FrancophonIA/ELRC3.0 huggingface dataset:
English: Major or massive pulmonary haemorrhage/haemoptysis can occur suddenly and up to two thirds of the serious pulmonary haemorrhages resulted in a fatal outcome.
Slovenian: Večja ali masivna krvavitev v pljučih/hemoptiza se lahko pojavi nenadoma, pri do dveh tretjinah resnih krvavitev v pljučih je prišlo do smrtnega izida.
English: There were no grade 4 or 5 hypertension events.
Slovenian: Hipertenzije stopnje 4 ali 5 niso opazili.
English: High-grade glioma
Slovenian: Gliom visoke stopnje
English: Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Slovenian: Svojemu zdravniku takoj povejte, če ste noseči, če ste med zdravljenjem s tem zdravilom zanosili ali če v kratkem načrtujete zanositev.
English: The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.
Slovenian: Varnost in učinkovitost sočasnega zdravljenja z radioterapijo in zdravilom Avastin nista bili ugotovljeni.
English: Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Slovenian: Neželeni učinki so v spodnjih preglednicah razdeljeni v ustrezno skupino po pogostnosti glede na najvišjo incidenco, ki so jo opazili pri kateri koli indikaciji.
English: A cross-trial comparison of the efficacy and safety data is limited by differences between these studies, most notably in patient populations, previous bevacizumab exposure and chemotherapy regimens.
Slovenian: Primerjava podatkov o učinkovitosti in varnosti med študijama je omejena zaradi razlik med njima, še posebej v populaciji bolnikov, predhodni izpostavljenosti bevacizumabu in uporabljeni kemoterapiji.
English: There were no complete responses and 2 partial responses (MacDonald criteria).
Slovenian: Popolnih odgovorov na zdravljenje ni bilo, bila pa sta 2 delna odgovora na zdravljenje (kriterij po Macdonaldu).
English: Final overall survival analysis performed when 46.9% of the patients had died.
Slovenian: Končna analiza celokupnega preživetja je bila narejena, ko je približno 46,9 % bolnic umrlo.
English: ● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Slovenian: · to zdravilo poveča tveganje za pojav beljakovin v seču, še posebej, če že imate visok krvni tlak;
English: Efficacy results for study JO25567
Slovenian: Rezultati učinkovitosti študije JO25567
English: Symptoms usually resolve or improve within days after treatment discontinuation, although some patients have experienced some neurologic sequelae.
Slovenian: Simptomi ponavadi izginejo ali se izboljšajo v nekaj dneh po prekinitvi zdravljenja, kljub temu so nekateri bolniki imeli nevrološke posledice.
English: Q2 2019
Slovenian: 2. četrtletje 2019
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Slovenian: Če boste operirani, če je od večje operacije minilo manj kot 28 dni, ali če se vaša rana po operaciji še ni zacelila, tega zdravila ne smete prejeti;
English: • feeling weak and having no energy,
Slovenian: · občutek šibkosti in pomanjkanja energije,
English: Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Slovenian: Kombinacija zdravila Avastin z drugim zdravilom, imenovanim sunitinib malat (predpisanem za zdravljenje raka ledvic in prebavil), lahko povzroči hude neželene učinke.
English: Avastin use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Slovenian: Uporaba zdravila Avastin ni priporočena pri otrocih in mladostnikih, mlajših od 18 let, ker varnosti in koristi zdravila pri tej populaciji niso dokazali.
English: In addition, the primary endpoint was also assessed by an independent review committee (IRC).
Slovenian: Dodatno je primarni cilj ocenil tudi odbor za neodvisni pregled (IRC, independent review committee).
English: The majority of patients (CP: 64.6%; CPB: 68.8%) were in the age category < 65 years.
Slovenian: Večina bolnic (CP: 64,6 %; CPB: 68,8 %) je bila iz starostne skupine < 65 let.
English: * Primary analysis was performed with a data cut-off date of 14 November 2011.
Slovenian: *Primarna analiza je bila pripravljena s podatki, zajetimi do 14. novembra 2011.
English: Objective Response Rate**
Slovenian: Objektivni odgovor**
English: The median age of patients was 61.0 (range: 25−84) years.
Slovenian: Mediana starosti bolnic je bila 61,0 let (razpon: 25 do 84 let).
English: Table 2 also includes adverse reactions which are considered by the MAH to be clinically significant or severe.
Slovenian: Preglednica 2 vključuje tudi neželene učinke, za katere imetnik dovoljenja za promet smatra, da so klinično pomembni ali hudi.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in Table 6 for trial NO16966.
Slovenian: V skupini, ki je prejemala kemoterapijo, so pri zdravljenju po shemi FOLFOX-4 uporabljali enake odmerke in sheme, kot je prikazano v preglednici 6 za preskušanje NO16966.
English: Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see section 5.3).
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih na živalih so pokazale, da ima bevacizumab lahko škodljiv učinek na plodnost žensk (glejte poglavje 5.3).
English: Secondary endpoints included overall survival, response rate, disease control rate, duration of response, and safety.
Slovenian: Sekundarni cilji so vključevali celokupno preživetje, odgovor na zdravljenje, stopnjo nadzora bolezni, trajanje odgovora in varnost.
English: ● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Slovenian: · to zdravilo lahko poveča tveganje za krvavitve ali poveča tveganje za težave pri celjenju ran po operaciji.
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Slovenian: Farmakokinetika bevacizumaba je bila linearna pri odmerkih v intervalu od 1 do 10 mg/kg.
English: It rarely resulted in discontinuation of Avastin treatment or hospitalisation.
Slovenian: Redko je prišlo do prekinitve zdravljenja z zdravilom Avastin ali hospitalizacije.
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anticancer therapies, which may have impacted the analysis of overall survival.
Slovenian: Velik del bolnikov (približno 62 %) je prejemal različna zdravila za zdravljenje novotvorb, ki niso bila določena v protokolu študije, kar je lahko vplivalo na analizo celokupnega preživetja.
English: On documented disease progression, patients who entered the optional open-label phase could receive open-label Avastin together with a wide-range of second line therapies.
Slovenian: Pri dokumentiranem napredovanju bolezni so lahko bolniki, ki so vstopili v opcijsko odprto fazo, odprto prejemali zdravilo Avastin skupaj z različnimi vrstami zdravljenj v drugi liniji.
English: A total of 1873 patients were randomised in equal proportions to the following three arms:
Slovenian: Skupno je bilo randomiziranih 1873 bolnic v enakem razmerju v naslednje tri skupine:
English: b stratified by the duration of treatment free-interval prior to enrolling onto this study per the registration form, and secondary surgical debulking status Yes/No.
Slovenian: b stratificirane s trajanjem intervala brez zdravljenja pred vključitvijo v to študijo glede na registracijski obrazec in sekundarno s statusom kirurške odstranitve Da/Ne.
English: What Avastin is and what it is used for
Slovenian: Kaj je zdravilo Avastin in za kaj ga uporabljamo
English: This study included a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase.
Slovenian: To preskušanje je vključevalo fazo s slepim zdravljenjem, opcijsko odprto fazo po napredovanju bolezni in nadaljevalno fazo, v kateri so spremljali preživetje.
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment.
Slovenian: · redek neželen učinek, povezan z živci, imenovan sindrom posteriorne reverzibilne encefalopatije (PRES), povezujejo z zdravljenjem z zdravilom Avastin.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
English: If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Slovenian: Če imate stanje, ki povzroča trebušno vnetje (npr. divertikulitis, želodčno razjedo, s kemoterapijo povezan kolitis), se o tem pogovorite s svojim zdravnikom;
English: Table 2 provides the frequency of severe adverse reactions.
Slovenian: Preglednica 2 navaja pogostnost hudih neželenih učinkov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001 - 100 mg/4 ml vial EU/1/04/300/002 - 400 mg/16 ml vial
Slovenian: EU/1/04/300/001 - 100 mg/4 ml viala EU/1/04/300/002 - 400 mg/16 ml viala
English: Objective Response Rate 1
Slovenian: Objektivni odgovor 1
English: If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.
Slovenian: Če pride do reakcije, je treba infundiranje prekiniti ter uvesti ustrezno zdravljenje.
English: Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Slovenian: Prosimo, obvestite svojega zdravnika, če ste pred kratkim prejeli ali prejemate zdravljenje z obsevanjem.
English: An independent review of the primary endpoint was also conducted.
Slovenian: Opravljen je bil tudi neodvisen pregled primarnega cilja.
English: Avastin is not approved for use in patients under the age of 18 years.
Slovenian: Zdravilo Avastin ni odobreno za uporabo pri bolnikih, mlajših od 18 let.
English: After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Slovenian: Po prilagoditvi glede na telesno maso so imeli bolniki višji očistek bevacizumaba (+17 %) kot bolnice.
English: Patients with recent pulmonary haemorrhage/ haemoptysis (> 2.5 ml of red blood) should not be treated with Avastin.
Slovenian: Bolnike, ki so nedavno imeli krvavitev v pljučih/hemoptizo (> 2,5 ml rdeče krvi), z zdravilom Avastin ne smemo zdraviti.
English: There is evidence suggesting that all Grade (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Slovenian: Obstajajo dokazi, da je proteinurija vseh stopenj (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) lahko povezana z odmerkom.
English: b Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Slovenian: b Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: 878 patients were randomised to the two arms.
Slovenian: 878 bolnikov je bilo randomiziranih v dve skupini.
English: The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Slovenian: Največji odmerek, ki so ga preizkušali pri ljudeh (20 mg/kg telesne mase, intravensko na 2 tedna), je bil pri nekaj bolnikih povezan s hudo migreno.
English: Intravitreal use Avastin is not formulated for intravitreal use.
Slovenian: Intravitrealna uporaba Zdravilo Avastin ni namenjeno intravitrealni uporabi.
English: Avastin therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Slovenian: Zdravljenje z zdravilom Avastin je treba pri bolnikih, pri katerih se razvije nekrotizirajoči fasciits, nemudoma prekiniti in takoj začeti z ustreznim zdravljenjem.
English: Best Overall Response - Primary analysis6
Slovenian: Najboljši celokupni odgovor na zdravljenje - primarna analiza6
English: The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Slovenian: Na voljo so farmakokinetični podatki o bevacizumabu iz desetih kliničnih preskušanj pri bolnikih s solidnimi tumorji.
English: Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Slovenian: Zdravilo Avastin vsebuje zdravilno učinkovino bevacizumab, ki je humanizirano monoklonsko protitelo (vrsta beljakovine, ki jo običajno proizvaja imunski sistem, da pomaga telesu pri obrambi proti okužbam in raku).
English: Avastin is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Avastin je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
Slovenian: V študijah na opicah cynomolgus, ki so trajale do 26 tednov, so pri mladih živalih z odprtimi rastnimi ploščami opazili fizalno displazijo pri srednjih koncentracijah bevacizumaba v serumu, ki so bile pod pričakovanimi povprečnimi terapevtskimi koncentracijami v serumu pri ljudeh.
English: The incidence of each histologic sub-type of EOC was similar between the treatment arms; 69% of patients in each treatment arm had serous adenocarcinoma histologic type.
Slovenian: Incidenca vseh histoloških podtipov epitelijskega raka jajčnikov je bila podobna v obeh skupinah; 69 % bolnic v vsaki skupini je imelo serozni histološki tip adenokarcinoma.
English: 19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
Slovenian: 19 % teh bolnikov je predhodno prejemalo kemoterapijo, 14 % pa radioterapijo.
English: Do not use Avastin if you notice any particulate matter or discolouration prior to administration.
Slovenian: Ne uporabljajte zdravila Avastin, če opazite kakršne koli delce ali obarvanje pred dajanjem.
English: After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Slovenian: Po prekinitvi zdravljenja z bevacizumabom se je delovanje jajčnikov izboljšalo pri 86,2 % opazovanih žensk.
English: The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Slovenian: Pri odraslih in pediatričnih bolnikih so z analizo populacijske farmakokinetike proučili vpliv demografskih značilnosti na farmakokinetiko .
English: The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Slovenian: Varnost in učinkovitost bevacizumaba pri otrocih, mlajših od 18 let, nista bili dokazani.
English: ● Avastin may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Slovenian: · zdravilo Avastin lahko poveča tveganje za razvoj neobičajne povezave ali prehoda med dvema organoma ali žilami.
English: The initial dose should be delivered over 90 minutes as an intravenous infusion.
Slovenian: Začetni odmerek je treba dajati v obliki intravenske infuzije 90 minut.
English: XELOX or XELOX + Avastin
Slovenian: XELOX ali XELOX+ Avastin
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + Avastin) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Slovenian: Med 110 bolniki, randomiziranimi v skupino 3 (5-FU/FA + Avastin), je bila mediana celokupnega preživetja pred ukinitvijo te skupine 18,3 meseca, mediana preživetja brez napredovanja bolezni pa 8,8 meseca.
English: What Avastin is and what it is used for What you need to know before you use Avastin How to use Avastin
Slovenian: Kaj je zdravilo Avastin in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Avastin Kako uporabljati zdravilo Avastin
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Slovenian: To je bilo randomizirano preskušanje faze II, v katerem so primerjali učinkovitost in varnost bevacizumaba in placeba.
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (<65 years).
Slovenian: V enem kliničnem preskušanju je bila incidenca hipertenzije stopnje ≥ 3 dvakrat višja pri bolnikih, starih nad 65 let, v primerjavi s skupino, ki je vključevala mlajše bolnike (< 65 let).
English: Dosage and frequency of administration
Slovenian: Odmerjanje in pogostnost dajanja
English: Randomised patients with stage IV disease
Slovenian: Randomizirane bolnice z boleznijo stadija IV
English: CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Slovenian: Podatek o rasi obstaja za 29,3 % bolnic in skoraj vse bolnice so bile belke.
English: Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.
Slovenian: Bolniki z metastazami v osrednjem živčevju, vključno s predhodno zdravljenimi ali odstranjenimi lezijami v možganih, niso bili vključeni.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: · Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Slovenian: 3 Končno celokupno analizo so opravili, ko je 46,7 % bolnic umrlo (s podatki zbranimi do 31. marca 2013).
English: All treatments were continued until disease progression.
Slovenian: Vsa zdravljenja so izvajali, dokler ni bolezen napredovala.
English: The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Slovenian: Večina bolnic je imela serozni histološki tip adenokarcinoma (85 % v CPP in CPB15, 86 % v CPB15+ skupini).
English: The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Slovenian: Analiza primarnega cilja raziskave ni pokazala razlik med skupino z zdravilom Avastin + placebom in skupino z zdravilom Avastin + erlotinibom (mediana preživetja brez napredovanja bolezni 8,5 v primerjavi z 9,9 meseca).
English: 3 One-sided log-rank p-value Subject to a p-value boundary of 0.0116.
Slovenian: Odvisna od meje p-vrednosti, ki je 0,0116.
English: Please let your doctor, pharmacist or nurse know if you have previously experienced problems after injections, such as dizziness/feeling of fainting, breathlessness, swelling or skin rash.
Slovenian: Svojega zdravnika, farmacevta ali medicinsko sestro obvestite, če ste že imeli težave po injiciranju, kot je omotica/občutek slabotnosti, težave pri dihanju (zasoplost), otekanje ali kožni izpuščaj;
English: See Section 4.
Slovenian: Preglednica 4.
English: These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the Avastin treatment regimen.
Slovenian: Večinoma je šlo za epistakse stopnje 1 po lestvici NCI-CTCAE v.3, ki so trajale manj kot 5 minut, so prenehale brez zdravniške pomoči in niso zahtevale sprememb sheme zdravljenja z zdravilom Avastin.
English: Fistulae have also been reported in post-marketing experience.
Slovenian: O fistulah so poročali tudi v obdobju trženja zdravila.
English: Approximately 350 patients were randomised into each of the 4 trial arms in the Part II of the trial.
Slovenian: V vsako od štirih skupin preskušanja v delu II preskušanja je bilo randomiziranih približno 350 bolnikov.
English: With or without gross residual disease.
Slovenian: 2 Z ali brez preostanka bolezni.
English: ● This medicine may cause bleeding, especially tumour-related bleeding.
Slovenian: · to zdravilo lahko povzroči krvavitve, posebno krvavitve, povezane s tumorjem.
English: Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
Slovenian: Vaš zdravnik vam bo svetoval uporabo primerne kontracepcije med zdravljenjem z zdravilom Avastin in še najmanj 6 mesecev po njegovem zadnjem odmerku.
English: Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so vsi neželeni učinki navedeni po padajoči resnosti.
English: ● Avastin can increase the incidence of high blood pressure.
Slovenian: · zdravilo Avastin lahko poveča pojavnost visokega krvnega tlaka.
English: ● It is possible that Avastin may cause bleeding in and around your brain.
Slovenian: · možno je, da lahko zdravilo Avastin povzroči krvavitve v možganih in okoli možganov.
English: Frequency Not Known
Slovenian: Neznana pogostnost
English: The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies using a population pharmacokinetic model.
Slovenian: Farmakokinetiko bevacizumaba so ocenili pri 152 otrocih, mladostnikih in mlajših odraslih (7 mesecev do 21 let; 5,9 do 125 kg) v 4 kliničnih študijah z uporabo populacijskega farmakokinetičnega modela.
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on Day 1 only every 4 weeks.
Slovenian: · PLD 40 mg/m2 kot intravenska infuzija s hitrostjo 1 mg/min samo 1. dan vsake 4 tedne.
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Slovenian: a Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
English: The dose of Avastin needed depends on your body weight and the kind of cancer to be treated.
Slovenian: Potrebni odmerek zdravila Avastin je odvisen od telesne mase in vrste raka, ki ga zdravimo.
English: Avastin should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Slovenian: Zdravilo Avastin dokončno opustimo, če klinično pomembne hipertenzije ni mogoče ustrezno uravnati z antihipertenzivnimi zdravili ali če se je pri bolniku pojavila hipertenzivna kriza ali hipertenzivna encefalopatija.
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Slovenian: Tveganje za krvavitev v osrednjem živčevju pri teh bolnikih zato ni bilo prospektivno ocenjeno v randomiziranih kliničnih preskušanjih (glejte poglavje 4.8).