natgillin/translations-raw huggingface dataset:
A more pronounced transient increase of liver enzymes without clinical symptoms was observed in the 5-ALA HCl- treated patients.
Pri 5 bolnikih, ki so prejeli 5- ALA HCl, so opazili izrazitejše prehodno zvišanje jetrnih encimov brez kliničnih simptomov.
Within a clinical trial, a 63-year old patient with known cardiovascular disease was accidentally given an overdose of 5-ALA HCl (3000 mg instead of 1580 mg).
V kliničnem preskušanju so 63- letnemu bolniku z znano kardiovaskularno boleznijo pomotoma dali prevelik odmerek 5- ALA HCl (3000 namesto 1580 mg).
In the event of overdose, supportive measures should be provided as necessary, including sufficient protection from strong light sources (e. g. direct sunlight).
Ob prevelikem odmerjanju je treba po potrebi uporabiti podporne ukrepe, vključno z zadostno zaščito pred viri močne svetlobe (npr. neposredna sončna svetloba).
Pharmacotherapeutic group: sensitisers used in photodynamic therapy, ATC code:
Farmakoterapevtska skupina: pripravki za fotodinamično terapijo, oznaka ATC:
L01XD04
L01XD04.
5-aminolevulinic acid (5-ALA), the active substance of Gliolan, is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly protoporphyrin IX (PPIX).
5- aminolevulinska kislina (5- ALA), zdravilna učinkovina v zdravilu Gliolan, je naravni biokemijski prekurzor hema, ki se presnavlja v nizu encimskih reakcij v fluorescenčne porfirine, zlasti protoporfirin IX (PPIX).
5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism.
Sintezo 5- ALA regulira znotrajcelični prosti hem prek mehanizma negativne povratne zanke.
Systemic administration of 5-ALA results in an overload of the cellular porphyrin metabolism and accumulation of PPIX in various epithelia and cancer tissues.
Sistemska uporaba 5- ALA povzroči čezmerno presnovo celičnega porfirina ter kopičenje PPIX v različnih epitelijskih in tumorskih tkivih.
Malignant glioma tissue (WHO-grade III and IV, e. g. glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma) has also been demonstrated to synthesise and accumulate porphyrins in response to 5-ALA administration.
Pokazali so, da se v tkivu malignega glioma (III. in IV. stopnje po SZO, npr. multiformni glioblastom, gliosarkom ali anaplastični astrocitom) tudi sintetizirajo in kopičijo porfirini kot odziv na uporabo 5- ALA.
However, 5-ALA induced PPIX formation is significantly higher in malignant tissue than in normal brain.
Vendar pa je nastanek PPIX, ki ga sproži 5- ALA, bistveno večji v malignem tkivu kakor v normalnem možganskem tkivu.
In contrast, in low-grade tumours (WHO-grade I and II, e. g. medulloblastoma, oligodendroglioma) no fluorescence could be observed after application of the active substance.
V nasprotju s tem, pri tumorjih nizke stopnje (I. in II. stopnje po SZO, npr. meduloblastomih, oligodendrogliomih) po uporabi zdravilne učinkovine ni mogoče opaziti fluorescence.
The phenomenon of PPIX accumulation in WHO grade III and IV malignant gliomas may be explained by higher 5-ALA uptake into the tumour tissue or an altered pattern of expression or activity of enzymes (e. g.
Pojav kopičenja PPIX v malignih gliomih III. in IV. stopnje po SZO je mogoče pojasniti z večjim privzemom 5- ALA v tumorsko tkivo ali s spremenjeno ekspresijo ali delovanjem encimov (npr. ferokelataze), ki sodelujejo pri biosintezi hemoglobina v tumorskih celicah.
Ferrochelatase) involved in haemoglobin biosynthesis in tumour cells.
Med razlagami za večji
Explanations for higher 5-ALA uptake include a disrupted blood-brain barrier, increased neo-vascularisation, and the overexpression of membrane transporters in glioma tissue.
5 privzem 5- ALA so prekinjena krvno- možganska pregrada, povečana neovaskularizacija in čezmerna ekspresija membranskih transportnih proteinov v tkivu glioma.
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.
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.
5 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.
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.
In a phase I/ II-trial including 21 patients, a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core was detected:
V preskušanju I. / II. faze, v katerem je sodelovalo 21 bolnikov, so določili razmerje med odmerkom in stopnjo ter kakovostjo fluorescence v sredici tumorja.
Higher doses of 5-ALA HCl enhanced the fluorescence quality and the fluorescence extent of the tumour core compared to demarcation of the tumour core under standard white illumination in a monotone, non-falling fashion.
Večji odmerki 5- ALA HCl so krepili kakovost in stopnjo fluorescence sredice tumorja v primerjavi z demarkacijo sredice tumorja pod standardno belo osvetlitvijo na enakomeren, nepadajoč način.
The highest dose (20 mg/ kg body weight) was determined to be the most efficient.
Ugotovili so, da je največji odmerek (20 mg/ kg telesne mase) najučinkovitejši.
A positive predictive value of tissue fluorescence of 84.8% (90% CI:
Ugotovili so pozitivno napovedno vrednost fluorescence tkiva 84, 8% (90% IZ:
70.7 %-93.8%) was found.
70, 7– 93, 8%).
The positive predictive value of strong fluorescence was higher (100.0%; 90% CI:
Pozitivna napovedna vrednost močne fluorescence je bila večja (100, 0%; 90% IZ:
91.1 %-100.0%) than of weak fluorescence (83.3%; 90% CI:
91, 1– 100, 0%) od pozitivne napovedne vrednosti šibke fluorescence (83, 3%; 90% IZ:
68.1 %-93.2%).
68, 1– 93, 2%).
Results were based on a phase-II trial including 33 patients receiving 5- ALA HCl in a dose of 20 mg/ kg body weight.
Rezultati temeljijo na preskušanju II. faze, v katerem je sodelovalo 33 bolnikov, ki so prejeli 5- ALA HCl v odmerku 20 mg/ kg telesne mase.
In a phase-III trial with 349 patients with suspected malignant glioma amenable to complete resection of contrast-enhancing tumour were randomised to fluorescence-guided resection after administration of 20 mg/ kg body weight 5-ALA HCl or conventional resection under white light.
V preskušanju III. faze, v katerem je sodelovalo 349 bolnikov, pri katerih so sumili maligni gliom, primernih za popolno resekcijo tumorja z okrepljenim kontrastom, so naključno razporedili v skupino, pri kateri so opravili resekcijo, vodeno s fluorescenco, po uporabi 20 mg 5- ALA HCl/ kg telesne mase, ali v skupino, pri kateri so opravili običajno resekcijo pod belo svetlobo.
Contrast-enhancing tumour was resected in 64% of patients in the experimental group compared to 38% in the control- group (p < 0.001).
Tumor z okrepljenim kontrastom so uspešno odstranili pri 64% bolnikov v poskusni skupini in pri 38% bolnikov v kontrolni skupini (p < 0, 001).
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.
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.
The difference was statistically significant using the chi-square test (p=0.015).
Razlika je bila pri testu hi- kvadrat statistično pomembna (p = 0, 015).
No significant increase in overall survival has been observed in this study, however, the trial was not powered to detect such a difference.
V tej študiji niso opazili povečanega skupnega preživetja, vendar preskušanje ni bilo oblikovano za določanje te razlike.
General characteristics This medicinal product shows good solubility in aqueous solutions.
Splošne značilnosti Zdravilo je dobro topno v vodnih raztopinah.
After ingestion, 5-ALA itself is not fluorescent but is taken up by tumour tissue (see section 5.1) and is intracellularily metabolised to fluorescent porphyrins, predominantly protoporphyrin IX (PPIX).
Po zaužitju 5- ALA ni fluorescenčna, vendar jo privzame tumorsko tkivo (glejte poglavje 5. 1), kjer se znotraj celic presnavlja v fluorescenčne porfirine, predvsem protoporfirin IX (PPIX).
Absorption 5-ALA HCl as drinking solution is rapidly and completely absorbed and peak plasma levels of 5-ALA are reached 0.5– 2 hours after oral administration of 20 mg/ kg body weight.
Absorpcija 5- ALA HCl v obliki raztopine, ki jo bolniki spijejo, se hitro in popolno absorbira, največje koncentracije 5- ALA v plazmi pa so dosežene 0, 5 do 2 uri po peroralni uporabi odmerka 20 mg/ kg telesne mase.
Plasma levels return to baseline values 24 hours after administration of an oral dose of 20 mg/ kg body weight.
Koncentracije v plazmi se vrnejo na izhodiščne vrednosti 24 ur po zaužitju peroralnega odmerka 20 mg/ kg telesne mase.
Distribution and Biotransformation 5-ALA is preferentially taken up by the liver, kidney, endothelials and skin as well as by malignant gliomas (WHO grade III and IV) and metabolised to fluorescent PPIX.
6 5- ALA privzamejo predvsem jetra, ledvice, endoteliji in koža ter maligni gliomi (III. in IV. stopnje po SZO), kjer se presnavljajo v fluorescenčni PPIX.
Four hours after oral administration of 20 mg/ kg body weight 5-ALA HCl, the maximum PPIX plasma level is reached.
Največja koncentracija PPIX v plazmi je dosežena štiri ure po peroralni uporabi 20 mg 5- ALA HCl/ kg telesne mase.
At the recommended oral dose of 20 mg/ kg body weight, tumour to normal brain fluorescence ratios are usually high and offer lucid contrast for visual perception of tumour tissue under violet-blue light for at least 9 hours.
Pri priporočenem peroralnem odmerku 20 mg/ kg telesne mase je razmerje fluorescence tumorja in normalnega možganskega tkiva po navadi veliko in vsaj še 9 ur ponuja jasen kontrast za vizualno percepcijo tumorskega tkiva pod vijoličasto- modro svetlobo.
6 Besides tumour tissue, faint fluorescence of the choroid plexus was reported.
Poleg tumorskega tkiva so poročali tudi o rahli fluorescenci horoidnega pleksusa.
5-ALA is also taken up and metabolised to PPIX by other tissues, e. g. liver, kidneys or skin (see section 4.4).
5- ALA privzamejo in presnavljajo v PPIX tudi druga tkiva, npr. jetra, ledvica ali koža (glejte poglavje 4. 4).
Plasma protein binding of 5-ALA is unknown.
Stopnja vezave 5- ALA na beljakovine v plazmi ni znana.
Elimination 5-ALA is eliminated quickly with a terminal half-life of 1-3 hours.
Izločanje 5- ALA se izloča hitro, končni razpolovni čas pa je 1 do 3 ure.
Approximately 30% of an orally administered dose of 20 mg/ kg body weight are excreted unchanged in urine within 12 hours.
Približno 30% peroralno zaužitega odmerka 20 mg/ kg telesne mase se v 12 urah izloči nespremenjenega v urinu.
Linearity/ non-linearity There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
5- ALA so sorazmerne z različnimi peroralnimi odmerki tega zdravila.
Patients with renal or hepatic impairment Pharmacokinetics of 5-ALA in patients with renal or liver impairment has not been investigated.
Bolniki z ledvično ali jetrno okvaro Farmakokinetike 5- ALA pri bolnikih z ledvično ali jetrno okvaro niso raziskovali.
5-ALA HCl administration does not influence the function of the gastro-intestinal and central nervous systems.
Uporaba 5- ALA HCl ne vpliva na delovanje prebavil in živčevja.
Single administration of high doses of 5-ALA HCl to mice or rats leads to unspecific findings of intolerance without macroscopic abnormalities or signs of delayed toxicity.
Enkratna uporaba velikih odmerkov 5- ALA HCl pri miših in podganah povzroči nespecifično intoleranco brez makroskopskih abnormalnosti ali znakov zapoznele toksičnosti.
Repeat-dose toxicity studies performed in rats and dogs demonstrate dose-dependent adverse reactions affecting changes in bile duct histology (non-reversible within a 14 day recovery period), transient increase in transaminases, LDH, total bilirubin, total cholesterin, creatinine, urea and vomiting (only in dogs).
Študije toksičnosti pri ponavljajočih se odmerkih pri podganah in psih so pokazale od odmerka odvisne neželene reakcije v histologiji, ki so vplivale na spremembe histologije žolčevoda (ireverzibilne v 14- dnevnem obdobju okrevanja), prehodno zvišanje transaminaz, LDH, skupnega bilirubina, skupnega holesterina, kreatinina in sečnine ter povečano bruhanje (samo pri psih).
Signs of systemic toxicity (cardiovascular and respiratory parameters) occurred at higher doses in the anaesthetised dog: at 45 mg/ kg body weight intravenously a slight decrease in peripheral arterial blood pressure and systolic left ventricular pressure was recorded.
Znaki sistemske toksičnosti (kardiovaskularni in respiratorni parametri) so se pojavili pri večjih odmerkih pri anesteziranih psih: pri intravenskem odmerku 45 mg/ kg telesne mase so opazili rahlo povečanje perifernega arterijskega krvnega tlaka in sistoličnega tlaka levega ventrikla.
Phototoxicity observed after 5-ALA HCl treatment in vitro and in vivo is obviously closely related to dose- and time- dependent induction of PPIX synthesis in the irradiated cells or tissues.
Fototoksičnost, ki so jo opazili po uporabi 5- ALA HCl in vitro in in vivo, je očitno tesno povezana z indukcijo sinteze PPIX, odvisne od odmerka in časa, v obsevanih celicah in tkivih.
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.
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.
Excessive single dose treatment of rats with 5-ALA reversibly impaired male fertility for two weeks after dosing.
Uporaba prevelikih enkratnih odmerkov 5- ALA pri podganah je reverzibilno okvarila plodnost samcev v obdobju dveh tednov po odmerjanju.
The majority of genotoxicity studies performed in the dark do not reveal a genotoxic potential of 5-ALA.
Večina študij genotoksičnosti, opravljenih v temi, ni pokazala genotoksičnega potenciala 5- ALA.
7 6.
7 Dolgoročnih študij kancerogenosti in vivo niso opravili.
The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.
Rekonstituirana raztopina je fizikalno in kemijsko stabilna 24 ur pri 25 ºC.
Colourless type II glass vial, with rubber stopper.
Brezbarvno steklo vrste II z gumijastim zamaškom.
1, 2 and 10 vials of powder.
1, 2 in 10 vial s praškom.
The oral solution is prepared by dissolving the amount of powder of one vial in 50 ml of tap water.
Peroralna raztopina se pripravi z raztapljanjem praška iz ene viale v 50 ml pitne vode.
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg, Germany Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D- 20354 Hamburg, Nemčija Tel.: + 49 4103 8006 0 Faks: +49 4103 8006 100
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6 D-22880 Wedel Germany
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6 D- 22880 Wedel Nemčija
a) Theory and core principles of Gliolan-fluorescence-guided surgery and malignant glioma resection, including methods of eloquent sites identification; b) On-site instructions on the use of the fluorescence-microscope, including pitfalls and recognition of problems; c) Differentiation of fluorescence intensity, maintaining safety distances from eloquent areas, etc. d) The practice of Gliolan-fluorescence-guided surgery (including participation in at least one cases using Gliolan-fluorescence-guided surgery in the operating room with on-site instructions on the use of the microscope or demonstration of a fluorescence-guided resection by video); e) The current understanding of the benefits and risks of cytoreductive surgery in the management of patients with malignant gliomas; f) The theoretical base for porphyrin accumulation in malignant gliomas; g) The technical principles behind fluorescence-guided resections using Gliolan; h) How to identify suitable candidates for fluorescence-guided resections using Gliolan; i) How to apply Gliolan in the correct dosage and timing regimen, and to understand the importance of concurrent corticosteroids; j) How to identify patients at risk for neurological deficits using fluorescence-guided resections with Gliolan with special focus on aphasias and other critical focal deficits;
a) teoriji in osnovnih načelih kirurških posegov in resekcije malignih gliomov, vodenih s fluorescenco zdravila Gliolan, vključno z metodami za identifikacijo elokventnih območij; b) navodilih za uporabo fluorescenčnega mikroskopa, vključno s pastmi in prepoznavanjem težav, ki bodo podana na mestu tečaja; c) diferenciaciji intenzitete fluorescence, ohranjanju varne razdalje od elokventnih izrazitih območij itd. d) praktični izvedbi kirurgije, vodene s fluorescenco zdravila Gliolan (vključno s sodelovanjem pri vsaj enem primeru uporabe zdravila Gliolan pri kirurškem posegu, vodenim s fluorescenco v operacijski sobi, z navodili za uporabo mikroskopa in video- prikazom resekcije, vodene s fluorescenco); e) trenutnem razumevanju prednosti in tveganj citoreduktivne kirurgije pri obravnavanju bolnikov z malignimi gliomi; f) teoretični osnovi kopičenja porfirina v malignih gliomih; g) tehničnih načelih uporabe zdravila Gliolan pri resekciji, vodeni s fluorescenco; h) načinih za identifikacijo ustreznih kandidatov za kirurške posege, vodene s fluorescenco in uporabo zdravila Gliolan; i) uporabi ustreznih odmerkov zdravila Gliolan in časovnem režimu ter o razumevanju pomena sočasne uporabe kortikosteroidov;
10 k) Techniques for intraoperative risk reduction (microsurgical technique, neurophysiological monitoring, choice of approach) and how to implement them; l) How to identify fluorescence for resection through using the operating microscope in a hands- on setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan;
11 j) identifikaciji bolnikov s tveganjem za nevrološke deficite pri resekciji, vodeni s fluorescenco z uporabo zdravila Gliolan, s posebnim poudarkom na afazijah in drugih kritičnih deficitih; k) tehnikah zmanjševanja intraoperativnega tveganja (mikrokirurška tehnika, nevrofiziološki nadzor, izbira pristopa) in njihovi uporabi; l) identifikaciji fluorescence za resekcijo z uporabo kirurškega mikroskopa v dejanskem okolju v operacijski sobi; m) koristih in tveganjih resekcij, vodenih s fluorescenco ob uporabi zdravila Gliolan.
Minimum requirements for a qualified trainer are:
¸Minimalne zahteve za kvalificiranega predavatelja so:
III trial;
- izkušnje v vsaj 20 primerih uporabe zdravila Gliolan pri kirurških posegih, vodenih s
- Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
fluorescenco.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, postavljen in delujoč pred prihodom zdravila na trg in v času trženja zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvajal študije in opravil dodatne aktivnosti farmakovigilance, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 5 načrta za obvladovanje tveganja (RMP), predstavljeni v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini, mora biti posodobljen RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, na načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; • v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja); • na zahtevo Evropske agencije za zdravila (EMEA).
Outer carton/ Vial label
Zunanja škatla/ nalepka na viali
Gliolan 30 mg/ ml powder for oral solution 5-aminolevulinic acid hydrochloride
Gliolan 30 mg/ ml prašek za peroralno raztopino Hidroklorid 5- aminolevulinske kisline
1.5 g 5-aminolevulinic acid hydrochloride
Samo viala 1, 5 g hidroklorida 5- aminolevulinske kisline
Outer carton only:
Samo zunanja škatla:
1 vial 2 vials 10 vials
1 viala 2 viali 10 vial
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D- 20354 Hamburg Nemčija
What Gliolan is and what it is used for 2.
Kaj je zdravilo Gliolan in za kaj ga uporabljamo 2.
Before you take Gliolan 3.
Kaj morate vedeti, preden boste vzeli zdravilo Gliolan 3.
How to take Gliolan 4.
Kako jemati zdravilo Gliolan 4.
How to store Gliolan 6.
Shranjevanje zdravila Gliolan 6.
WHAT GLIOLAN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO GLIOLAN IN ZA KAJ GA UPORABLJAMO
Gliolan contains a substance called aminolevulinic acid hydrochloride (5-ALA).
Zdravilo Gliolan vsebuje snov, imenovano hidroklorid aminolevulinske kisline (5- ALA).
5-ALA is taken up more by tumour cells where it is transformed into another similar substance.
5- ALA v večji meri vstopa v tumorske celice, kjer se pretvori v drugo, podobno snov.
If then the tumour is put under blue light exposure this new substance emits a red-violet light which helps to see better what normal tissue is and what tumour tissue is.
Če se tumor osvetli z modro svetlobo, ta nova snov oddaja rdeče- vijoličasto svetlobo, ki omogoča boljše ločevanje med normalnim in tumorskim tkivom.
This helps the surgeon to remove the tumour more completely while sparing healthy tissue.
To kirurgu omogoča popolnejšo odstranitev tumorja, pri tem pa lahko ohrani zdravo tkivo.
BEFORE YOU TAKE GLIOLAN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO GLIOLAN
Do not take Gliolan
Ne jemljite zdravila Gliolan: