FrancophonIA/ELRC3.0 huggingface dataset:
English: • high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin
Croatian: • visoke doze od najmanje 1 grama dnevno niacina (nikotinske kiseline) ili liječenje koje sadrži niacin (lijek za snižavanje razina masnoća u krvi)
English: They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
Croatian: Obje djelatne tvari koriste se za snižavanje razina ukupnog kolesterola, "lošeg" kolesterola (LDL kolesterol) i masnih tvari koje se zovu trigliceridi u krvi.
English: Pancreatitis*
Croatian: Pankreatitis*
English: Pharmacotherapeutic group: Lipid modifying substances, HMG-CoA reductase inhibitors in combination with other lipid modifying substances, ATC code: C10BA04
Croatian: Farmakoterapijska skupina: lijekovi koji modificiraju lipide, inhibitori HMG-CoA reduktaze u kombinaciji s drugim lijekovima koji modificiraju lipide, ATK oznaka: C10BA04
English: If you are allergic to peanut, soya or arachis oil do not use Cholib.
Croatian: Ako ste alergični na kikiriki, soju ili ulje od kikirikija nemojte uzimati Cholib.
English: • muscle problems
Croatian: • problemi s mišićima
English: Cholib contains sunset yellow FCF (E110) that may cause allergic reactions.
Croatian: Cholib sadrži bojilo sunset yellow FCF (E110) koje može uzrokovati alergijske reakcije.
English: Interaction between simvastatin and fenofibrate
Croatian: Interakcije između simvastatina i fenofibrata
English: The combination F145/S40 showed superiority over S40 for LDL-C reduction only at 24 weeks from a non-significant additional 1.2% reduction of LDL-C at 12 weeks to a statistically significant 7.2% reduction at 24 weeks.
Croatian: Kombinacija F145/S40 pokazala je superiornost u odnosu na S40 u snižavanju LDL-C-a samo u 24. tjednu, od beznačajnog dodatnog 1,2%-tnog sniženja LDL-C-a u 12. tjednu do statistički značajnog 7,2%-tnog sniženja u 24. tjednu.
English: Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p=0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Croatian: Analiza druge unaprijed definirane podskupine pokazala je statistički značajni utjecaj spola na ishod liječenja (p=0,01), pokazujući moguću korist liječenja kombiniranom terapijom kod muškaraca (p=0,037), ali potencijalno viši rizik za primarni ishod kod žena liječenih kombiniranom terapijom u usporedbi s monoterapijom simvastatinom (p=0,069).
English: P450 (CYP) 3A4 inhibitors (see section 4.5)
Croatian: P450 (CYP) 3A4 (vidjeti dio 4.5)
English: In rats and mice, liver tumours have been found in carcinogenicity studies, which are attributable to peroxisome proliferation.
Croatian: U ispitivanjima karcinogenosti na štakorima i miševima nađeni su tumori jetre, što se pripisuje proliferaciji peroksisoma.
English: Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis) may experience loss of efficacy of simvastatin.
Croatian: Budući da je rifampicin potentni induktor CYP 3A4 koji interferira s metabolizmom simvastatina, kod bolesnika koji započinju dugotrajnu terapiju rifampicinom (npr. liječenje tuberkuloze) može doći do gubitka djelotvornosti simvastatina.
English: Do not exceed one Cholib 145 mg/20 mg per day, unless clinical benefit outweigh the risk
Croatian: Ne smije se prekoračiti doza od jedne tablete lijeka Cholib 145 mg/20 mg dnevno, osim ako je klinička korist veća od rizika
English: • Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down.
Croatian: • Neobjašnjiva bol, osjetljivost ili slabost mišića može biti znak razgradnje mišića.
English: Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8).
Croatian: Pankreatitis je prijavljen u bolesnika koji su uzimali fenofibrat (vidjeti dijelove 4.3 i 4.8).
English: Fenofibric acid is not eliminated by hemodialysis.
Croatian: Fenofibrična kiselina ne eliminira se hemodijalizom.
English: Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII.
Croatian: Kroz aktivaciju PPARα, fenofibrat aktivira stvaranje lipoprotein lipaze i smanjuje stvaranje apoproteina CIII.
English: All patients starting therapy, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness.
Croatian: Potrebno je savjetovati sve bolesnike koji započinju terapiju, ili čija je doza simvastatina povećana, na rizik od miopatije i reći im da odmah prijave bilo koju neobjašnjivu bol, osjetljivost ili slabost mišića.
English: • a fibrate (e.g. fenofibrate, gemfibrozil)
Croatian: • fibrat (npr. fenofibrat, gemfibrozil)
English: Concomitant intake of large quantities (over 1 liter daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in plasma exposure to simvastatin acid.
Croatian: Istodobni unos velikih količina (više od 1 litre dnevno) soka od grejpa i simvastatina rezultiralo je povećanjem izloženosti simvastatinskoj kiselini od 7 puta u plazmi.
English: LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque.
Croatian: LDL kolesterol često se naziva "lošim" kolesterolom zato što se može nakupiti u stijenkama arterija i stvoriti plak.
English: Week 12 to Week 24
Croatian: Od 12. tjedna do 24. tjedna
English: Simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction.
Croatian: Simvastatin se dobro apsorbira i prolazi opsežan prvi prolazak kroz jetru.
English: This medicinal product contains sunset yellow FCF (E110) that may cause allergic reactions.
Croatian: Ovaj lijek sadrži bojilo sunset yellow FCF (E110) koje može uzrokovati alergijske reakcije.
English: The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose.
Croatian: Raspoloživost beta-hidroksi kiseline u sistemskoj cirkulaciji nakon peroralne doze simvastatina niža je od 5% primijenjene doze.
English: Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors.
Croatian: Više mehanizama može doprinijeti mogućim interakcijama s inhibitorima HMG Co-A reduktaze.
English: If you are worried about this, talk to your doctor or pharmacist.
Croatian: Ako ste zabrinuti zbog toga, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: The risk of rhabdomyolysis is also increased in patients concomitantly receiving other fibrates or statins.
Croatian: Rizik od rabdomiolize također je povećan u bolesnika koji istodobno primaju druge fibrate ili statine.
English: • cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
Croatian: • grčevi ili bolni, osjetljivi ili slabi mišići - to mogu biti znakovi upale ili razgradnje mišića, što može dovesti do oštećenja bubrega ili čak do smrti
English: Temporary suspension of Cholib treatment may be considered
Croatian: Možda će biti potrebno razmotriti privremenu obustavu liječenja Cholibom
English: Creatine kinase measurement
Croatian: Mjerenje kreatin kinaze
English: Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if aspartate aminotransferase (AST) or also known as serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or also known as serum glutamic pyruvic transaminase (SGPT) levels increase to more than 3 times the upper limit of the normal range.
Croatian: Potrebno je obratiti pažnju na bolesnike koji razviju povišenje razina transaminaza, a terapiju treba prekinuti ako je povišenje razina aspartat-aminotransferaze (AST), također poznata i kao serumska glutamat-oksaloacetat transaminaza (SGOT), i alanin-aminotransferaze (ALT), također poznata i kao serumska glutamat-piruvat-transaminaza (SGPT), preko 3 puta iznad raspona gornje granice normale.
English: In patients with SLCO1B1 polymorphism there is a risk of increased exposure of simvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4).
Croatian: U bolesnika s polimorfizmom SLCO1B1 postoji rizik od povećane izloženosti simvastatinu, što može rezultirati povećanim rizikom od rabdomiolize (vidjeti dio 4.4).
English: • Pregnancy and breast-feeding (see section 4.6)
Croatian: • Trudnoća i dojenje (vidjeti dio 4.6)
English: Intake of 240 mL of grapefruit juice in the morning and simvastatin in the evening also resulted in a 1.9-fold increase in plasma exposure to simvastatin acid.
Croatian: Unos 240 ml soka od grejpa ujutro i simvastatina navečer također je rezultirao povećanjem izloženosti simvastatinskoj kiselini od 1,9 puta u plazmi.
English: Because the dose of simvastatin should not exceed 10 mg daily in patients taking ciclosporin, the co-administration of Cholib with ciclosporin is contraindicated (see section 4.3).
Croatian: Budući da doza simvastatina ne smije prijeći 10 mg dnevno u bolesnika koji uzimaju ciklosporin, istodobna primjena Choliba sa ciklosporinom je kontraindicirana (vidjeti dio 4.3).
English: As simvastatin is contraindicated during pregnancy (see hereafter), Cholib is contraindicated during pregnancy (see section 4.3).
Croatian: Budući da je simvastatin kontraindiciran tijekom trudnoće (vidjeti u nastavku), Cholib je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Carriers of the SLCO1B1 gene c.521T>C allele have lower OATP1B1 activity.
Croatian: Nositelji alela c.521T>C gena SLCO1B1 imaju nižu aktivnost OATP1B1.
English: Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.
Croatian: Pokazalo se da simvastatin snižava koncentraciju normalnog i povišenog LDL-C-a.
English: Fenofibrate is water-insoluble and must be taken with food to facilitate absorption.
Croatian: Fenofibrat je topiv u vodi i mora se uzimati uz hranu radi bolje apsorpcije.
English: Cholib contains types of sugars called lactose and sucrose.
Croatian: Cholib sadrži vrste šećera koji se zovu laktoza i saharoza.
English: Although the mechanism is not fully understood, ciclosporin has been shown to increase the plasma exposure (AUC) to simvastatin acid, presumably due in part to inhibition of CYP 3A4 and OATP-1B1 transporter.
Croatian: Iako mehanizam nije posve jasan, pokazalo se da ciklosporin povećava izloženost u plazmi (AUC) simvastatinskoj kiselini, a pretpostavlja se djelomično zbog inhibicije CYP 3A4 i OATP-1B1 transportera.
English: • nefazodone (a medicine for depression)
Croatian: • nefazodon (lijek za depresiju)
English: Based on the results of the SEARCH trial, homozygote C allele carriers (also called CC) treated with 80 mg have a 15% risk of myopathy within one year, while the risk in heterozygote C allele carriers (CT) is 1.5%.
Croatian: Na temelju rezultata ispitivanja SEARCH, nositelji homozigotnog alela C (koji se još nazivaju CC) liječeni s 80 mg imaju 15%-tni rizik od javljanja miopatije unutar jedne godine, dok je u nositelja heterozigotnog alela C (CT) rizik 1,5%.
English: As well as the medicines listed previously, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:
Croatian: Osim navedenih lijekova, obavijestite svog liječnika ili ljekarnika ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koji od sljedećih lijekova:
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Croatian: Sveukupni učinak je smanjeni omjer lipoproteina male i vrlo male gustoće u odnosu na lipoproteine visoke gustoće.
English: Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway.
Croatian: Gemfibrozil povećava AUC simvastatinske kiseline za 1,9 puta, vjerojatno zbog inhibicije glukuronidacijskog puta.
English: In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended.
Croatian: Radi utvrđivanja referentne početne vrijednosti, potrebno je izmjeriti razine kreatin fosfokinaze i preporučuje se kliničko praćenje.
English: In a clinical trial, myopathy was reported in 6% of patients receiving simvastatin 80 mg and amiodarone, versus 0.4% in patients on simvastatin 80 mg only.
Croatian: U kliničkom ispitivanju, miopatija je prijavljena u 6% bolesnika koji su primali simvastatin 80 mg i amiodaron, naspram 0,4% u bolesnika koji su primali samo simvastatin 80 mg.
English: Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate.
Croatian: Neki dokazi ukazuju da statini kao skupina lijekova povisuju glukozu u krvi, a u nekih bolesnika, s visokim rizikom od razvoja šećerne bolesti, mogu prouzročiti razinu hiperglikemije kod koje je prikladno propisano zbrinjavanje šećerne bolesti.
English: The mean exposure (AUC) of the main active metabolite, simvastatin acid is 120% in heterozygote carriers (CT) of the C allele and 221% in homozygote (CC) carriers relative to that of patients who have the most common genotype (TT).
Croatian: Srednja izloženost (AUC) glavnom aktivnom metabolitu, simvastatinskoj kiselini, je 120% u heterozigotnih nositelja (CT) alela C i 221% u homozigotnih nositelja (CC) u odnosu na onu u bolesnika koji imaju najčešći genotip (TT).
English: • If you are allergic to peanut, arachis oil, soya lecithin or related substances
Croatian: • Ako ste alergični na kikiriki, ulje od kikirikija, sojin lecitin ili srodne tvari
English: The risk of muscle toxicity may be increased if Cholib is administered with another fibrate, statin, niacin, fusidic acid or other specific concomitant substances (for specific interactions see section 4.5).
Croatian: Rizik od mišićne toksičnosti može se povećati ako se Cholib primjenjuje istodobno s drugim fibratom, statinom, niacinom, fusidatnom kiselinom ili drugim specifičnim lijekovima (za specifične interakcije vidjeti dio 4.5).
English: • itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections)
Croatian: • itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)
English: • If you have moderate or severe kidney problems
Croatian: • Ako imate umjerene ili teške probleme s bubrezima
English: Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPAR).
Croatian: Fenofibrat je derivat fibrične kiseline, čiji su dokumentirani učinci na modifikaciju lipida u čovjeka posredovani aktivacijom peroksisomskih proliferator aktivirajućih receptora tipa alfa (Peroxisome Proliferator Activated Receptor type alpha, PPARα).
English: Maximum plasma concentrations (Cmax) of fenofibrate occur within 2 to 4 hours after oral administration.
Croatian: Maksimalne koncentracije fenofibrata u plazmi (Cmax) postižu se 2 do 4 sata nakon peroralne primjene.
English: • stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
Croatian: • bol u trbuhu - to može biti znak da Vam je gušterača upaljena (pankreatitis)
English: Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU.
Croatian: Kategorije učestalosti temelje se na informacijama dostupnim iz Sažetaka opisa svojstava lijeka simvastatina i fenofibrata koji su dostupni u EU.
English: In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations:
Croatian: Radi utvrđivanja referentne početne vrijednosti, u sljedećim je situacijama potrebno izmjeriti razinu kreatin kinaze prije početka liječenja:
English: A few cases of simvastatin overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae.
Croatian: Prijavljeno je nekoliko slučajeva predoziranja simvastatinom; maksimalna uzeta doza bila je 3,6 g.
English: Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy.
Croatian: Potentni inhibitori citokroma P450 3A4 povećavaju rizik od miopatije i rabdomiolize povećavajući koncentraciju inhibitorne aktivnosti HMG-CoA reduktaze u plazmi tijekom terapije simvastatinom.
English: Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below.
Croatian: Dodatne informacije o pojedinačnim djelatnim tvarima u fiksnoj kombinaciji doze Dodatne nuspojave povezane uz primjenu lijekova koji sadrže simvastatin ili fenofibrat opažene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet koje bi se mogle pojaviti s Cholibom navedene su u nastavku.
English: Your doctor may do a blood test to check your muscles before and after starting treatment.
Croatian: Liječnik Vas može uputiti na pretragu krvi radi provjere Vaših mišića prije početka liječenja.
English: Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4)
Croatian: Tendinopatija Imunološki posredovana nekrotizirajuća miopatija (vidjeti dio 4.4)
English: In one study the AUC of the simvastatin acid (SVA), a major active metabolite of simvastatin, was reduced by 42% (90% CI 24%-56%) when a single dose of 40 mg simvastatin was combined with repeated administration of fenofibrate 160 mg.
Croatian: U jednom ispitivanju AUC simvastatinske kiseline (SVA), glavnog aktivnog metabolita simvastatina, bio je smanjen za 42% (90% CI 24%-56%) kada je jednokratna doza od 40 mg simvastatina kombinirana s ponovljenom primjenom 160 mg fenofibrata.
English: Blood homocysteine level increased (see section 4.4)*****
Croatian: Povišenje razine homocisteina u krvi (vidjeti dio 4.4)*****
English: Intake of grapefruit juice during treatment with Cholib should therefore be avoided.
Croatian: Zato je potrebno izbjegavati unos soka od grejpa tijekom liječenja Cholibom.
English: This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment.
Croatian: Općenito su povišenja serumskog kreatinina bila stabilna tijekom vremena i nije bilo dokaza o njegovim daljnjim povišenjima kod dugotrajne terapije, a vrijednosti su se vratile na početne nakon prekida liječenja.
English: The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of (CYP) 3A4 (see section 4.5).
Croatian: Rizik od miopatije i rabdomiolize značajno se povećava istodobnom primjenom simvastatina s potentnim inhibitorima (CYP) 3A4 (vidjeti dio 4.5).
English: 0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values >200 µmol/l.
Croatian: 0,3% bolesnika koji su istodobno primali navedene lijekove imalo je klinički značajna povišenja kreatinina do vrijednosti >200 µmol/l.
English: • ciclosporin (a medicine often used in organ transplant patients)
Croatian: • ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)
English: Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.
Croatian: Sekundarni uzroci hiperlipidemije, kao što je nekontrolirana šećerna bolest tipa 2, hipotireoza, nefrotski sindrom, disproteinemija, opstruktivna bolest jetre, farmakološko liječenje (poput peroralnih estrogena) i alkoholizam moraju se odgovarajuće liječiti prije razmatranja terapije Cholibom, a bolesnici se moraju staviti na standardnu dijetu za snižavanje kolesterola i triglicerida koju trebaju nastaviti tijekom liječenja.
English: After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Croatian: Nakon peroralne primjene fenofibrat se brzo hidrolizira uz pomoć esteraza u aktivni metabolit fenofibričnu kiselinu.
English: In the other study [Bergman et al, 2004] repeated co-administration of both simvastatin 80 mg and fenofibrate 160 mg led to a reduction in the AUC of the SVA of 36% (90% CI 30%-42%).
Croatian: U drugom ispitivanju [Bergman et al, 2004] ponovljena istodobna primjena 80 mg simvastatina i 160 mg fenofibrata dovela je do smanjenja AUC-a SVA-a za 36% (90% CI 30%-42%).
English: Simvastatin is a substrate of CYP 3A4 and of the efflux transporter BCRP.
Croatian: Simvastatin je supstrat CYP 3A4 i efluksnog transportera BCRP-a.
English: The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption.
Croatian: Uporaba mikroniziranog fenofibrata i tehnologije NanoCrystal za formulaciju tablete fenofibrata 145 mg poboljšava njezinu apsorpciju.
English: Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis.
Croatian: Smanjena funkcija jetrenih transportnih proteina OATP (polipeptidni transporter anorganskih aniona) može povećati sistemsku izloženost simvastatinu i povećati rizik od miopatije i rabdomiolize.
English: • amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions)
Croatian: • amiodaron (lijek za nepravilne otkucaje srca) ili verapamil (lijek za povišeni krvni tlak, boli u prsima povezana s bolešću srca ili s drugim srčanim tegobama)
English: You may need to stop taking Cholib for a short time.
Croatian: Možda ćete trebati nakratko prestati uzimati
English: During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin.
Croatian: Tijekom četiri dvostruko slijepa klinička ispitivanja u trajanju od 24 tjedna, 1237 bolesnika istodobno je liječeno fenofibratom i simvastatinom.
English: • If you have liver or gallbladder problems
Croatian: • Ako imate problema s jetrom ili žučnim mjehurom
English: Veno-thromboembolic events
Croatian: Venski tromboembolijski događaji
English: Cholib is not expected to affect you being able to drive or use tools or machines.
Croatian: Ne očekuje se da će Cholib utjecati na Vašu sposobnost upravljanja vozilima ili rada na strojevima.
English: Maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Croatian: Liječenje majke simvastatinom može smanjiti fetalne razine mevalonata, koji je prekursor biosinteze kolesterola.