FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee therefore concluded that, based on currently available information, the benefit-risk balance of pholcodine-containing products in the treatment of non-productive cough is positive under normal conditions of use.
Slovenian: Odbor je tako sklenil, da je na podlagi trenutno dostopnih informacij razmerje med koristmi in tveganji zdravil, ki vsebujejo folkodin, za zdravljenje neproduktivnega kašlja v običajnih pogojih uporabe pozitivno.
English: Data from Sweden where pholcodine has not been marketed since the 80's is indicative, like in Norway, that the level of IgE-sensitisation to pholcodine has been decreasing over time in parallel to a decrease in the number of NMBA-related anaphylaxis cases3.
Slovenian: Podobno kot na Norveškem, podatki iz Švedske, kjer se folkodin ne trži že od 80. let prejšnjega stoletja, kažejo, da se je stopnja IgEsenzibilizacije za folkodin čez čas zmanjšala, vzporedno z zmanjšanjem primerov anafilaksije, povezane z živčno-mišičnimi blokatorji3.
English: The evidence in support of this derives from ecological studies conducted by a single research team relying on spontaneously reported adverse reactions to NMBAs.
Slovenian: Podporni dokazi izvirajo iz ekoloških študij, ki jih je opravila ena sama raziskovalna skupina, ki se je pri tem oprla na spontana poročila o neželenih učinkih na živčno-mišične blokatorje.
English: The absence of any report of IgE-mediated anaphylactic reaction to NMBAs in Sweden since 1990 raises further questions on the reliability of the data, as regardless of pholcodine use NMBAs would still be expected to cause anaphylactic reactions and the Swedish data does not appear to reflect this expected background rate.
Slovenian: Ker na Švedskem od leta 1990 niso na voljo nobena poročila o anafilaktičnih reakcijah na živčnomišične blokatorje, pri katerih sodeluje IgE, je to sprožilo nadaljnja vprašanja o zanesljivosti podatkov, saj se neodvisno od uporabe folkodina lahko pričakuje, da povzroča uporaba živčnomišičnih blokatorjev anafilaktične reakcije, podatki s Švedske pa tega pričakovanega osnovnega deleža ne kažejo.
English: The group had split views about the strength of the evidence of an association between pholcodine exposure and allergic reactions to NMBAs, although it was agreed that this is an issue that warrants further investigation.
Slovenian: Mnenja skupine o utemeljenosti dokazov povezave med izpostavljenostjo folkodinu in alergijskimi reakcijami na živčno-mišične blokatorje so bila različna, čeprav se je strinjala, da so v zvezi s tem potrebne dodatne raziskave.
English: Nevertheless the Committee considered that the possibility of an association between pholcodine use and NMBA-related anaphylaxis needs to be further investigated.
Slovenian: Vseeno pa Odbor meni, da je treba možnost povezave med uporabo folkodina in anafilaksijo, povezano z živčno-mišičnimi blokatorji, dodatno raziskati.
English: The Committee therefore recommended the maintenance of the marketing authorisation for pholcodinecontaining products.
Slovenian: Odbor zato priporoča, da se dovoljenje za promet z zdravilom za zdravila, ki vsebujejo folkodin, ohrani.
English: Being an old product, the methodology used in most efficacy studies with pholcodine would be considered poor by modern standards.
Slovenian: Ker je to zdravilo staro, je po sodobnih merilih metodologija, uporabljena v večini študij učinkovitosti za folkodin, neustrezna.
English: An ad-hoc expert group composed mainly of immunologists and anaesthesiologists was consulted to provide advice to CHMP on this issue.
Slovenian: Odbor za zdravila za uporabo v humani medicini je za nasvet glede te težave zaprosil začasno strokovno skupino, sestavljeno pretežno iz imunologov in anesteziologov.
English: Literature has been published suggesting a link between pholcodine consumption and cross sensitisation to NMBAs, resulting in anaphylactic reactions during surgery.
Slovenian: V objavljeni literaturi je nakazana povezava med uživanjem folkodina in navzkrižno senzibilizacijo za živčno-mišične blokatorje, ki je med kirurškim posegom povzročila anafilaktične reakcije.
English: Considering that as a part of this procedure: - The CHMP already assessed the evidence available to date from across the Member States on this topic, and during the assessment has been able to identify its shortcomings - The preliminary proposals for the study protocol submitted by different MAHs have already been reviewed by the CHMP during this referral procedure
Slovenian: Ob upoštevanju, da je kot del postopka: - odbor CHMP že ocenil podatke, ki so do danes na voljo iz posameznih držav članic glede tega vprašanja, in da je med ocenjevanjem ugotovil njihove pomanjkljivosti, - predhodne predloge za protokol študije, ki so jih predložili različni imetniki dovoljenj za promet, CHMP že pregledal med tem napotitvenim postopkom, odbor meni, da je treba uskladiti preglede protokola s študijo s „kontrolno skupino“, da se zagotovi, da bodo študije ustrezno zasnovane za pridobitev podatkov, ki so potrebni za ocenitev morebitne povezave med uporabo folkodina in anafilaktičnimi reakcijami, povezanimi z živčnomišičnimi blokatorji.
English: The Committee therefore concluded that, based on currently available information, the benefits of pholcodine in the treatment of non-productive cough outweigh the risks, and that the benefit-risk balance of pholcodinecontaining products in the treatment of non-productive cough is positive under normal conditions of use.
Slovenian: Zato je Odbor sklenil, da so na podlagi trenutno dostopnih podatkov koristi folkodina za zdravljenje neproduktivnega kašlja večje od tveganj, razmerje med tveganji in koristmi pri uporabi zdravil, ki vsebujejo folkodin za zdravljenje neproduktivnega kašlja, pa je v običajnih okoliščinah uporabe pozitivno.
English: The Committee considered that evidence of an association between pholcodine use and development of NMBA-related anaphylaxis is circumstantial, not entirely consistent and therefore does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Slovenian: Odbor meni, da so dokazi o povezavi uporabe folkodina in pojavom anafilaksije, povezane z živčnomišičnimi blokatorji, posredni in ne povsem dosledni ter zato ne podpirajo sklepa o pomembnem tveganju navzkrižne senzibilizacije za živčno-mišične blokatorje ter posledičnim nastankom anafilaksije med kirurškim posegom.
English: Taking into account all of the above, the CHMP concluded that the evidence of a link between pholcodine and NMBA-related anaphylaxis is circumstantial, not entirely consistent and does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Slovenian: Ob upoštevanju zgoraj navedenega je Odbor za zdravila za uporabo v humani medicini zaključil, da so dokazi o povezavi med folkodinom in anafilaksijo, povezano z živčno-mišičnimi blokatorji, posredni, ne povsem dosledni in da ne podpirajo sklepa o pomembnem tveganju za navzkrižno senzibilizacijo za živčno-mišične blokatorje in posledični pojav anafilaksije med kirurškim posegom.
English: Divergent opinions were expressed on the strength of the epidemiological evidence, based on the Swedish and the Norwegian experiences and the quasi experiment resulting from the discontinuation of the drug in the two countries at different timings and the biological plausibility of the hypothesis.
Slovenian: Na podlagi švedskih in norveških izkušenj in nepravih poskusov zaradi prekinitve uporabe zdravila v teh dveh državah ob različnem času ter biološke verodostojnosti hipoteze so bila mnenja o utemeljenosti epidemioloških dokazov različna.
English: Further data needs to be generated to clarify the possibility of an association between pholcodine use and NMBA-related anaphylaxis.
Slovenian: Za pojasnitev mogoče povezave med uporabo folkodina in anafilaksijo, povezano z živčnomišičnimi blokatorji, so potrebni dodatni podatki.
English: Ian Hudson (United Kingdom)
Slovenian: Ian Hudson (Združeno kraljestvo)
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Slovenian: Rezultat postopka v skladu s členom 29 Direktive 2001/83/ES, kakor je bila spremenjena
English: Patrick Salmon (Ireland)
Slovenian: Patrick Salmon (Irska)
English: The amended information to healthcare professionals and patients is available here.
Slovenian: Dopolnjene informacije za zdravstvene delavce in bolnike so na voljo tukaj.
English: Rapporteur:
Slovenian: Poročevalec:
English: The company wanted the authorisation to be recognised in United Kingdom (the ‘concerned Member State').
Slovenian: Družba je želela, da se dovoljenje prizna tudi v Združenem kraljestvu (zadevna država članica).
English: CHX Technologies Europe Limited submitted Prevora for mutual recognition on the basis of the initial authorisation granted by Ireland on 5 May 2006.
Slovenian: Družba CHX Technologies Europe Limited je predložila vlogo za medsebojno priznavanje zdravila Prevora na podlagi prvotnega dovoljenja, ki ga je izdala Irska dne 5. maja 2006.
English: Why was Prevora reviewed?
Slovenian: Zakaj je bilo zdravilo Prevora pregledano?
English: It works by disrupting the membrane of bacteria, fungi and other organisms, blocking their growth.
Slovenian: Deluje tako, da uničuje membrane bakterij, glivic in drugih organizmov, s čemer onemogoči njihovo rast.
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 26 November 2009.
Slovenian: Ker pa državi članici nista dosegli soglasja, je irski regulatorni organ dne 26. novembra 2009 zadevo napotil na CHMP v arbitražo.
English: The European Commission issued a decision on 03 December 2010
Slovenian: Evropska komisija je odločbo izdala dne 3. decembra 2010.
English: Opinion date:
Slovenian: Datum izdaje mnenja:
English: The United Kingdom had concerns that the results from the main study with Prevora were not sufficient to support the proposed indication, and that another study was needed to confirm the results seen to date with the medicine.
Slovenian: Združeno kraljestvo je izrazilo zadržke, da rezultati glavne študije zdravila Prevora ne zadostujejo za podporo predlagani indikaciji in da je potrebna dodatna študija, ki bi potrdila doslej zbrane rezultate o zdravilu.
English: Therefore the marketing authorisation for Prevora should be granted in the United Kingdom.
Slovenian: Zato se dovoljenje za promet z zdravilom Prevora v Združenem kraljestvu lahko odobri.
English: The active substance in Prevora, chlorhexidine, is an antiseptic.
Slovenian: Zdravilna učinkovina zdravila Prevora, klorheksidin, je antiseptik.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prevora.
Slovenian: Evropska agencija za zdravila je po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Prevora zaključila arbitražni postopek.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Prevora outweigh its risks, and the marketing authorisation granted in Ireland can be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Prevora odtehtajo z njim povezana tveganja ter da se lahko dovoljenje za promet z zdravilom, odobreno na Irskem, prizna tudi v drugih državah članicah Evropske unije.
English: Procedure start date:
Slovenian: Datum začetka postopka:
English: 28 July 2010, 15 September 2010
Slovenian: 28. julija 2010, 15. septembra 2010
English: Based on evaluation of the newly available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Prevora outweigh its risks in the prevention of coronal and root caries in adult patients at high-risk of dental caries.
Slovenian: Na podlagi ocene najnovejših podatkov in znanstvene razprave znotraj Odbora, je CHMP zaključil, da koristi zdravila Prevora odtehtajo z njim povezana tveganja pri zdravljenju kariesa zobne krone in korenine pri odraslih bolnikih z visokim tveganjem za zobni karies.
English: Co-rapporteur(s):
Slovenian: Soporočevalec:
English: Company responses provided on:
Slovenian: Družba je odgovore poslala dne:
English: Prevora is a dental solution used to reduce dental caries (tooth decay) in permanent teeth of adolescents and adults.
Slovenian: Zdravilo Prevora je dentalna raztopina, ki se uporablja za zmanjševanje zobnega kariesa (zobne gnilobe) na stalnih zobeh mladostnikov in odraslih.
English: The grounds for the referral were that the United Kingdom could not approve the proposed indication, prevention of root caries in adult patients at high-risk of dental caries.
Slovenian: Združeno kraljestvo je kot razlog za napotitev navedlo, da ne more priznati predlagane indikacije, tj. preprečevanje kariesa zobnih korenin pri odraslih bolnikih z visokim tveganjem za zobni karies.
English: What is Prevora?
Slovenian: Kaj je zdravilo Prevora?
English: Prevora is applied to the surface of permanent teeth by a dental professional in two stages.
Slovenian: Zdravnik specialist za dentalno medicino nanese zdravilo Prevora na površino stalnih zob v dveh fazah.
English: 03 December 2010
Slovenian: 3. decembra 2010
English: First a chlorhexidine coating solution is applied followed immediately by an inert sealant coating.
Slovenian: Najprej premaže zobe z raztopino klorheksidina, takoj zatem pa nanese inertni tesnilni premaz.
English: The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Slovenian: Referenčna država članica je bila Nizozemska, zadevne države članice pa so bile Avstrija, Belgija, Ciper, Češka, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Norveška, Poljska, Portugalska, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo.
English: The scientific conclusions are provided in Annex II.
Slovenian: Znanstveni zaključki so na voljo v Dodatku II.
English: The Rapporteur was Dr Jean-Louis Robert and CoRapporteur was Dr Janos Borvendeg.
Slovenian: Poročevalec je bil dr. Jean-Louis Robert, soporočevalec pa dr. Janos Borvendeg.
English: Article 5(11) of Commission Regulation (EC) No 1084/2003
Slovenian: Člen 5(11) Uredbe Komisije (ES) št. 1084/2003
English: The final opinion was converted into a Decision by the European Commission on 17 June 2008.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 17. junija 2008.
English: A positive opinion was adopted by majority on 13 December 2007.
Slovenian: Pozitivno mnenje je bilo sprejeto z večino glasov dne 13. decembra 2007.
English: London, 17 June 2008 EMEA/337156/2008
Slovenian: London, 17. junija 2008 EMEA/CHMP/40502/2008
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP)
English: International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol
Slovenian: Mednarodno nelastniško ime (INN): Drospirenon + Etinilestradiol
English: OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 5(11)1 ZA
English: The list of the product names concerned is given in Annex I.
Slovenian: Seznam zadevnih imen izdelkov je podan v Dodatku I.
English: The Mutual Recognition Procedure started on 18 June 2007.
Slovenian: Postopek medsebojnega priznavanja se je začel 18. junija 2007.
English: During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Slovenian: Med svojim zasedanjem decembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med koristmi in tveganji za zdravilo Yasminelle in z njim povezana imena ugodno, ter da ugovori, ki jih je podala Madžarska, ne bi smeli preprečiti odobritve vloge za spremembo in da naj bodo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice končne različice, dogovorjene med postopkom Skupine za usklajevanje.
English: Yasminelle and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Slovenian: Zdravilo Yasminelle in z njim povezana imena je kombinirano peroralno kontracepcijsko sredstvo, ki vsebuje 0,02 mg etinilestradiola in 3 mg drospirenona.
English: Hungary referred the reasons for disagreement to the EMEA on 12 October 2007.
Slovenian: Madžarska je Evropski agenciji za zdravila posredovala razloge za nesoglasje dne 12. oktobra 2007.
English: The arbitration procedure started on 18 October 2007.
Slovenian: Arbitražni postopek se je začel 18. oktobra 2007.
English: These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/2003.
Slovenian: Te države članice niso uspele doseči soglasja v zvezi s spremembo dovoljenja za promet v roku, določenem v členu 5(6) Uredbe Komisije (ES) št. 1084/2003.
English: Yasminelle and associated names (see Annex I)
Slovenian: zdravilo Yasminelle in z njim povezana imena (glejte Dodatek I)
English: Furthermore the Braille text could not be read through the outer packaging as the cellophane is slippery and moves when touched.
Slovenian: Poleg tega besedila v Braillovi pisavi ni mogoče prebrati skozi ovojnino, saj je celofan spolzek in se premika ob dotiku.
English: The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/2003.
Slovenian: Imetnik dovoljenja za promet je predložil vlogo za spremembo, ki je predmet postopka medsebojnega priznavanja dovoljenj za promet z zdravilom v okviru člena 5 Uredbe Komisije (ES) št. 1084/2003.
English: The cellophane wrapping could not be accepted as an outer packaging due to the risk that during usage the product (wallets) would get separated from the package leaflet.
Slovenian: Celofanski ovoj se ne more dovoliti kot ovojnina zaradi nevarnosti, da bi se zdravilo (denarnica) med uporabo ločilo od navodila za uporabo.
English: The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern.
Slovenian: Predlagana zasnova embalaže, t.i. denarnica z zdravilom in navodilom za uporabo, zavitima v prozorni celofan, naj bi predstavljala resno nevarnost za zdravje ljudi.
English: 31 July 2012
Slovenian: 31. julij 2012
English: Many may feel quite normal.
Slovenian: Veliko se jih lahko počuti čisto normalno.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Slovenian: ponedeljek torek sreda četrtek petek sobota nedelja
English: You may need to read it again.
Slovenian: Morda ga boste želeli ponovo prebrati.
English: Rare:
Slovenian: redki:
English: Therefore, caution should be exercised in these patients.
Slovenian: Zato je pri teh bolnikih potrebna previdnost.
English: Within a month following the Commission Decision
Slovenian: V roku enega meseca po odobritvi.
English: Paediatric patients (below 18 years)
Slovenian: Pediatrični bolniki (mlajši od 18 let)
English: The mean half-life is about 40 hours (range 34-41 hours).
Slovenian: Povprečen razpolovni čas je približno 40 ur (v okviru 34 - 41 ur).
English: It is recommended that you take the tablets with some water.
Slovenian: Tablete je priporočljivo zaužiti z malo vode.
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Slovenian: AUC je pri starejših (> 65 let) 50 % večja kot pri mladih osebah.
English: Second and third trimesters of pregnancy (see section 4.6).
Slovenian: Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6).
English: No interactions have been identified.
Slovenian: Pri teh učinkovinah niso ugotovili nobenih interakcij.
English: However, if it is almost time for your next dose you should simply take the next tablet at the usual time.
Slovenian: Če pa je že skoraj čas za naslednji odmerek, preprosto vzemite samo naslednji odmerek ob običajnem času.
English: High blood pressure increases the workload of the heart and arteries.
Slovenian: Visok krvni tlak povečuje obremenitev srca in arterij.
English: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italy
Slovenian: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italija
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Elderly patients (over 65 years)
Slovenian: Starejši bolniki (starejši od 65 let)
English: The use of Sprimeo in children and adolescents is not recommended.
Slovenian: Uporaba zdravila Sprimeo pri otrocih in mladostnikih ni priporočena.
English: People who have high blood pressure often do not notice any signs of the problem.
Slovenian: Ljudje, ki imajo visok krvni tlak, pogosto ne čutijo s tem povezanih težav.
English: WHAT SPRIMEO IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO SPRIMEO IN ZA KAJ GA UPORABLJAMO
English: There are no data on the use of aliskiren in pregnant women.
Slovenian: Ni podatkov o uporabi aliskirena pri nosečnicah.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba posodobljen RMP predložiti hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja)
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Sprimeo.
Slovenian: Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke zdravila Sprimeo.
English: If you forget to take a dose of Sprimeo, take it as soon as you remember and then take the next dose at its usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Sprimeo, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
English: The absolute bioavailability of aliskiren is approximately 2-3%.
Slovenian: Absolutna biološka uporabnost aliskirena je približno 2 - 3 %.
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures:
Slovenian: • OBVEZNOST IZVEDBE UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
English: Approximately 1.4% of the total oral dose is metabolised.
Slovenian: Približno 1,4 % celotnega peroralnega odmerka se presnovi.
English: Mechanisms responsible for deviation from linearity have not been identified.
Slovenian: Mehanizmov, ki povzročajo odstopanje od linearnosti, še niso pojasnili.