natgillin/translations-raw huggingface dataset:
and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
SZO); - tehnike za nevrofiziološki nadzor pri kirurških posegih v elokventnih območjih možganov.
5-ALA is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX.
5-ALA je naravni biokemijski prekurzor hema, ki se presnavlja v nizu encimskih reakcij v fluorescenčne porfirine, zlasti PPIX.
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.
Tissue surrounding the tumour and normal brain may also be affected.
Koncentracija je lahko povečana tudi v tkivu, ki obkroža tumor, in v normalnih možganih.
• immediate side effects after having taken Gliolan and before anaesthesia
• takojšnji neželeni učinki po uporabi zdravila Gliolan in pred anastezijo
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.
Zlasti je treba biti pozoren pri bolnikih, pri katerih je tumor v neposredni bližini območjas pomembno nevrološko funkcijo, in pri bolnikih z obstoječim fokalnim deficitom (npr. afazija, motnje vida in pareza), ki se ne izboljša pri zdravljenju s kortikosteroidi.
The resulting fluorescence was used as an intraoperative marker for malignant glioma tissue with the aim of improving the surgical resection of these tumours.
Nastalo fluorescenco so uporabili kot intraoperativni označevalec za tkivo malignega glioma, da bi tako izboljšali kirurško resekcijo teh tumorjev.
Breast-feeding should be interrupted for 24 hours after treatment with this medicinal product.
Dojenje je treba prekiniti v obdobju 24 ur po uporabi tega zdravila.
This course shall consist of measures aiming to minimise adverse events associated with the Gliolan-fluorescence-guided surgery (in particular neurological serious adverse events) through adequate education about:
Tečaj bo vseboval ukrepe, namenjene zmanjševanju neželenih učinkov, povezanih z izvajanjem kirurških posegov, vodenih s fluorescenco zdravila Gliolan (zlasti resnih nevroloških neželenih učinkov), ki bodo predstavljeni skozi izobraževanje o:
6 22880 Wedel Germany
6 22880 Wedel Nemčija
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.
Zdravilo smejo uporabljati samo nevrokirurgi z izkušnjami pri operacijah malignih gliomov in s poglobljenim znanjem funkcionalne anatomije možganov, ki so zaključili tečaj iz opravljanja kirurških posegov, vodenih s fluorescenco.
Plasma protein binding of 5-ALA is unknown.
Stopnja vezave 5-ALA na beljakovine v plazmi ni znana.
During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation.
Med kirurškim posegom je prišlo do respiratorne insuficience, ki so jo obravnavali s prilagoditvijo ventilacije.
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.
O neželenih učinkih, ki so vsaj morebiti povezani z uporabo zdravila, so poročali pri 2/201 bolnikov (1,0 %): blago bruhanje 48 ur po kirurškem posegu in blaga fotosenzitivnost 48 ur po kirurškem posegu v preskušanju.
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.
The Marketing Authorisation Holder in agreement with the competent authorities in the Member States shall implement, prior to launch:
Imetnik dovoljenja za promet z zdravilom mora pred prihodom zdravila na trg, v dogovoru s pristojnimi organi v državah članicah, izvesti:
Besides tumour tissue, faint fluorescence of the choroid plexus was reported.
Poleg tumorskega tkiva so poročali tudi o rahli fluorescenci horoidnega pleksusa.
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.
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:
Država članica mora zagotoviti implementacijo vseh spodaj opisanih pogojev in omejitev v zvezi z varno in učinkovito uporabo zdravila:
5-ALA-induced fluorescence of brain tissue does not provide information about the tissue's underlying neurological function.
Fluorescenca možganskega tkiva, ki jo sproži 5-ALA, ne daje informacij o osnovni nevrološki funkciji tkiva.
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.
Če se tumor osvetli z modro svetlobo, ta nova snov oddaja rdeče-vijoličasto svetlobo, ki omogoča boljše ločevanje med normalnim in tumorskim tkivom.
Therefore, Gliolan should not be used during pregnancy.
Zato zdravila Gliolan ne smete uporabljati pri nosečnicah.
EXP Shelf life of the reconstituted solution: 24 hours at 25 °C.
EXP Rok uporabe pripravljene raztopine: 24 ur pri 25 °C.
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 mg namesto 1580 mg).
If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).
Če ste vzeli večji odmerek zdravila Gliolan, kot bi smeli Če ste vzeli večji odmerek zdravila Gliolan, kot bi smeli, se bo zdravnik odločil o nujnih ukrepih za preprečevanje težav, vključno z zadostno zaščito pred viri močne svetlobe (na primer neposredna sončna svetloba).
- 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).
- takojšnje reakcije, ki se pojavijo po peroralni uporabi zdravila, pred anestezijo (= neželeni učinki, značilni za učinkovino); - kombinirani učinki 5-ALA, anestezije in resekcije tumorja (= neželeni učinki, značilni za postopek).
The oral solution is prepared by dissolving the amount of powder of one bottle in 50 ml of drinking water.
Peroralna raztopina se pripravi z raztapljanjem praška iz ene steklenice v 50 ml pitne vode.
After surgery the patient also displayed facial erythema.
Po kirurškem posegu je imel bolnik tudi eritem obraza.
Therefore, this medicine should be used with caution in such patients.
Zato je treba biti pri uporabi tega zdravila pri teh bolnikih previden.
hypesthesia
hipestezija
The powder is a white to off-white cake.
Prašek je v obliki bele do umazano bele pogače.
The reconstituted solution is physically-chemically stable for 24 hours at 25 °C.
Pripravljena raztopina je fizikalno-kemijsko stabilna 24 ur pri 25 °C.
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.
Minimalne zahteve za kvalificiranega predavatelja so: - dovoljenje odbora kot nevrokirurg v skladu z lokalnimi zahtevami; - predhodno sodelovanje na tečaju ali na ustreznem tečaju med preskušanjem III. faze; - izkušnje v vsaj 20 primerih uporabe zdravila Gliolan pri kirurških posegih, vodenih s fluorescenco.
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).
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 holesterola, kreatinina in sečnine ter povečano bruhanje (samo pri psih).
Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism.
Najbolj resni stranski učinki vključujejo anemijo, trombocitopenijo, levkocitozo, nevrološke motnje in tromboembolijo.
Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue.
S prekomerno uporabo eksogenega 5-ALA se izognemo negativnemu povratnemu nadzoru, v ciljnem tkivu pa se pojavi kopičenje PPIX.
This medicine is given once only at the day of surgery, 2 - 4 hours before start of anaesthesia.
To zdravilo se uporablja samo enkrat, na dan kirurškega posega, 2 do 4 ure pred začetkom anestezije.
All patients received the medicinal product in a dose of 20 mg/kg body weight and underwent fluorescence-guided resection.
Vsi bolniki so prejeli zdravilo v odmerku 20 mg/kg telesne mase in vsem so opravili resekcijo, vodeno s fluorescenco.
If the surgery is delayed by one or more days, another dose of this medicine can be taken 24 hours before anaesthesia.
Če je kirurški poseg prestavljen za en dan ali več, lahko drug odmerek tega zdravila vzamete 2 do 4 ure pred anestezijo.
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.
5-ALA privzamejo predvsem jetra, ledvice, endoteliji in koža ter maligni gliomi (III. in IV. stopnje po SZO), kjer se presnavljajo v fluorescenčni PPIX.
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).
V preskušanju z enim krakom, v katerem je sodelovalo 36 bolnikov z malignim gliomom, so o neželenih učinkih zdravila poročali pri 4 bolnikih (blaga diareja pri enem bolniku, zmerna hipestezija pri enem bolniku, zmerna mrzlica pri enem bolniku in arterijska hipotenzija 30 minut po zaužitju 5-ALA pri enem bolniku).
Therefore, resection of fluorescing tissue should be weighed up carefully against the neurological function of fluorescing tissue.
Zato je treba pri resekciji fluorescirajočega tkiva temeljito pretehtati njegovo nevrološko funkcijo.
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.
5-ALA 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.
Brain metastases revealed inconsistent or no fluorescence.
V zasevkih v možganih je fluorescenca nedosledna ali pa je ni.
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.
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).
Slabost (navzea), bruhanje, motnje, ki vplivajo na živčni sistem (nevrološke bolezni), kot so delna paraliza ene strani telesa (hemipareza), popolna ali delna izguba zmožnosti razumevanja ali govora (afazija), epileptični napadi (konvulzije) in slepota polovice vidnega polja v enem ali obeh očeh (hemianopsija), in krvni strdki, ki lahko zamašijo krvne žile (trombembolija).
Renal or hepatic impairment Pharmacokinetics of 5-ALA in patients with renal or liver impairment has not been investigated.
Ledvična ali jetrna okvara Farmakokinetike 5-ALA pri bolnikih z ledvično ali jetrno okvaro niso raziskovali.
Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.
Matere, ki dojijo, ne smejo dojiti vsaj 24 ur po uporabi tega zdravila.
• Hypersensitivity to the active substance or porphyrins.
• Preobčutljivost na učinkovino ali porfirine;
Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits.
Ugotovili so, da pri teh bolnikih resekcija, vodena s fluorescenco, poveča tveganje za kritični nevrološki primanjkljaj.
Very common: anaemia, thrombocytopenia, leukocytosis
Zelo pogosti: anemija, trombocitopenija, levkocitoza
• combined side effects of Gliolan, anaesthesia, and tumour resection.
• kombinirani neželeni učinki zdravila Gliolan, anestezije in odstranitve tumorja.
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.
stopnje po SZO, npr. meduloblastomih, oligodendrogliomih) po uporabi učinkovine ni mogoče opaziti fluorescence.
Very common side effects (may affect more than 1 in 10 people):
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 ljudi):
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.
Po zaužitju 5-ALA ni fluorescenčna, vendar jo privzame tumorsko tkivo (glejte poglavje 5.1), kjer se znotraj celic presnavlja v fluorescenčne porfirine, predvsem PPIX.
Gliolan contains a substance called aminolevulinic acid (5-ALA).
Zdravilo Gliolan vsebuje snov, imenovano aminolevulinska kislina (5-ALA).
The solution should be administered orally three hours (range 2-4 hours) before anaesthesia.
Raztopino je treba dati peroralno tri ure (interval 2-4 ur) pred anestezijo.
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.
Fototoksičnost, ki so jo opazili po uporabi 5-ALA in vitro in in vivo, je očitno tesno povezana z indukcijo sinteze PPIX, odvisne od odmerka in časa, v obsevanih celicah in tkivih.
hemiparesis, aphasia, convulsions, hemianopsia)
nevrološke motnje (npr. hemipareza, afazija, konvulzije, hemianopsija)
The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
Priporočeni odmerek je 20 mg 5-ALA HCl na kilogram telesne mase.
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.
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.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
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.
Opazili so razpad celic lojnih žlez, fokalno epidermalno nekrozo s prehodnim akutnim vnetjem in difuznimi reaktivnimi spremembami keratinocitov ter prehoden sekundarni edem in vnetje usnjice.
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.
This medicine is a powder for oral solution.
Zdravilo je prašek za peroralno raztopino.
Not relevant, the treatment itself will have an influence on the ability to drive and use machines.
Zdravljenje samo bo imelo učinek na sposobnost vožnje in upravljanja strojev.
Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Zdravilo Gliolan je indicirano za vizualizacijo malignega tkiva pri odraslih med kirurškim posegom zaradi malignega glioma (III. in IV. stopnje po SZO).
What Gliolan looks like and contents of the pack
Izgled zdravila Gliolan in vsebina pakiranja
Colourless type I glass bottle with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.
Brezbarvna steklena steklenica vrste I z zamaškom iz butilne gume ki vsebuje 1.5 g praška za rekonstitucijo v 50 ml pitne vode.
Name and address of the manufacturer responsible for batch release medac
Ime in naslov izdelovalca, odgovornega za sproščanje serij medac
What you need to know before you take Gliolan Do not take Gliolan
Kaj morate vedeti, preden boste vzeli zdravilo Gliolan
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).
There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
Linearnost/Nelinearnost Vrednosti AUC0-inf. 5-ALA so sorazmerne z različnimi peroralnimi odmerki tega zdravila.
thromboembolism
trombembolija
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.
Po uporabi tega zdravila bolnik 24 ur ne sme izpostavljati oči in kože virom močne svetlobe (npr. osvetlitvi za kirurške posege, neposredni sončni svetlobi ali bleščeči osvetlitvi prostorov).
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.
Patients should not be exposed to any photosensitizing agent up to 2 weeks after administration of Gliolan.
Bolniki vsaj 2 tedna po uporabi zdravila Gliolan ne smejo biti izpostavljeni nobenem fotosenzitirajočem sredstvu.
Gliolan 30 mg/ml powder for oral solution 5-aminolevulinic acid hydrochloride
Gliolan 30 mg/ml prašek za peroralno raztopino klorid 5-aminolevulinske kisline
This medicinal product shows good solubility in aqueous solutions.
Zdravilo je dobro topno v vodnih raztopinah.
The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
Države članice morajo pred prihodom zdravila na trg v dogovoru z imetnikom dovoljenja za uporabo zdravila zagotoviti izvajanje naslednjega:
You should not drink or eat for at least 6 hours before anaesthesia.
Vsaj 6 ur pred začetkom anestezije ne bi smeli zaužiti nobene hrane ali pijače.
You have to drink the prepared solution 2-4 hours before anaesthesia.
Pripravljeno raztopino morate spiti 2 do 4 ure pred anestezijo.
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).
Najhujši neželeni učinki vključujejo manjše spremembe v številu krvnih celic (rdeče in bele krvničke, krvne ploščice), motnje, ki vplivajo na živčni sistem (nevrološke bolezni), kot so delna paraliza ene strani telesa (hemipareza) in krvni strdki, ki lahko zamašijo krvne žile (tromboembolija).
Patient body weight (kg) x 20 mg/kg Administration volume (ml) = ------------------30 mg/ml
Telesna masa bolnika (kg) x 20 mg/kg
This medicinal product should, therefore, not be administered to pregnant women.
To zdravilo se zato ne sme uporabljati pri nosečnicah.
Results were based on a phase II trial including 33 patients receiving 5-ALA HCl in a dose of 20 mg/kg body weight.
faze, v katerem je sodelovalo 33 bolnikov, ki so prejeli 5-ALA HCl v odmerku 20 mg/kg telesne mase.
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.
V drugem enocentričnem preskušanju je 21 bolnikov z malignim gliomom prejelo 0,2, 2 ali 20 mg 5-ALA HCl/kg telesne mase, čemur je sledila resekcija tumorja, vodena s fluorescenco.
Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.
Zdravilo Gliolan se uporablja za vizualno upodobitev nekaterih možganskih tumorjev (imenovanih maligni gliomi) med operativnimi posegi na tumorjih.
Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase.
Pogosto opaženi stranski učinki so bruhanje, slabost in povišanje bilirubina alanin aminotransferaze, aspartat aminotransferaze, gama glutamiltransferaze in amilaze v krvi.
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.
V primerjalnem, neslepem preskušanju III. faze (MC-ALS.3/GLI) je 201 bolnik z malignim gliomom prejel 5-ALA HCl v odmerku 20 mg/kg telesne mase, med njimi pa so pri 176 bolnikih opravili resekcijo, vodeno s fluorescenco, ki ji je sledila radioterapija.
The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Učinkovina je klorid 5-aminolevulinske kisline (5-ALA HCl).
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
This medicine itself has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost vožnje in upravljanja s stroji.
5-ALA administration does not influence the function of the gastrointestinal and central nervous system.
Uporaba 5-ALA ne vpliva na delovanje prebavil in živčevja.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA STEKLENICI
Talk to your doctor or pharmacist before taking Gliolan.
Pred začetkom jemanja zdravila Gliolan se posvetujte z zdravnikom ali farmacevtom.