FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu./
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: In conclusion, taking into account the exposure margins based on AUC, a risk of eltrombopag-related cataracts in paediatric patients cannot be excluded.
Croatian: Zaključno, uzimajući u obzir granice izloženosti temeljem AUC-a, rizik od katarakti povezanih s eltrombopagom u pedijatrijskih bolesnika ne može se isključiti.
English: Blood tests for liver function
Croatian: Krvne pretrage za provjeru funkcije jetre
English: Increase of alanine aminotransferase and aspartate aminotransferase may occur simultaneously, although at a lower frequency.
Croatian: Porast alanin aminotransferaze i aspartat aminotransferaze može se dogoditi usporedno, iako s vrlo niskom učestalošću.
English: Loss of response to eltrombopag
Croatian: Izostanak odgovora na eltrombopag
English: Eltrombopag dose (once daily)
Croatian: Doza eltrombopaga (jednom dnevno)
English: In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between patients aged at least 65 years and younger patients.
Croatian: U kliničkim ispitivanjima eltrombopaga, sveukupno nisu zamijećene klinički značajne razlike u sigurnosti njegove primjene između bolesnika od 65 ili više godina i mlađih bolesnika.
English: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nuremberg, Germany
Croatian: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nürnberg, Njemačka
English: • minerals such as iron, calcium, magnesium, aluminium, selenium and zinc which may be found in vitamin and mineral supplements (see also ‘When to take it' in section 3)
Croatian: • minerali poput željeza, kalcija, magnezija, aluminija, selena i cinka koje možemo naći u nadomjescima vitamina i minerala (također pogledajte „Kada uzeti lijek“ u dijelu 3.)
English: The above warnings and precautions for ITP also apply to the paediatric population.
Croatian: Prethodno navedena upozorenja i mjere opreza za ITP odnose se i na pedijatrijsku populaciju.
English: The laminate material is comprised of polyester (PET) / orientated polyamide (OPA) / 9 µm aluminium foil (AL) / low density polyethylene heat seal layer (LDPE).
Croatian: Laminirani materijal se sastoji od poliestera (PET) / orijentiranog poliamida (OPA) / 9 µm aluminijske folije (Al) / toplinski zavarenog sloja polietilena niske gustoće (LDPE).
English: More than half of all patients in each treatment group had ≥3 prior ITP therapies and 36% had a prior splenectomy.
Croatian: Više od polovice svih bolesnika u svakoj ispitivanoj skupini je imalo ≥3 prethodnih pokušaja liječenja ITP, a 36% je prethodno bilo splenektomirano.
English: Haematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting eltrombopag (see section 5.1).
Croatian: Hematološki odgovor zahtijeva titraciju doze, općenito do 150 mg, i može potrajati do 16 tjedana nakon početka primjene eltrombopaga (vidjeti dio 5.1).
English: Renal tubular toxicity was observed in studies of up to 14 days duration in mice and rats at exposures that were generally associated with morbidity and mortality.
Croatian: Toksičnost za bubrežne tubule primijećena je u ispitivanjima u trajanju do 14 dana u miševa i štakora, pri izloženostima koje su općenito bile povezane s morbiditetom i mortalitetom.
English: Fifty-four percent of the eltrombopag-treated patients and 13% of placebo-treated patients achieved this level of response after 6 weeks of treatment.
Croatian: Pedeset četiri posto bolesnika liječenih eltrombopagom i 13% bolesnika koji su primali placebo postiglo je ovaj stupanj odgovora nakon 6 tjedana liječenja.
English: A daily dose of 75 mg must not be exceeded.
Croatian: Ne smije se prekoračiti dnevna doza od 75 mg.
English: Nine of these patients achieved a multi-lineage response, 4 of the 9 remain on treatment and 5 tapered off treatment with eltrombopag and maintained the response (median follow up: 20.6 months, range: 5.7 to 22.5 months).
Croatian: Devetero od tih bolesnika postiglo je odgovor u više loza, 4 od 9 je nastavilo liječenje, a 5 je postupno prekinulo terapiju eltrombopagom i održalo odgovor (medijan praćenja: 20,6 mjeseci, raspon: 5,7 do 22,5 mjeseci).
English: Routine ophthalmologic monitoring of patients is recommended.
Croatian: Preporučuje se rutinsko oftalmološko praćenje bolesnika.
English: In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
Croatian: U slučaju predoziranja, broj trombocita se može prekomjerno povisiti i izazvati trombotičke/tromboembolijske komplikacije.
English: Get medical help immediately if you develop signs and symptoms of a blood clot, such as:
Croatian: Odmah potražite liječničku pomoć ako se kod Vas pojave znakovi i simptomi stvaranja krvnih ugrušaka, poput:
English: Eltrombopag has negligible influence on the ability to drive and use machines.
Croatian: Eltrombopag zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Tubular toxicity was also observed in a 2-year oral carcinogenicity study in mice at doses of 25, 75 and 150 mg/kg/day.
Croatian: Toksičnost za tubule je također primijećena u dvogodišnjem oralnom ispitivanju karcinogenosti na miševima, u dozama od 25, 75 i 150 mg/kg/dan.
English: Because eltrombopag is not significantly renally excreted and is highly bound to plasma proteins, haemodialysis would not be expected to be an effective method to enhance the elimination of eltrombopag.
Croatian: Obzirom da se eltrombopag ne izlučuje značajnije bubregom i da je u visokom postotku vezan za proteine plazme, ne očekuje se da bi hemodijaliza bila učinkovita metoda za poboljšanje eliminacije eltrombopaga.
English: Clinical studies comparing eltrombopag to other treatment options (e.g. splenectomy) have not been conducted.
Croatian: Nisu provedena klinička ispitivanja koja uspoređuju eltrombopag s drugim opcijama liječenja (npr. splenektomija).
English: No case of TEE was identified from a clinical study in refractory SAA, however the risk of these events cannot be excluded in this patient population due to the limited number of exposed patients.
Croatian: U kliničkim ispitivanjima refraktorne teške aplastične anemije nije bilo prepoznatih TED-ova, međutim, rizik od tih događaja ne može se isključiti u ovoj populaciji bolesnika zbog ograničenog broja izloženih bolesnika.
English: The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between paediatric and adult patients.
Croatian: Učinci rase i spola na procjene plazmatskog CL/F-a eltrombopaga bili su dosljedni između pedijatrijskih i odraslih bolesnika.
English: After mixing, Revolade oral suspension should be administered immediately, but may be stored for no more than 30 minutes at room temperature.
Croatian: Nakon miješanja, Revolade oralnu suspenziju treba odmah primijeniti, ali može se pohraniti na sobnoj temperaturi najdulje 30 minuta.
English: NO dairy products, antacids or mineral supplements
Croatian: NE uzimati mliječne proizvode, antacide ili nadomjestke minerala
English: 1 to 5 years (n=38)
Croatian: 1 do 5 godina (n=38)
English: Furthermore, a clinical pharmacology study in 36 subjects showed no evidence that photosensitivity was increased following administration of eltrombopag 75 mg.
Croatian: Nadalje, kliničko farmakološko ispitivanje na 36 ispitanika nije pokazalo da je fotoosjetljivost povećana nakon primjene 75 mg eltrombopaga.
English: Eighty-six percent of patients were RBC transfusion dependent, and 91% were platelet transfusion dependent.
Croatian: Osamdeset šest posto bolesnika bilo je ovisno o transfuziji eritrocita, a 91% je bilo ovisno o transfuziji trombocita.
English: d p-value <0.05 for eltrombopag versus placebo e 64% patients participating in ENABLE 1 and ENABLE 2 were genotype 1 f Post-hoc analyses
Croatian: d p-vrijednost <0,05 za eltrombopag u odnosu na placebo e 64% bolesnika koji su sudjelovali u ENABLE 1 i ENABLE 2 imali su genotip 1 f post-hoc analize
English: • Pull back the plunger until all the medicine is in the syringe.
Croatian: • Povlačite klip unatrag dok sav lijek ne bude u štrcaljki.
English: The primary efficacy endpoint for both studies was sustained virologic response (SVR), defined as the percentage of patients with no detectable HCV-RNA at 24 weeks after completion of the planned treatment period.
Croatian: Primarna mjera ishoda djelotvornosti u oba ispitivanja je bila održani virološki odgovor (SVR, engl. sustained virologic response), definiran kao postotak bolesnika s nemjerljivom razinom HCV-RNA u 24. tjednu nakon završetka planiranog razdoblja liječenja.
English: For ENABLE 1, 682 patients were randomised to the antiviral treatment phase; however 2 patients then withdrew consent prior to receiving antiviral therapy.
Croatian: U ENABLE 1 ispitivanju, 682 bolesnika su randomizirana za fazu antivirusnog liječenja; međutim, 2 su bolesnika povukla pristanak prije početka uzimanja antivirusnog liječenja.
English: If you stop taking Revolade
Croatian: Ako prestanete uzimati Revolade
English: Patients with diagnosis of Fanconi anaemia, infection not responding to appropriate therapy, PNH clone size in neutrophils of ≥50%, where excluded from participation.
Croatian: Bolesnici s dijagnozom Fanconijeve anemije, infekcije koja ne odgovara na primjerenu terapiju, s veličinom klona PNH u neutrofilima od ≥50%, bili su isključeni iz sudjelovanja.
English: Your doctor may also carry out tests to directly check your bone marrow during treatment with Revolade.
Croatian: Vaš liječnik također može provesti ove testove kako bi direktno provjerio koštanu srž tijekom liječenja lijekom Revolade.
English: • Make sure not to spill the powder outside the mixing bottle.
Croatian: • Pazite da ne prospete prašak izvan boce za miješanje.
English: How to take the tablets Swallow the tablet whole, with some water.
Croatian: Progutajte tabletu cijelu, s malo vode.
English: The powder for oral suspension may lead to higher eltrombopag exposure than the tablet formulation (see section 5.2).
Croatian: Prašak za oralnu suspenziju može dovesti do veće izloženosti eltrombopagu nego formulacija tablete (vidjeti dio 5.2).
English: Marketing authorisation holder Novartis Europharm Limited Vista Building
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Novartis Europharm Limited Vista Building
English: The pharmacokinetics of eltrombopag have been evaluated in 168 paediatric ITP patients dosed once daily in two studies, TRA108062/PETIT and TRA115450/PETIT-2.
Croatian: Farmakokinetika eltrombopaga ocijenjena je u 168 pedijatrijskih bolesnika s ITP-om koji su primali dozu jednom dnevno u dva ispitivanja, TRA108062/PETIT i TRA115450/PETIT-2.
English: Absorbed eltrombopag is extensively metabolised.
Croatian: Apsorbirani eltrombopag se vrlo opsežno metabolizira.
English: If you have spilt any powder or mixed medicine, clean it up with a damp disposable cloth.
Croatian: Ako ste prosuli malo praška ili zamiješanog lijeka, očistite ga vlažnom krpicom za jednokratnu uporabu.
English: Hepatocyte degeneration and/or necrosis, often accompanied by increased serum liver enzymes, was observed in mice, rats and dogs at doses that were associated with morbidity and mortality or were poorly tolerated.
Croatian: Degeneracija i/ili nekroza hepatocita, često praćena porastom jetrenih enzima u serumu, zamijećena je u miševa, štakora i pasa, pri dozama koje su bile povezane s morbiditetom i mortalitetom ili su bile slabo podnošljive.
English: Approximately 21% of an eltrombopag dose could undergo oxidative metabolism.
Croatian: Otprilike 21% primijenjene doze eltrombopaga je podvrgnuto oksidativnom metaboliziranju.
English: Your doctor will adjust your dose of Revolade to ensure that your platelet count does not become too high.
Croatian: Vaš će liječnik prilagoditi dozu lijeka Revolade tako da broj trombocita ne naraste previše.
English: • blood in your stools
Croatian: • krv u stolicama
English: Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years on study were 85,000/l, 85,000/l, 105,000/l, 64,000/l, 75,000/l, 119,000/l and 76,000/l, respectively.
Croatian: Medijan broja trombocita nakon 1, 2, 3, 4, 5, 6 i 7 godina ispitivanja iznosio je redom 85 000/l, 85 000/l, 105 000/l, 64 000/l, 75 000/l, 119 000/l i 76 000/l.
English: In people who have problems with their bone marrow, medicines like Revolade could make the problems worse.
Croatian: U ljudi koji imaju problema s koštanom srži lijekovi kao što je Revolade mogu pogoršati probleme.
English: OATP1B1 and BCRP substrates
Croatian: Supstrati OATP1B1 i BCRP
English: If you do not use it within 30 minutes of mixing it, you will need to mix a new dose.
Croatian: Ako ga ne upotrijebite u roku od 30 minuta otkad ste ga zamiješali, morat ćete zamiješati novu dozu.
English: Following reconstitution, the medicinal product should be administered immediately but may be stored for a maximum period of 30 minutes.
Croatian: Nakon rekonstitucije lijek treba odmah primijeniti, ali može se pohraniti na najviše 30 minuta.
English: People taking Revolade for either ITP or low blood platelet counts due to hepatitis C could develop signs of potentially serious side effects.
Croatian: Osobe koje uzimaju Revolade zbog ITP-a ili niske razine krvnih pločica uzrokovane hepatitisom C mogu razviti znakove potencijalno ozbiljnih nuspojava.
English: p-value a a Logistic regression model adjusted for randomisation stratification variables
Croatian: p-vrijednost a a Model logističke regresije prilagođen za varijable randomizirane u stratuse
English: The majority of patients were HCV genotype 1 (64%) and had bridging fibrosis/cirrhosis.
Croatian: Većina bolesnika imala je HCV genotip 1 (64%) i premoštavajuću („bridging“) fibrozu/cirozu.
English: Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin.
Croatian: Interakcije se također očekuju s ostalim inhibitorima HMG-CoA reduktaze uključujući atorvastatin, fluvastatin, lovastatin, pravastatin i simvastatin.
English: • if you have cataracts (the lens of the eye getting cloudy)
Croatian: • ako imate kataraktu (zamućenje očne leće)
English: Baseline disease characteristics were similar in both studies and were consistent with compensated cirrhotic HCV patient population.
Croatian: Ishodišne karakteristike bolesti bile su slične u oba ispitivanja i bile su u skladu s HCV populacijom bolesnika s kompenziranom cirozom.
English: Before you start taking Revolade, your doctor will carry out blood tests to check your blood cells, including platelets.
Croatian: Prije nego počnete uzimati Revolade Vaš će liječnik učiniti krvne pretrage kojima će prekontrolirati krvne stanice, uključujući i trombocite.
English: The safety of Revolade in paediatric patients (aged 1 to 17 years) with previously treated ITP has been demonstrated in two studies.
Croatian: Sigurnost Revoladea u pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s prethodno tretiranim ITP-om je dokazana u dva ispitivanja.
English: • Empty all contents of each sachet into the mixing bottle
Croatian: • Ispraznite sav sadržaj svake vrećice u bočicu za miješanje
English: Some of them are not to be taken with Revolade, or the dose may need adjusting, or you may need to alter the timing of when you take them.
Croatian: Neki od njih se ne smiju uzimati u kombinaciji s lijekom Revolade ili im je potrebno prilagoditi dozu ili vrijeme uzimanja.
English: Eltrombopag was an inhibitor of a number of UGT enzymes in vitro.
Croatian: Eltrombopag je bio i inhibitor niza UGT enzima in vitro.
English: • Slowly push the plunger all the way down so the medicine goes into the child's mouth.
Croatian: • Polako gurajte klip do kraja kako bi lijek ušao u djetetova usta.
English: If no haematological response has occurred after 16 weeks of therapy with eltrombopag, therapy should be discontinued.
Croatian: Ako se nije pojavio hematološki odgovor nakon 16 tjedana terapije eltrombopagom, potrebno je prekinuti terapiju.
English: Medicinal products used in the treatment of ITP in combination with eltrombopag in clinical studies included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Croatian: Lijekovi koji su korišteni u liječenju ITP-a u kombinaciji s eltrombopagom tijekom kliničkih ispitivanja uključivali su kortikosteroide, danazol i/ili azatioprin, intravenske imunoglobuline (IVIG) i anti-D imunoglobuline.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister
English: ENABLE 1 utilised peginterferon alfa-2a plus ribavirin for antiviral treatment and ENABLE 2 utilised peginterferon alfa-2b plus ribavirin.
Croatian: U ispitivanju ENABLE 1 je kao antivirusno liječenje korišten peginterferon alfa-2a uz ribavirin, a u ispitivanju ENABLE 2 peginterferon alfa-2b uz ribavirin.
English: Revolade is not recommended for children aged under 1 year who have ITP.
Croatian: Revolade se ne preporučuje djeci mlađoj od 1 godine koja imaju ITP.
English: Eltrombopag should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus (see section 4.6).
Croatian: Eltrombopag se tijekom trudnoće može koristiti samo ako očekivana korist opravdava potencijalni rizik za fetus (vidjeti dio 4.6).
English: The treatment should not be initiated when the patients has existing cytogenetic abnormalities of chromosome 7.
Croatian: Liječenje se ne smije započinjati u bolesnika s postojećim citogenetskim abnormalnostima na kromosomu 7.
English: In the pre- and post-natal development study in rats, there were no undesirable effects on pregnancy, parturition or lactation of F0 female rats at maternally non-toxic doses (10 and 20 mg/kg/day) and no effects on the growth, development, neurobehavioural or reproductive function of the offspring (F1).
Croatian: U studiji pre- i post-natalnog razvoja štakora, nije bilo nepoželjnih učinaka na trudnoću, porod ili laktaciju F0 ženki štakora, u dozama netoksičnim po majku (10 i 20 mg/kg/dan) i nije bilo učinka na rast, razvoj, neurobihevioralnu ili reproduktivnu funkciju potomstva (F1).
English: Some everyday medicines interact with Revolade - including prescription and non-prescription medicines and minerals.
Croatian: Neki često upotrebljavani lijekovi utječu na lijek Revolade - uključujući minerale i lijekove sa i bez recepta, kao što su:
English: A total of 14 patients entered the extension phase of the trial.
Croatian: Ukupno je 14 bolesnika uključeno u produženu fazu ispitivanja.
English: The absolute oral bioavailability of eltrombopag after administration to humans has not been established.
Croatian: Apsolutna oralna bioraspoloživost eltrombopaga nakon primjene u ljudi nije ustanovljena.
English: The primary endpoint was haematological response assessed after 12 weeks of eltrombopag treatment.
Croatian: Primarni ishod bio je hematološki odgovor procijenjen nakon 12 tjedana liječenja eltrombopagom.
English: Eltrombopag inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinaemia.
Croatian: Eltrombopag inhibira UGT1A1 i OATP1B1 što može dovesti do indirektne hiperbilirubinemije.
English: Bleeding following discontinuation of eltrombopag
Croatian: Krvarenje nakon prestanka primjene eltrombopaga
English: Patients achieving target platelet counts and initiating antiviral therapy c
Croatian: Bolesnici koji su dostigli ciljni broj trombocita i započeli antivirusno liječenje c
English: Revolade is not recommended in women of childbearing potential not using contraception.
Croatian: Primjena lijeka Revolade se ne preporučuje u žena reproduktivne dobi koje ne primjenjuju kontracepciju.
English: • Add 10 ml of water to the mixing bottle and mix gently.
Croatian: • Dodajte 10 ml vode u bočicu za miješanje i lagano promućkajte.
English: • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Croatian: • praćen kliničkim simptomima oštećenja jetre ili znakovima dekompenzacije jetre.
English: Fill the syringe with the medicine.
Croatian: 9. Napunite štrcaljku lijekom.
English: Cohort 3 (1 to 5 years)
Croatian: Kohorta 3 (1 do 5 godina)
English: Monitoring and dose adjustment
Croatian: Praćenje i prilagodba doze
English: If you have any questions, or if you damage or lose any of the supplies in your kit, ask your doctor, nurse or pharmacist for advice
Croatian: Ako imate ikakvih pitanja ili ako oštetite ili izgubite bilo koji od dijelova u kompletu, upitajte svog liječnika, medicinsku sestru ili ljekarnika za savjet.
English: If you stop taking Revolade, your blood platelet count is likely to become low again within several days.
Croatian: Ako prekinete uzimanje lijeka Revolade, broj trombocita će se najvjerojatnije opet smanjiti nakon nekoliko dana.
English: Patients are analysed according to the treatment received (total safety double-blind population, Revolade n=955 and placebo n=484).
Croatian: Bolesnici su analizirani na temelju primljenog liječenja (ukupna sigurnosna populacija iz dvostruko slijepog ispitivanja, Revolade n=955 i placebo n=484).
English: The clinical significance of these QTc prolongation events is unknown.
Croatian: Nije poznata klinička značajnost ovih produljenja QTc intervala.
English: No specific temporal relationship between start of treatment and event of TEE were observed.
Croatian: Nije uočena specifična vremenska povezanost početka liječenja i pojave TED.
English: Eltrombopag treatment delayed and reduced the number of peginterferon dose reductions.
Croatian: Liječenje eltrombopagom je odgodilo i smanjilo broj smanjenja doze peginterferona.
English: Women of childbearing potential / Contraception in males and females
Croatian: Žene reproduktivne dobi / kontracepcija za muškarce i žene
English: Eltrombopag treatment should be initiated by and remain under the supervision of a physician who is experienced in the treatment of haematological diseases or the management of chronic hepatitis C and its complications.
Croatian: Liječenje eltrombopagom treba započeti i provoditi pod nadzorom liječnika specijalista s iskustvom u liječenju hematoloških bolesti ili s iskustvom u liječenju kroničnog hepatitisa C i njegovih komplikacija.
English: Food low in calcium (<50 mg calcium), including fruit, lean ham, beef and unfortified (no added calcium, magnesium or iron) fruit juice, unfortified soya milk and unfortified grain, did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content (see sections 4.2 and 4.5).
Croatian: Hrana s niskim udjelom kalcija (<50 mg kalcija), uključujući voće, nemasnu šunku, govedinu i neobogaćeni (bez dodanog kalcija, magnezija ili željeza) voćni sok, neobogaćeno sojino mlijeko i neobogaćene žitarice, nije značajno utjecala na plazmatsku izloženost eltrombopagu, bez obzira na kalorijsku vrijednost i sadržaj masnoća (vidjeti dijelove 4.2 i 4.5).
English: If counts remain stable after 8 weeks at the reduced dose, then eltrombopag must be discontinued and blood counts monitored.
Croatian: Ako krvna slika ostane stabilna nakon 8 tjedana na smanjenoj dozi, mora se prekinuti liječenje eltrombopagom i pratiti krvnu sliku.
English: • Revolade may also be used to treat adult patients with low blood counts caused by severe aplastic anaemia (SAA).
Croatian: • Revolade se može koristiti i za liječenje odraslih bolesnika s niskim razinama krvnih stanica uzrokovanim teškom aplastičnom anemijom.
English: The aim of treatment with eltrombopag should be to achieve the minimum level of platelet counts needed to initiate antiviral therapy, in adherence to clinical practice recommendations.
Croatian: Cilj liječenja eltrombopagom treba biti postizanje najniže razine broja trombocita za započinjanje antivirusnog liječenja, u skladu s preporukama kliničke prakse.