FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines should now only be used for treating acute (short-term) pain in adults who cannot use other painkillers, such as non-steroidal anti-inflammatory drug (NSAIDs) and weak opioids, and treatment should not last longer than 2 weeks.
Slovenian: Ta zdravila se smejo uporabljati samo za zdravljenje akutne (kratkotrajne) bolečine pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil, kot so nesteroidna protivnetna zdravila in šibki opioidi, zdravljenje pa ne sme trajati dlje kot 2 tedna.
English: The events ranged from asymptomatic increases in liver enzymes to liver failure.
Slovenian: Dogodki so obsegali od asimptomatskega povečanja ravni jetrnih encimov do jetrne odpovedi.
English: In addition, patients' liver function should be checked after each full week of treatment and treatment should be stopped if the patient has any signs of liver problems.
Slovenian: Poleg tega je treba v času zdravljenja vsak teden preveriti delovanje bolnikovih jeter in prekiniti zdravljenje, če ima bolnik kakršne koli znake težav z jetri.
English: • Treatment must be stopped in any patient with abnormal liver function tests results or symptoms of liver disease.
Slovenian: • Zdravljenje je treba prekiniti pri vsakem bolniku z nenormalnimi izvidi preiskav jetrnega delovanja ali simptomi bolezni jeter.
English: As the CMDh position was adopted by majority it will be sent to the European Commission, which will take a legally binding position throughout the EU.
Slovenian: Ker je skupina CMDh to stališče sprejela z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in sprejela končni pravno zavezujoči sklep, veljaven v celotni EU.
English: Flupirtine must also not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Slovenian: Flupirtin se prav tako ne sme uporabljati pri bolnikih z obstoječo jetrno boleznijo ali težavami z zlorabo alkohola ali pri bolnikih, ki jemljejo druga zdravila, za katera je znano, da povzročajo težave z jetri.
English: Flupirtine works as a ‘selective neuronal-potassium-channel opener'.
Slovenian: Flupirtin deluje kot „selektivni odpiralec kalijevih kanalčkov v živčnih celicah“.
English: • Flupirtine must not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Slovenian: • Flupirtin se ne sme uporabljati pri bolnikih z obstoječo jetrno boleznijo ali težavami z zlorabo alkohola ali pri bolnikih, ki jemljejo druga zdravila, za katera je znano, da povzročajo težave z jetri.
English: • If you are being treated with flupirtine and have any questions or concerns about your treatment,
Slovenian: • Če se zdravite s flupirtinom in imate kakršna koli vprašanja ali pomisleke v zvezi z zdravljenjem, se posvetujte z zdravnikom ali farmacevtom.
English: The PRAC evaluated the available data on liver safety, noting that there were no cases of liver failure or liver transplantation reported in patients who took the medicine for 2 weeks or less.
Slovenian: Odbor PRAC je ocenil razpoložljive podatke o varnosti za jetra, pri čemer je ugotovil, da pri bolnikih, ki so zdravilo jemali 2 tedna ali manj, niso poročali o nobenem primeru jetrne odpovedi ali presaditve jeter.
English: • Oral flupirtine medicines and suppositories should only be used to treat adults with acute pain and only if treatment with other painkillers (such as NSAIDs and weak opioids) is contraindicated.
Slovenian: • Peroralna zdravila in svečke, ki vsebujejo flupirtin, se smejo uporabljati samo za zdravljenje odraslih z akutno bolečino in samo kadar so drugi analgetiki (kot so nesteroidna protivnetna zdravila in šibki opioidi) kontraindicirani.
English: • Oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as NSAIDs and weak opioids).
Slovenian: • Peroralna zdravila in svečke, ki vsebujejo flupirtin, se smejo uporabljati samo za zdravljenje akutne (kratkotrajne) bolečine pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil (kot so nesteroidna protivnetna zdravila in šibki opioidi).
English: The CMDh position will now be sent to the European Commission, which will take a legally binding decision to be valid throughout the EU.
Slovenian: Stališče skupine CMDh je bilo poslano Evropski komisiji, ki ga je potrdila in dne 5. septembra 2013 sprejela končni pravno zavezujoči sklep, ki velja za celotno EU.
English: No cases of liver failure or liver transplantation were reported in patients who took the medicine for 2 weeks or less.
Slovenian: Pri bolnikih, ki so zdravilo jemali 2 tedna ali manj, niso poročali o nobenem primeru jetrne odpovedi ali presaditve jeter.
English: Restrictions in the use of flupirtine-containing medicinesCMDh endorses PRAC recommendation
Slovenian: Omejitve pri uporabi zdravil, ki vsebujejo flupirtin
English: The European Commission issued a decision on 31 October 2013.
Slovenian: Evropska komisija je izdala sklep 31. oktobra 2013.
English: The companies that market these medicines are Novartis group of companies and associated companies.
Slovenian: Družbe, ki tržijo ta zdravila, so skupina Novartis in povezane družbe.
English: The package leaflet was amended accordingly.
Slovenian: Navodilo za uporabo je bilo ustrezno spremenjeno.
English: They are also used to treat autoimmune diseases.
Slovenian: Prav tako se uporabljata za zdravljenje avtoimunskih bolezni.
English: The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding).
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (posebna opozorila in previdnostni ukrepi), 4.5 (medsebojno delovanje z drugimi zdravili) in 4.6 (uporaba med nosečnostjo in dojenjem).
English: The CHMP agreed on specific dose ranges for the various indications, which should serve as guidelines only, and recommended that these medicines should be given in two divided doses equally distributed throughout the day.
Slovenian: CHMP se je strinjal s posebnimi razponi odmerkov za različne indikacije, ki jih je treba upoštevati zgolj kot smernice, in priporočil, naj se zdravili dajeta v dveh deljenih odmerkih, enakomerno porazdeljenih čez dan.
English: In addition, the capsules and oral solutions may also be used to treat the following autoimmune diseases:
Slovenian: Poleg tega se lahko kapsule in peroralne raztopine uporabljajo tudi za zdravljenje naslednjih avtoimunskih bolezni:
English: Both medicines are available in the EU under other trade names: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral and Sandimmune.
Slovenian: Obe zdravili sta v EU na voljo pod drugimi trgovskimi imeni: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral in Sandimmune.
English: Both medicines contain the active substance ciclosporin.
Slovenian: Obe zdravili vsebujeta zdravilno učinkovino ciklosporin.
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Slovenian: To je povzročilo razlike med državami članicami glede načina, kako se zdravili lahko uporabljata, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravili tržita.
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue.
Slovenian: Avtoimunska bolezen je bolezen, pri kateri obrambni sistem telesa napade normalna tkiva.
English: The CHMP did not recommend use in aplastic anaemia (a blood disorder in which the bone marrow doesn't make enough new blood cells), which was approved in only one Member State.
Slovenian: CHMP ni priporočil uporabe pri aplastični anemiji (bolezni krvi, pri kateri se v kostnem mozgu ne tvori dovolj novih krvnih celic), ki je bila odobrena samo v eni državi članici.
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should be used in the following indications, which were already approved in several but not all EU Member States:
Slovenian: CHMP se je strinjal, da bi se morali zdravili Sandimmun in Sandimmun Neoral uporabljati za naslednje indikacije, ki so že odobrene v več državah članicah EU, vendar ne v vseh:
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave znotraj odbora menil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo po vsej EU.
English: Sandimmun and Sandimmun Neoral are available as capsules (10, 25, 50 and 100 mg) and oral solution (100 mg/ml).
Slovenian: Zdravili Sandimmun in Sandimmun Neoral sta na voljo v obliki kapsul (10 mg, 25 mg, 50 mg in 100 mg) in peroralne raztopine (100 mg/ml).
English: Sandimmun and Sandimmun Neoral are authorised in the EU via national procedures.
Slovenian: Zdravili Sandimmun in Sandimmun Neoral sta bili v EU odobreni po nacionalnih postopkih.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o predpisovanju zdravil Sandimmun in Sandimmun Neoral v Evropski uniji (EU).
English: Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences).
Slovenian: Sandimmun in Sandimmun Neoral sta imunosupresivni zdravili (zdravili, ki zmanjšata aktivnost imunskega sistema, tj. naravnega obrambnega sistema telesa).
English: • Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
Slovenian: • endogenega uveitisa (vnetja žilnice, tj. srednje plasti očesa);
English: Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graftversus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Slovenian: Zdravili Sandimmun in Sandimmun Neoral se uporabljata pri bolnikih po presaditvi za preprečevanje zavrnitve (ko imunski sistem napade presajeni organ) in za zdravljenje ali preprečevanje reakcije presadka proti gostitelju (ko imunski sistem presajenega organa napade tkiva bolnika).
English: Information on how to switch between different ciclosporin medicines was also included in the product information of these medicines.
Slovenian: V informacije o zdravilu za ti dve zdravili so bile vključene tudi informacije v zvezi s prehodom med različnimi zdravili, ki vsebujejo ciklosporin.
English: On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral.
Slovenian: Evropska agencija za zdravila je 27. junija 2013 zaključila pregled zdravil Sandimmun in Sandimmun Neoral.
English: • Nephrotic syndrome (a kidney disease);
Slovenian: • nefrotskega sindroma (ledvične bolezni);
English: • Solid organ transplantation (for the prevention and treatment of graft rejection);
Slovenian: • presaditev parenhimskih organov (za preprečevanje in zdravljenje zavrnitve presadka);
English: The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in autoimmune diseases, normal tissue.
Slovenian: Zdravilna učinkovina v zdravilih Sandimmun in Sandimmun Neoral, ciklosporin, deluje na nekatere posebne celice imunskega sistema, imenovane T-celice, ki so odgovorne za napadanje presajenih organov oziroma normalnega tkiva pri avtoimunskih boleznih.
English: Why were Sandimmun and Sandimmun Neoral reviewed?
Slovenian: Zakaj sta bili zdravili Sandimmun in Sandimmun Neoral pregledani?
English: Sandimmun is also available as a concentrate for solution for infusion (50
Slovenian: Zdravilo Sandimmun je na voljo tudi v obliki koncentrata za raztopino za infundiranje (50 mg/ml).
English: However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.
Slovenian: Razlika je, da je zdravilo Sandimmun pripravek ciklosporina na oljni osnovi, zdravilo Sandimmun Neoral pa je pripravek v obliki mikroemulzije, ki omogoča enakomernejšo absorpcijo ciklosporina v telesu.
English: What are Sandimmun and Sandimmun Neoral?
Slovenian: Kaj sta zdravili Sandimmun in Sandimmun Neoral?
English: • Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).
Slovenian: • presaditev kostnega mozga (za preprečevanje zavrnitve presadka in preprečevanje ali zdravljenje reakcije presadka proti gostitelju).
English: • Severe psoriasis (a disease causing red, scaly patches on the skin);
Slovenian: • hude psoriaze (bolezni, ki povzroča rdeče luskaste zaplate na koži);
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should not be used in patients who are hypersensitive (allergic) to the active substance.
Slovenian: CHMP se je strinjal, da se zdravili Sandimmun in Sandimmun Neoral ne smeta uporabljati pri bolnikih, ki so preobčutljivi za zdravilno učinkovino ali alergični nanjo.
English: • Severe atopic dermatitis (eczema, an itchy red rash of the skin).
Slovenian: • hudega atopijskega dermatitisa (ekcema, tj. srbečega rdečega izpuščaja na koži).
English: Sandimmun and Sandimmun Neoral should only be prescribed by, or in close collaboration with, a doctor experienced in the diseases that these medicines are used to treat.
Slovenian: Zdravili Sandimmun in Sandimmun Neoral lahko predpiše samo zdravnik, ki ima izkušnje z boleznimi, za zdravljenje katerih se uporabljata ti zdravili, oziroma se lahko predpišeta v tesnem sodelovanju z njim.
English: • Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
Slovenian: • hudega revmatoidnega artritisa (bolezni, ki povzroča okvaro in vnetje sklepov);
English: They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).
Slovenian: Prav tako se ne smeta uporabljati v kombinaciji z zdravilom rastlinskega izvora, imenovanim šentjanževka (uporablja se za zdravljenje depresije), in z zdravili, katerih koncentracije v krvi bi se lahko zaradi ciklosporina zvišale in povzročile resne neželene učinke.
English: On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdraviloma Sandimmun in Sandimmun Neoral v EU je Evropska komisija dne 15. decembra 2011 napotila zadevo na odbor CHMP.
English: Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravili Sandimmun in Sandimmun Neoral potrebno usklajevanje.
English: As the medicine is no longer authorised in the EU no further action will be taken by the European Commission.
Slovenian: Ker zdravilo v EU ni več odobreno, Evropska komisija ne bo več nadalje ukrepala.
English: 18 March 2018 EMA/286850/2018
Slovenian: 18. marec 2018 EMA/286850/2018
English: Zinbryta is no longer available in hospitals and pharmacies in the EU.
Slovenian: Zdravilo Zinbryta ni več na voljo v bolnišnicah in lekarnah v EU.
English: The PRAC report will be sent to EMA's Committee for Medicinal Products for Human Use (CHMP).
Slovenian: Poročilo odbora PRAC bo poslano Odboru za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA.
English: Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Slovenian: Zinbryta je zdravilo, ki je bilo odobreno leta 2016 za zdravljenje recidivnih oblik multiple skleroze.
English: Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
Slovenian: Zdravilo za multiplo sklerozo ni več odobreno in je bilo odpoklicano iz bolnišnic in lekarn
English: Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.
Slovenian: Zdravstveni delavci morajo še naprej spremljati bolnike, ki so se zdravili z zdravilom Zinbryta, v skladu s priporočili, izdanimi marca 2018.
English: Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected.
Slovenian: Bolniki so lahko ogroženi od začetka zdravljenja in še več mesecev po njegovi prekinitvi.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji EMA je potrdil, da zdravilo za multiplo sklerozo Zinbryta (daklizumab beta) pomeni tveganje za hude in potencialno smrtno nevarne imunske reakcije, ki prizadenejo možgane, jetra in druge organe.
English: To date over 10,000 patients have been treated with Zinbryta worldwide.
Slovenian: Do zdaj se je po svetu z njim zdravilo več kot 10 000 bolnikov.
English: There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.
Slovenian: Neposrednih posledic pregleda PRAC ni, saj zdravilo Zinbryta v EU ni več odobreno.
English: The PRAC has now concluded its review of the available evidence on Zinbryta.
Slovenian: Odbor PRAC je zdaj zaključil pregled razpoložljivih dokazov o zdravilu Zinbryta.
English: The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Slovenian: Evropska komisija je 8. marca 2018 izdala pravno zavezujoč sklep za začasni preklic dovoljenja za promet z zdravilom.
English: The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Slovenian: Odbor PRAC je zato potrdil svoje predhodne zaključke, da so tveganja zdravila Zinbryta pri bolnikih z multiplo sklerozo večja od njegovih koristi.
English: EMA review of Zinbryta confirms medicine's risks outweigh its benefits
Slovenian: Pregled zdravila Zinbryta, ki ga je opravila agencija EMA, potrjuje, da so tveganja zdravila večja od njegovih koristi
English: On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Slovenian: Evropska komisija je 27. marca 2018 na zahtevo imetnika dovoljenja za promet z zdravilom, družbe Biogen Idec Ltd, umaknila dovoljenje za promet z zdravilom.
English: On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji EMA je 6. marca 2018, v času pregleda, priporočil začasni preklic dovoljenja za promet z zdravilom Zinbryta in odpoklic zdravila.
English: On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Slovenian: Na zahtevo družbe Biogen Idec Ltd, ki je tržilo zdravilo, je bilo 27. marca 2018 dovoljenje za promet z zdravilom umaknjeno.
English: 0.5 mL (0.5 mg/mL) 5 pre-filled syringes
Slovenian: 0,5 ml (0,5 mg/ml) 5 napolnjenih injekcijskih brizg
English: 0.5 mL (0.5 mg/mL) 1 pre-filled syringe
Slovenian: 0,5 ml (0,5 mg/ml) 1 napolnjena injekcijska brizga
English: This summary was last updated in 03-2011.
Slovenian: Povzetek je bil nazadnje posodobljen 03-2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Valtropin, veljavno po vsej Evropski uniji, odobrila družbi BioPartners GmbH dne 24. aprila 2006.
English: The full EPAR for Valtropin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Valtropin je na voljo na spletni strani Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The study lasted 12 months, and measured the children's height at the beginning and the end of the study, and the speed of growth during the study.
Slovenian: V raziskavi, ki je trajala 12 mesecev, so merili višino otrok na začetku in koncu raziskave ter hitrost rasti med raziskavo.
English: After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Slovenian: Po 12 mesecih je zdravljenje z zdravilom Valtropin in zdravilom Humatrope izkazalo podobna povečanja telesne višine in hitrosti rasti (hitrost +11,4 oziroma +10,5 cm na leto).
English: This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
Slovenian: To pomeni, da je zdravilo Valtropin podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je v Evropski uniji (EU) že odobreno, in da zdravilo Valtropin in referenčno zdravilo vsebujeta enako zdravilno učinkovino.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Valtropin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Valtropin.
English: This is a summary of the European public assessment report (EPAR) for Valtropin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Valtropin.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Slovenian: Proizvaja se po metodi, imenovani “tehnologija rekombinantne DNK”: hormon tvori kvasovka, ki je prejela gen (DNK), ki ji omogoča tvorbo somatropina.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Slovenian: Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori , ki je na voljo tukaj.
English: Valtropin was compared with Humatrope in 149 children with a lack of growth hormone and who had not been treated before.
Slovenian: Valtropin so primerjali z zdravilom Humatrope pri 149 otrocih s pomanjkanjem rastnega hormona, ki predhodno še niso bili zdravljeni.