FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Cholib 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 Cholib je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Cholib
Slovenian: Druge informacije o zdravilu Cholib
English: The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Slovenian: Prav tako je odbor upošteval, da se kombinacija fenofibrata in simvastatina že uporablja v klinični praksi.
English: This is a summary of the European public assessment report (EPAR) for Cholib.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cholib.
English: A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Cholib je bil pripravljen načrt obvladovanja tveganj.
English: Fenofibrate is a ‘PPARα agonist'.
Slovenian: Fenofibrat je „agonist receptorja PPARα“.
English: Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Slovenian: Izdaja zdravila Cholib je le na recept, na voljo pa je v obliki tablet (145/20 mg in 145/40 mg).
English: The Committee therefore concluded that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: CHMP je zato zaključil, da so koristi zdravila Cholib večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Cholib?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
English: What are the risks associated with Cholib?
Slovenian: Kakšna tveganja so povezana z zdravilom Cholib?
English: What benefits of Cholib have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cholib izkazalo v študijah?
English: What is Cholib and what is it used for?
Slovenian: Kaj je zdravilo Cholib in za kaj se uporablja?
English: With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
Slovenian: Kar se tiče varnosti zdravila Cholib, so bili neželeni učinki, o katerih so poročali v študijah, skladni s tem, kar je že znano o obeh zdravilnih učinkovinah, zato ni bilo nobenih večjih zadržkov.
English: It is not intended to provide practical advice on how to use Cholib.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Slovenian: Prav tako ga ne smejo uporabljati ženske, ki so noseče ali dojijo, osebe z znano dovzetnostjo za s svetlobo povzročene reakcije na fibrate ali ketoprofen, osebe z boleznijo jeter ali žolčnika, pankreatitisom ali zmerno ali hudo okvaro delovanja ledvic, in osebe, ki so v preteklosti med jemanjem statinov ali fibratov imele težave z mišicami.
English: This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
Slovenian: To pomeni, da aktivira vrsto receptorja, imenovanega „s peroksisomskim proliferatorjem aktiviran receptor tipa alfa“ (PPARα), ki sodeluje pri razgradnji maščob iz hrane, še zlasti trigliceridov.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Cholib vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Slovenian: Pred začetkom zdravljenja z zdravilom Cholib je treba možne vzroke za nenormalne ravni maščob v krvi že ustrezno zdraviti in pri bolnikih uvesti standardno dieto za zniževanje ravni maščob.
English: Why is Cholib approved?
Slovenian: Zakaj je bilo zdravilo Cholib odobreno?
English: In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
Slovenian: V glavni študiji, v kateri so zdravilo Cholib 145/20 mg primerjali s simvastatinom 40 mg pri 1 050 bolnikih, pri katerih monoterapija z 20 mg simvastatina ni bila dovolj učinkovita, je po 12 tednih zdravilo Cholib znižalo ravni trigliceridov za približno 36 %, simvastatin pa za 12 %.
English: Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Slovenian: Zdravila Cholib ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) arašide, sojin lecitin ali katero koli drugo sestavino zdravila.
English: The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Slovenian: Holesterol, ki se na tak način odstrani iz krvi, je „slabi“ holesterol.
English: The second active substance, simvastatin, belongs to the group called ‘statins'.
Slovenian: Druga zdravilna učinkovina, simvastatin, spada v skupino zdravil, ki jih imenujemo „statini“.
English: For more information about treatment with Cholib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cholib preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Slovenian: Ker jetra potrebujejo holesterol za proizvajanje žolča, nižja raven holesterola v krvi povzroči, da jetrne celice začnejo proizvajati receptorje, ki črpajo holesterol iz krvi in tako še bolj znižajo njegovo raven.
English: It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Slovenian: Rezultati so pokazali, da je zdravilo Cholib v večji meri znižalo ravni trigliceridov (za 33 % v primerjavi s 7 %) in zvišalo ravni dobrega holesterola (zvišanje za 6 % v primerjavi z znižanjem za 1 %).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo dokazano, da kombinacija fenofibrata in simvastatina učinkovito zniža ravni maščob v krvi.
English: For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cholib naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Slovenian: Zdravilni učinkovini v zdravilu Cholib, fenofibrat in simvastatin, delujeta na različna načina, njuni učinki pa se med seboj dopolnjujejo.
English: Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad' cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Slovenian: Zdravilo Cholib je namenjeno uporabi pri odraslih z velikim tveganjem za bolezni srca, pri katerih so ravni „slabega“ holesterola (holesterola LDL) že obvladane z ustreznim odmerkom samega simvastatina.
English: Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
Slovenian: V nadaljnjih dveh študijah so zdravilo Cholib primerjali z drugimi statini (atorvastatinom in pravastatinom) in ugotovili, da je bilo zdravilo Cholib učinkovitejše od samih statinov.
English: In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Slovenian: Poleg tega je zdravilo Cholib zvišalo ravni dobrega holesterola za približno 7 %, simvastatin pa za približno 2 %.
English: Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
Slovenian: V drugi študiji so primerjali zdravilo Cholib 145/40 mg in simvastatin 40 mg pri 450 bolnikih, pri katerih monoterapija s 40 mg simvastatina ni bila dovolj učinkovita.
English: When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad' cholesterol and triglycerides.
Slovenian: Aktiviranje teh receptorjev pospeši razgradnjo maščob, kar pomaga pri odstranjevanju „slabega“ holesterola in trigliceridov iz krvi.
English: It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
Slovenian: Vsebuje dve zdravilni učinkovini, fenofibrat in simvastatin, ter se uporablja v kombinaciji s prehrano z majhnim vnosom maščob in telesno vadbo za zniževanje ravni trigliceridov (vrsta maščobe) ter zviševanje ravni „dobrega“ holesterola (holesterola HDL) pri bolnikih.
English: The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Slovenian: Najpogostejši neželeni učinki zdravila Cholib so zvišane ravni kreatinina v krvi, okužba zgornjih dihal (prehladi), zvišano število trombocitov, gastroenteritis (driska in bruhanje) ter zvišane ravni alaninaminotransferaze (jetrnega encima).
English: Cholib fenofibrate / simvastatin
Slovenian: Povzetek EPAR za javnost fenofibrat/simvastatin
English: Cholib is a medicine for improving blood fat levels.
Slovenian: Cholib je zdravilo, ki se uporablja za zniževanje ravni maščob v krvi.
English: Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
Slovenian: Zdravilo Cholib je bilo učinkovitejše od samih statinov pri znižanju ravni trigliceridov in zvišanju ravni dobrega holesterola.
English: For the full list of all side effects reported with Cholib, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cholib, glejte navodilo za uporabo.
English: It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Slovenian: Znižuje raven skupnega holesterola v krvi, tako da zavira delovanje reduktaze HMG-CoA, tj. encima v jetrih, ki sodeluje pri tvorbi holesterola.
English: Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
Slovenian: Med zdravljenjem z zdravilom Cholib se je treba izogibati soku grenivke, ki dokazano vpliva na količino simvastatina v krvi.
English: How is Cholib used?
Slovenian: Kako se zdravilo Cholib uporablja?
English: How does Cholib work?
Slovenian: Kako zdravilo Cholib deluje?
English: In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone.
Slovenian: Zdravilo Cholib je v vseh študijah v večji meri znižalo ravni trigliceridov in zvišalo ravni dobrega holesterola kot sami statini.
English: Intravenous use ampoule (glass) 10 ml
Slovenian: Ampula (steklo) 10 ml
English: 10 ampoules
Slovenian: 10 ampul
English: * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Slovenian: * Enota relativne potence s ELISA antigen kvantifikacijo (in vitro test potence) v primerjavi z referenčnim cepivom.
English: --1 Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Slovenian: --1 Inaktivirani rekombinantni himerni prašičji cirkovirus tipa 1, ki vsebuje prašičjega cirkovirusa tipa 2, beljakovino ORF2 2,3-12,4 RP * Inaktivirana Mycoplasma hyopneumoniae sev P-5722-3 (inaktivirano) 1,5-3,8 RP *
English: Route of administration
Slovenian: 10 vial
English: Withdrawal period
Slovenian: 1 viala
English: Strength Pharmaceutical form
Slovenian: 1 injekcijski vložek
English: For full details, see the Summary of Product Characteristics, also part of the EPAR.
Slovenian: Za vse podrobnosti glejte povzetek glavnih značilnosti zdravila, ki je prav tako del EPAR.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino.
English: EPAR summary for the public topotecan
Slovenian: Povzetek EPAR za javnost topotekan
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Slovenian: Zdravilo se uporablja tudi skupaj s cisplatinom (drugim zdravilom proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v napredovalem stadiju (stadiju IVB: rak se je razširil zunaj materničnega vratu).
English: The company provided data from the published literature on topotecan.
Slovenian: Družba je predstavila podatke o topotekanu iz objavljene literature.
English: For more information about treatment with Topotecan Eagle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Topotecan Eagle preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because Topotecan Eagle is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Topotecan Eagle biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Topotecan Eagle.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Topotecan Eagle.
English: Treatment with Topotecan Eagle should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Slovenian: Zdravljenje z zdravilom Topotecan Eagle lahko poteka samo pod nadzorom zdravnika, izkušenega v uporabi kemoterapije.
English: The full EPAR for Topotecan Eagle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Druge informacije o zdravilu Topotecan Eagle decembraCelotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Topotecan Eagle je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What are the benefits and risks of Topotecan Eagle?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Topotecan Eagle?
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 Topotecan Eagle.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Topotecan Eagle, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The Committee recommended that Topotecan Eagle be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Topotecan Eagle odobri dovoljenje za promet.
English: The dose of Topotecan Eagle to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Slovenian: Odmerek zdravila Topotecan Eagle je odvisen od vrste raka, ki ga zdravimo, in bolnikove telesne mase in višine.
English: The CHMP concluded that, in accordance with EU requirements, Topotecan Eagle has been shown to have comparable quality and to be bioequivalent to Hycamtin.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Topotecan Eagle primerljivo raven kakovosti kot zdravilo Hycamtin ter da mu je biološko enakovredno.
English: For lung cancer, Topotecan Eagle is given every day for five days with a three-week interval between the start of each course.
Slovenian: Pri pljučnem raku se zdravilo Topotecan Eagle daje vsak dan pet dni zapored, čemur sledi tritedenski premor pred pričetkom novega cikla zdravljenja.
English: When used with cisplatin in cervical cancer, Topotecan Eagle is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Slovenian: Kadar zdravilo Topotecan Eagle uporabljamo skupaj s cisplatinom za zdravljenje raka materničnega vratu, ga dajemo v obliki infuzije na 1., 2. in 3. dan (cisplatin dajemo na 1. dan).
English: Topotecan Eagle also has a different (higher) strength from Hycamtin.
Slovenian: Prav tako je jakost zdravila Topotecan Eagle drugačna (višja) od zdravila Hycamtin.
English: Topotecan Eagle also affects non-cancer cells, which causes side effects.
Slovenian: Zdravilo Topotecan Eagle vpliva tudi na nerakave celice, kar povzroča neželene učinke.
English: While the reference medicine, Hycamtin, is available as a powder to be made up into a concentrate, Topotecan Eagle is available as a ready-made concentrate.
Slovenian: Referenčno zdravilo Hycamtin je na voljo v obliki praška za pripravo koncentrata, zdravilo Topotecan Eagle pa je že v obliki koncentrata.
English: The active substance in Topotecan Eagle, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Slovenian: Zdravilna učinkovina v zdravilu Topotecan Eagle, topotekan, je zdravilo proti raku, ki spada v skupino zaviralcev topoizomeraze.
English: Topotecan Eagle is an anticancer medicine.
Slovenian: Topotecan Eagle je zdravilo proti raku.
English: Topotecan Eagle is a medicine that contains the active substance topotecan.
Slovenian: Topotecan Eagle je zdravilo, ki vsebuje zdravilno učinkovino topotekan.
English: Topotecan Eagle is a ‘hybrid generic medicine'.
Slovenian: Zdravilo Topotecan Eagle je „generično zdravilo“.
English: Why has Topotecan Eagle been approved?
Slovenian: Zakaj je bilo zdravilo Topotecan Eagle odobreno?
English: How has Topotecan Eagle been studied?
Slovenian: Kako je bilo zdravilo Topotecan Eagle raziskano?
English: What is Topotecan Eagle?
Slovenian: Kaj je zdravilo Topotecan Eagle?
English: How does Topotecan Eagle work?
Slovenian: Kako zdravilo Topotecan Eagle deluje?
English: No additional studies in patients were needed as Topotecan Eagle is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Slovenian: Zdravilo Topotecan Eagle se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, zato niso bile potrebne nobene dodatne študije z bolniki.
English: What is Topotecan Eagle used for?
Slovenian: Za kaj se zdravilo Topotecan Eagle uporablja?
English: How is Topotecan Eagle used?
Slovenian: Kako se zdravilo Topotecan Eagle uporablja?
English: Risk management plan (RMP)
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: Measurement of serum concentration
Slovenian: Merjenje serumske koncentracije
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Slovenian: • Odbor je upošteval napotitev v skladu s členom 30 Direktive 2001/83/ES;
English: • Bacteraemia/ Septicaemia / Sepsis
Slovenian: • Bakteriemija/septikemija/sepsa
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of the Commission Implementing Regulation (EC) No 520/2012.
Slovenian: Protokoli, povzetki in zaključna poročila o študiji bodo predložena v obliki, kot je navedena v Prilogi III Izvedbene uredbe Komisije (EU) št. 520/2012.
English: • Infective endocarditis
Slovenian: • Infektivni endokarditis
English: The PASS protocol should also be included in the RMP.
Slovenian: V RMP mora biti vključen tudi protokol PASS.
English: Overall summary of the scientific evaluation of Targocid and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Targocid in povezanih imen (glejte Prilogo I)
English: Risk minimisation activities
Slovenian: Dejavnosti za zmanjšanje tveganja
English: Information on development, manufacture and control of the finished product has been presented in a satisfactory manner.
Slovenian: Informacije o razvoju, proizvodnji in nadzoru končnega zdravila so bile zadovoljivo predstavljene.
English: It can be concluded that batch results prove good consistency of the manufacturing process.
Slovenian: Zaključiti je mogoče, da rezultati serije dokazujejo dobro doslednost proizvodnega procesa.
English: Measurement of trough serum concentrations is also recommended at least once a week during the maintenance treatment.
Slovenian: Merjenje najmanjših serumskih koncentracij je prav tako priporočeno vsaj enkrat na teden med vzdrževalnim zdravljenjem.
English: In all (pooled data), 72 episodes of infection were treated in 71 adult patients.
Slovenian: V vseh primerih skupaj (skupni podatki) so zdravili 72 epizod okužb pri 71 odraslih bolnikih.
English: Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4.
Slovenian: Zdravilo Targocid se ne daje po intraventrikularni poti in je omenjeno kot posebno opozorilo v poglavju 4.4.
English: Four clinical studies provided data in children treated with specific paediatric protocols, and one study that included 7 neonates.
Slovenian: Štiri klinične študije so zabeležile podatke pri otrocih, ki so prejemali zdravljenje s posebnimi pediatričnimi protokoli, ena študija pa je vključevala 7 novorojenčkov.
English: The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%.
Slovenian: Odstotek klinične ozdravitve in izboljšanja je znašal okrog 90 %, odstotek bakteriološkega uspeha pa 76 %.
English: Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Slovenian: Nekatere od podkomponent so v bistvu skupine manjših vrhov, zlasti A2-1, A2-3, A2-5 in A3.
English: The study protocol of this non-interventional PASS shall be submitted within 2 months as of the Commission Decision.
Slovenian: Protokol te neintervencijske študije varnosti zdravila po pridobitvi dovoljenja za promet bo predložen v dveh mesecih po sklepu Komisije.
English: Detailed information on the starting materials, fermentation and purification process was provided and found acceptable.
Slovenian: Podrobne informacije o začetnih materialih, postopku fermentacije in čiščenja so bile predložene in sprejemljive.