natgillin/translations-raw huggingface dataset:
Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
Whether these type-specific antibodies prevent disease in adult males has not been evaluated.
Če ta protitelesa preprečujejo bolezen pri odraslih moških, ni bilo preskušeno.
 is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”– see section 6).  has developed an allergic reaction after receiving a dose of Gardasil.
• oseb, alergičnih na (preobčutljivih za) katerokoli zdravilno učinkovino ali drugo sestavino cepiva Gardasil (navedene so pod “ Pomožne snovi so ” – glejte poglavje 6); • če se je po cepljenju s predhodnim odmerkom cepiva Gardasil pojavila alergijska reakcija; • če ima oseba bolezen z močno zvišano telesno temperaturo.
56  suffers from an illness with high fever.
56 Bodite posebno pozorni pri cepljenju s cepivom Gardasil
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
• Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tabletke) niso zmanjšali zaščite, dosežene s cepivom Gardasil.
57 Gardasil is given as an injection by your doctor.
Cepivo Gardasil v obliki injekcije da zdravnik.
58 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
The vaccine should not be used after the expiry date which is stated on the syringe label and the outer carton (after EXP).
Cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijske brizge in na škatli poleg oznake EXP.
Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Natrijev klorid, L- histidin, polisorbat 80, natrijev borat in voda za injekcije.
Gardasil is available in packs of 1, 10, or 20 pre-filled syringes with a needle guard (safety) device.
Cepivo Gardasil je na voljo v pakiranjih z 1, 10 ali 20 napolnjenimi injekcijskimi brizgami z varovalom (zaščito) za iglo.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, 59 France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon, Francija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
59 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Ireland Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Suomi/ Finland Ireland Sanofi Pasteur MSD, Puh Sanofi Pasteur MSD Ltd, Puh/ Tel: +358. 9. 565. 88. 30 Tel: +3531. 468. 5600
Ísland Sanofi Pasteur MSD, Sími: +32.2.726.95.84
Sverige Ísland Sanofi Pasteur MSD, Sanofi Pasteur MSD, Tel: +46. 8. 564. 888. 60 Sími: +32. 2. 726. 95. 84
 Gardasil is available in a pre-filled syringe, with needle guard (safety device) ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.  If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.  Parenteral drug products should be inspected visually for particulate matter and discolouration 60 prior to administration.
• Gardasil je na voljo v napolnjeni injekcijski brizgi z zaščito (varovalom) za iglo, pripravljeni za intramuskularno (i. m.) aplikacijo, najbolje v deltoidni predel nadlakti.
Discard the product if particulates are present or if it appears discoloured.
• Če sta v škatli 2 različno dolgi igli, izberite tisto, ki je najprimernejša za bolnika, glede na njegovo višino in telesno maso.
The needle guard (safety) device consists of a plastic cylinder (needle guard) that, before the dose is given, covers the syringe barrel.
60 Varovalo (zaščita) za iglo ima plastičen cilinder (varovalo), ki pred injiciranjem obdaja injekcijsko brizgo.
Remove the needle shield.
Odstranite zaščito igle.
Release the plunger slowly.
Za odstranitev nalepk vrtite bat, dokler se ne pokaže obarvana oznaka.
The needle guard will rapidly move to cover the needle.
Medtem ko vlečete za obarvano oznako, obračajte bat in odlepite nalepko.
61 To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
61 B2.
Pull on the coloured tab while continuing to rotate the plunger as needed.
NAVODILO ZA UPORABO (NAPOLNJENA INJEKCIJSKA BRIZGA BREZ ZAŠČITE (VAROVALA) ZA IGLO)
62 B2 PACKAGE LEAFLET (PREFILLED SYRINGE WITHOUT SAFETY DEVICE)
62 NAVODILO ZA UPORABO
64  suffers from an illness with high fever.
• oseb, alergičnih na (preobčutljivih za) katerokoli zdravilno učinkovino ali drugo sestavino cepiva Gardasil (navedene so pod “ Pomožne snovi so ” – glejte poglavje 6); • če se je po cepljenju s predhodnim odmerkom cepiva Gardasil pojavila alergijska reakcija; • če ima oseba bolezen z močno zvišano telesno temperaturo.
Take special care with Gardasil:
63 Bodite posebno pozorni pri cepljenju s cepivom Gardasil
65 Gardasil is given as an injection by your doctor.
Cepivo Gardasil v obliki injekcije da zdravnik.
66 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France 67 Manufacturer:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon, Francija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
66 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
 Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.  If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.  Parenteral drug products should be inspected visually for particulate matter and discolouration 68 prior to administration.
• Gardasil je na voljo v napolnjeni injekcijski brizgi, pripravljeni za intramuskularno (i. m.) aplikacijo, najbolje v deltoidni predel nadlakti.
Shake well before use.
67 Pred uporabo dobro pretresite.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZVAJATI DRŽAVE ČLANICE
Gliolan should be used only by neurosurgeons who have attended a training course in accordance with the standards detailed below:
Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
Zdravilo Gliolan smejo uporabljati samo nevrokirurgi, ki so opravili tečaj v skladu s spodaj opisanimi standardi:
− A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the product.
Države članice morajo pred prihodom zdravila na trg v dogovoru z imetnikom dovoljenja za uporabo zdravila zagotoviti izvajanje naslednjega: − izobraževalni tečaj za nevrokirurge, katerega namen je zmanjševanje tveganja in podpiranje varne in učinkovite uporabe zdravila.
- Board-certification as neurosurgeon according to local, national requirements;
- dovoljenje odbora kot nevrokirurg v skladu z lokalnimi zahtevami;
- Previous successful participation at a training course, or equivalent course during the phase
- predhodno sodelovanje na tečaju ali na ustreznem tečaju med preskušanjem III. faze;
- Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
- izkušnje v vsaj 20 primerih uporabe zdravila Gliolan pri kirurških posegih, vodenih s
- Microscope modified for fluorescence-guided resection;
- mikroskop, prilagojen za resekcijo, vodeno s fluorescenco;
- Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III and
- zadostno število primerov (vsaj 10 bolnikov na leto) malignih gliomov (III. in IV. stopnje po
IV);
SZO);
- Neurophysiological monitoring techniques for surgery in eloquent brain regions.
- tehnike za nevrofiziološki nadzor pri kirurških posegih v elokventnih območjih možganov.
It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ ml).
Vsebuje zdravilno učinkovino hidroklorid 5- aminolevulinske kisline (30 mg/ ml).
Because the number of patients with malignant glioma is low, the disease is considered ‘ rare’, and Gliolan was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 13 November 2002.
Ker je število bolnikov z malignim gliomom majhno, velja ta bolezen za redko, zato je bilo zdravilo Gliolan 13. novembra 2002 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
The active substance in Gliolan, 5-aminolevulinic acid, is a ‘ sensitiser used in photodynamic therapy’.
Zdravilna učinkovina v zdravilu Gliolan, 5- aminolevulinska kislina, je pripravek, namenjen uporabi pri fotodinamični terapiji.
It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
V telesu ga absorbirajo celice, v le- teh pa ga encimi pretvorijo v fluorescentne kemikalije, zlasti protoporfirin IX (PPIX).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Gliolan been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Gliolan raziskano?
However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.
Ker pa je 5- aminolevulinska kislina snov, ki se naravno pojavlja, ter se že uporablja pri nekaterih drugih stanjih, je podjetje predstavilo tudi podatke iz objavljene literature.
The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger (‘ progressing’).
Glavno merilo učinkovitosti sta bila delež bolnikov, ki na sliki možganov, posneti 72 ur po operaciji, ni imel vidnega tumorja, ter delež bolnikov, ki je 6 mesecev preživel brez ponovnega pojava tumorja ali njegove rasti (napredovanja).
At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
72 ur po operaciji 63, 6% bolnikov, ki so prejeli zdravilo Gliolan, ni imelo vidnega tumorja na sliki možganov, v primerjavi s 37, 6% med bolniki, ki niso prejeli zdravila Gliolan.
After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Po šestih mesecih je bilo še živih brez napredovanja bolezni 20, 5% bolnikov, ki so prejeli zdravilo Gliolan, v primerjavi z 11% bolnikov, ki zdravila niso prejeli.
The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Najpogostejši neželeni stranski učinki (opaženi pri več kot 1 od 10 bolnikov) so slabokrvnost (nizka koncentracija rdečih krvničk), trombocitopenija (nizka koncentracija krvnih ploščic), levkocitoza (visoka koncentracija levkocitov, vrste belih krvničk) ter povišane ravni jetrnih encimov v krvi (bilirubina, alanin- aminotransferaze, aspartat - aminotransferaze, gamaglutamil- transferaze in amilaze).
Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Zdravila Mimpara ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) hidroklorid 5- aminolevulinske kisline ali porfirine.
The Committee decided that Gliolan’ s benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Odbor je sklenil, da so koristi zdravila Gliolan za vizualizacijo malignega tkiva med operacijo malignega glioma večje od z njim povezanih tveganj.
EU number
Farmacevtska Številka EU
Route of
oblika
Powder for oral solution Powder for oral solution Powder for oral solution
Prašek za peroralno raztopino
Oral use Oral use Oral use
Prašek za peroralno raztopino
Vial (glass) Vial (glass) Vial (glass)
Viala (steklo)
1 vial 2 vials 10 vials
10 vial
Gliolan 30 mg/ ml powder for oral solution.
Gliolan 30 mg/ ml prašek za peroralno raztopino
One vial contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Ena viala vsebuje 1, 17 g 5- aminolevulinske kisline, kar ustreza 1, 5 g hidroklorida 5- aminolevulinske kisline (5- ALA HCl).
One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
En ml rekonstituirane raztopine vsebuje 23, 4 mg 5- aminolevulinske kisline, kar ustreza 30 mg hidroklorida 5- aminolevulinske kisline (5- ALA HCl).
The recommended dosage is 20 mg 5-aminolevulinic acid hydrochloride per kilogram body weight.
Priporočeni odmerek je 20 mg hidroklorida 5- aminolevulinske kisline na kilogram telesne mase.
The solution should be administered orally three hours (range 2-4 hours) before induction of anaesthesia.
Raztopino je treba dati peroralno tri ure (interval 2 do 4 ure) pred indukcijo narkoze.
Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
Uporaba 5 - aminolevulinske kisline v drugih razmerah, razen v tistih, v katerih se je uporabljala v kliničnih preskušanjih, ima lahko za posledico neznana tveganja.
Patients with renal or hepatic impairment No studies have been performed in patients with clinically relevant hepatic or renal impairment.
Bolniki z ledvično ali jetrno okvaro Študij pri bolnikih s klinično pomembno jetrno ali ledvično okvaro niso opravili.
Paediatric population There is no experience in children.
Pediatrična populacija Izkušenj pri otrocih ni.
Elderly patients There are no special instructions for use in elderly patients with regular organ function.
Starejši bolniki Ni posebnih navodil za uporabo pri starejših bolnikih z normalnim delovanjem organov.
• Hypersensitivity to 5-aminolevulinic acid hydrochloride or porphyrins. • Acute or chronic types of porphyria. • Pregnancy (see sections 4.6 and 5.3)
Preobčutljivost za hidroklorid 5- aminolevulinske kisline ali porfirine; • Akutni ali kronični znaki porfirije; • Nosečnost (glejte poglavji 4. 6 in 5. 3). •
2 4.4 Special warnings and precautions for use
2 Fluorescenca možganskega tkiva, ki jo sproži 5- ALA, ne daje informacij o osnovni nevrološki funkciji tkiva.
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, paresis etc.) 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, pareza, itd.), ki se ne izboljša pri zdravljenju s kortikosteroidi.
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.
Pri vseh bolnikih, ki imajo tumor v bližini območja s pomembno nevrološko funkcijo, je treba uporabiti pred - ali intraoperativne ukrepe, s katerimi se določi položaj tega območja glede na tumor in tako ohrani varno razdaljo.
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).
Co-administration with other potentially phototoxic substances (e. g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
Treba se je izogibati sočasni uporabi drugih potencialno fototoksičnih snovi (npr. tetraciklinov, sulfonamidov, fluorokinolonov, ekstraktom hipericina) (glejte tudi poglavje 5. 3).
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 pressures, pulmonary artery systolic and diastolic pressures as well as pulmonary vascular resistance.
Pri bolnikih z obstoječo kardiovaskularno boleznijo je treba to zdravilo uporabljati previdno, saj so poročila v literaturi pokazala, da lahko pride do zmanjšanja sistoličnega in diastoličnega krvnega tlaka, sistoličnega in diastoličnega tlaka pljučne arterije in pljučne vaskularne rezistence.
One case of an increased phototoxic reaction (severe sunburn lasting for 5 days) has been reported in a patient after co-administration of 5-aminolevulinic acid and a hypericin extract (a known phototoxic agent).
Poročali so o enem primeru povečane fototoksične reakcije (huda sončna opeklina, ki je trajala pet dni), pri bolniku, pri katerem so sočasno uporabili 5- aminolevulinsko kislino in ekstrakt hipericina (znane fototoksične snovi).
Use in pregnancy There are no adequate data from the use of this medicinal product in pregnant woman.
Uporaba v nosečnosti Ni zadostnih podatkov o uporabi tega zdravila pri nosečnicah.
Some limited animal studies suggest an embryotoxic acitivity of 5-ALA plus light exposure (see section 5.3).
Nekatere študije na živalih kažejo na embriotoksično aktivnost uporabe 5- ALA in izpostavljenosti svetlobi (glejte poglavje 5. 3).
Therefore, this medicinal product should not be used during pregnancy.
Zato tega zdravila ne smete uporabljati med nosečnostjo.
Use in lactation It is unknown whether 5-ALA or its metabolite PPIX are excreted in human breast milk.
Uporaba med dojenjem Ni znano, ali se 5- aminolevulinska kislina ali njen presnovek PPIX izloča v materino mleko.
The excretion of 5-ALA or PPIX in milk has not been studied in animals.
Izločanja 5- ALA ali PPIX v mleko pri živalih niso raziskovali.
Gliolan has no influence on the ability to drive and use machines.
Zdravilo Gliolan nima vpliva na sposobnost vožnje in upravljanja s stroji.
- immediate reactions occurring after oral administration of the medicinal product before induction
- kombinirani učinki 5- ALA, anestezije in resekcije tumorja (= neželeni učinki, značilni za
of anaesthesia (= active substance-specific side effects)
postopek).
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000) Very rare (≤ 1/ 10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100, < 1/ 10) Občasni (≥ 1/ 1. 000, < 1/ 100) Redki (≥ 1/ 10. 000, < 1/ 1000) Zelo redki (≤ 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Cardiac disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders
Neželeni učinki, značilni za učinkovino Srčne bolezni Bolezni prebavil Bolezni kože in podkožja
Photosensitivity reaction, photodermatosis
Občasni: hipotenzija Občasni: navzea Občasni: občutljivostna reakcija na svetlobo, fotodermatoza
The extent and frequency of procedure-related neurological side effects depend on the localisation of the brain tumour and the degree of resection of tumour tissue lying in eloquent brain areas (see section 4.4).
Obseg in pogostnost nevroloških neželenih učinkov, povezanih s postopkom, sta odvisna od položaja tumorja na možganih in stopnje resekcije tumorskega tkiva, ki leži v elokventnih območjih možganov (glejte poglavje 4. 4).
Anaemia, thrombocytopenia, leukocytosis
anemija, trombocitopenija, levkocitoza
Cardiac disorders Vascular disorders Gastrointestinal disorders
nevrološke motnje (npr. hemipareza, afazija, konvulzije, hemianopsija)
Hypotension Common:
hipestezija
Diarrhoea
Občasni: hipotenzija Pogosti: trombembolija Pogosti: bruhanje, navzea Zelo redki: diareja
Blood bilirubin increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma glutamyltransferase increased, Blood amylase increased
Zelo pogosti: zvišan bilirubin v krvi, zvišana alanin- aminotransferaza, zvišana aspartat- aminotransferaza, zvišana gamaglutamil- transferaza, zvišana amilaza v krvi.
In a single-arm study 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.
V enokračni študiji, v kateri je sodelovalo 21 zdravih moških prostovoljcev, so z neposredno izpostavljenostjo UVA- svetlobi v obdobju 24 ur po peroralni uporabi 20 mg 5- ALA HCl/ kg telesne mase lahko izzvali eritem kože.
Possibly drug-related mild nausea was reported in 1out of 21 volunteers.
Pri 1 od 21 prostovoljcev so poročali o blagi navzei, ki bi lahko bila povezana z jemanjem zdravila.
In another single-centre study, 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 drugi enocentrični študiji 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.
In a single-arm study including 36 patients with malignant glioma, drug-related adverse events were reported in 4 patients (one patient: mild diarrhoea, one patient: moderate hypesthesia, one patient: moderate chills, and one patient: arterial hypotension 30 minutes after application of 5-ALA HCl).
Vsi
All patients received the medicinal product in a dose of 20 mg/ kg body weight and underwent fluorescence-guided resection.
4 bolniki so prejeli zdravilo v odmerku 20 mg/ kg telesne mase in vsem so opravili resekcijo, vodeno s fluorescenco.
4 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.
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 study 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 študiji.