FrancophonIA/ELRC3.0 huggingface dataset:
English: Distribution and biotransformation
Maltese: Distribuzzjoni u bijotrasformazzjoni
English: Pharmacotherapeutic group: Antineoplastic agents, sensitisers used in photodynamic therapy, ATC code: L01XD04
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, sensitizzaturi użati f'terapija fotodinamika, Kodiċi ATC:
English: EU/1/07/413/001 EU/1/07/413/002 EU/1/07/413/003
Maltese: EU/1/07/413/002
English: Fertility There are no data available regarding the influence of 5-ALA on fertility.
Maltese: Fertilità M'hemmx dejta disponibbli dwar l-influwenza ta' 5-ALA fuq il-fertilità.
English: Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
Maltese: L-għoti ma' sustanzi oħra potenzjalment fototossiċi (eż. tetracyclines, sulfonamides, fluoroquinolones, estratti ta' hypericin) għandu jiġi evitat (ara wkoll sezzjoni 5.3).
English: Gliolan 30 mg/ml powder for oral solution.
Maltese: Gliolan 30 mg/ml trab għal soluzzjoni orali.
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.
Maltese: Reazzjonijiet avversi possibbilment relatati kienu rrapportati talanqas fi 2/201 (1.0%) pazjent: rimettar ħafif 48 siegħa wara l-kirurġija, u fotosensittività ħafifa 48 siegħa wara l-kirurġija tal-prova.
English: Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Maltese: Gliolan huwa indikat f'adulti għall-wiri ta' tessut malinn waqt operazzjoni għal glijoma malinna (WHO grad III u IV).
English: Other medicines and Gliolan
Maltese: Mediċini oħra u Gliolan
English: Respiratory insufficiency and erythema completely resolved.
Maltese: L-insuffiċjenza respiratorja u l-eritema telqu kompletament.
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.
Maltese: It-tessut ta' glijomi malinni (WHOgrad III u IV, eż. glioblastoma multiformi, gliosarcoma jew astrocytoma anaplastika) ġie muri li jissintetizza u jakkumula porphyrins b'reazzjoni għall-għoti ta' 5-ALA.
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.
Maltese: Kienu osservati żidiet fil-livelli ta' amylase, bilirubin totali u lewkoċiti, iżda tnaqqis fil-livelli tat-tromboċiti u tal-eritroċiti, madankollu ddifferenzi bejn il-gruppi ta' kura ma kinux statistikament sinifikanti.
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.
Maltese: L-emissjoni ta' fluworexxenza tista' tiġi kklassifikata bħala fluworexxenza ħamra intensa (solida) (li tikkorrispondi ma' tessut ta' tumur solidu, vitali) u fluworexxenza roża mhux ċara (li tikkorrispondi ma' ċelloli ta' tumur infiltranti), filwaqt li t-tessut tal-moħħ normali nieqes mil-livelli akbar ta' PPIX jirrifletti d-dawl ultra-vjola u jidher blu.
English: General characteristics
Maltese: Karatteristiċi ġenerali
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.
Maltese: Wara stimulazzjoni b'dawl blu (λ=400-410 nm), il-PPIX ikun fluworexxenti ħafna (l-ogħla punt f'λ=635 nm) u jkun jista' jidher wara li jsiru modifikazzjonijiet xierqa għal mikroskopju newroloġiku standard.
English: How to store Gliolan
Maltese: Tieħux Gliolan
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 hands-on setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan.
Maltese: d) Il-prattika tal-kirurġija ggwidata bil-fluworexxenza ta' Gliolan (inkluż il-parteċipazzjoni f'għallinqas każ wieħed ta' użu ta' kirurġija ggwidata bil-fluworexxenza ta' Gliolan fis-sala ta' l-operazzjonijiet bi struzzjonijiet fuq is-sit fuq l-użu ta' mikroskopju jew demostrazzjoni ta' risezzjoni ggwidata bil-fluworexxenza permezz ta' vidjo); e) L-għarfien preżenti fuq il-benefiċċji u r-riskji ta' kirurġija ċitoreduttiva fil- maniġġar ta' pazjenti bi glijomi malinni; f) Il-bażi teoretika għall-akkumulazzjoni ta' porphyrin fi glijomi malinni; g) Il-prinċipji tekniċi wara r-risezzjonijiet iggwidati bil-fluworexxenza li jużaw Gliolan; h) Kif għandhom jiġu identifikati kandidati xierqa għar-risezzjonijiet iggwidati bilfluworexxenza li jużaw Gliolan; i) Kif għandu jiġi applikat Gliolan fid-dożaġġ korrett u reġimen ta' żmien, u kif għandha tiġi mifhuma l-importanza ta' kortikosterojdi li jkunu preżenti fl-istess ħin; j) Kif għandhom jiġu identifikati pazjenti b'riskju ta' defiċit newroloġiku li jużaw risezzjonijiet iggwidati bil-fluworexxenza li jużaw Gliolan b'fokus speċjali fuq afasji u defiċit fokali kritiku ieħor; k) Tekniki għat-tnaqqis intra-operattiv tar-riskji (teknika tal-mikro-kirurġija, monitoraġġ newrofiżjoloġiku, għażla tal-metodu) u kif dawn għandhom jiġu implimentati;
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 %).
Maltese: 0%) minn talfluworexxenza dgħajfa (83.3%; 90% CI: 68.1%-93.2%).
English: Patient body weight (kg) x 20 mg/kg Administration volume (ml) = ------------------30 mg/ml
Maltese: Piż tal-ġisem tal-pazjent (kg) x 20 mg/kg
English: There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
Maltese: Hemm proporzjonalità tad-doża bejn l-AUC0-inf. tal-valuri ta' 5-ALA u dożi orali differenti ta' dan ilprodott mediċinali.
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.
Maltese: B'kuntrast, fit-tumuri ta' grad baxx (WHO-grad I u II, eż. medulloblastoma, oligodendroglijoma) ma setgħet tiġi osservata l-ebda fluworexxenza wara l-applikazzjoni tas-sustanza attiva.
English: One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Maltese: 1 ml ta' soluzzjoni rikostitwita fih 23.4 mg ta' 5-ALA, li jikkorrispondu għal 30 mg 5-ALA HCl).
English: Very common: blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, gamma glutamyltransferase increased, blood amylase increased
Maltese: żieda fil-bilirubin fid-demm, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fil-gamma glutamyltransferase, żieda fl-amylase fid-demm
English: The safety and efficacy of Gliolan in children and adolescents aged 0 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Gliolan fit-tfal u adoloxxenti minn età 0 sa 18 snin ma ġewx determinati s'issa.
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.
Maltese: 5-ALA bħala soluzzjoni li tinxtorob tiġi assorbita malajr u kompletament u l-ogħla livelli fil-plażma ta' 5-ALA jintlaħqu 0.5-2 sigħat wara l-għoti b'mod orali ta' 20 mg/kilogramm ta' piż tal-ġisem.
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).
Maltese: Studji tattossiċità minn dożi ripetuti li twettqu fuq il-firien u l-klieb juru reazzjonijiet avversi dipendenti fuq iddoża li jaffettwaw bidliet fl-istoloġija tal-kanal tal-bile (mhux riversibbli sa perjodu ta' rkupru ta' 14-il jum), żieda għaddiena fit-transaminases, LDH, bilirubin totali, cholesterol totali, kreatinina, urea u rimettar (fil-klieb biss).
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.
Maltese: Is-sinjali ta' tossiċità sistemika (parametri kardjovaskulari u respiratorji) seħħew b'dożi aktar gholjin fil-kelb anestetizzat: b'45 mg/kilogramm ta' piż tal-ġisem minn ġol-vina ġie rreġistrat tnaqqis żgħir fil-pressjoni tad-demm tal-arterji periferali u l-pressjoni sistolika filventrikolu tax-xellug.
English: Reporting of suspected adverse reactions
Maltese: Effetti sekondarji relatati mal-proċedura
English: • Acute or chronic types of porphyria.
Maltese: • Tipi akuti jew kroniċi ta' poryphyria.
English: Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase.
Maltese: Barra minn hekk, effetti mhux mixtieqa osservati ta' spiss oħra huma remettar, tqalligħ u żieda tal-bilirubin fid-demm, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase u amylase fid-demm.
English: During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation.
Maltese: Waqt l-operazzjoni huwa żviluppa insuffiċjenza respiratorja, li kienet ġestita bl-adattament tal-ventilazzjoni.
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.
Maltese: 5% tal-pazjenti trattati bil-5-ALA u 11% tal-pazjenti li għamlu operazzjoni standard kienu ħajjin fil-viżta tas-sitt xahar mingħajr progressjoni.
English: Patient body weight (kg) Number of bottles = -------------75 kg/bottle
Maltese: Piż tal-ġisem tal-pazjent (kg) Numru ta' fliexken = -------------75 kg/flixkun
English: Very rare side effects (may affect up to 1 in 10,000 people) or not known (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw minn persuna 1 f'10,000) jew mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli):
English: Another patient accidentally received an overdose of the medicinal product (3000 mg instead of 1580 mg).
Maltese: Pazjent ieħor aċċidentalment irċieva doża eċċessiva tal-prodott mediċinali (3000 mg minflok 1580 mg).
English: 5-ALA administration does not influence the function of the gastrointestinal and central nervous system.
Maltese: L-għoti ta' 5-ALA ma jaffettwax il-funzjoni tas-sistema gastro-intestinali u tas-sistema nervuża ċentrali.
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).
Maltese: Fi prova klinika, pazjent ta' 63 sena b'mard kardjovaskulari magħruf aċċidentalment ingħata doża eċċessiva ta' 5-ALA HCl (3000 mg minflok 1580 mg).
English: Brain metastases revealed inconsistent or no fluorescence.
Maltese: Il-metastasi ċerebrali żvelaw fluworexxenza inkonsistenti jew l-ebda fluworexxenza.
English: Standard safety pharmacology experiments were performed under light protection in the mouse, rat and dog.
Maltese: Esperimenti standard ta' sigurtà farmakoloġika ġew imwettqa taħt protezzjoni mid-dawl fil-ġurdien, il-far u l-kelb.
English: 5-ALA is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX.
Maltese: 5-ALA, huwa prekursur bijokimiku naturali ta' heme li jiġi metabolizzat f'sensiela ta' reazzjonijiet enzimatiċi għal porphyrins fluworexxenti, b'mod partikulari lPPIX.
English: An adverse drug reaction of mild nausea was reported in 1 out of 21 volunteers.
Maltese: Reazzjoni avversa tal-mediċina li kien jikkonsisti minn tqalligħ ħafif ġie rrappurtat f'1 mill-21 voluntier.
English: Contrast-enhancing tumour was resected in 64 % of patients in the experimental group compared to 38 % in the controlgroup (p<0.0001).
Maltese: Tumur li jkabbar il-kuntrast ġie mneħħi f'64% tal-pazjenti fil-grupp sperimentali meta mqabbel mat-38% tal-grupp ta' kontroll (p<0.0001).
English: • Keep this leaflet.
Maltese: • jekk taf jew tissuspetta li inti tqila.
English: Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism.
Maltese: L-aktar effetti mhux mixtieqa serji jinkludu anemija, tromboċitopenija, lewkoċitosi, disturbi newroloġiċi u tromboemboliżmu.
English: A more pronounced transient increase of liver enzymes without clinical symptoms was observed in the 5-ALA-treated patients.
Maltese: Żieda għaddiena aktar evidenti ta' enzimi tal-fwied kienet osservata fil-pazjenti trattati bi 5-ALA.
English: Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue.
Maltese: L-għoti eċċessiv ta' 5-ALA eksoġenu jevita l-kontroll ta' feedback negattiv, u l-akkumulazzjoni ta' PPIX fittessuti bersalljati.
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.
Maltese: L-għoti sistemiku ta' 5-ALA jirriżulta f'tagħbija eċċessiva tal-metaboliżmu ċellulari tal-porphyrin u lakkumulazzjoni ta' PPIX f'diversi epitelji u tessuti tal-kanċer.
English: Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles.
Maltese: Gliolan jiġi f'flixkun tal-ħġieġ u huwa ppreżentat f' pakketti ta' 1, 2 u 10 fliexken.
English: Tabulated summary of adverse reactions Very common (≥1/10)
Maltese: Sommarju f'tabella ta' reazzjonijiet avversi Komuni ħafna (≥1/10)
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).
Maltese: Flixkun wieħed ta' Gliolan 30 mg/ml trab għal soluzzjoni orali rikostitwit f'50 ml ta' ilma tax-xorb jikkorrispondi għal doża totali ta' 1500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
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.
Maltese: 5-ALA huwa assorbit b'mod preferenzjali mill-fwied, il-kliewi, l-endotelji u l-ġilda kif ukoll minn glijomi malinni (WHO grad III u IV) u jiġi metabolizzat għal PPIX fluworexxenti.
English: vomiting, nausea
Maltese: anemija, tromboċitopenija, lewkoċitożi
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).
Maltese: Fi prova single-arm li kien jinkludi 36 pazjent bi glijoma malinnja, reazzjonijiet avversi relatati malmediċina kieny rapportati f'erba' pazjenti (dijarea ħafifa f'pazjent minnhom, ipoestesija moderata f'pazjent ieħor, tertir moderat f'pazjent ieħor u pressjoni arterjali baxxa arterjali 30 minuta wara l-għoti ta' 5-ALA HCl f'pazjent ieħor).
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).
Maltese: 1 ml tas-soluzzjoni rikostitwita fih 23.4 mg ta' 5-aminolevulinic acid, li jikkorrispondu għal 30 mg ta' 5-aminolevulinic acid hydrochloride (5-ALA HCl).
English: brain oedema
Maltese: Wedel Il-Ġermanja
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jseħħu f'aktar minn persuna 1 f'10):
English: medac
Maltese: dardir
English: Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.
Maltese: Gliolan jintuża għall-viżwalizzazzjoni ta' ċerti tumuri tal-moħħ (imsejħa glijomi malinni) matul kirurġija tat-tumuri.
English: The usual dose is 20 mg 5-ALA HCl per kilogram body weight.
Maltese: Id-doża normali hija 20 mg 5-ALA HCI għal kull kilogramm ta' piż tal-ġisem.
English: 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism.
Maltese: Is-sinteżi tal-5-ALA hija regolata minn ġabra intraċellulari ta' heme liberu permezz ta' mekkaniżmu ta' rispons negattiv.
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).
Maltese: - reazzjonijiet immedjati li jseħħu wara l-għoti mill-ħalq tal-prodott mediċinali qabel l -anestesija (= effetti sekondarji speċifiċi għas-sustanza attiva) - effetti kombinati tal-5-ALA, l-anestesija, u r-risezzjoni tat-tumur (= effetti sekondarji speċifiċi għall-proċedura).
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.
Maltese: III, tat-tip unblinded (MC-ALS.3/GLI), 201 pazjent bi glijomi malinni rċevew 5-ALA HCl f'doża ta' 20 mg/kilogramm ta' piż tal-ġisem u 176 minn dawn il-pazjenti kienu sottoposti għal tneħħija ggwidata bil-fluworexxenza b'radjuterapija sussegwenti. 173 pazjent irċevew tneħħija standard mingħajr ma ngħataw il-prodott mediċinali u r-radjuterapija sussegwenti.
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.
Maltese: Fi prova oħra ta' ċentru wieħed (single-centre study), 21 pazjent bi glijoma malinna rċevew 0.2, 2, jew 20 mg/kg ta' piż tal-ġisem ta' 5-ALA HCl segwit mir-risezzjoni tat-tumur iggwidata bilfluworexxenza.
English: Name and address of the manufacturer responsible for batch release medac
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott medac
English: thromboembolism
Maltese: tromboemboliżmu
English: nausea
Maltese: Pożoloġija
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.
Maltese: Il-fenomenu tal-akkumulazzjoni ta' PPIX fi glijomi malinni ta' WHO grad III u IV jista' jiġi spjegat mit-teħid akbar ta' 5-ALA fit-tessut ta' tumur jew mudell mibdul tal-espressjoni jew attività talenzimi (eż. ferrochelatase) involuti fil-bijosinteżi tal-emoglobina fiċ-ċelloli ta' tumur.
English: • if you are allergic to 5-ALA or porphyrins.
Maltese: • jekk inti allerġiku għal 5-ALA jew porphyrins
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.
Maltese: Wara l-inġestjoni, 5-ALA nnifsu ma jkunx fluworexxenti iżda jiġi assorbit mit-tessut tat-tumur (ara sezzjoni 5.1) u jiġi metabolizzat b'mod intraċellulari għal porphyrins fluworexxenti, l-aktar PPIX.
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.
Maltese: Fi prova single-arm li kien jinkludi 21 voluntier raġel b'saħħtu, eritema tal-ġilda setgħet tiġi pprovokata b'esponiment dirett għad-dawl UVA sa 24 siegħa wara l-applikazzjoni orali ta' 20 mg/kg piż tal-ġisem 5-ALA HCl.
English: However, considering the therapeutic indication, a single oral treatment with 5-ALA might not be related to any serious potential carcinogenic risk.
Maltese: Madankollu, meta titqies l-indikazzjoni terapewtika, trattament orali wieħed b'5-ALA jista' ma jkunx relatat ma' xi riskju karċinoġeniku potenzjali serju.
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.
Maltese: Flixkun wieħed fih 1.17 g ta' 5-aminolevulinic acid (5-ALA), li jikkorrispondi għal 1.5 g 5-ALA HCI.
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).
Maltese: U KWANTITATTIVA Flixkun wieħed fih 1.17 g ta' 5-aminolevulinic acid (5-ALA), li jikkorrispondi għal 1.5 g ta' 5-aminolevulinic acid hydrochloride (5-ALA HCl).
English: Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
Maltese: L-użu ta' 5-ALA taħt kundizzjonijiet differenti minn dawk użati fil-provi kliniċi jinvolvi riskju mhux determinat.
English: hemiparesis, aphasia, convulsions, hemianopsia)
Maltese: disturbi newroloġiċi (eż. emiparesi, afasja, konvulżjonijiet, emianopsija)
English: and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Maltese: WHO); - Tekniċi ta' monitoraġġ newrofiżjoloġiċi għall-kirurġija f'oqsma tal-moħħ elokwenti.
English: One bottle contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Maltese: Flixkun wieħed fih 1.17 g ta' 5-aminolevulinic acid, li jikkorrispondi għal 1.5 g ta' 5-aminolevulinic acid hydrochloride (5-ALA HCl).
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.
Maltese: Għandha tinżamm distanza ta' sigurtà ta' mill-anqas 1 ċm minn żoni kortikali elokwenti jew strutturi subkortikali indipendentement mil-livell ta' fluworexxenza.
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.
Maltese: Il-fototossiċità osservata wara trattament bil-5-ALA in vitro u in vivo hija ovvjament marbuta millqrib mal-induzzjoni dipendenti fuq id-doża u l-ħin tas-sinteżi tal-PPIX fiċ-ċelloli jew it-tessuti mdawla.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Komuni: