.
English: photosensitivity reaction, photodermatosis
Slovenian: občutljivostna reakcija na svetlobo, fotodermatoza
English: Tabulated summary of adverse reactions Very common (≥1/10)
Slovenian: Tabelarični povzetek neželenih učinkov Zelo pogosti (≥1/10)
English: Light exposed skin recovered completely except for a persistent reduction in the number of hair follicles.
Slovenian: Koža, izpostavljena svetlobi, je popolnoma obnovljena, razen persistirajočega zmanjšanja števila lasnih mešičkov.
English: The majority of genotoxicity studies performed in the dark do not reveal a genotoxic potential of 5-ALA.
Slovenian: Večina študij genotoksičnosti, opravljenih v temi, ni pokazala genotoksičnega potenciala 5-ALA.
English: Gliolan with food and drink
Slovenian: Zdravilo Gliolan skupaj s hrano in pijačo
English: Respiratory insufficiency and erythema completely resolved.
Slovenian: Respiratorna insuficienca in eritem sta bila popolnoma odpravljena.
English: 5-ALA is eliminated quickly with a terminal half-life of 1-3 hours.
Slovenian: 5-ALA se izloča hitro, končni razpolovni čas pa je 1 do 3 ure.
English: Tell your doctor immediately if you experience any complaints.
Slovenian: Nemudoma obvestite zdravnika, če imate katero od teh težav.
English: Common (≥1/100 to <1/10)
Slovenian: Pogosti (≥1/100 do <1/10)
English: This value was defined as the percentage of patients with positive tumour cell identification in all biopsies taken from areas of weak and strong fluorescence.
Slovenian: To vrednost so opredelili kot odstotek bolnikov s pozitivno identifikacijo tumorskih celic pri vseh biopsijah, opravljenih na območju šibke in močne fluorescence.
English: There are no special instructions for use in elderly patients with normal organ function.
Slovenian: Starejši Ni posebnih navodil za uporabo pri starejših bolnikih z normalnim delovanjem organov.
English: Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.
Slovenian: 24 ur po uporabi zdravila Gliolan se izogibajte drugim zdravilom, ki lahko poškodujejo jetra.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John's wort extracts).
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katera koli druga zdravila, zlasti zdravila, ki lahko povzročajo težave s kožo ob izpostavitvi virom močne svetlobe (npr. nekatere vrste antibiotikov), ter tudi zdravila, ki ste jih dobili brez recepta (na primer ekstrakte hipericina ali šentjanževke).
English: Contrast-enhancing tumour was resected in 64 % of patients in the experimental group compared to 38 % in the controlgroup (p<0.0001).
Slovenian: Tumor z okrepljenim kontrastom so uspešno odstranili pri 64 % bolnikov v poskusni skupini in pri 38 % bolnikov v kontrolni skupini (p < 0,0001).
English: Follow-up time comprised at least 180 days after administration.
Slovenian: Čas sledenja je bil vsaj 180 dni po uporabi zdravila.
English: Respiratory insufficiency, which was reported in this patient, was managed by adaptation of ventilation and resolved completely.
Slovenian: Respiratorno insuficienco, o kateri so poročali pri tem bolniku, so obravnavali s prilagoditvijo ventilacije in jo v celoti odpravili.
English: Within 24 hours after administration, other potentially hepatotoxic medicinal products should be avoided.
Slovenian: 24 ur po uporabi se je treba izogibati tudi uporabi drugih potencialno hepatotoksičnih zdravil.
English: 173 patients received standard resection without administration of the medicinal product and subsequent radiotherapy.
Slovenian: Pri 173 bolnikih so opravili standardno resekcijo brez uporabe zdravila, nato pa so prejemali radioterapijo.
English: There is no experience with Gliolan in children and adolescents.
Slovenian: Izkušenj z uporabo zdravila Gliolan pri otrocih in mladostnikih ni.
English: What Gliolan is and what it is used for
Slovenian: Kaj je zdravilo Gliolan in za kaj ga uporabljamo
English: The cardiovascular effects seen are considered to be related to the intravenous route of administration.
Slovenian: Menijo, da so ti kardiovaskularni učinki povezani z intravensko potjo uporabe.
English: A positive predictive value of tissue fluorescence of 84.8 % (90 % CI: 70.7 %-93.8 %) was found.
Slovenian: Ugotovili so pozitivno napovedno vrednost fluorescence tkiva 84,8 % (90 % IZ: 70,7-93,8 %).
English: Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
Slovenian: Uporaba 5-ALA v drugih okoliščinah, razen v tistih, v katerih se je uporabljala v kliničnih preskušanjih, ima lahko za posledico neznana tveganja.
English: PPIX plasma levels rapidly decline during the subsequent 20 hours and are not detectable anymore 48 hours after administration.
Slovenian: Koncentracije PPIX v plazmi v naslednjih 20 urah hitro padajo, 48 ur po uporabi pa jih ni mogoče več določiti.
English: 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance.
Slovenian: 5-ALA se kopiči v tumorskih celicah, kjer se pretvori v drugo podobno snov.
English: Single use bottle - discard any content remaining after first use.
Slovenian: Steklenica za enkratno uporabo - po prvi uporabi zavrzite preostalo vsebino.
English: Patient body weight (kg) Number of bottles = -------------75 kg/bottle
Slovenian: Telesna masa bolnika (kg) Število steklenic = -------------75 kg/steklenico
English: The total number of bottles needed to achieve the intended dose for the individual patient can be determined according to the equation below (rounded up to the nearest whole bottle):
Slovenian: Skupno število steklenic, potrebnih za doseganje nameravanega odmerka za posamičnega bolnika, se lahko določi s spodnjo enačbo (zaokroženo na naslednjo polno steklenico):
English: The positive predictive value of strong fluorescence was higher (100.0 %; 90 % CI: 91.1 %-100.0 %) than of weak fluorescence (83.3 %; 90 % CI: 68.1 %-93.2 %).
Slovenian: Pozitivna napovedna vrednost močne fluorescence je bila večja (100,0 %; 90 % IZ: 91,1-100,0 %) od pozitivne napovedne vrednosti šibke fluorescence (83,3 %; 90 % IZ: 68,1-93,2 %).
English: Approximately 30 % of an orally administered dose of 20 mg/kg body weight is excreted unchanged in urine within 12 hours.
Slovenian: Približno 30 % peroralno zaužitega odmerka 20 mg/kg telesne mase se v 12 urah izloči nespremenjenega v urinu.
English: It is unknown whether 5-ALA or its metabolite protoporphyrin IX (PPIX) is excreted in human milk.
Slovenian: Ni znano, ali se 5-ALA ali njen presnovek protoporfirin IX (PPIX) izloča v materino mleko.
English: There are no or limited amount of data from the use of 5-ALA in pregnant women.
Slovenian: Ni zadostnih podatkov ali pa so ti omejeni, o uporabi 5-ALA pri nosečnicah.
English: Keep the bottle in the outer carton in order to protect from light.
Slovenian: Steklenico shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Other medicines and Gliolan
Slovenian: Druga zdravila in zdravilo Gliolan
English: Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
Slovenian: Treba se je izogibati sočasni uporabi drugih potencialno fototoksičnih snovi (npr. tetraciklinov, sulfonamidov, fluorokinolonov, ekstraktom hipericina) (glejte tudi poglavje 5.3).
English: • For 24 hours after administration of this medicine, protect your eyes and skin from strong light (for example direct sunlight or brightly focused indoor light).
Slovenian: • V obdobju 24 ur po uporabi tega zdravila zaščitite vaše oči in kožo pred močno svetlobo (na primer neposredna sončna svetloba ali bleščeča usmerjena notranja osvetlitev).
English: After having taken Gliolan and before start of anaesthesia, the following side effects may occur:
Slovenian: Po uporabi zdravila Gliolan in pred začetkom anestezije se lahko pojavijo naslednji neželeni učinki:
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Slovenian: Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (≤1/10.000)
English: The extent and frequency of procedure-related neurological side effects depends on the localisation of the brain tumour and the degree of resection of tumour tissue lying in eloquent brain areas (see section 4.4).
Slovenian: Obseg in pogostnost nevroloških neželenih učinkov, povezanih s postopkom, sta odvisna od položaja tumorja na možganih in stopnje resekcije tumorskega tkiva, ki leži v elokventnih območjih možganov (glejte poglavje 4.4).
English: • Acute or chronic types of porphyria.
Slovenian: • Akutni ali kronični znaki porfirije;
English: Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories:
Slovenian: Neželeni učinki, ki so jih opazili po uporabi tega zdravila pri resekciji glioma, vodeni s fluorescenco, so razdeljeni v naslednji dve skupini:
English: Another patient accidentally received an overdose of the medicinal product (3000 mg instead of 1580 mg).
Slovenian: En bolnik je pomotoma prejel prevelik odmerek zdravila (3000 mg namesto 1580 mg).
English: The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:
Slovenian: Količino dajanja, potrebno za doseganje nameravanega odmerka za posamičnega bolnika, se lahko izračuna s spodnjo enačbo:
English: Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles.
Slovenian: Zdravilo Gliolan je na voljo v stekleni steklenici v pakiranjih po 1, 2 in 10 steklenic.
English: If the anaesthesia/surgery is delayed by some hours, additional doses of this medicine must not be given.
Slovenian: Če sta anestezija/kirurški poseg prestavljena za nekaj ur, ne smete vzeti dodatnega odmerka zdravila.
English: This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma.
Slovenian: To zdravilo se na splošno uporablja samo enkrat, 2 do 4 ure pred anestezijo za kirurški poseg na nekaterih možganskih tumorjih, imenovanih gliomi.
English: At the visit six months after tumour resection, 20.5 % of 5-ALA-treated-patients and 11 % of patients who underwent standard surgery were alive at the six-month visit without progression.
Slovenian: Ob obisku šest mesecev po resekciji tumorja je bilo živih in brez napredovanja bolezni 20,5 % bolnikov, ki so prejeli 5-ALA, in 11 % bolnikov, pri katerih so opravili standardni kirurški poseg.
English: This helps the surgeon to remove the tumour while sparing healthy tissue.
Slovenian: To kirurgu omogoča popolnejšo odstranitev tumorja, pri tem pa lahko ohrani zdravo tkivo.
English: Although pivotal studies on the reproductive and developmental behaviour of 5-ALA have not been performed, it can be concluded that 5-ALA induced porphyrin synthesis may lead to embryotoxic activity in mouse, rat and chick embryos only under the condition of direct concomitant light exposure.
Slovenian: Čeprav ključnih študij o vplivu 5-ALA na razmnoževanje in razvoj niso opravili, je mogoče sklepati, da sinteza porfirina, ki jo spodbuja 5-ALA, lahko povzroči embriotoksičnost pri mišjih, podganjih in piščančjih embriih samo pri sočasnem neposrednem izpostavljanju svetlobi.
English: A slight increase in saluresis cannot be excluded.
Slovenian: Rahlega povečanja količine natrija v urinu ni mogoče izključiti.
English: In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis.
Slovenian: Ob prisotnosti vidne svetlobe,se lahko v določenih ciljnih tkivih za fotodinamično diagnozo uporabi fluorescenca PPIX (fotodinamični učinek).
English: Fertility There are no data available regarding the influence of 5-ALA on fertility.
Slovenian: Plodnost Ni podatkov o vplivu 5-ALA na plodnost.
English: Gliolan is for single use only and any content remaining after first use must be discarded.
Slovenian: Zdravilo Gliolan je namenjeno izključno za enkratno uporabo, preostalo vsebino je potrebno po prvi uporabi zavreči.
English: Accordingly, general light protective measures of eyes and skin are recommended for at least 24 hours after administration of this medicinal product.
Slovenian: Temu ustrezno so priporočeni splošni ukrepi za zaščito pred svetlobo vsaj 24 ur po uporabi tega zdravila.
English: After excitation with blue light (λ=400-410 nm), PPIX is strongly fluorescent (peak at λ=635 nm) and can be visualised after appropriate modifications to a standard neurosurgical microscope.
Slovenian: Po ekscitaciji z modro svetlobo (λ = 400-410 nm) je PPIX močno fluorescenčen (vrh je pri λ = 635 nm) in ga je po ustreznih modifikacijah mogoče videti s standardnim nevrokirurškim mikroskopom.
English: If you forget to take Gliolan
Slovenian: Če ste pozabili vzeti zdravilo Gliolan
English: Single administration of high doses of 5-ALA to mice or rats leads to unspecific findings of intolerance without macroscopic abnormalities or signs of delayed toxicity.
Slovenian: Enkratna uporaba velikih odmerkov 5-ALA pri miših in podganah povzroči nespecifično intoleranco brez makroskopskih abnormalnosti ali znakov zapoznele toksičnosti.
English: Pharmacotherapeutic group: Antineoplastic agents, sensitisers used in photodynamic therapy, ATC code: L01XD04
Slovenian: Farmakoterapevtska skupina: Druga zdravila z delovanjem na novotvorbe, pripravki za fotodinamično terapijo, oznaka ATC: L01XD04.
English: However, 5-ALA induced PPIX formation is significantly higher in malignant tissue than in normal brain.
Slovenian: Vendar pa je nastanek PPIX, ki ga sproži 5-ALA, bistveno večji v malignem tkivu kakor v normalnem možganskem tkivu.
English: vomiting, nausea
Slovenian: bruhanje, navzea
English: The compound potentially induces photogenotoxicity after subsequent irradiation or light exposure which is obviously related to the induction of porphyrin synthesis.
Slovenian: Ta spojina lahko potencialno povzroči fotogenotoksične učinke po naknadnem obsevanju ali izpostavljanju svetlobi, kar je očitno povezano s sprožanjem sinteze porfirina.
English: Increased levels of amylase, total bilirubin, and leukocytes, but decreased levels of thrombocytes and erythrocytes were observed, however differences between treatment groups were not statistically significant.
Slovenian: Opazili so zvišane ravni amilaze, skupnega bilirubina in levkocitov ter znižane ravni trombocitov in eritrocitov, vendar razlike med skupinami bolnikov niso bile statistično pomembne.
English: In the event of overdose, supportive measures should be provided as necessary, including sufficient protection from strong light sources (e.g. direct sunlight).
Slovenian: Ob prevelikem odmerjanju je treba po potrebi uporabiti podporne ukrepe, vključno z zadostno zaščito pred viri močne svetlobe (npr. neposredna sončna svetloba).
English: The only adverse reaction reported in this trial was one case of mild sunburn occurring in a patient treated with the highest dose.
Slovenian: Edini neželeni učinek, o katerem so poročali v tem preskušanju, je bil primer blage sončne opekline pri enem bolniku, ki je prejel največji odmerek.
English: Procedure-related side effects
Slovenian: Neželeni učinki, povezani s postopkom
English: Some limited animal studies suggest an embryotoxic activity of 5-ALA plus light exposure (see section 5.3).
Slovenian: Nekatere študije na živalih kažejo na embriotoksično aktivnost uporabe 5-ALA in izpostavljenosti svetlobi (glejte poglavje 5.3).
English: Fluorescence emission can be classified as intense (solid) red fluorescence (corresponds to vital, solid tumour tissue) and vague pink fluorescence (corresponds to infiltrating tumour cells), whereas normal brain tissue lacking enhanced PPIX levels reflects the violet-blue light and appears blue.
Slovenian: Oddajanje fluorescenčne svetlobe se lahko razvrsti kot intenzivna (enakomerna) rdeča fluorescenca (ustreza vitalnemu, solidnemu tkivu tumorja) in bledo rožnata fluorescenca (ustreza infiltrirajočim tumorskim celicam), medtem ko normalno možgansko tkivo, v katerem ni povečanih ravni PPIX, odbija vijoličasto-modro barvo in je videti modro.
English: In patients with pre-existing cardiovascular disease, this medicinal product should be used with caution since literature reports have shown decreased systolic and diastolic blood pressure, pulmonary artery systolic and diastolic pressure as well as pulmonary vascular resistance.
Slovenian: Pri bolnikih z obstoječo kardiovaskularno boleznijo je treba to zdravilo uporabljati previdno, saj so poročila v literaturi pokazala, da lahko pride do zmanjšanja sistoličnega in diastoličnega krvnega tlaka, sistoličnega in diastoličnega tlaka pljučne arterije in pljučne vaskularne rezistence.
English: You should not take any such products up to 2 weeks after you have taken Gliolan.
Slovenian: Nobenih takšnih zdravil ne smete jemati vsaj 2 tedna po uporabi zdravila Gliolan.
English: The highest dose (20 mg/kg body weight) was determined to be the most efficient.
Slovenian: Ugotovili so, da je največji odmerek (20 mg/kg telesne mase) najučinkovitejši.
English: The excretion of 5-ALA or PPIX in milk has not been studied in animals.
Slovenian: Izločanja 5-ALA ali PPIX v mleko pri živalih niso raziskovali.
English: These changes peak between 7 and 14 days after surgery.
Slovenian: Največje spremembe se pojavijo od 7. do 14. dne po kirurškem posegu.
English: Gliolan should be used only by neurosurgeons who have attended a training course in accordance with the standards detailed below:
Slovenian: Zdravilo Gliolan smejo uporabljati samo nevrokirurgi, ki so opravili tečaj v skladu s spodaj opisanimi standardi:
English: Peak values occurred between 7 and 14 days after administration.
Slovenian: Najvišje vrednosti so se pojavile med 7. in 14. dnevom po uporabi.
English: In all patients with a tumour in the vicinity of an important neurological function, either pre- or intraoperative measures should be used to localise that function relative to the tumour in order to maintain safety distances.
Slovenian: Pri vseh bolnikih, ki imajo tumor v bližini območja s pomembno nevrološko funkcijo, je treba uporabiti pred- ali intraoperativne ukrepe, s katerimi se določi položaj tega območja glede na tumor in tako ohrani varno razdaljo.
English: Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
Slovenian: Tel.: + 49 4103 8006 0 Faks: +49 4103 8006 100
English: 22880 Wedel Germany
Slovenian: 22880 Wedel Nemčija
English: The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Slovenian: Rekonstituirana raztopina je bistra in brezbarvna do rahlo rumenkasta tekočina.
English: Minimum requirements for a qualified training centre are: - Microscope modified for fluorescence-guided resection; - Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III
Slovenian: Minimalne zahteve za kvalificirani izobraževalni center so: - mikroskop, prilagojen za resekcijo, vodeno s fluorescenco; - zadostno število primerov (vsaj 10 bolnikov na leto) malignih gliomov (III. in IV. stopnje po
English: What Gliolan is and what it is used for What you need to know before you take Gliolan How to take Gliolan
Slovenian: Kaj je zdravilo Gliolan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Gliolan Kako jemati zdravilo Gliolan Možni neželeni učinki
English: A safe distance to eloquent cortical areas and subcortical structures of at least 1 cm should be maintained independent of the degree of fluorescence.
Slovenian: Treba je vzdrževati varno razdaljo vsaj 1 centimeter od elokventnih območij korteksa ne glede na stopnjo fluorescence.
English: and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Slovenian: SZO); - tehnike za nevrofiziološki nadzor pri kirurških posegih v elokventnih območjih možganov.