FrancophonIA/ELRC3.0 huggingface dataset:
English: Having assessed the totality of the risk minimisation measures proposed, the PRAC concluded that given the risk and the unpredictability of serious cutaneous adverse reactions with tetrazepam the proposed measures were not sufficient to reduce the risk to a clinically acceptable level.
Slovenian: Po preučitvi vseh predlaganih ukrepov za zmanjšanje tveganja je PRAC zaključil, da glede na tveganje in nepredvidljivost resnih neželenih učinkov na kožo, povezanih z uporabo tetrazepama, predlagani ukrepi ne bi zadostovali za zmanjšanje tveganja na klinično sprejemljivo raven.
English: In addition, cases of rechallenge with new skin disorders episodes were reported.
Slovenian: Poleg tega so poročali o primerih ponovne uporabe tetrazepama z novimi epizodami bolezni kože.
English: Following reporting of new serious cutaneous reactions with the use of tetrazepam, the French National Competent Authority reviewed in November 2012 the cutaneous risk associated with tetrazepam based on results of a national pharmacovigilance survey.
Slovenian: Zaradi poročil o novih resnih neželenih učinkih na kožo, povezanih z uporabo tetrazepama, je francoski nacionalni pristojni organ novembra 2012 na podlagi rezultatov nacionalne raziskave farmakovigilance ponovno pregledal tveganje za kožne reakcije, povezano z uporabo tetrazepama.
English: The CMDh, having considered the PRAC recommendation dated 11 April 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC and the oral explanation attended by a Marketing Authorisation Holder on 22 April 2013, reached a position on the suspension of the marketing authorisations of tetrazepam containing medicinal products.
Slovenian: CMDh je na podlagi preučitve priporočila, ki ga je dne 11. aprila 2013 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES podal PRAC, in ustnih obrazložitev, ki jih je dne 22. aprila 2013 podal imetnik dovoljenja za promet z zdravilom, sprejel stališče o začasnem umiku dovoljenj za promet z zdravili, ki vsebujejo tetrazepam.
English: These included 33 cases of SJS (including 1 fatal case), 33 cases of Lyell's Syndrome (TEN) (including 9 fatal cases), 59 cases of EM (including 1 fatal case), 15 cases of DRESS Syndrome, 3 possible cases of DRESS Syndrome and 5 cases of acute generalised exanthematous pustulosis.
Slovenian: Med temi je bilo 33 primerov SJS (vključno z 1 smrtnim primerom), 33 primerov Lyellovega sindroma (TEN) (vključno z 9 smrtnimi primeri), 59 primerov multiformnega eritema (vključno z 1 smrtnim primerom), 15 primerov sindroma DRESS, 3 domnevni primeri sindroma DRESS in 5 primerov akutne generalizirane eksantemske pustuloze.
English: Benzodiazepines (BZP) facilitate the inhibitory activity of gamma-aminobutyric acid (GABA) leading to sedative, hypnotic, anticonvulsant and muscle relaxant properties.
Slovenian: Benzodiazepini (BZP) spodbujajo zaviralno delovanje gama-aminomaslene kisline (GABA) in posledično delujejo pomirjevalno, hipnotično in antikonvulzivno ter sproščajo mišice.
English: Therefore, following the provisions under Article 107i of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for all medicinal products referred to in Annex I.
Slovenian: Zato je PRAC v skladu z določbami člena 107i Direktive 2001/83/ES priporočil začasen umik dovoljenj za promet z vsemi zdravili, navedenimi v Prilogi I.
English: As provided by the Marketing Authorisation Holder of the originator medicinal product in their written response to the PRAC list of questions, according to the MAH's pharmacovigilance database since the product launch in 1969 up to the 31 of May 2012 (Data Lock Point), 513 cutaneous or allergic distinct cases referring to 748 reactions were reported with tetrazepam.
Slovenian: Kot je v pisnem odgovoru na seznam vprašanj, ki jih je zastavil PRAC, navedel imetnik dovoljenja za promet z izvornim zdravilom, so v zbirki podatkov farmakovigilance imetnika dovoljenja od prihoda zdravila na trg leta 1969 do 31. maja 2012 (zaključek vnosa podatkov) zabeležili 513 različnih primerov neželenih učinkov na kožo ali alergij, ki so bili povezani s 748 reakcijami.
English: On 20 December 2012 France informed the European Medicines Agency, pursuant to Article 107i of Directive 2001/83/EC, of their consideration to revoke the marketing authorisations for Tetrazepam containing medicines further to the evaluation of data resulting from pharmacovigilance activities.
Slovenian: Dne 20. decembra 2012 je Francija v skladu s členom 107i Direktive 2001/83/ES obvestila Evropsko agencijo za zdravila, da na podlagi ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, razmišlja o razveljavitvi dovoljenj za promet z zdravili, ki vsebujejo tetrazepam.
English: Cases of anaphylaxis were also reported.
Slovenian: Poročali so tudi o primerih anafilaksije.
English: In addition, 10 cases of angioedema evoking an immediate hypersensitivity mechanism and 67 cases of drug eruption, in addition to the previous cases, with or without the involvement of at least one organ were described.
Slovenian: Poleg zgoraj omenjenih primerov so opazili še 10 primerov angioedema, ki je izzval takojšnjo preobčutljivostno reakcijo, in 67 primerov izpuščaja zaradi delovanja zdravila, ki so ali niso bili povezani z vsaj enim organom.
English: Within these 1616 cases, 805 (49.80 %) ADRs involved “skin and subcutaneous tissue disorders” SOC, of which 305 (37.9%) were serious cases including life threatening and fatal cases.
Slovenian: Med temi primeri je bilo 805 (49,8 %) neželenih učinkov zdravila povezanih z organskim sistemom „bolezni kože in podkožja”, od katerih je bilo 305 (37,9 %) resnih primerov, vključno z življenjsko nevarnimi in smrtnimi primeri.
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za začasen umik dovoljenj za promet z zdravili
English: This review of pharmacovigilance concerned skin adverse drug reactions (ADRs) recorded in the French National Pharmacovigilance database since the granting of the first marketing authorisations of tetrazepam in 1967 in that Member State.
Slovenian: Pregled farmakovigilance je bil namenjen oceni neželenih učinkov zdravila na kožo, ki so jih v francoski zbirki podatkov farmakovigilance zabeležili od odobritve prvih dovoljenj za promet s tetrazepamom v tej državi članici leta 1967.
English: Overall, the most frequently reported skin reactions are by decreasing order various types of rashes without any specificity (162 cases), pruritus (94 cases), Erythema Multiforme (48 cases), urticaria (47 cases), Toxic Epidermal Necrolysis (35 cases), angioedema (34 cases), Stevens-Johnson Syndrome (31 cases), erythema (28 cases), toxic skin eruption (19 cases), skin exfoliation (16 cases), dermatitis bullous, Not Otherwise Specified (NOS) (16 cases) and DRESS Syndrome (7 cases).
Slovenian: Na splošno so neželeni učinki na kožo, o katerih so najpogosteje poročali, po padajočem vrstnem redu različne vrste izpuščajev brez kakršnih koli posebnosti (162 primerov), pruritus (94 primerov), multiformni eritem (48 primerov), urtikarija (47 primerov), toksična epidermalna nekroliza (35 primerov), angioedem (34 primerov), Stevens-Johnsonov sindrom (31 primerov), eritem (28 primerov), toksični kožni izpuščaj (19 primerov), eksfoliacija kože (16 primerov), bulozni dermatitis, neželeni učinki, ki niso drugače opredeljeni (16 primerov) in sindrom DRESS (7 primerov).
English: In view of the unpredictability of this type of adverse reactions, a restricted indication would not be an effective risk minimisation measure.
Slovenian: Omejitev indikacije zaradi nepredvidljivosti omenjenih vrst neželenih učinkov ne bi bila učinkovit ukrep za zmanjšanje tveganja.
English: The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
Slovenian: PRAC je menil, da razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet z zdravilom, kažejo na zelo majhno klinično učinkovitost tetrazepama pri odobrenih indikacijah.
English: Based on the above, the PRAC concluded that tetrazepam is associated with safety concerns in relation to serious, potentially fatal, skin reactions and shows limited clinical efficacy.
Slovenian: Na podlagi vsega navedenega je PRAC zaključil, da je tetrazepam povezan z varnostnimi tveganji, povezanimi z resnimi kožnimi reakcijami, ki so lahko tudi smrtne, njegova klinična učinkovitost pa je majhna.
English: This included data from the Member States and published literature data which became available since the original marketing authorisations, as well as the MAH responses and the Stakeholders submissions.
Slovenian: Med njimi so bili podatki, ki so jih predložile države članice, in podatki iz literature, ki so bili objavljeni po odobritvi prvih dovoljenj za promet, ter tudi odgovori imetnika dovoljenja za promet z tetrazepamom in vloge zainteresiranih strani;
English: The MAH presented its views on the possible mechanism of cutaneous reactions induced by tetrazepam: a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam) may be linked to the various cutaneous hypersensitivity reactions observed for tetrazepam.
Slovenian: promet je predstavil svoje mnenje o možnem mehanizmu kožnih reakcij, povezanih s tetrazepamom: različne preobčutljivostne kožne reakcije, ki so jih opazili pri uporabi tetrazepama, bi lahko bile posledica razlike v strukturi tetrazepama in drugih benzodiazepinov (tj. substituirani cikloheksenilov obroč pri tetrazepamu).
English: • The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
Slovenian: • PRAC je menil, da razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet z zdravilom, kažejo na zelo majhno klinično učinkovitost tetrazepama pri odobrenih indikacijah;
English: The PRAC considered that the risk minimisations measures discussed during the assessment, including reduction of duration of treatment and restricted indication, were not sufficient to reduce the risk.
Slovenian: PRAC je menil, da ukrepi za zmanjšanje tveganja, ki so bili obravnavani med ocenjevanjem, vključno s skrajšanjem časa zdravljenja in omejitvijo indikacije, ne zadostujejo za zmanjšanje tveganja.
English: Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology or spasticity.
Slovenian: Tetrazepam je benzodiazepin, indiciran za boleče mišične krče pri revmatoloških boleznih ali za spastičnost.
English: Overall, more than 40% of the reported cases are related to the skin disorder SOC; severe Cutaneous Adverse Reactions to Drugs (SCARs), such as SJS, TEN, DRESS Syndrome and EM were diagnosed upon tetrazepam treatment and 11 fatal cases were reported; in 8 cases, it was reported as the result of the skin reaction and in 3 cases, it was related to an associated reaction.
Slovenian: Skupno je bilo več kot 40 % primerov, o katerih so poročali, povezanih z organskim sistemom „bolezni kože‟; pri zdravljenju s tetrazepamom so diagnosticirali resne neželene učinke zdravila na kožo, kot so SJS, TEN, sindrom DRESS in multiformni eritem, ter poročali o 11 smrtnih primerih; v 8 primerih je bila smrt posledica kožne reakcije, v 3 primerih pa z njo povezane reakcije.
English: • The PRAC noted that serious adverse cutaneous reactions have been reported with tetrazepam, including fatal cases.
Slovenian: • PRAC je upošteval, da so pri uporabi tetrazepama poročali o resnih neželenih učinkih na kožo, med katerimi so bili tudi smrtni primeri;
English: In view of the above, the PRAC considered that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and DRESS syndrome which can be life threatening and fatal.
Slovenian: Ob upoštevanju vsega naštetega je PRAC menil, da je tetrazepam v primerjavi z zdravili iz iste farmakološke skupine povezan z večjim tveganjem za resne neželene učinke na kožo, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo, multiformnim eritemom in sindromom DRESS, ki so lahko življenjsko nevarni in tudi smrtni.
English: Overall, the efficacy of tetrazepam in the painful contractures indication is supported mainly by two small double blind placebo-controlled clinical trial (Arbus 1987
Slovenian: Na splošno učinkovitost tetrazepama pri indikaciji za boleče mišične krče podpirata predvsem dve manjši dvojno slepi s placebom nadzorovani klinični študiji (Arbus 1987 in Salzmann 1993), v kateri je bilo skupno vključenih 70 bolnikov (50 oziroma 20 bolnikov).
English: Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology and in spastic syndromes across the Members States.
Slovenian: Tetrazepam je benzodiazepin, ki je v državah članicah indiciran za boleče mišične krče pri revmatoloških boleznih in spastične sindrome.
English: • The PRAC considered that the risk minimisations measures discussed during the assessment, including reduction of duration of treatment and restricted indication, were not sufficient to reduce the risk of serious cutaneous reactions.
Slovenian: • PRAC je menil, da ukrepi za zmanjšanje tveganja, ki so bili obravnavani med ocenjevanjem, vključno s skrajšanjem časa zdravljenja in omejitvijo indikacije, ne zadostujejo za zmanjšanje tveganja za resne neželene učinke na kožo.
English: • The PRAC considered, after having reviewed the available data that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and Drug Reaction of Eosinophilia Systemic Symptoms (DRESS) which can be life threatening and fatal.
Slovenian: • PRAC je po pregledu razpoložljivih podatkov menil, da je tetrazepam v primerjavi z zdravili iz iste farmakološke skupine povezan z večjim tveganjem za resne neželene učinke na kožo, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo, multiformnim eritemom in neželenimi učinki z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko nevarni in tudi smrtni;
English: This evaluation highlighted an increased cutaneous risk of tetrazepam in addition to the pharmacological expected ADRs of benzodiazepines: half of the ADRs reported with tetrazepam were cutaneous and amongst the 648 serious cases reported, 305 cases were reported under the System Organ Class (SOC) “Skin and subcutaneous disorders”: 33 cases of Stevens - Johnson syndrome (SJS), 33 of Toxic Epidermal Necrolysis (TEN), 59 Erythema Multiforme (EM) and 15 cases of Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms (DRESS Syndrome) were detected with fatal outcome in 11 cases.
Slovenian: Med pregledom so poleg pričakovanih neželenih učinkov zaradi farmakološkega delovanja benzodiazepinov opazili povečano tveganje za kožne reakcije, povezano z uporabo tetrazepama: polovica neželenih učinkov, o katerih so poročali pri uporabi tetrazepama, je bila povezanih s kožo, pri čemer je bilo z organskim sistemom „bolezni kože in podkožja‟ povezanih 305 od 648 poročil o resnih primerih: poročali so o 33 primerih Stevens-Johnsonovega sindroma (SJS), 33 primerih toksične epidermalne nekrolize (TEN), 59 primerih multiformnega eritema in 15 primerih neželene reakcije (ali izpuščaja) z eozinofilijo in sistemskimi simptomi (sindrom DRESS), pri čemer se je 11 primerov končalo s smrtnim izidom.
English: 1 Sanchez I et al. Stevens-Johnson syndrome from tetrazepam.
Slovenian: 1 Sanchez, I. et al., „Stevens-Johnson syndrome from tetrazepam‟, Allergol Immunopathol, št. 26, 1998, str.
English: Results of clinical studies with the use of tetrazepam in both indications have been published since the marketing authorisations of tetrazepam.
Slovenian: Po odobritvi dovoljenj za promet s tetrazepamom so bili objavljeni rezultati kliničnih študij uporabe tetrazepama pri obeh indikacijah.
English: 2 Camarasa JG et al. Tetrazepam allergy detected by patch test.
Slovenian: 2 Camarasa, J. G. et al., „Tetrazepam allergy detected by patch test‟, Contact Dermatitis, št. 22, 1990, str. 246.
English: Grounds for PRAC recommendation
Slovenian: Podlaga za priporočilo PRAC Ob upoštevanju:
English: • The PRAC considered the totality of the data available for tetrazepam containing products in relation to the risk of cutaneous adverse reactions.
Slovenian: • PRAC je preučil vse razpoložljive podatke v zvezi s tveganjem za neželene učinke na kožo, povezanim z zdravili, ki vsebujejo tetrazepam.
English: Tetrazepam affinity for skin could explain the localization of the hypersensitivity reaction.
Slovenian: Afiniteta tetrazepama do kože bi lahko pojasnila, zakaj se preobčutljivostne reakcije pojavljajo na tem mestu.
English: Skin adverse events were also submitted in responses from other MAHs and the Stakeholders submissions.
Slovenian: Podatke o neželenih dogodkih, povezanih s kožo, so v odgovoru predložili tudi drugi imetniki dovoljenj za promet s tetrazepamom in zainteresirane strani.Imetnik dovoljenja za
English: A specific analysis about the most relevant serious adverse cutaneous reactions reported by the MAH in relationship of their nature and severity was made in the MAH's response to the PRAC list of questions.
Slovenian: V odgovoru na seznam vprašanj, ki jih je zastavil PRAC, je imetnik dovoljenja za promet izvedel posebno analizo vrste in resnosti najpomembnejših poročanih resnih neželenih učinkov na kožo.
English: J Investig Allergol Clin Immunol 2007;17(3):205-6 Delesalle F et la.
Slovenian: 5 Cabreizo Ballesteros et al., „Erythema multiforme to tetrazepam‟, J Investig Allergol Clin Immunol, št. 17(3), 2007, str. 205-6.
English: However the imputability of tetrazepam is strong in a high number of cases.
Slovenian: Vendar pa je bil v velikem številu primerov z neželenimi učinki zelo verjetno povezan tetrazepam.
English: Toxic epidermal necrolysis caused by tetrazepam.
Slovenian: 6 Delesalle, F. et al., „Toxic epidermal necrolysis caused by tetrazepam‟, International Journal of Dermatology,
English: Allergy 1997;52(11):1145-6 10 LagnouiR et al.
Slovenian: Blanco, R. et al., „Delayed hypersensitivity to tetrazepam‟, Allergy, št. 52(11), 1997, str. 1145-6.
English: J Investig Allergol Clin Immunol 2008;18(5):404-406 9 Blanco R et la.
Slovenian: 18(5), 2008, str. 404-406.
English: Dermatol Venereol 2008;22(7):887-8 Cabreizo Ballesteros et al. Erythema multiforme to tetrazepam.
Slovenian: 3 Quinones, D. et al., „Photodermatitis from tetrazepam‟, Contact Dermatitis, št. 39(2), 1998, str. 84. 4 Bachmeyter, C., „Probable drug rash with eosinophilia and systemic symptoms syndrome related to tetrazepam‟, J Eur Acad Dermatol Venereol, št. 22(7), 2008, str. 887-8.
English: Allergy 1999;54(11):1226-27 Sanchez-Morillas L et al.
Slovenian: Del Pozo, M. D. et al., „Tetrazepam Allergy‟, Allergy, št. 54(11), 1999, str. 1226-27.
English: The PRAC considered risk minimisations measures, including reduction of duration of treatment to 6 days and a restricted indication, to mitigate the risk of serious cutaneous adverse reactions.
Slovenian: PRAC je preučil ukrepe za zmanjšanje tveganja za resne neželene učinke na kožo, ki so vključevali skrajšanje trajanja zdravljenja na 6 dni in omejitev indikacije.
English: Fatal toxic epidemal necrolysis associated with tetrazepam.
Slovenian: Lagnoui, R. et al., „Fatal toxic epidemal necrolysis associated with tetrazepam‟, Therapie, št. 56(2), 2001, str.
English: J Eur Acad
Slovenian: Priloga II
English: International Journal of Dermatology 2006;45(4):480 Del Pozo MD et al. Tetrazepam Allergy.
Slovenian: št. 45(4), 2006, str. 480.
English: Where can I get more information?
Slovenian: Kje lahko dobite več informacij?
English: What else do I need to know?
Slovenian: Kaj še morate vedeti?
English: What should I do with this card?
Slovenian: Kaj morate storiti s to kartico?
English: This can be fatal.
Slovenian: Ta je lahko smrtna.
English: In particular, tell your doctor:
Slovenian: Še zlasti morate zdravniku povedati:
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Slovenian: Datum prve odobritve: 13. julij 2017 Datum zadnjega podaljšanja:
English: • if you are taking medicines for high blood pressure.
Slovenian: • če jemljete zdravila za visok krvni tlak.
English: No additional safety signals were identified.
Slovenian: Pri tem niso zaznali nobenih novih varnostnih signalov.
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Slovenian: Vendar pa možnega tveganja za razvoj solidnih tumorjev za zdaj ni mogoče izključiti.
English: It also includes your name and doctor's name and phone number on the back.
Slovenian: Na hrbtni strani sta zapisani tudi vaše in zdravnikovo ime ter telefonska številka.
English: • if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries.
Slovenian: • če menite, da boste v kratkem potrebovali katero koli cepljenje, vključno s cepljenji, ki bi jih potrebovali za potovanje v druge države.
English: • you have a severe active infection at the moment
Slovenian: • imate trenutno hudo, aktivno okužbo;
English: There are no adequate and well-controlled data from studies in pregnant women,
Slovenian: Za nosečnice ni zadostnih in dobro nadzorovanih podatkov iz študij.
English: 95.1%b CI (−3.2%, 24.3%) a
Slovenian: 95,1 %b IZ (−3,2 %, 24,3 %) a
English: Key results from all four studies are summarised in Table 6.
Slovenian: Ključni rezultati vseh štirih preskušanj so povzeti v preglednici 6.
English: This is usually given every 3 weeks up to 8 times.
Slovenian: Ta se po navadi daje na 3 tedne, do osemkrat.
English: - CI = confidence interval.
Slovenian: IZ = interval zaupanja.
English: • What to do if you think you might be getting an infection.
Slovenian: • Kaj storite, če menite, da imate morda okužbo
English: Survival Time (Months)
Slovenian: Čas preživetja (meseci)
English: Similar effects have been observed in animal studies (see section 5.3).
Slovenian: Podobne učinke so opažali v študijah na živalih (glejte poglavje 5.3).
English: Complete remission at 12 and 18 months
Slovenian: Popolna remisija po 12 in 18 mesecih
English: Proportion of patients with no erosive change
Slovenian: Delež bolnikov brez erozivnih sprememb
English: Three cases had no reported adverse event.
Slovenian: V treh primerih niso poročali o nobenem neželenem dogodku.
English: It is important that you keep this Alert Card and show it to your partner or caregiver.
Slovenian: Pomembno je, da to kartico hranite pri sebi in da jo pokažete vašemu partnerju ali skrbniku.
English: The final efficacy analysis included all patients randomised to both parts of the study.
Slovenian: Končna analiza učinkovitosti je vključevala vse bolnike, ki so bili randomizirani v oba dela študije.
English: These cases occurred in non-approved indications and the majority of patients were HIV positive.
Slovenian: Ti primeri so se pojavili pri neodobrenih indikacijah, večina bolnikov je bila HIV-pozitivna.
English: Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: This card tells you:
Slovenian: V tej kartici je opisano:
English: Two patients were re-treated twice in the study.
Slovenian: Dva bolnika sta bila v študiji dvakrat ponovno zdravljena.
English: * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Slovenian: * ob koncu vzdrževalnega zdravljenja/spremljanja; rezultati končne analize temeljijo na mediani spremljanja 73 mesecev.