FrancophonIA/ELRC3.0 huggingface dataset:
English: Pimecrolimus had no genotoxic, antigenic, phototoxic, photoallergenic or photocarcinogenic potential.
Slovenian: Pimekrolimus nima genotoksičnega, antigenskega, fototoksičnega, fotoalergenskega in fotokancerogenega potenciala.
English: Please consult your doctor.
Slovenian: O tem se posvetujte s svojim zdravnikom.
English: The efficacy and safety profile of <Invented Name> has been evaluated in more than 2,000 patients including infants (≥3 months), children, adolescents, and adults enrolled in phase II and III studies.
Slovenian: Profil učinkovitosti in varnosti {Lastniško ime} je bil ocenjen na več kot 2000 bolnikih, tudi dojenčkih (≥3 mesece), otrocih, mladostnikih in odraslih, vključenih v raziskave druge in tretje faze.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing topical pimecrolimus.
Slovenian: Ker je Odbor obravnaval napotitev s skladu s členom 31 Direktive 2001/83/ES, s spremembami, za zdravila, ki vsebujejo lokalni pimekrolimus.
English: Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The affected body surface area (BSA) ranged from 15-59%.
Slovenian: Telesna površina (BSA) je bila 15-59%.
English: The use of <Invented Name> in patients under 2 years of age is not recommended until further data become available.
Slovenian: Uporaba {Lastniško ime} pri bolnikih, mlajših od 2 let, ni priporočljiva, dokler ne bodo na voljo nadaljnji podatki.
English: The maximum body surface area treated was 92% in clinical pharmacology studies and up to 100% in Phase III trials.
Slovenian: Največja zdravljena telesna površina je bila 92% v kliničnofarmakoloških raziskavah in do 100% v preizkusih III faze.
English: Absorption in adults
Slovenian: Absorpcija pri odraslih
English: Over 1,500 of these patients were treated with <Invented Name> and over 500 were treated with control treatment i.e. either <Invented Name> vehicle and/or topical corticosteroids.
Slovenian: Več kot 1500 teh bolnikov je bilo zdravljenih z {Lastniško ime} in več kot 500 jih je bilo tretiranih s kontrolnim zdravljenjem, tj. z vehiklom {Lastniško ime} in/ali z lokalnimi kortikosteroidi.
English: Pimecrolimus blood concentrations were consistently low regardless of the extent of lesions treated or duration of therapy.
Slovenian: Koncentracije pimekrolimusa v krvi so bile stalno nizke, ne glede na obseg zdravljenih lezij ali trajanje zdravljenja.
English: Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
Slovenian: Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison Francija
English: If you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: If you have erythroderma (redness of almost the entire body) or a skin condition called Netherton's syndrome, speak to your doctor before you start using <Invented Name> .
Slovenian: Če imate eritrodermijo (rdečo kožo po skoraj celem telesu) ali kožno bolezen, ki se imenuje Nethertonov sindrom, se posvetujte z zdravnikom preden začnete uporabljati <Lastniško ime>.
English: Clinical studies with <Invented Name> did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.
Slovenian: Klinične raziskave z {Lastniško ime} niso zajele dovolj bolnikov iz te starostne skupine, da bi bilo lahko ugotovljeno, ali se odzivajo drugače od mlajših bolnikov.
English: The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with <Invented Name> and 16% of patients in the control groups.
Slovenian: Najpogostejši neželeni učinki so reakcije na mestu uporabe, o katerih je bilo poročano pri približno 19% bolnikov, zdravljenih z {Lastniško ime}, in pri 16% bolnikov v kontrolni skupini.
English: The diagnosis of atopic dermatitis should be re-evaluated and further therapeutic options considered.
Slovenian: Diagnozo atopijskega dermatitisa je treba ponovno pretehtati in razmisliti o nadaljnjih možnostih zdravljenja.
English: The CHMP also expressed concerns about the degree of use of topical pimecrolimus in children under the age of 2 (not approved) when the immune system is still developing.
Slovenian: CHMP je tudi izrazil zaskrbljenost glede razširjenosti lokalne uporabe pimekrolimusa pri otrocih, starih manj kot dve leti (uporaba ni odobrena), ko se imunski sistem še vedno razvija.
English: Note: This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 31 referral for pimecrolimus containing medicinal products.
Slovenian: Opomba: Ta Dodatek III (Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo) je bil priložen k odločbi Komisije o napotitvenem postopku iz člena 31 za zdravila, ki vsebujejo pimekrolimus.
English: Active substance-related radioactivity was excreted principally via the faeces (78.4%) and only a small fraction (2.5%) was recovered in urine.
Slovenian: Z učinkovino povezana radioaktivnost se je izločala predvsem z blatom (78,4%) in le majhen delež (2,5%) je bil prestrežen v urinu.
English: Novartis (Hellas) AEBE 12km Athens-Lamia Metamorfosi GR-14451 Athens Greece
Slovenian: Novartis (Hellas) AEBE 12km Athens-Lamia Metamorfosi GR-14451 Athens Grčija
English: AUC ranges observed in patients with <40% BSA affected at baseline were comparable to those in patients with ≥40% BSA.
Slovenian: Razponi AUC pri bolnikih, ki so imeli v izhodišču prizadete <40% BSA, so bili primerljivi s tistimi pri bolnikih z ≥40% BSA.
English: The CHMP also considered the available data from clinical trials and epidemiological studies.
Slovenian: CHMP je preučil tudi razpoložljive podatke kliničnih preskušanj in epidemioloških študij.
English: Following this request, the CHMP reviewed data on efficacy and the available data on the mentioned safety issue, including post-marketing reports, data from non-clinical studies, clinical trials and epidemiological studies.
Slovenian: Na podlagi te prošnje je CHMP pregledal podatke o učinkovitosti in razpoložljive podatke, ki se nanašajo na omenjeno vprašanje varnosti, vključno s postmarketinškimi poročili, podatki iz nekliničnih raziskav, kliničnih preskušanj in epidemioloških študij.
English: In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of pimecrolimus cannot be ruled out and therefore further data are needed to ensure an acceptable long term safety profile.
Slovenian: Glede na razpoložljive podatke (vključno s predkliničnimi, kliničnimi in epidemiološkimi), je CHMP zaključil, da potencialne povezave med temi obolenji in uporabo pimekrolimusa ni mogoče izključiti in da so torej potrebni dodatni podatki, ki bi zagotovili sprejemljiv varnostni profil pri dolgotrajni uporabi zdravila.
English: On the view of these results, the necessity for further studies should be rediscussed with the RMS.
Slovenian: Glede na dobljene rezultate se je treba o potrebi po dodatnih študijah ponovno pogovoriti z referenčno državo članico.
English: The efficacy of <Invented Name> was maintained over time.
Slovenian: Učinkovitost {Lastniško ime} se je s časom ohranjala.
English: Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown.
Slovenian: Dolgoročni učinek na lokalni kožni imunski odziv in na pogostnost kožnih malignih bolezni ni znan.
English: Infants: A similar 6-week study was conducted in 186 patients aged 3-23 months.
Slovenian: Dojenčki: Podobna šesttedenska raziskava je bila narejena na 186 bolnikih, starih 3-23 mesecev.
English: Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal development.
Slovenian: Študije na živalih z uporabo na koži ne kažejo na neposredne ali posredne škodljive vplive na razvoj zarodka/plodu.
English: Data from clinical studies support intermittent treatment with <Invented Name> for up to 12 months.
Slovenian: Podatki iz kliničnih študij podpirajo intermitentno zdravljenje z {Lastniško ime}do 12 mesecev.
English: If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated.
Slovenian: Če je lokalna reakcija zdravila resna, je treba oceniti razmerje med tveganjem in koristnostjo zdravljenja.
English: There are no adequate data from the use of <Invented Name> in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi {Lastniško ime} pri nosečnicah.
English: Vehicle (N=63)
Slovenian: Vehikel (N=63)
English: Systemic exposure to pimecrolimus was investigated in 58 paediatric patients aged 3 months to 14 years.
Slovenian: Sistemska izpostavljenost pimekrolimusu je bila raziskana pri 58 pediatričnih bolnikih, starih od 3 mesecev do 14 let.
English: Dermal application in embryo/fetal developmental studies in rats and rabbits and in carcinogenicity studies in mice and rats were negative.
Slovenian: Rezultati uporabe na koži v razvojnih raziskavah zarodkov in plodov pri podganah in kuncih in v raziskavah kancerogenosti pri miših in podganah so bili negativni.
English: If no improvement occurs after 6 weeks, or in case of disease exacerbation, <Invented Name> should be stopped.
Slovenian: Če v 6 tednih ne nastopi izboljšanje ali če bolezen eksacerbira, je treba {Lastniško ime} ukiniti.
English: very common: application site burning.
Slovenian: Zelo pogost: pečenje na mestu uporabe.
English: Absorption in children
Slovenian: Absorpcija pri otrocih
English: Vehicle (N=136)
Slovenian: Vehikel (N=136)
English: Children and adolescents: Two 6-week, vehicle-controlled trials were conducted including a total of 403 paediatric patients aged 2 to 17 years.
Slovenian: Otroci in mladostniki: Narejeni sta bili dve šesttedenski, z vehiklom kontrolirani raziskavi, ki sta zajeli 403 pediatričnih bolnikov, starih od 2 do 17 let.
English: The most common side effects of <Invented Name> are reactions (e.g. discomfort) at the application site.
Slovenian: Najbolj pogosti neželeni učinki <Lastniško ime> so reakcije (npr. neprijeten občutek) na mestu uporabe.
English: <Invented Name> should not be applied under occlusion (see Section 4.4 “Special warnings and precautions for use”).
Slovenian: {Lastniško ime} se ne sme uporabljati pod okluzivnim zavojem (glejte poglavje 4.4 “Posebna opozorila in previdnostni ukrepi”).
English: These reactions are usually mild and last only for a short time.
Slovenian: Te reakcije so običajno blage in trajajo le kratek čas.
English: Tell your doctor before starting treatment with <Invented Name> if you are pregnant or think that you may be pregnant.
Slovenian: Preden začnete zdravljenje z <Lastniško ime>, povejte zdravniku, če ste noseči ali menite, da bi lahko bili.
English: As the safety of <Invented Name> has not been established in erythrodermic patients, the use of the product in this patient population cannot be recommended.
Slovenian: Ker varnost {Lastniško ime} pri bolnikih z eritrodermijo ni bila dokazana, uporabe zdravila v tej skupini bolnikov ne moremo priporočati.
English: Signs of recovery and/or at least partial reversibility of the effects were noted upon cessation of dosages in a few animals.
Slovenian: Pri nekaterih živalih so opazili znake okrevanja in/ali vsaj delne reverzibilnosti učinkov po prenehanju dajanja zdravila.
English: Topical corticosteroid medication was used on 14.2 ± 24.2% of the days of the 24-week treatment period in <Invented Name> group and on 37.2 ± 34.6% of the days in the control group (p<0.001).
Slovenian: V skupini z {Lastniško ime} je bilo uporabljeno lokalno kortikosteroidno zdravljenje na 14,2 ± 24,2% dni 24-tedenskega zdravljenja, v kontrolni skupini pa na 37,2 ± 34,6% dni (p<0,001).
English: A 6-month randomized, double-blind, parallel group, vehicle-controlled study of similar design was performed in 192 adults with moderate to severe atopic dermatitis.
Slovenian: Podobno zasnovana 6-mesečna randomizirana, dvojno slepa, z vehiklom kontrolirana raziskava na paralelni skupini je bila opravljena na 192 odraslih z zmernim do težkim atopijskim dermatitisom.
English: The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%.
Slovenian: Biološka uporabnost pimekrolimusa pri prašičkih po enem kožnem odmerku (danem za 22 ur pod semi-okluzijo) je bila 0,03%.
English: 3: p-value based on ANCOVA model of EASI at Day 43 endpoint, with centre and treatment as factors and baseline (Day 1) EASI a covariate;
Slovenian: 3: Vrednost p temelji na modelu ANCOVA EASI(-ja) glede na končno stanje na 43. dan, pri čemer sta center in zdravljenje faktorja, izhodiščni EASI (na 1. dan) pa kovariabla.
English: If your skin is infected, your doctor may ask you to use an appropriate medicine to treat the infection.
Slovenian: Če imate na koži okužbo, vam bo zdravnik svetoval ustrezno zdravilo za zdravljenje okužbe.
English: You may find it helpful to write the date you opened the tube in the space provided on the carton.
Slovenian: Morda vam bo prišlo prav, če boste datum prve uporabe zapisali na za to predviden prostor na škatli.
English: The DSMB will be composed of independent physicians with expertise in Dermatology, Pediatric Medicine, Immunology, Epidemiology and Oncology.
Slovenian: Odbor za spremljanje podatkov o varnosti bodo sestavljali neodvisni zdravniki s specializacijo iz dermatologije, pediatrije, imunologije, epidemiologije in onkologije.
English: These children were treated with <Invented Name> twice daily for 3 weeks and five out of them were treated for up to 1 year on a “as needed” basis.
Slovenian: Večina otrok je bila zdravljena z {Lastniško ime} dvakrat na dan 3 tedne, pet otrok pa po načelu “po potrebi” do 1 leta.
English: Surrey GUI6 7SR, United Kingdom
Slovenian: Surrey GUI6 7SR, Velika Britanija
English: Potential interactions between <Invented Name> and other medicinal products have not been systematically evaluated.
Slovenian: Možno medsebojno delovanje med {Lastniško ime} in drugimi zdravili ni sistematično proučeno.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains 10 mg of pimecrolimus.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g kreme vsebuje 10 mg pimekrolimusa.
English: The CHMP agreed that these skin malignancies may mimic AD and that their diagnosis can be difficult.
Slovenian: CHMP se je strinjal s tem, da lahko tovrstna maligna kožna obolenja posnemajo atopični dermatitis in da je njihovo diagnosticiranje težavno.
English: The duration of the exposure to pimecrolimus cream until the diagnosis of malignancy was also different in all cases, and it was not possible to detect any specific trend.
Slovenian: Tudi trajanje izpostavljenosti kremi s pimekrolimusom do postavitve diagnoze malignega obolenja je bilo od primera do primera različno, razen tega ni bilo mogoče ugotoviti nobenega specifičnega trenda.
English: Non-clinical pharmacology
Slovenian: Neklinična farmakologija
English: <Invented Name> cream is for external use only.
Slovenian: Krema <Lastniško ime> je namenjen samo za zunanjo uporabo.
English: If you are using <Invented Name> , do not cover the treated skin with bandages, dressings or wraps.
Slovenian: Če uporabljate <Lastniško ime>, ne pokrivajte kože z obvezami ali s povoji.
English: 2Improvement=lower IGA than at baseline
Slovenian: 2Izboljšanje=manjši IGA od izhodiščnega.
English: • A statement reflecting the cases of malignancies reported in the post-marketing
Slovenian: Navedba, ki podaja primere malignih obolenj, zabeleženih v postmarketinškem obdobju.
English: The MAHs should provide to the Reference Member State (RMS), as part of the Risk Management Plan, the final copies of the educational materials for the prescribers and patients prior to distribution.
Slovenian: Kot del načrta za obvladovanje tveganj morajo imetniki dovoljenja za promet z zdravilom referenčni državi članici (RMS) pred začetkom distribucije dostaviti končne izvode izobraževalnih materialov za predpisovalce zdravila in bolnike.
English: The present data indicate that <Invented Name> can be used simultaneously with antibiotics, antihistamines and corticosteroids (oral/nasal/inhaled).
Slovenian: Trenutno dostopni podatki kažejo, da se lahko {Lastniško ime} uporablja sočasno z antibiotiki, antihistaminiki in kortikosteroidi (peroralnimi/nazalnimi/za inhalacijo).
English: Physicians should advise patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing (see Section 4.5 “Interaction with other medicinal products and other forms of interaction”).
Slovenian: Zdravniki morajo bolnikom svetovati glede ustrezne zaščite pred soncem, kot so npr. čim krajši čas sončenja, uporaba kreme za sončenje z ustreznim zaščitnim faktorjem in zaščita kože s primerno obleko (glejte poglavje 4.5 “Medsebojno delovanje z drugimi zdravili in druge oblike interakcij”).
English: Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients.
Slovenian: Preobčutljivost za pimekrolimus, druge makrolaktame ali katerokoli pomožno snov.
English: DATE OF REVISION OF THE TEXT <<Date of revision>>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA {Datum zadnje revizije}
English: The amount of active substance-related material in the skin at the application site (almost exclusively unchanged pimecrolimus) remained practically constant for 10 days.
Slovenian: Količina učinkovine in sorodnih snovi, povezanih z zdravilom, v koži na mestu uporabe (praktično samo nespremenjen pimekrolimus) je v časovnem intervalu 10 dni ostala praktično konstantna.
English: Surrey GU16 7SR, UK
Slovenian: Surrey GU16 7SR, Velika Britanija
English: Treatment should be intermittent, short-term and not continuous.
Slovenian: Zdravljenje naj bo intermitentno, kratkotrajno in ne neprekinjeno.
English: The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of pimecrolimus cream is unknown.
Slovenian: Tveganja za človeka ni mogogče popolnoma izključiti, ker ni znano, kakšna je možnost lokalne imunosupresije ob dolgotrajni uporabi pimekrolimusa.
English: Animal studies on milk excretion after topical application were not conducted and the use of <Invented Name> in breastfeeding women has not been studied.
Slovenian: Študije na živalih o izločanju v mleko po lokalni uporabi niso bile izvedene in uporabe {Lastniško ime} pri doječih materah niso preučevali.
English: Both studies showed a significant reduction in the incidence of flares (p<0.001) in favour of <Invented Name> treatment; <Invented Name> treatment showed better efficacy in all secondary assessments (Eczema Area Severity Index, Investigators Global Assessment, subject assessment); pruritus was controlled within a week with <Invented Name>.
Slovenian: Obe raziskavi sta pokazali statistično signifikantno zmanjšanje pogostnosti izbruhov (p<0,001) v korist zdravljenja z {Lastniško ime}; zdravljenje z {Lastniško ime} je pokazalo boljšo učinkovitost pri vseh sekundarnih ocenjevanjih (indeks prizadetosti ekcemskega predela, globalna ocena raziskovalcev, ocena s strani bolnika); {Lastniško ime} je obvladal pruritus znotraj enega tedna.
English: Based on the minimal extent of absorption, a potential systemic interaction with vaccination is unlikely to occur.
Slovenian: Zaradi minimalnega obsega absorpcije ni verjetno, da bi prišlo do morebitnega sistemskega medsebojnega delovanja s cepljenjem, čeprav to medsebojno delovanje ni raziskano.
English: Via Umberto Boccioni, 1 21040 Origgio, Varese Italy
Slovenian: Via Umberto Boccioni, 1 21040 Origgio, Varese Italija
English: A total of 50.0% of the patients treated with <Invented Name> did not experience any flare compared with 24.0% of the patients randomized to the control group.
Slovenian: Vsega skupaj 50,0% bolnikov, zdravljenih z {Lastniško ime}, ni imelo nobenega izbruha, od bolnikov, randomiziranih v kontrolno skupino, pa ni imelo nobenega izbruha 24,0%.
English: Denmark requested the CHMP to give its opinion on the benefit/risk profile of pimecrolimus considering efficacy and safety concerns with regards to the potential risk of cancer.
Slovenian: Danska je Odbor za zdravila za uporabo v humani medicini (CHMP) zaprosila, naj poda mnenje o razmerju med koristmi in tveganji učinkovine pimekrolimus, kar zadeva učinkovitost in varnost z ozirom na potencialno tveganje za nastanek rakavega obolenja.
English: Populations with potentially higher risk of systemic exposure.
Slovenian: Skupine bolnikov z možnostjo večjega tveganja za sistemsko izpostavljenost
English: Systemic exposure to pimecrolimus was investigated in 12 adults with atopic dermatitis who were treated with <Invented Name> twice daily for 3 weeks.
Slovenian: Sistemska izpostavljenost pimekrolimusu je bila raziskana pri 12 odraslih bolnikih z atopijskim dermatitisom, zdravljenih z {Lastniško ime} dvakrat na dan 3 tedne.
English: The MAHs should implement a comprehensive non-promotional communication plan designed to reach both prescribers and patients in order to highlight the correct use of pimecrolimus according to the approved indication; to provide guidance when to start and to stop and how to administer the cream in relation to the disease extent; and further to discourage off-label use (with regard to age groups and non-approved high risk groups).
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo poskrbeti za izčrpen nepromocijski načrt sporočanja, ki je zasnovan tako, da doseže tako tiste, ki zdravilo predpisujejo, kot tudi bolnike, da bi na ta način zagotovili pravilno uporabo pimekrolimusa, skladno z odobrenimi indikacijami; da bi zagotovili smernice glede tega, kdaj z uporabo kreme začeti in kdaj končati in kako jo, z ozirom na obseg obolenja, nanašati; in da bi poleg tega skušali preprečiti uporabo zdravila, ki v indikacijah ni navedena (z ozirom na starostne skupine in skupine z velikim tveganjem, pri katerih uporaba ni odobrena).
English: In view of the available data so far, the CHMP concluded that the long term safety of pimecrolimus needs to be further established.
Slovenian: Glede na doslej razpoložljive podatke je CHMP zaključil, da je treba dolgotrajno varnost uporabe pimekrolimusa še natančneje raziskati.
English: <Invented Name> contains cetyl alcohol and stearyl alcohol which may cause local skin reactions.
Slovenian: {Lastniško ime} vsebuje cetilalkohol in stearilalkohol, ki lahko povzročata lokalne kožne reakcije.
English: This may include:
Slovenian: Navodilo vsebuje:
English: However, patients with atopic dermatitis treated with <Invented Name> have not been found to have significant systemic pimecrolimus levels.
Slovenian: Vendar pa pri bolnikih z atopijskim dermatitisom, ki so se zdravili z {Lastniško ime}, niso odkrili pomembnih sistemskih koncentracij pimekrolimusa.
English: Storing <Invented Name> cream Further information
Slovenian: Shranjevanje kreme <Lastniško ime> Dodatne informacije
English: After single oral administration of radiolabeled pimecrolimus in healthy subjects, unchanged pimecrolimus was the major active substance-related component in blood and there were numerous minor metabolites of moderate polarity that appeared to be products of O-demethylations and oxygenation.
Slovenian: Po eni sami peroralni aplikaciji radioaktivno označenega pimekrolimusa zdravim osebam je bil nespremenjeni pimekrolimus poglavitna z učinkovino povezana sestavina v krvi, bili pa so še številni manj pomembni presnovki zmerne polarnosti, za katere se je izkazalo, da so produkti O-demetilacij in oksigenacije.
English: There is no clinical data beyond 1 year of treatment.
Slovenian: O zdravljenju, ki bi trajalo dlje kot 1 leto, ni nobenih kliničnih podatkov.