FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u popisu referentnih datuma Unije (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: The patients were asked whether they felt improved overall since the start of treatment, and if so, whether the improvement was “slight” 25%, “moderate “50%, “great” 75% or “complete cure” 100%.
Croatian: Bolesnici su odgovarali na pitanje o tome jesu li osjetili cjelokupno poboljšanje od početka liječenja i ako jesu je li to poboljšanje „neznatno” 25 %, „umjereno” 50 %, „veliko” 75 % ili „potpuno izlječenje” 100 %.
English: Non-clinical data reveal no special hazard for humans based on conventional repeated dose toxicity, genotoxicity and long-term carcinogenicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, genotoksičnosti i dugoročne kancerogenosti.
English: • accumulation of fluid in arms or legs
Croatian: • nakupljanje tekućine u rukama ili nogama
English: Do not store above 30°C.
Croatian: Nemojte čuvati na temperaturi iznad 30 °C.
English: What elmiron looks like and contents of the pack
Croatian: Kako elmiron izgleda i sadržaj pakiranja
English: Total daily urine volume (cc)
Croatian: Ukupni dnevni volumen urina (cm
English: No dose adjustment is recommended for these patients.
Croatian: Prilagodba doze nije potrebna u takvih bolesnika.
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje česte: mogu se pojaviti u do 1 na 100 osoba
English: The used scale for the investigators assessment included the categories “worse”, “no change”, “fair”, “good”, “very good”, and “excellent”.
Croatian: Ispitivači su za ocjenu upotrebljavali ljestvicu koja je uključivala sljedeće kategorije: „pogoršanje”, „bez promjene”, „neznatno bolje”, „dobro”, „vrlo dobro” i „odlično”.
English: Uncommon Severe Emotional Lability/Depression
Croatian: Manje često Teška emocionalna labilnost / depresija
English: The primary efficacy endpoint of the study was the overall improvement as self-reported by the patient after three months of treatment.
Croatian: Primarna mjera ishoda djelotvornosti ispitivanja bila je sveukupno poboljšanje koje su bolesnici sami prijavili nakon tri mjeseca liječenja.
English: Accordingly, oral administration of pentosan polysulfate sodium 3-times daily is expected to lead to accumulation of pentosan polysulfate sodium over the first 7 days of administration (accumulation factor 5-6.7).
Croatian: U skladu s tim, očekuje se da će peroralna primjena natrijeva pentozanpolisulfata 3 puta dnevno dovesti do akumulacije natrijeva pentozanpolisulfata tijekom prvih 7 dana primjene (faktor akumulacije 5 - 6,7).
English: If you take more elmiron than you should
Croatian: Ako uzmete više lijeka elmiron nego što ste trebali
English: The hard capsules are white and non-transparent, provided in a plastic bottle with child resistant closure or plastic/aluminium blisters, packed in a carton.
Croatian: Tvrde kapsule su bijele i neprozirne, isporučuju se u plastičnoj bočici sa sigurnosnim zatvaračem za djecu i/ili plastičnim/aluminijskim blisterima, u kutiji.
English: Animal studies with respect to reproductive toxicity were not conducted.
Croatian: Nisu provedena ispitivanja na životinjama u pogledu reproduktivne toksičnosti.
English: For early detection of retinal disorders, eye examination will be performed regularly.
Croatian: Radi ranog otkrivanja poremećaja mrežnice, redovito ćete obavljati preglede očiju.
English: Tell your doctor immediately if you experience visual changes such as reading difficulty and slower adjustment to low or reduced light.
Croatian: Odmah obavijestite liječnika ako primijetite promjene vida poput otežanog čitanja ili sporije prilagodbe na slabu ili smanjenu svjetlost.
English: 1 capsule, 3 times daily Your doctor will assess your response to elmiron every 6 months.
Croatian: Vaš će liječnik ocijeniti vaš odgovor na elmiron svakih 6 mjeseci.
English: After taking the medicine it passes into the urine and attaches to the lining of the bladder, helping to form a protective layer.
Croatian: Nakon uzimanja lijek prelazi u urin i veže se na sluznicu mjehura i stvara zaštitni sloj.
English: The secondary efficacy endpoints included the investigators evaluation of improvement.
Croatian: Sekundarne mjere ishoda djelotvornosti uključivale su ocjenu poboljšanja od strane ispitivača.
English: • bleeding (other than menstrual bleeding)
Croatian: • krvarite (isključujući menstrualno krvarenje)
English: Children and adolescents elmiron is not recommended in children under 18 years as safety and efficacy have not been established in this group.
Croatian: Elmiron se ne preporučuje u djece mlađe od 18 godina budući da njegova sigurnost i djelotvornost nisu utvrđeni u ovoj grupi bolesnika.
English: • a blood clotting disorder or increased risks of bleeding, such as using a medicine that inhibits blood clotting
Croatian: • imate poremećaj zgrušavanja krvi ili povećan rizik od krvarenja, na primjer koristite lijek koji sprječava zgrušavanje krvi
English: 81479 Munich GERMANY
Croatian: 81479 München NJEMAČKA
English: If you forget to take elmiron
Croatian: Ako ste zaboravili uzeti elmiron
English: Blister 21 months
Croatian: 21 mjesec
English: A responder analysis based on a patientreported Global Response Assessment (GRA) after 24 weeks of treatment was defined as primary endpoint.
Croatian: Global Response Assessment, GRA) nakon 24 tjedna liječenja definirana je kao primarna mjera ishoda.
English: • loss of appetite, weight gain or loss
Croatian: • manjak apetita, gubitak težine ili dobivanje na težini
English: • allergic to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ste alergični na natrijev pentozanpolisulfat ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: • severe mood swings or depression
Croatian: • velike promjene raspoloženja ili depresija
English: Comparison of those patients receiving pentosan polysulfate sodium with those not receiving pentosan polysulfate sodium (irrespective of treatment with oral hydroxyzine) revealed no statistically significant difference between the two group, but a trend for better efficacy was observed for the primary endpoint in those patients treated with pentosan polysulfate sodium (either alone or in combination with hydroxyzine) (20 of 59, 34%) compared to the those patients not receiving pentosan polysulfate sodium, but who might receive hydroxyzine (11 of 62, 18%, p0.064):
Croatian: Usporedba bolesnika koji su primali natrijev pentozanpolisulfat s bolesnicima koji nisu primali natrijev pentozanpolisulfat (bez obzira na liječenje oralnim hidroksizinom) otkrila je da ne postoji statistički značajna razlika između te dvije skupine, no primijećen je trend poboljšanja djelotvornosti za primarnu mjeru ishoda u ispitanika koji su primali natrijev pentozanpolisulfat (sam ili u kombinaciji s hidroksizinom) (20 od 59, 34 %) u odnosu na one bolesnike koji nisu primali natrijev pentozanpolisulfat, ali su mogli primati hidroksizin (11 od 62, 18 %, p0,064):
English: BG, CZ, EE, EL, IS, IT, CY, LV, LT, HU, MT, PL, PT, RO, SK
Croatian: BG, CZ, EE, EL, IS, IT, CY, LV, LT, HU, MT, PL, PT, RO, SK bene-Arzneimittel GmbH, D-81479 Munich,
English: elmiron is not recommended during pregnancy.
Croatian: Primjena lijeka elmiron ne preporučuje se tijekom trudnoće.
English: Pharmacotherapeutic group: Urologicals, other urologicals, ATC code: G04BX15.
Croatian: Farmakoterapijska skupina: urološki lijekovi, drugi urološki lijekovi, ATK oznaka: G04BX15.
English: Capsule content Microcrystalline cellulose Magnesium stearate
Croatian: Sadržaj kapsule Mikrokristalična celuloza Magnezijev stearat
English: • bleeding, including small bleeding beneath the skin
Croatian: • krvarenje, uključujući malo potkožno krvarenje
English: The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established.
Croatian: Sigurnost i djelotvornost natrijeva pentozanpolisulfata u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: Response to treatment with pentosan polysulfate sodium should be reassessed every 6 months.
Croatian: Odgovor na liječenje natrijevim pentozanpolisulfatom treba se ponovno ocijeniti svakih 6 mjeseci.
English: What elmiron is and what it is used for 2.
Croatian: Što je elmiron i za što se koristi
English: • need to urinate more frequently than usual
Croatian: • češća potreba za mokrenjem nego inače
English: The effect of pentosan polysulfate sodium on reproductive and developmental toxicity has not been investigated.
Croatian: Učinak natrijeva pentozanpolisulfata na reproduktivnu i razvojnu toksičnost nije ispitivan.
English: Inform your doctor or pharmacist, particularly if you use medicines that prevent blood clotting, or painkillers that reduce blood clotting.
Croatian: Obratite se liječniku ili ljekarniku ako uzimate lijekove koji sprječavaju zgrušavanje krvi ili lijekove protiv bolova koji smanjuju zgrušavanje krvi.
English: The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily.
Croatian: Preporučena doza natrijeva pentozanpolisulfata je 300 mg dnevno, a uzima se peroralno u obliku jedne kapsule od 100 mg triput dnevno.
English: • skin rash, increased mole size
Croatian: • kožni osip, povećanje veličine madeža
English: Side effects have been observed with the following frequencies:
Croatian: Primijećene su nuspojave sa sljedećom učestalošću:
English: Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron (especially after long term use).
Croatian: Prijavljeni su rijetki slučajevi poremećaja mrežnice oka (pigmentna makulopatija) uz primjenu elmirona (naročito nakon dugotrajne primjene).
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Croatian: BROJ SERIJE<, OZNAKE DONACIJE I PROIZVODA> Broj serije
English: 3 voids less per day (% pts)
Croatian: 3 mokrenja manje po danu (% bodova)
English: In case no improvement is reached 6 months after treatment initiation, treatment with pentosan polysulfate sodium should be stopped.
Croatian: Ako se u roku od 6 mjeseci nakon početka liječenja ne ostvari napredak, liječenje natrijevim pentozanpolisulfatom treba se prekinuti.
English: A study in healthy subjects revealed no pharmacokinetic or pharmacodynamic interactions between therapeutic doses of warfarin and pentosan polysulfate sodium.
Croatian: Ispitivanje zdravih ispitanika otkrilo je da ne postoje farmakokinetičke ili farmakodinamičke interakcije između terapijskih doza vafarina i natrijeva pentozanpolisulfata.
English: • infections, flu
Croatian: • infekcije, gripa
English: EU/1/17/1189/001 90 hard capsules EU/1/17/1189/003 300 (3 bottles x 100) hard capsules
Croatian: EU/1/17/1189/003 300°(3°bočice°x°100) tvrdih kapsula
English: All studies describe very low systemic availability of unchanged pentosan polysulfate sodium after oral administration.
Croatian: Sva ispitivanja opisuju vrlo nisku sustavnu dostupnost nepromijenjenog natrijeva pentozanpolisulfata nakon peroralne primjene.
English: Increased sweating, insomnia, hyperkinesia, paraesthesia
Croatian: Pojačano znojenje, nesanica, hiperkineza, parestezija
English: Secondary outcome measures included the O'Leary-Sant IC Symptom and Problem Index, the University of Wisconsin Symptom score, patient reported symptoms of pain/discomfort and urgency, and results of a 24-hour voiding diary.
Croatian: Sekundarne mjere ishoda uključivale su rezultat na O'Leary-Santovom upitniku o simptomima i problemima povezanim s intersticijskim cistitisom (IC), rezultat na ljestvici simptoma Sveučilišta u Wisconsinu, simptome boli/nelagode i urgencije koje su prijavili bolesnici i rezultate 24-satnog dnevnika mokrenja.
English: Less than 10% of orally administered pentosan polysulfate sodium are slowly absorbed from the gastrointestinal tract and are available in systemic circulation in the form of unchanged pentosan polysulfate sodium or it's metabolites.
Croatian: Manje od 10 % peroralno primijenjenog natrijeva pentozanpolisulfata sporo se apsorbira iz gastrointestinalnog trakta te je u sustavnoj cirkulaciji dostupno u obliku nepromijenjenog natrijeva pentozanpolisulfata ili njegovih metabolita.
English: • breathing difficulties
Croatian: • poteškoće s disanjem
English: Hard capsule.
Croatian: OBLIK Tvrda kapsula.
English: Patients who reported at least moderate (50%) improvement were counted as responders.
Croatian: Bolesnici koji su prijavili barem umjereno (50 %) poboljšanje zabilježeni su kao ispitanici s pozitivnim odgovorom na liječenje.
English: Infections, influenza
Croatian: Infekcije, gripa
English: Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in patients who actively bleed.
Croatian: Zbog slabog antikoagulantnog učinka natrijeva pentozanpolisulfata, elmiron se ne smije primjenjivati u bolesnika s aktivnim krvarenjem.
English: About 6% of the administered dose of pentosan polysulfate sodium were excreted via urine after desulfation and depolymerisation.
Croatian: Otprilike 6 % primijenjene doze natrijeva pentozanpolisulfata izlučuje se putem urina nakon desulfatacije i depolimerizacije.
English: Each carton contains 90 capsules.
Croatian: Svaka kutija sadrži 90 kapsula.
English: What you need to know before you take elmiron 3.
Croatian: Što morate znati prije nego počnete uzimati elmiron
English: The following two studies were conducted following very comparable double-blind, randomized, placebo-controlled multicentre study designs.
Croatian: Sljedeća dva ispitivanja provedena su prema vrlo usporedivim dvostruko slijepim, randomiziranim, placebom kontroliranim multicentričnim dizajnima ispitivanja.
English: Inform your doctor, in the case of an overdose.
Croatian: U slučaju predoziranja obavijestite svojeg liječnika.
English: • headache, back pain
Croatian: • glavobolja, bol u leđima
English: Name and address of the manufacturer responsible for batch release bene-Arzneimittel GmbH Herterichstr.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet bene-Arzneimittel GmbH Herterichstr.
English: Pentosan polysulfate sodium is a weak anticoagulant.
Croatian: Natrijev pentozanpolisulfat ima slab antikoagulantni učinak.
English: Each carton contains 300 (3 bottles x 100) capsules.
Croatian: Svaka kutija sadrži 300 (3 bočice x 100) kapsula.
English: Visual symptoms might include complaints of reading difficulty and slow adjustment to low or reduced light environments.
Croatian: Simptomi vezani uz vid mogu uključivati otežano čitanje i sporu prilagodbu na okruženje sa slabom ili smanjenom rasvjetom.
English: No. responders (%)
Croatian: ukupan broj (%)
English: The most common adverse events reported from the clinical studies are headache, dizziness and gastro-intestinal events like diarrhoea, nausea, abdominal pain and rectal bleeding.
Croatian: Najčešće nuspojave prijavljene u kliničkim ispitivanjima su glavobolja, omaglica i gastrointestinalne nuspojave kao što su proljev, mučnina, bol u abdomenu i rektalno krvarenje.
English: This pooled analysis showed that the percentage of patients responding to treatment with pentosan polysulfate sodium with a clinically relevant improvement in their overall assessment, pain and urgency was approximately 2-fold higher than the respective responder rates under placebo:
Croatian: Ta skupna analiza pokazala je da je postotak bolesnika koji su odgovorili na liječenje natrijevim pentozanpolisulfatom s klinički relevantnim poboljšanjem svojeg cjelokupnog stanja, boli i urgencije približno 2 puta veći od postotka ispitanika koji su odgovorili na liječenje placebom:
English: This binding of glycosaminoglycans to the bladder mucous reduces bacterial adherence to the inner surface of the bladder and in consequence the incidence of infections is reduced as well.
Croatian: Vezanje glikozaminoglikana na deficijentnu sluznicu mokraćnog mjehura smanjuje prianjanje bakterija na unutrašnju površinu mjehura te se posljedično smanjuje incidencija infekcija.
English: The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
Croatian: O mogućoj povezanosti tih nuspojava i liječenja natrijevim pentozanpolisulfatom nije se raspravljalo u predmetnim publikacijama.
English: In the case of an accidental overdose, patients should be evaluated for potential adverse effects of pentosan polysulfate sodium like gastrointestinal symptoms or bleeding.
Croatian: U slučaju slučajnog predoziranja, bolesnike treba pregledati kako bi se utvrdilo postoje li moguće nuspojave natrijeva pentozanpolisulfata, kao što su gastrointestinalni simptomi ili krvarenje.
English: Coagulation disorders
Croatian: Koagulacijski poremećaji
English: • increased sweating, sleeplessness
Croatian: • pojačano znojenje, nesanica
English: In all of these studies, patients reported a better subjective improvement of bladder pain syndrome under treatment with pentosan polysulfate sodium compared to placebo.
Croatian: U svim tim ispitivanjima bolesnici su prijavili subjektivno poboljšanje sindroma bolnog mjehura tijekom liječenja natrijevim pentozanpolisulfatom u usporedbi s liječenjem placebom.
English: There are no data from the use of pentosan polysulfate sodium in pregnant women.
Croatian: Ne postoje podaci o primjeni natrijeva pentozanpolisulfata u trudnica.
English: The second of the two very comparable studies enrolled 148 patients and demonstrated a statistically significant benefit pentosan polysulfate sodium over placebo was demonstrated on the patient reported overall improvement evaluated as primary endpoint and an the investigator-assessed overall improvement, all evaluations on pain and urgency.
Croatian: Drugo od dva vrlo usporediva ispitivanja koje je uključivalo 148 bolesnika dokazalo je statistički značajnu korist primjene natrijeva pentozanpolisulfata u odnosu na primjenu placeba u pogledu cjelokupnog poboljšanja koje su ocijenili bolesnici kao primarne mjere ishoda, te cjelokupnog poboljšanja koje je ocjenjivao ispitivač, svih ocjena boli i urgencije.
English: An evaluation of all data generated in the study showed that for all four symptoms statistically significant more patients responded to pentosan polysulfate sodium treatment compared to placebo:
Croatian: Ocjena svih podataka dobivenih u ispitivanju pokazala je da je za sva četiri simptoma statistički značajno više bolesnika odgovorilo na liječenje natrijevim pentozanpolisulfatom nego na liječenje placebom:
English: Driving and using machines elmiron has no or negligible influence on the ability to drive and use machines.
Croatian: Elmiron ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pentosan polysulfate sodium has not been specifically studied in special patient populations like elderly or patients with renal or hepatic impairment (see section 4.4).
Croatian: Natrijev pentozanpolisulfat nije posebno ispitivan u posebnih populacija kao što su stariji ili bolesnici s oštećenjem jetre ili bubrega (vidjeti dio 4.4).
English: The hypothetic mechanism of action of pentosan polysulfate sodium includes a local effect in the bladder after systemic administration and excretion into the urine by binding of glycosaminoglycans to the deficient mucous of the bladder.
Croatian: Hipotetski mehanizam djelovanja natrijeva pentozanpolisulfata obuhvaća lokalno djelovanje u mjehuru nakon sustavne primjene i izlučivanja u urin vezanjem glikozaminoglikana na deficijentnu sluznicu mokraćnog mjehura.
English: Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to treatment with other medicinal products influencing coagulation such as anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal antiinflammatory medicinal products (see section 4.5)) should be evaluated for haemorrhagic events.
Croatian: Bolesnike koji se podvrgavaju invazivnim zahvatima ili pokazuju znakove/simptome podležeće koagulopatije ili imaju drugi povećani rizik od krvarenja (zbog liječenja drugim lijekovima koji utječu na koagulaciju, na primjer antikoagulansima, derivatima heparina, trombolitičkim lijekovima ili lijekovima protiv agregacije trombocita, uključujući acetilsalicilatnu kiselinu, ili nesteroidnim protuupalnim lijekovima (vidjeti dio 4.5)) treba pregledati zbog mogućeg krvarenja.
English: No. complete secondary end point data (%) Mean pain score ± SD (0-9) Mean urgency score ± SD (0-9) Mean 24-hr frequency ± SD Mean IC symptom index ± SD (0-20) Mean IC problem index ± SD (0-16) Mean Wisconsin IC score ± SD (0-42)
Croatian: Broj ispitanika s odgovorom (%) Broj potpunih podataka sekundarne mjere ishoda (%) 49 (83) Prosječna ocjena boli ± SD (0 - 9) Prosječna ocjena urgencije ± SD (0 - 9) Prosječna 24-satna učestalost ± SD Prosječni zbroj bodova IC simptoma ± SD (0 - 20) -2,6 ± 3,4 Prosječni zbroj bodova IC problema ± SD (0 - 16) Prosječna Wisconsin IC ocjena ± SD (0 - 42)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: Patients were randomized to four treatment group and were treated for six months with 3x100 mg pentosane polysulfate sodium, 1x50 mg hydroxyzine, both active treatments or placebo.
Croatian: Bolesnici su randomizirani u četiri grupe za liječenje te su šest mjeseci primali 3 x 100 mg natrijeva pentozanpolisulfata, 1 x 50 mg hidroksizina, oba aktivna lijeka ili placebo.
English: The GRA assessment was evaluated via a 7-point centred scale, in which the patients can assess their global response compared to baseline as markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved or markedly improved.
Croatian: GRA ocjena temelji se na ljestvici od 7 bodova kojom bolesnici mogu ocijeniti svoj opći odgovor u usporedbi s početnim stanjem sljedećim ocjenama: značajno pogoršanje, umjereno pogoršanje, neznatno pogoršanje, nema promjene, neznatno poboljšanje, umjereno poboljšanje ili značajno poboljšanje.
English: A trend for better efficacy under pentosan polysulfate sodium was observed for improved sexual intercourse:
Croatian: Primijećena je veća djelotvornost natrijeva pentozanpolisulfata u pogledu poboljšanog spolnog odnosa:
English: The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium.
Croatian: U sljedećem dijelu navedene su nuspojave prijavljene u literaturi iz kliničkih ispitivanja natrijeva pentozanpolisulfata.
English: Bladder pain syndrome is a diagnosis of exclusion and other urologic disorders should be eliminated by the prescriber, such as urinary tract infection or bladder cancer.
Croatian: Sindrom bolnog mjehura je dijagnoza isključenja te bi propisivač lijeka trebao isključiti druge urološke poremećaje, na primjer infekciju urinarnog trakta ili rak mjehura.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.