FrancophonIA/ELRC3.0 huggingface dataset:
English: There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.
Croatian: Postoje dokazi da liječenje fibratima može smanjiti omjer koronarnih srčanih bolesti, ali nije dokazano da smanjuju smrtnost u primarnoj ili sekundarnoj prevenciji kardiovaskularnih bolesti.
English: Fenofibrate has a uricosuric effect and is therefore of additional benefit in such patients.
Croatian: Fenofibrat ima urikozurični učinak i stoga dodatno koristi ovim bolesnicima.
English: Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin.
Croatian: Iako su te promjene bile male nužan je oprez kada se pravastatin primjenjuje s eritromicinom ili klaritromicinom.
English: Studies on mutagenicity of fenofibrate have been negative.
Croatian: Ispitivanja mutagenosti fenofibrata bila su negativna.
English: Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
Croatian: Razine mokraćne kiseline u plazmi povišene su u približno 20% bolesnika s hiperlipidemijom, osobito u onih s bolešću tipa IV.
English: - To raise the level of your ‘good' cholesterol (HDL cholesterol).
Croatian: - za podizanje razine "dobrog" kolesterola (HDL kolesterol).
English: This is why medicinal products that are metabolised by, or are inhibitors of, the cytochrome P450 system can be added to a stable regimen of pravastatin without causing significant changes in the plasma levels of pravastatin, as have been seen with other statins.
Croatian: To je razlog zbog kojeg se lijekovi koji se metaboliziraju putem ili inhibiraju sustav citokroma P450 mogu dodavati stabilnom režimu pravastatina bez da to uzrokuje značajne promjene razina pravastatina u plazmi, kao što je viđeno s drugim statinima.
English: In some patients, however, the increase in pravastatin exposure may be larger.
Croatian: Međutim u nekih bolesnika ovo povećanje izloženosti pravastatinu može biti veće.
English: Special attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceed 3 times the ULN and persist.
Croatian: Posebnu pažnju treba posvetiti bolesnicima kod kojih se razvije povišenje razina transaminaza, a terapiju treba prekinuti ako povišenja aspartat aminotransferaze (AST) i alanin aminotransferaze (ALT) premaše 3 puta GGN i ostanu povišene.
English: Response to therapy should be monitored by determination of serum lipid values.
Croatian: Odgovor na terapiju mora se nadzirati određivanjem vrijednosti lipida u serumu.
English: Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests.
Croatian: Prijavljeni slučajevi predoziranja bili su asimptomatski i nisu uzrokovali nenormalne rezultate laboratorijskih testova.
English: Adverse reactions have usually been mild and transient.
Croatian: Nuspojave su obično bile blage i prolazne.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, deficijencijom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
English: Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.
Croatian: Ako ste zaboravili uzeti Pravafenix Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, samo uzmite svoju normalnu količinu Pravafenixa sljedećeg dana u uobičajeno vrijeme.
English: • Problems with sight such as blurred or double vision.
Croatian: • Problemi s vidom poput zamućenog vida i dvoslika.
English: Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing.
Croatian: Iznenadne teške alergijske reakcije uključujući oticanje lica, usnice, jezika ili dušnika mogu uzrokovati velike teškoće pri disanju.
English: Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Croatian: Učestalosti nuspojava navedene su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000).
English: Sleep disturbance including insomnia and nightmares
Croatian: Psihijatrijski poremećaji poremećaj spavanja uključujući nesanicu i noćne more
English: Co-administration of this combination may cause increased plasma concentrations of both agents.
Croatian: Istodobna primjena ove kombinacije može uzrokovati povišenje koncentracija u plazmi oba lijeka.
English: There are no data on the excretion of fenofibrate and/or its metabolites into human breast milk.
Croatian: Nema podataka o izlučivanju fenofibrata i/ili njegovih metabolita u majčino mlijeko u ljudi.
English: Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)
Croatian: Moguće nuspojave koje su prijavljene s nekim statinima (iste vrste lijekova za snižavanje kolesterola kao i pravastatin)
English: The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Croatian: Povećan rizik od venskih trombotičkih događaja mogu biti povezani s povećanjem razine hemocisteina, faktora rizika za trombozu i drugih neutvrđenih faktora.
English: • Breathing problems including persistent cough/or shortness of breath or fever.
Croatian: • Problemi pri disanju uključujući stalni kašalj/ili nedostatak zraka ili vrućicu.
English: The combination has not been tested in reproductive toxicity studies.
Croatian: Ova kombinacija nije ispitana u ispitivanjima reproduktivne toksičnosti.
English: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
Croatian: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgija
English: Technimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
Croatian: Tecnimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
English: After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation.
Croatian: Nakon intravenske primjene 47% doze eliminira se izlučivanjem putem bubrega, a 53% izlučivanjem putem žuči i biotransformacijom.
English: No sign of any effect on fertility has been detected.
Croatian: Nije primijećen bilo kakav znak učinka na plodnost.
English: Pravastatin is not significantly metabolised by cytochrome P450 nor does it appear to be a substrate or an inhibitor of P-glycoprotein but rather a substrate of other transport proteins.
Croatian: Pravastatin se ne metabolizira značajno putem citokroma P450 niti se čini da je supstrat ili inhibitor Pglikoproteina, već da je supstrat drugih transportnih proteina.
English: Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Croatian: Ispitivanjima kronične toksičnosti nisu dobivene značajne informacije o specifičnoj toksičnosti fenofibrata.
English: Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels).
Croatian: Prekid liječenja treba također razmotriti kada su mišićni simptomi teški i uzrokuju svakodnevnu nelagodu (bez obzira razine KF).
English: After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
Croatian: Nakon apsorpcije 66% pravastatina prolazi ekstrakciju prvim prolaskom kroz jetru, koja je i primarno mjesto njegovog djelovanja i primarno mjesto sinteze kolesterola i klirensa LDL kolesterola.
English: In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation.
Croatian: U većini slučajeva razine jetrenih transaminaza vratile su se na početne vrijednosti bez potrebe prekidanja liječenja.
English: The plasma elimination half-life of fenofibric acid is approximately 20 hours.
Croatian: Poluvijek eliminacije fenofibrične kiseline iz plazme je približno 20 sati.
English: If a patient plans to become pregnant or becomes pregnant, the physician has to be informed immediately and pravastatin should be discontinued because of the potential risk to the foetus.
Croatian: Ako bolesnica planira zatrudnjeti ili zatrudni mora o tome odmah obavijestiti liječnika a liječenje pravastatinom mora se odmah prekinuti zbog potencijalnog rizika za fetus.
English: Pravastatin is administered orally in the active form.
Croatian: Pravastatin se primjenjuje peroralno u aktivnom obliku.
English: This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Croatian: Ovo nije zabilježeno u spomenutoj podskupini oboljelih od dislipidemije, ali također nema jasnih dokaza o koristi kod žena oboljelih od dislipidemije liječenih fenofibratom uz simvastatin, i mogući štetni učinak u ovoj podskupini ne može se isključiti.
English: Concomitant administration resulted in approximately 40 to 50% decrease in the bioavailability of pravastatin.
Croatian: Istodobna primjena rezultirala je približno 40 do 50%-tnim smanjenjem bioraspoloživosti pravastatina.
English: - Before starting taking Pravafenix, you should be on a diet to lower your cholesterol.
Croatian: - Prije nego počnete uzimati Pravafenix morate biti na dijeti za snižavanje kolesterola.
English: - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
Croatian: - Poznata fotoalergija ili fototoksična reakcija tijekom liječenja fibratima ili ketoprofenom.
English: The presence of food in the gastrointestinal tract leads to a reduction in the bioavailability, but the cholesterol-lowering effect of pravastatin is identical whether taken with or without food.
Croatian: Prisutnost hrane u gastrointestinalnom traktu dovodi do smanjenja bioraspoloživosti, ali je učinak na snižavanje kolesterola pravastatina jednak onome kada se uzima s hranom ili bez nje.
English: The absorption of fenofibrate is increased when administered with food.
Croatian: Apsorpcija fenofibrata je povećana kada se primjenjuje s hranom.
English: Colestyramine/Colestipol
Croatian: Kolestiramin/kolestipol
English: Alopecia, photosensitivity reactions
Croatian: Manje često alopecija, reakcije fotoosjetljivosti
English: Also see section 4.4
Croatian: Također vidjeti dio 4.4.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: Animal studies have not demonstrated any teratogenic effects.
Croatian: Ispitivanja na životinjama nisu pokazala bilo kakve teratogene učinke.
English: However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment.
Croatian: Ipak, prilikom upravljanja vozilima ili rada na strojevima treba uzeti u obzir da tijekom liječenja mogu nastupiti omaglica ili smetnje vida.
English: The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy.
Croatian: Početne razine CK mogu biti korisne kao referentne u slučaju kasnijeg povećanja tijekom kombinirane terapije.
English: Each hard capsule contains 19 mg of lactose.
Croatian: Svaka tvrda kapsula sadrži 19 mg laktoze.
English: Pravastatin is more effective in reducing LDL-C and total cholesterol but presents only modest effects on TG and HDL-C while fenofibrate is very effective in decreasing TG and increasing HDL-C, but with few effects on LDL-C.
Croatian: Pravastatin je djelotvorniji u snižavanju LDL-C i ukupnog kolesterola ali ima samo male učinke na TG i HDL-C, dok je fenofibrat vrlo djelotvoran na snižavanje TG i povišenje HDL-C, ali s nekim učincima na LDL-C.
English: The results of this study show that food has effect on the rate and extent of absorption in the fixed dose combination.
Croatian: Rezultati ovog ispitivanja pokazuju da hrana ima učinak na stopu i opseg apsorpcije kombinacije fiksne doze.
English: Also see section 4 of this leaflet.
Croatian: Vidjeti također dio 4 u ovoj Uputi.
English: In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Croatian: U sličnom ispitivanju s klaritromicinom primijećeno je statistički značajno povećanje AUC (110%) i Cmax (127%).
English: Pravafenix contains fenofibrate and pravastatin, which have different modes of action and show additive effects in terms of reduction of serum lipid.
Croatian: Pravafenix sadrži fenofibrat i pravastatin koji imaju različite načine djelovanja i pokazuju dodatne učinke u smislu snižavanja lipida u serumu.
English: What Pravafenix looks like and contents of the pack
Croatian: Kako Pravafenix izgleda i sadržaj pakiranja
English: When the blood flow is blocked, the result can be a heart attack or stroke.
Croatian: Kad je protok krvi blokiran to može imati za posljedicu srčani ili moždani udar.
English: Special caution is recommended in women of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy.
Croatian: Preporučuje se poseban oprez u žena reproduktivne dobi u smislu da su dobro shvatile potencijalni rizik koji je povezan s terapijom pravastatinom tijekom trudnoće.
English: Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Croatian: Kinetička ispitivanja nakon primjene jednokratne doze i kontinuiranog liječenja nisu pokazala da se lijek akumulira.
English: Excipient(s) with known effect:
Croatian: Pomoćna tvar s poznatim učinkom:
English: Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Croatian: Fenofibrat se uglavnom izlučuje u obliku fenofibrične kiseline i njegovog glukuronidnog konjugata.
English: In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
Croatian: U štakora i miševa tumori jetre su nađeni pri visokim dozama što se pripisuje proliferaciji peroksisoma.
English: Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Croatian: Osobitosti koje se javljaju mogu uključivati dispneju, neproduktivni kašalj i pogoršanje općeg zdravlja (umor, gubitak na težini i vrućica).
English: Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding.
Croatian: Fenofibrat pojačava učinak oralnih antikoagulansa i može povećati rizik od krvarenja.
English: In the event of an overdose, symptomatic and supportive measures should be employed.
Croatian: U slučaju predoziranja potrebno je poduzeti mjere simptomatskog i potpornog liječenja.
English: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
Croatian: Nepromijenjeni fenofibrat ne može se utvrditi u plazmi, gdje mu je glavni metabolit fenofibrična kiselina.
English: - Your doctor should do a blood test before you start taking Pravafenix.
Croatian: - Liječnik Vam treba učiniti krvnu pretragu prije nego počnete uzimati Pravafenix.
English: Both are cholesterol/lipid modifying medicines.
Croatian: Oboje su lijekovi koji modificiraju kolesterol/lipide.
English: Before you take Pravafenix you should tell your doctor if you have or have had any medical problems.
Croatian: Prije početka uzimanja Pravafenixa trebate reći svom liječniku ako ste imali bilo kakvih zdravstvenih problema.
English: Additionally, fibrates have the properties to modify the size and density of LDL-C particles to make them less atherogenic.
Croatian: Dodatno, fenofibrati imaju svojstva modificiranja veličine i gustoće čestica LDL-C, čineći ih tako manje aterogenim.
English: The plasma concentrations are proportional to the doses administered.
Croatian: Koncentracije u plazmi proporcionalne su primijenjenim dozama.
English: This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Croatian: Ovo je vjerojatnije ako imate povišene razine šećera i masnoća u krvi, ako ste predebeli i ako imate povišen krvni tlak.
English: Check with your doctor or pharmacist before taking Pravafenix if you have severe respiratory failure, e.g. you have breathing problems including, persistent non-productive cough, deterioration in general health like fatigue (tiredness), weight loss and/or shortness of breath or fever.
Croatian: Prije nego počnete uzimati Pravafenix provjerite sa svojim liječnikom ili ljekarnikom imate li ozbiljno zatajivanje disanja, npr. imate teškoća pri disanju uključujući stalni neproduktivni kašalj, pogoršanje općeg zdravlja poput umora (umor), gubitka na težini i/ili nedostatka zraka ili vrućicu.
English: The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.
Croatian: Stoga se bubrežna funkcija ovih bolesnika mora pomno pratiti i prekinuti liječenje fenofibratom u slučaju teških alteracija laboratorijskih parametara.
English: It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
Croatian: To čini snižavanjem razine ukupnog kolesterola i masnih tvari zvanih trigliceridi u krvi.
English: This is because on very rare occasions (may affect up to 1 in 10,000 people), muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Croatian: Ovo je iz razloga što, u rijetkim slučajevima (mogu se javiti u do 1 na 10 000 osoba), problemi s mišićima mogu biti ozbiljni, uključujući razgradnju mišića s posljedičnim oštećenjem bubrega, a vrlo rijetko može nastupiti i smrt.
English: Clinical and biochemical monitoring of patients receiving this combination is recommended.
Croatian: Preporučuje se kliničko i laboratorijsko praćenje bolesnika koji primaju ovu kombinaciju lijekova.
English: Interactions relevant to pravastatin
Croatian: Interakcije značajne za pravastatin
English: Other medicines and Pravafenix
Croatian: Drugi lijekovi i Pravafenix
English: Dietary restrictions instituted before therapy should be continued.
Croatian: Dijetalne restrikcije započete prije terapije treba nastaviti.
English: Fenofibrate is excreted in milk of female rat.
Croatian: Fenofibrat se izlučuje u mlijeko ženke štakora.
English: Children and adolescents Do not take Pravafenix if you are under 18 years old
Croatian: Nemojte uzimati Pravafenix ako ste mlađi od 18 godina.
English: In all clinical trials, patients were instructed to take Pravafenix daily during the evening meal and dietary restrictions instituted before therapy should be continued.
Croatian: U svim kliničkim ispitivanjima bolesnici su dobili uputu da uzimaju Pravafenix svakodnevno tijekom večernjeg obroka i da nastave restriktivnu dijetu započetu prije početka terapije.
English: In total, these studies enrolled 1,637 patients who have not had an adequate response to treatment with pravastatin 40 mg monotherapy or simvastatin 20 mg in Europe and in the USA.
Croatian: Sveukupno je u ova ispitivanja bilo uključeno 1637 bolesnika u Europi i SAD-u koji nisu imali odgovarajući odgovor na liječenje monoterapijom pravastatinom u dozi od 40 mg ili simvastatinom u dozi od 20 mg.
English: (anticoagulants) - An antibiotic such as erythromycin, clarithromycin to treat infections caused by bacteria.
Croatian: - antibioticima poput eritomicina, klaritromicina radi liječenja infekcija uzrokovanih bakterijama,
English: • Tiredness, weakness, influenza-like illness.
Croatian: • Umor, slabost, bolest nalik gripi.
English: In these cases, CK levels should be measured.
Croatian: U tim slučajevima potrebno je mjeriti razine KF.
English: Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
Croatian: Rabdomioliza je akutno stanje skeletnih mišića s mogućim smrtnim ishodom, koje se može razviti u bilo kojem trenutku tijekom liječenja, a karakteriziraju ga masivna destrukcija mišića povezana s velikim povišenjem CK (obično > 30 ili 40 puta GGN) koje dovodi do mioglobinurije.
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Croatian: Prijavljeni su iznimni slučajevi intersticijske bolesti pluća tijekom s nekim statinima, naročito s dugotrajnom terapijom (vidjeti dio 4.8).
English: If CK levels are significantly elevated > 5 times the ULN at baseline, the results should be controlled after 5-7 days.
Croatian: Ako su razine CK na početku liječenja značajno povišene > 5 puta GGN, rezultate treba kontrolirati nakon 5-7 dana.
English: • Effects on liver: raised serum transaminases.
Croatian: • Učinci na jetru: povišene transaminaze u serumu.
English: It contains two active substances: pravastatin and fenofibrate.
Croatian: Sadrži dvije djelatne tvari: pravastatin i fenofibrat.
English: Peripheral polyneuropathy
Croatian: Rijetko periferna polineuropatija
English: Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Croatian: Prvo, reverzibilnom i specifičnom kompetitivnom inhibicijom HMG-KoA reduktaze izaziva malo smanjenje sinteze intracelularnog kolesterola.
English: In line with several formulations for fenofibrate, the fixed combination is recommended to be taken with food because the bioavailability of fenofibrate is increased when administered with food and the lipid-lowering efficacy of pravastatin is not altered.
Croatian: Jednako kao i kod nekih drugih formulacija fenofibrata, fiksnu se kombinaciju savjetuje uzimati s hranom jer se bioraspoloživost fenofibrata povećava kada se primjenjuje s hranom, a djelotvornost pravastatina na snižavanje lipida nije promijenjena.
English: - Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Pravafenix.
Croatian: Vaš će liječnik možda također htjeti ponoviti krvne pretrage nakon što počnete uzimati Pravafenix kako bi provjerio koliko dobro radi jetra.
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Croatian: Ukupni učinak je snižavanje omjera između lipoproteina niske i vrlo niske gustoće i lipoproteina visoke gustoće.
English: Elderly patients (≥ 65 years old)
Croatian: Posebne populacije Stariji bolesnici (> 65 godina)
English: In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g for the treatment of severe infections, the need for co-administration of pravastatin and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Croatian: iznimnim okolnostima, kada je potrebna produžena primjena sistemske fusidatne kiseline, npr. za liječenje teških infekcija, potrebu za istodobnom primjenom pravastatina i fusidatne kiseline treba razmotriti od slučaja do slučaja i pod strogim liječničkim nadzorom.