FrancophonIA/ELRC3.0 huggingface dataset:
English: 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. ferrochelatase) involved in haemoglobin biosynthesis in tumour cells.
Croatian: Fenomen nakupljanja PPIX-a u zloćudnim gliomima stupnja III i IV prema SZO-u može se objasniti pojačanom apsorpcijom 5-ALA u tumorsko tkivo ili promijenjenim obrascem enzimske ekspresije odnosno aktivnosti (npr. ferokelataze) enzima uključenih u biosintezu hemoglobina unutar tumorskih stanica.
English: Results were based on a phase II trial including 33 patients receiving 5-ALA HCl in a dose of 20 mg/kg body weight.
Croatian: Rezultati se temelje na fazi II ispitivanja koje je uključilo 33 bolesnika koji su primili 5-ALA u dozi od 20 mg/kg tjelesne težine.
English: In a single-arm trial including 36 patients with malignant glioma, adverse drug reactions were reported in 4 patients (mild diarrhoea in one patient, moderate hypesthesia in another patient, moderate chills in another patient, and arterial hypotension 30 minutes after application of 5-ALA in another patient).
Croatian: U ispitivanju koje je uključivalo samo jednu skupinu od 36 bolesnika sa zloćudnim gliomom, nuspojave na lijek su primijećene u 4 bolesnika (blagi proljev u jednog, umjerena hipoestezija u drugog, umjerena groznica u trećeg i arterijska hipotenzija 30 minuta nakon primjene 5-ALA u četvrtog bolesnika).
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).
Croatian: • Tijekom 24 sata nakon uzimanja ovog lijeka zaštitite oči i kožu od jakog svjetla (npr.
English: 5-ALA is also taken up and metabolised to PPIX by other tissues, e.g. liver, kidneys or skin (see section 4.4).
Croatian: 5-ALA se apsorbira i metabolizira u PPIX i u drugim tkivima, npr. jetri, bubrezima i koži (vidjeti dio 4.4).
English: • Hypersensitivity to the active substance or porphyrins.
Croatian: • Preosjetljivost na djelatnu tvar ili porfirine.
English: This medicinal product should, therefore, not be administered to pregnant women.
Croatian: Ovaj se lijek stoga ne smije primjenjivati u trudnica.
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba):
English: You have to drink the prepared solution 2-4 hours before anaesthesia.
Croatian: Pripremljenu otopinu trebate popiti 2-4 sata prije anestezije.
English: Peak values occurred between 7 and 14 days after administration.
Croatian: Vršne vrijednosti dostignute su između 7. i 14. dana nakon primjene lijeka.
English: Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.
Croatian: Majke koje doje ne smiju dojiti 24 sata nakon uzimanja ovog lijeka.
English: Pregnancy and breast-feeding Pregnancy
Croatian: Trudnoća i dojenje
English: 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.
Croatian: Utvrđeno je da tkivo zloćudnog glioma (stupnja III i IV prema SZO-u, npr. glioblastoma multiforme, gliosarkom ili anaplastički astrocitom) također može sintetizirati i nakupljati porfirine kao odgovor na primjenu 5-ALA.
English: Four hours after oral administration of 20 mg/kg body weight 5-ALA HCl, the maximum PPIX plasma level is reached.
Croatian: Četiri sata nakon peroralne primjene 20 mg/kg tjelesne težine 5-ALA HCl razina PPIX u plazmi dostiže svoj maksimum.
English: 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.
Croatian: 5-ALA se prvenstveno distribuira u jetru, bubrege, endotele i kožu, kao i zloćudne gliome (stupanj III i IV prema SZO-u), te metabolizira u fluorescentni PPIX.
English: After administration of this medicinal product, exposure of eyes and skin to strong light sources (e.g. operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours.
Croatian: Nakon primjene ovog lijeka potrebno je tijekom 24 sata izbjegavati izlaganje očiju i kože izvorima jakog svjetla (npr. operacijskim lampama, izravnom sunčevom svjetlu ili jakoj i fokusiranoj umjetnoj rasvjeti).
English: All patients received the medicinal product in a dose of 20 mg/kg body weight and underwent fluorescence-guided resection.
Croatian: Svi su bolesnici primili lijek u dozi od 20 mg/kg tjelesne težine i podvrgnuti resekciji tumora uz pomoć fluorescencije.
English: • combined side effects of Gliolan, anaesthesia, and tumour resection.
Croatian: • udružene nuspojave zbog Gliolana, anestezije i resekcije tumora.
English: This medicine is a powder for oral solution.
Croatian: Ovaj lijek je u obliku praška za oralnu otopinu.
English: Tel. +49 4103 8006-0 Fax: +49 4103 8006-100
Croatian: Fax: +49 4103 8006-100
English: Phototoxicity observed after 5-ALA treatment in vitro and in vivo is obviously closely related to doseand time-dependent induction of PPIX synthesis in the irradiated cells or tissues.
Croatian: Fototoksičnost primijećena in vitro i in vivo nakon primjene 5-ALA očito je tijesno povezana s indukcijom sinteze PPIX-a ovisnoj o dozi i vremenu primjene u ozračenim stanicama i tkivima.
English: The reconstituted solution is physically-chemically stable for 24 hours at 25 °C.
Croatian: Pripremljena je otopina fizikalno i kemijski stabilna 24 sata na temperaturi od 25 ºC.
English: The solution should be administered orally three hours (range 2-4 hours) before anaesthesia.
Croatian: Otopinu treba primijeniti peroralno, 3 sata (u rasponu od 2 do 4 sata) prije anestezije.
English: The Marketing Authorisation Holder in agreement with the competent authorities in the Member States shall implement, prior to launch:
Croatian: Prije stavljanja lijeka u promet nositelj odobrenja za stavljanje lijeka u promet u dogovoru s nadležnim vlastima u zemljama članicama provest će:
English: Brain metastases revealed inconsistent or no fluorescence.
Croatian: Kod moždanih metastaza fluorescencija se nije dosljedno pojavljivala ili je uopće nije bilo.
English: Most serious side effects include mild alterations of blood cell counts (red and white cells, platelets), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis) and blood clots that may obstruct blood vessels (thromboembolism).
Croatian: Najozbiljnije nuspojave uključuju blage promjene broja krvnih stanica (crvenih i bijelih krvnih stanica i krvnih pločica), poremećaje živčanog sustava (neurološke poremećaje) poput djelomične paralize jedne strane tijela (hemipareza) i krvne ugruške koji mogu začepiti krvne žile (tromboembolija).
English: 2 bottles
Croatian: broj boca
English: The oral solution is prepared by dissolving the amount of powder of one bottle in 50 ml of drinking water.
Croatian: Oralna otopina priprema se otapanjem praška sadržanog u jednoj boci u 50 ml vode za piće.
English: Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits.
Croatian: Utvrđeno je da je u ovih bolesnika resekcija uz pomoć fluorescencije povezana s povišenim rizikom od kritičnih neuroloških ispada.
English: Minimum requirements for a qualified trainer are: - Board-certification as neurosurgeon according to local, national requirements; - Previous successful participation at a training course, or equivalent course during the phase III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
Croatian: Minimalni zahtjevi koje mora zadovoljavati osoba koja obučava je: - Specijalist neurokirurg prema važećim lokalnim i državnim propisima; - Uspješno prethodno sudjelovanje u tečaju za obuku, ili odgovarajući tečaj tijekom faze III ispitivanja; - Iskustvo u primjeni kirurškog postupka uz pomoć Gliolanom izazvane fluorescencije na najmanje 20 slučajeva.
English: Name and address of the manufacturer responsible for batch release medac
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet medac
English: Very common: blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, gamma glutamyltransferase increased, blood amylase increased
Croatian: povišen bilirubin u krvi, povišena alanin-aminotransferaza, povišena aspartat-aminotransferaza, povišena gama-glutamiltransferaza, povišena amilaza u krvi
English: Systemic administration of 5-ALA results in an overload of the cellular porphyrin metabolism and accumulation of PPIX in various epithelia and cancer tissues.
Croatian: Sistemska primjena 5-ALA rezultira opterećenjem staničnog metabolizma porfirina i nakupljanjem PPIX-a u različitim epitelima i tumorskom tkivu.
English: Gliolan contains a substance called aminolevulinic acid (5-ALA).
Croatian: Gliolan sadrži tvar zvanu aminolevulinatna kiselina (5-ALA).
English: Breast-feeding should be interrupted for 24 hours after treatment with this medicinal product.
Croatian: Dojenje treba prekinuti tijekom 24 sata od primjene ovog lijeka.
English: In a comparative, unblinded phase III trial (MC-ALS.3/GLI), 201 patients with malignant gliomas received 5-ALA HCl in a dose of 20 mg/kg body weight and 176 of these patients underwent fluorescence-guided resection with subsequent radiotherapy.
Croatian: U fazi III usporednog, otvorenog ispitivanja (MC-ALS.3/GLI), 201 bolesnik s malignim gliomom primio je 5-ALA HCl u dozi od 20 mg/kg tjelesne težine i 176 od njih podvrgnuto je resekciji tumora uz pomoć fluorescencije nakon koje je slijedila radioterapija.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Gliolan Lijek čuvajte izvan pogleda i dohvata djece.
English: The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Croatian: Rekonstituirana otopina je bistra, bezbojna do blago žućkasta tekućina.
English: 5-ALA 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.
Croatian: 5-ALA u obliku napitka brzo se i u cijelosti apsorbira, a njegove vršne vrijednosti razine u plazmi, nakon peroralne primjene doze od 20 mg/kg tjelesne težine, dostiže za 0,5-2 sata.
English: Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue.
Croatian: Primjenom viška egzogenog 5-ALA izbjegava se kontrola negativnom povratnom spregom te se PPIX nakuplja u ciljnom tkivu.
English: The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Croatian: Djelatna tvar je klorid 5-aminolevulinatne kiseline (5-ALA HCl).
English: No trials have been performed in patients with poor liver or kidney function.
Croatian: Nisu provedena ispitivanja u bolesnika s oslabljenom funkcijom jetre ili bubrega.
English: - immediate reactions occurring after oral administration of the medicinal product before anaesthesia (= active substance-specific side effects) - combined effects of 5-ALA, anaesthesia, and tumour resection (= procedure-specific side effects).
Croatian: (= nuspojave specifične za djelatnu tvar) - kombinirani učinci 5-ALA, anestezije i resekcije tumora (= nuspojave specifične za postupak).
English: The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
Croatian: Preporučena doza je 20 mg 5-ALA HCl po kilogramu tjelesne težine.
English: How to store Gliolan
Croatian: Kako čuvati Gliolan
English: Renal or hepatic impairment Pharmacokinetics of 5-ALA in patients with renal or liver impairment has not been investigated.
Croatian: Oštećenje funkcije bubrega ili jetre Farmakokinetika 5-ALA u bolesnika s oštećenjem funkcije jetre ili bubrega nije ispitana.
English: In another single-centre trial, 21 patients with malignant glioma received 0.2, 2, or 20 mg/kg body weight 5-ALA HCl followed by fluorescence-guided tumour resection.
Croatian: U drugom ispitivanju provedenom u jednom centru, 21 bolesnik sa zloćudnim gliomom primio je 0,2, 2 ili 20 mg/kg tjelesne težine 5-ALA HCl, nakon čega je slijedila resekcija tumora uz pomoć fluorescencije.
English: Gliolan 30 mg/ml powder for oral solution 5-aminolevulinic acid hydrochloride
Croatian: Gliolan 30 mg/ml prašak za oralnu otopinu klorid 5-aminolevulinatne kiseline
English: Within 24 hours after administration, other potentially hepatotoxic medicinal products should be avoided.
Croatian: Primjenu drugih potencijalno hepatotoksičnih lijekova treba izbjegavati 24 sata od primjene ovog lijeka.
English: EU/1/07/413/001 EU/1/07/413/002 EU/1/07/413/003
Croatian: EU/1/07/413/002
English: One bottle of Gliolan 30 mg/ml powder for oral solution reconstituted in 50 ml of drinking water corresponds to a total dose of 1500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Croatian: Jedna boca Gliolana 30 mg/ml praška za oralnu otopinu rekonstituiranog u 50 ml vode za piće odgovara ukupnoj dozi od 1500 mg klorida 5-aminolevulinatne kiseline (5-ALA HCl).
English: 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; d) The practice of Gliolan-fluorescence-guided surgery (including participation in at least one case 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 dose 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; 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 handson setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan.
Croatian: Tehnička načela resekcije uz pomoć fluorescencije izazvane primjenom Gliolana; h) Kako prepoznati kandidate koji su prikladni za postupak resekcije uz pomoć fluorescencije izazvane primjenom Gliolana; i) Kako primijeniti Gliolan u ispravnoj dozi i pravom vremenu primjene, i razumijevanje važnosti istovremene primjene kortikosteroida; j) Kako prepoznati bolesnike s rizikom od razvoja neurološkog ispada nakon postupka resekcije uz pomoć fluorescencije izazvane primjenom Gliolana, s posebnim težištem na afaziju i druge kritične žarišne ispade; k) Tehnike smanjivanja intraoperacijskog rizika (mikrokirurške tehnike, neurofiziološki nadzor, odabir pristupa) i kako ih primijeniti; l) Kako prepoznati fluorescenciju tkiva koje treba resecirati pomoću operacijskog mikroskopa u osobnoj praktičnoj primjeni u operacijskoj dvorani; m) Koristi i rizici resekcije uz pomoć fluorescencije izazvane primjenom Gliolana.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
English: There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
Croatian: Linearnost/nelinearnost Vrijednosti AUC0-inf. za 5-ALA kod različitih peroralnih doza ovog lijeka proporcionalne su s dozom.
English: Mild alterations of blood cell counts (red and white cells, platelets), and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Croatian: Blage promjene broja krvnih stanica (crvenih i bijelih krvnih stanica i krvnih pločica) i blagi porast razine nekih enzima (transaminaze, γ-GT, amilaze) ili bilirubina (žučnog pigmenta koji se stvara u jetri razgradnjom crvenog krvnog pigmenta) u krvi.
English: Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase.
Croatian: Nadalje, često primijećene nuspojave su povraćanje, mučnina, porast razine bilirubina u krvi, alanin aminotransferaze, aspartat aminotransferaze, gama glutamiltransferaze i amilaze u krvi.
English: 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.
Croatian: U fazi III ispitivanja u kojem je 349 bolesnika sa sumnjom na zloćudni gliom pristalo na postupak potpune resekcije tumora uz pomoć primjene kontrasta bolesnici su metodom slučajnog odabira podvrgnuti resekciji uz pomoć fluorescencije nakon primjene 20 mg/kg tjelesne težine 5-ALA, odnosno konvencionalnoj resekciji pod bijelim svjetlom.
English: Colourless type I glass bottle with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.
Croatian: I s čepom od butilne gume koja sadrži 1,5 g praška za rekonstituciju u 50 ml vode za piće.
English: Patients should not be exposed to any photosensitizing agent up to 2 weeks after administration of Gliolan.
Croatian: Nakon primjene Gliolana bolesnici se ne smiju izlagati nikakvoj fotosenzibilizirajućoj tvari tijekom iduća 2 tjedna.
English: One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Croatian: Jedan ml rekonstituirane otopine sadrži 23,4 mg 5-ALA, što odgovara 30 mg 5-ALA HCl.
English: hypesthesia
Croatian: hipoestezija
English: No trials have been performed in patients with clinically relevant hepatic or renal impairment.
Croatian: Nisu provedena ispitivanja u bolesnika s klinički značajnim oštećenjem funkcije bubrega ili jetre.
English: Tabulated summary of adverse reactions Very common (≥1/10)
Croatian: Vrlo često (≥ 1/10)
English: Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Croatian: Druge učestalo primijećene nuspojave su povraćanje, mučnina i blagi porast razine nekih enzima (transaminaze, γ-GT, amilaze) ili bilirubina (žučnog pigmenta koji se stvara u jetri razgradnjom crvenog krvnog pigmenta) u krvi.
English: After surgery the patient also displayed facial erythema.
Croatian: U istog se bolesnika nakon kirurškog postupka pojavio eritem lica.
English: Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.
Croatian: Izbjegavajte sve druge lijekove koji bi mogli oštetiti jetru 24 sata nakon što ste uzeli Gliolan.
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
Croatian: Minimalni zahtjevi koje mora zadovoljavati centar za obuku je: - Mikroskop prilagođen za uporabu tijekom postupka resekcije uz pomoć fluorescencije; - Dovoljan broj slučajeva (najmanje 10 bolesnika godišnje) sa zloćudnim gliomom (stupnja III i IV prema SZO-u); - Tehničke mogućnosti za neurofiziološki nadzor elokventnih moždanih regija tijekom kirurškog postupka.
English: Powder for oral solution.
Croatian: OBLIK Prašak za oralnu otopinu.
English: Package leaflet: Information for the user Gliolan 30 mg/ml powder for oral solution
Croatian: Uputa o lijeku: Informacije za korisnika Gliolan 30 mg/ml prašak za oralnu otopinu klorid 5-aminolevulinatne kiseline
English: One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Croatian: Jedan ml pripremljene otopine sadrži 23,4 mg 5-aminolevulinatne kiseline, što odgovara 30 mg klorida 5-aminolevulinatne kiseline (5-ALA HCl).
English: General characteristics
Croatian: Opće značajke
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.
Croatian: Jedna boca sadrži 1,17 g 5-aminolevulinatne kiseline (5-ALA), što odgovara 1,5 g 5-ALA HCl.
English: Very common: anaemia, thrombocytopenia, leukocytosis
Croatian: anemija, trombocitopenija, leukocitoza
English: In combination with anaesthesia and tumour resection further side effects may occur:
Croatian: U kombinaciji s anestezijom i resekcijom tumora mogu se pojaviti sljedeće nuspojave: Vrlo česte nuspojave (mogu se pojaviti u više od 1 od 10 osoba) :
English: Gliolan 30 mg/ml powder for oral solution.
Croatian: NAZIV LIJEKA Gliolan 30 mg/ml prašak za oralnu otopinu.
English: thromboembolism
Croatian: tromboembolija
English: Justification for not including Braille accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: PC:
Croatian: SN:
English: EXP Shelf life of the reconstituted solution: 24 hours at 25 °C.
Croatian: Rok valjanosti pripremljene otopine: 24 sata na temperaturi od 25 °C.
English: Feeling sick (nausea), decrease of blood pressure (hypotension), skin reactions (for example rash, looking like sunburn).
Croatian: Nakon što ste uzeli Gliolan, a prije početka anestezije, mogu se pojaviti sljedeće nuspojave: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba): Mučnina, pad krvnog tlaka (hipotenzija), kožne reakcije (npr. osip, može nalikovati sunčanim opeklinama).
English: One bottle contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Croatian: Jedna boca sadrži 1,17 g 5-aminolevulinatne kiseline, što odgovara 1,5 g klorida 5-aminolevulinatne kiseline (5-ALA HCl).
English: nausea
Croatian: Doziranje
English: Decrease of blood pressure (hypotension), brain swelling (brain oedema).
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba): Sniženje krvnog tlaka (hipotenzija), oticanje mozga (edem mozga).
English: hemiparesis, aphasia, convulsions, hemianopsia)
Croatian: hemipareza, afazija, konvulzije, hemianopsija) Manje često: edem mozga Vrlo rijetko:
English: medac GmbH
Croatian: Spezialpräparate mbH
English: Substance-specific side effects:
Croatian: Nuspojave specifične za djelatnu tvar: Srčani poremećaji
English: and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Croatian: - Dovoljan broj slučajeva (najmanje 10 bolesnika godišnje) sa zloćudnim gliomom (stupnja III i IV prema SZO-u); - Tehničke mogućnosti za neurofiziološki nadzor elokventnih moždanih regija tijekom kirurškog postupka.
English: EXP
Croatian: proljev
English: Patient body weight (kg) Number of bottles = -------------75 kg/bottle
Croatian: tjelesna težina bolesnika (kg)
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca sadrži 1,17 g 5-aminolevulinatne kiseline (5-ALA), što odgovara 1,5 g klorida 5-aminolevulinatne kiseline (5-ALA HCl).
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA KOJI SE IMAJU PROVESTI