FrancophonIA/ELRC3.0 huggingface dataset:
English: Gliolan should be used only by neurosurgeons who have attended a training course in accordance with the standards detailed below:
Croatian: Gliolan smiju primjenjivati samo neurokirurzi koji su završili edukacijski tečaj u skladu s dolje opisanim standardima:
English: In the event of overdose, supportive measures should be provided as necessary, including sufficient protection from strong light sources (e.g. direct sunlight).
Croatian: U slučaju predoziranja, po potrebi treba osigurati potporne mjere, uključujući zadovoljavajuću zaštitu od jakih svjetlosnih izvora (npr. izravnog sunčevog svjetla).
English: Approximately 30 % of an orally administered dose of 20 mg/kg body weight is excreted unchanged in urine within 12 hours.
Croatian: Oko 30 % peroralno primijenjene doze od 20 mg/kg tjelesne težine izlučuje se nepromijenjeno urinom unutar 12 sati.
English: The compound potentially induces photogenotoxicity after subsequent irradiation or light exposure which is obviously related to the induction of porphyrin synthesis.
Croatian: Ovaj spoj potencijalno je fotogenotoksičan nakon izlaganja zračenju ili svjetlu, što je očito povezano s indukcijom sinteze porfirina.
English: Respiratory insufficiency, which was reported in this patient, was managed by adaptation of ventilation and resolved completely.
Croatian: Respiratorna insuficijencija zabilježena u ovog bolesnika liječena je prilagodbom ventilacije i u potpunosti se povukla.
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.
Croatian: Iako ključna ispitivanja o utjecaju 5-ALA na reprodukciju i razvoj nisu provedena, može se zaključiti da sinteza porfirina inducirana pomoću 5-ALA može imati embriotoksično djelovanje na embrije miševa, štakora i pilića samo pod uvjetom istovremenog izlaganja svjetlu.
English: Single use bottle - discard any content remaining after first use.
Croatian: Boca za jednokratnu primjenu - nakon prve primjene preostali sadržaj baciti.
English: Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
Croatian: + 49 4103 8006 0 Fax: +49 4103 8006 100
English: It is unknown whether 5-ALA or its metabolite protoporphyrin IX (PPIX) is excreted in human milk.
Croatian: Nije poznato izlučuje li se 5-ALA ili njegov metabolit protoporfirin IX (PPIX) u majčino mlijeko.
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):
Croatian: Ukupan broj boca potrebnih za postizanje doze namijenjene za pojedinog bolesnika može se odrediti prema sljedećoj jednadžbi (zaokruženo na najbliži cijeli broj boca):
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.
Croatian: Ova je vrijednost definirana kao postotak bolesnika s pozitivnim nalazom tumorskih stanica u svim uzorcima bioptičkog materijala dobivenog iz područja slabe i jake fluorescencije.
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.
Croatian: Primijećeno je povišenje razine amilaze, ukupnog bilirubina i broja leukocita, ali sniženje broja trombocita i eritrocita, međutim razlika između različito liječenih skupina nije bila statistički značajna.
English: Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
Croatian: Potrebno je izbjegavati istovremenu primjenu drugih potencijalno fototoksičnih tvari (npr. tetracikline, sulfonamide, fluorokinolone, ekstrakte hipericina) (vidjeti također dio 5.3).
English: Patient body weight (kg) x 20 mg/kg Administration volume (ml) = ------------------30 mg/ml
Croatian: tjelesna težina bolesnika (kg) x 20 mg/kg volumen za primjenu (ml) = ------------------30 mg/ml
English: The only adverse reaction reported in this trial was one case of mild sunburn occurring in a patient treated with the highest dose.
Croatian: Jedina primijećena nuspojava u tom ispitivanju bio je jedan slučaj blage sunčane opekline u bolesnika koji je primio najvišu dozu.
English: Gliolan is for single use only and any content remaining after first use must be discarded.
Croatian: Gliolan je samo za jednokratnu primjenu i sva preostala količina nakon prve primjene mora se baciti.
English: • immediate side effects after having taken Gliolan and before anaesthesia
Croatian: • nuspojave neposredno nakon uzimanja Gliolana i prije anestezije
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Croatian: Zemlje članice moraju osigurati da su provedeni svi uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka opisani niže:
English: Procedure-related side effects
Croatian: Nuspojave povezane s postupkom
English: The influence of food has not been investigated because this medicinal product is generally given on empty stomach prior to induction of anaesthesia.
Croatian: Ispitivanje utjecaja hrane na apsorpciju nije ispitivano jer se ovaj lijek primjenjuje na prazan želudac prije uvođenja u anesteziju.
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.
Croatian: Nakon podraživanja plavim svjetlom (λ = 400-410 nm), PPIX jako fluorescira (vršna aktivnost na λ = 635 nm) i može biti vizualiziran odgovarajuće modificiranim standardnim neurokirurškim mikroskopom.
English: The excretion of 5-ALA or PPIX in milk has not been studied in animals.
Croatian: Izlučivanje 5-ALA ili PPIX mlijekom nije ispitano na životinjama.
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.
Croatian: Jednokratna primjena visokih doza 5-ALA na miševima i štakorima dovela je do nespecifičnih nalaza nepodnošenja bez makroskopskih poremećaja ili znakova zakašnjele toksičnosti.
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).
Croatian: Opseg i učestalost neuroloških nuspojava povezanih s postupkom ovise o lokalizaciji tumora mozga i stupnju resekcije tumorskog tkiva u elokventnim područjima mozga (vidjeti dio 4.4).
English: Some limited animal studies suggest an embryotoxic activity of 5-ALA plus light exposure (see section 5.3).
Croatian: Neka ograničena ispitivanja na životinjama ukazuju na embriotoksično djelovanje 5-ALA kod izlaganja svjetlu (vidjeti dio 5.3).
English: 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 cholesterol, creatinine, urea and vomiting (only in dogs).
Croatian: Ispitivanja toksičnosti ponovljenih doza na štakorima i psima pokazala su nuspojave ovisne o dozi koje su utjecale na histološke promjene u žučovodu (nereverzibilne tijekom razdoblja oporavka od 14 dana), prolazni porast razine transaminaza, LDH, ukupnog bilirubina, ukupnog kolesterola, kreatinina i ureje te pojavu povraćanja (samo u pasa).
English: neurological disorders (e.g.
Croatian: neurološki poremećaji (npr.
English: 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance.
Croatian: 5-ALA se nakuplja prvenstveno u stanicama tumora gdje se pretvara u drugu sličnu tvar.
English: Excessive single dose treatment of rats with 5-ALA reversibly impaired male fertility for two weeks after dosing.
Croatian: Prekomjerna jednokratna doza 5-ALA primijenjena štakorima reverzibilno je narušila plodnost mužjaka tijekom dva tjedna nakon njene primjene.
English: The concentration of PPIX is significantly lower in white matter than in cortex and tumour.
Croatian: Koncentracija PPIX-a značajno je niža u bijeloj tvari nego li u moždanoj kori i tumoru.
English: 22880 Wedel Germany
Croatian: 22880 Wedel Njemačka
English: The resulting fluorescence was used as an intraoperative marker for malignant glioma tissue with the aim of improving the surgical resection of these tumours.
Croatian: Izazvana fluorescencija poslužila je intraoperacijskom označavanju tkiva zloćudnog glioma u cilju bolje kirurške resekcije ovih tumora.
English: A more pronounced transient increase of liver enzymes without clinical symptoms was observed in the 5-ALA-treated patients.
Croatian: Značajnije prolazno povišenje jetrenih enzima, bez kliničkih simptoma, primijećeno je u bolesnika koji su primili 5-ALA.
English: Besides tumour tissue, faint fluorescence of the choroid plexus was reported.
Croatian: Osim fluorescencije tumorskog tkiva zabilježena je i blaga fluorescencija koroidnog pleksusa.
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.
Croatian: Fluorescentna emisija može se odrediti kao intenzivna (solidna) crvena fluorescencija (koja odgovara vitalnom, solidnom tumorskom tkivu) i kao blago ružičasta fluorescencija (koja odgovara infiltrirajućim tumorskim stanicama), dok zdravo moždano tkivo, zbog nedostatka povišene razine PPIX reflektira ljubičasto-plavo svjetlo i prikazuje se u plavoj boji.
English: 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.
Croatian: Znakovi sustavne toksičnosti (kardiovaskularni i respiratorni parametri) pojavili su se pri višim dozama u anesteziranog psa: pri intravenskoj dozi od 45 mg/kg tjelesne težine zabilježen je blagi pad perifernog arterijskog tlaka i snižen sistolički tlak lijevog ventrikula.
English: There are no special instructions for use in elderly patients with normal organ function.
Croatian: Starije osobe Nema posebnih uputa za primjenu ovog lijeka u starijih bolesnika s normalnom funkcijom organa.
English: Standard safety pharmacology experiments were performed under light protection in the mouse, rat and dog.
Croatian: Standardni sigurnosni farmakološki pokusi provedeni su na miševima, štakorima i psima u uvjetima zaštićenim od svjetla.
English: Special care must be taken in patients with a tumour in the immediate vicinity of an important neurological function and pre-existing focal deficits (e.g. aphasia, vision disturbances and paresis) that do not improve on corticosteroid treatment.
Croatian: Posebna je pozornost nužna u bolesnika s tumorom u neposrednoj blizini važnog neurološkog centra i s već postojećim žarišnim ispadima (npr. afazijom, smetnjama vida i parezom) koji se ne poboljšavaju unatoč terapiji kortikosteroidima.
English: At least possibly related adverse reactions were reported in 2/201 (1.0 %) patients: mild vomiting 48 hours after surgery, and mild photosensitivity 48 hours after trial surgery.
Croatian: Nuspojave za koje postoji moguća povezanost s primjenom lijeka zabilježene su u 2 od 201 (1,0 %) bolesnika: blago povraćanje 48 sati nakon kirurškog postupka i blaga foto-osjetljivost 48 sati nakon ispitivanog kirurškog postupka.
English: This medicinal product should only be used by experienced neurosurgeons conversant with surgery of malignant gliomas and in-depth knowledge of functional brain anatomy who have completed a training course in fluorescence-guided surgery.
Croatian: Ovaj lijek smiju primjenjivati samo iskusni neurokirurzi koji su dobro svladali kirurgiju zloćudnih glioma i detaljno poznaju funkcionalnu anatomiju mozga te su završili tečaj usavršavanja iz florescencijski navođene kirurgije.
English: During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation.
Croatian: Tijekom kirurškog postupka bolesnik je razvio respiratornu insuficijenciju koja je liječena prilagodbom ventilacije.
English: 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).
Croatian: Tijekom kliničkog ispitivanja 63-godišnjem bolesniku s poznatom kardiovaskularnom bolešću slučajno je dana prekomjerna doza 5-ALA HCl (3000 mg umjesto 1580 mg).
English: If the tumour is then exposed to blue light, this new substance emits a red-violet light which helps to better see what is normal tissue and what is tumour tissue.
Croatian: Ako se tumor nakon toga izloži plavom svjetlu, ova nova tvar emitira crveno-ljubičasto svjetlost koje pomaže boljem razlučivanju zdravog moždanog tkiva od tumorskog tkiva.
English: One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract.
Croatian: Opisan je slučaj teških sunčanih opeklina koje su trajale 5 dana u jednog bolesnika koji je uzeo ovaj lijek i ekstrakt gospine trave.
English: Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism.
Croatian: Najozbiljnije nuspojave uključuju anemiju, trombocitopeniju, leukocitozu, neurološke poremećaje i tromboemboliju.
English: 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.
Croatian: Pri preporučenoj oralnoj dozi od 20 mg/kg tjelesne težine omjer fluorescencije tumorskog tkiva i zdravog moždanog tkiva obično je visok i omogućuje jasni kontrast za vizualno razlikovanje tumorskog tkiva pod ljubičasto-plavim svjetlom tijekom najmanje 9 sati.
English: Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.
Croatian: Gliolan se primjenjuje za vizualizaciju određenih tumora mozga (koji se zovu zloćudni gliomi) za vrijeme operacije tumora.
English: 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism.
Croatian: Sinteza 5-ALA regulirana je intracelularnim nakupljanjem slobodnog hema mehanizmom negativne povratne sprege.
English: The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
Croatian: Zemlje članice dogovorit će s nositeljem odobrenja za stavljanje lijeka u promet, a prije njegovog stavljanja u promet, ostvarenje sljedećeg:
English: The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:
Croatian: Volumen za primjenu, potreban za postizanje doze namijenjene za pojedinog bolesnika, može se izračunati prema sljedećoj jednadžbi:
English: This medicinal product shows good solubility in aqueous solutions.
Croatian: Ovaj je lijek dobro topljiv u vodenim otopinama.
English: If the surgery is delayed by one or more days, another dose of this medicine can be taken 24 hours before anaesthesia.
Croatian: Ako je operacija pomaknuta za jedan ili više dana, smije se uzeti nova doza ovog lijeka 2-4 sata prije anestezije.
English: There are no or limited amount of data from the use of 5-ALA in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni 5-ALA u trudnica ograničeni.
English: 5-ALA is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX.
Croatian: 5-ALA je prirodni biokemijski prekursor hema koji se metabolizira nizom enzimskih reakcija do fluorescerirajućih porfirina, naročito porfirina PPIX.
English: The highest dose (20 mg/kg body weight) was determined to be the most efficient.
Croatian: Utvrđeno je da je najviša doza (20 mg/kg tjelesne težine) i najučinkovitija.
English: 5-ALA-induced fluorescence of brain tissue does not provide information about the tissue's underlying neurological function.
Croatian: Fluorescencija moždanog tkiva inducirana pomoću 5-ALA ne daje podatke o neurološkoj funkciji toga tkiva.
English: Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Croatian: Gliolan je indiciran u odraslih za vizualizaciju zloćudnog tkiva tijekom kirurškog liječenja zloćudnog glioma (stupanj III i IV prema Svjetskoj zdravstvenoj organizaciji [SZO]).
English: How to take Gliolan
Croatian: Kako uzimati Gliolan
English: 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.
Croatian: Nasuprot ovome, kod tumora nižeg stupnja (stupanj I i II prema SZO-u, npr. meduloblastom, oligodendrogliom) nije primijećena fluorescencija nakon primjene djelatne tvari.
English: What you need to know before you take Gliolan Do not take Gliolan
Croatian: Što morate znati prije nego počnete uzimati Gliolan
English: 173 patients received standard resection without administration of the medicinal product and subsequent radiotherapy.
Croatian: U 173 bolesnika proveden je standardni postupak resekcije tumora bez primjene ovog lijeka nakon čega je slijedila radioterapija.
English: • in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
Croatian: • u slučaju da je prisutan ili se sumnja na akutni ili kronični oblik porfirije (tj. urođenih ili stečenih poremećaja određenih enzima koji sudjeluju u putu sinteze krvnog pigmenta)
English: However, 5-ALA induced PPIX formation is significantly higher in malignant tissue than in normal brain.
Croatian: Ipak, stvaranje PPIX-a inducirano pomoću 5-ALA značajno je veće u malignom nego u zdravom moždanom tkivu.
English: This medicine is given once only at the day of surgery, 2 - 4 hours before start of anaesthesia.
Croatian: Ovaj se lijek uzima samo jedanput na sam dan operacije, 2-4 sata prije početka anestezije.
English: Plasma levels return to baseline values 24 hours after administration of an oral dose of 20 mg/kg body weight.
Croatian: Razina u plazmi vraća se na početne vrijednosti 24 sata nakon primjene peroralne doze od 20 mg/kg tjelesne težine.
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.
Croatian: Ovaj lijek treba primijeniti s oprezom u bolesnika s već postojećom kardiovaskularnom bolešću, jer postoje podaci u literaturi da on snižava sistolički i dijastolički sistemski krvni tlak, sistolički i dijastolički tlak u plućnoj arteriji, kao i plućni vaskularni otpor.
English: Destruction of sebaceous cells, focal epidermal necrosis with a transient acute inflammation and diffuse reactive changes in the keratinocytes as well as transient secondary oedema and inflammation of dermis are observed.
Croatian: Primijećeno je propadanje lojnih stanica, fokalna nekroza epidermisa s prolaznom akutnom upalom i difuznim reaktivnim promjenama u keratinocitima, kao i prolazni sekundarni edem i upala dermisa.
English: Not relevant, the treatment itself will have an influence on the ability to drive and use machines.
Croatian: Nije značajno, jer će sam kirurški zahvat utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: SN: NN:
Croatian: NN:
English: In a single-arm trial including 21 healthy male volunteers, erythema of the skin could be provoked by direct exposure to UVA light up to 24 hours after oral application of 20 mg/kg body weight 5-ALA HCl.
Croatian: U ispitivanju koje je uključivalo samo jednu skupinu od 21 zdravog dobrovoljca muškog spola, pojava eritema na koži nakon izravnog izlaganja UV-A svjetlu mogla je biti izazvana do 24 sata nakon peroralne primjene 20 mg/kg tjelesne težine 5-ALA HCl.
English: 5-ALA administration does not influence the function of the gastrointestinal and central nervous system.
Croatian: Primjena 5-ALA ne utječe na funkciju probavnog i središnjeg živčanog sustava.
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.
Croatian: U svih bolesnika s tumorom u blizini važnih funkcionalnih centara mozga potrebno je poduzeti bilo preoperacijske bilo intraoperacijske mjere radi utvrđivanja položaja tumora u odnosu na funkcionalni centar kako bi se zadržala sigurna udaljenost.
English: Feeling sick (nausea), being sick (vomiting), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis), total or partial loss of ability to use or understand language (aphasia), seizures (convulsions) and blindness for half the field of vision in one or both eyes (hemianopsia), and blood clots that may obstruct blood vessels (thromboembolism).
Croatian: Mučnina, povraćanje, poremećaji živčanog sustava (neurološki poremećaji) poput djelomične paralize jedne strane tijela (hemipareza), potpuni ili djelomični gubitak sposobnosti govora ili razumijevanja govora (afazija), napadaji (konvulzije) i sljepoća polovice vidnog polja na jednom ili oba oka (hemianopsija) te krvni ugrušci koji mogu začepiti krvne žile (tromboembolija).
English: Reconstituted solution The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.
Croatian: Rekonstituirana otopina Rekonstituirana otopina je fizikalno-kemijski stabilna 24 sata na temperaturi od 25ºC.
English: 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: higher doses of 5-ALA 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.
Croatian: U fazi I/II ispitivanja koje je uključilo 21 bolesnika utvrđen je odnos između veličine doze i opsega i kvalitete fluorescencije u središtu tumora: više doze 5-ALA omogućile su bolju kvalitetu fluorescencije i veći opseg fluorescencije tumorske jezgre jednolikim intenzitetom boje i bez slabljenja u usporedbi s demarkacijom tumorske jezgre pod standardnim bijelim svjetlom.
English: 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 PPIX.
Croatian: Nakon uzimanja kroz usta 5-ALA ne fluorescira sam po sebi već se apsorbira u tumorsko tkivo (vidjeti dio 5.1) gdje se intracelularno metabolizira u fluorescentne porfirine, najviše u PPIX.
English: Explanations for higher 5-ALA uptake include a disrupted blood-brain barrier, increased neo-vascularisation, and the overexpression of membrane transporters in glioma tissue.
Croatian: Objašnjenje za pojačanu apsorpciju 5-ALA uključuje oštećenje krvno-moždane barijere, pojačanu neovaskularizaciju i pojačanu ekspresiju membranskih transportera u gliomskom tkivu.