FrancophonIA/ELRC3.0 huggingface dataset:
English: Levemir FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1-80 units in increments of 1 unit.
Croatian: Levemir FlexTouch je napunjena brizgalica (označena bojom) namijenjena uporabi s jednokratnim iglama NovoFine ili NovoTwist, duljine do 8 mm.
English: INFORMATION IN BRAILLE Levemir FlexTouch
Croatian: Priprema Levemir FlexTouch brizgalice
English: How to handle Levemir FlexTouch
Croatian: Kako rukovati brizgalicom Levemir FlexTouch
English: Dispose of your used FlexPen carefully without the needle attached.
Croatian: Iskorišteni FlexPen pažljivo bacite u otpad, bez nataknute igle.
English: Levemir InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit.
Croatian: Levemir InnoLet je napunjena brizgalica namijenjena uporabi s jednokratnim iglama NovoFine ili NovoTwist, duljine do 8 mm.
English: MARKETING AUTHORISATION NUMBERS EU/1/04/278/007 1 pen of 3 ml EU/1/04/278/008 5 pens of 3 ml EU/1/04/278/009 10 pens of 3 ml
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/278/007 1 brizgalica od 3 ml
English: • If you are under 18 years of age
Croatian: • Ako ste mlađi od 18 godina
English: Practically all the drug is eliminated within 6 days.
Croatian: Unutar 6 dana eliminira se praktički sav lijek.
English: Patients should be closely monitored.
Croatian: Mora se pažljivo pratiti bolesnike.
English: Take the next tablet at your regular time on the next day.
Croatian: Uzmite sljedeću tabletu u uobičajeno vrijeme sljedećeg dana.
English: Reduced function of transport proteins
Croatian: Smanjena funkcija transportnih proteina
English: Cholib with food and drink
Croatian: Cholib s hranom i pićem
English: It is higher in female patients or in patients 65 years or older.
Croatian: Viši je u ženskih bolesnica ili u bolesnika u dobi od 65 godina ili stariji.
English: The C allele has a frequency of 18% in the European population.
Croatian: Alel C ima učestalost od 18% u europskoj populaciji.
English: • you drink large amounts of alcohol (more than 21 units (210 mL) a week of pure alcohol)
Croatian: • ako pijete velike količine alkohola (više od 21 jedinice (210 ml) tjedno čistog alkohola)
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Croatian: Mehanizam ove interakcije (bilo da je farmakodinamički ili farmakokinetički, ili oboje) još nije poznat.
English: If you take more Cholib than you should
Croatian: Ako uzmete više Choliba nego što ste trebali
English: Do not take Cholib if any of the above applies to you.
Croatian: Nemojte uzimati Cholib ako se bilo što od navedenog odnosi na Vas.
English: They may raise your risk of having heart problems.
Croatian: Mogu povisiti Vaš rizik od srčanih tegoba.
English: • muscle weakness that is constant
Croatian: • mišićna slabost koja je konstantna
English: Safety in pregnant women has not been established.
Croatian: Sigurnost u trudnica nije utvrđena.
English: The clinical significance of this is not clear.
Croatian: Klinički značaj navedenog nije jasan.
English: What should I know about cholesterol and triglycerides?
Croatian: Što moram znati o kolesterolu i trigliceridima?
English: Therefore, fenofibrate should only be used during pregnancy after a careful benefit/risk assessment.
Croatian: Stoga se fenofibrat smije koristiti tijekom trudnoće samo nakon pažljive procjene koristi/rizika.
English: The usual dose is one tablet per day.
Croatian: Uobičajena doza je jedna tableta dnevno.
English: They may be taken with or without food (see section 5.2).
Croatian: Mogu se uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: Each tablet should be swallowed whole with a glass of water.
Croatian: Svaku tabletu treba progutati cijelu s čašom vode.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 16 May 2018
Croatian: Datum posljednje obnove odobrenja: 16. svibnja 2018.
English: The exact mechanism of interaction is not known.
Croatian: Točan mehanizam interakcije nije poznat.
English: Sleep disorder, including nightmares, depression not known
Croatian: Poremećaji spavanja, uključujući noćne more, depresija nepoznato
English: Four pivotal clinical studies were carried out in the clinical program.
Croatian: Četiri ključna klinička ispitivanja provedena su u kliničkom programu.
English: Grapefruit juice contains one or more components that alter how the body uses Cholib.
Croatian: Sok od grejpa sadrži jedan ili više sastojaka koji mijenjaju način kako tijelo koristi Cholib.
English: What Cholib is and what it is used for
Croatian: Što je Cholib i za što se koristi
English: There is no specific treatment in the event of overdose.
Croatian: Ne postoji specifično liječenje u slučaju predoziranja.
English: Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.
Croatian: Liječnik će odrediti koja Vam jačina odgovara, ovisno o Vašem zdravstvenom stanju, Vašem trenutnom liječenju i rizicima kojima ste skloni.
English: The results on the biological parameters of interest at 24 weeks are presented in the table below.
Croatian: Rezultati bioloških parametara od interesa u 24. tjednu prikazani su u donjoj tablici.
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Croatian: Tijekom vremena, to nakupljanje plaka može dovesti do začepljenja Vaših arterija.
English: Before the treatment
Croatian: Prije liječenja
English: This is to check how well your liver is working.
Croatian: Time će provjeriti koliko dobro radi
English: In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Croatian: U takvim situacijama mora se razmotriti rizik liječenja u odnosu na moguću korist i preporučuje se kliničko praćenje.
English: Excipient(s) with known effect:
Croatian: Pomoćna(e) tvari s poznatim učinkom:
English: The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
Croatian: Sljedeće nuspojave također su prijavljene, ali se njihova učestalost ne može procijeniti iz dostupnih podataka (učestalost nije poznata):
English: Simvastatin is contraindicated during pregnancy.
Croatian: Simvastatin je kontraindiciran tijekom trudnoće.
English: You can take Cholib with or without food.
Croatian: Možete uzimati Cholib s hranom ili bez nje.
English: In the majority of cases these elevations were transient, minor and asymptomatic without the need for treatment discontinuation.
Croatian: U većini slučajeva ta povišenja su bila prolazna, manja i asimptomatska bez potrebe za prekidom liječenja.
English: • Female gender
Croatian: • Ženski spol
English: Therefore please contact your doctor immediately if you experience these symptoms.
Croatian: Stoga se odmah obratite liječniku ako imate takve simptome.
English: Avoid with Cholib unless clinical benefit outweigh the risk
Croatian: Izbjegavajte s Cholibom osim ako su kliničke koristi veće od rizika
English: Cholib must not be given to children and adolescents (age below 18 years).
Croatian: Cholib ne smiju uzimati djeca i adolescenti (mlađi od 18 godina).
English: These changes are specific to rodents and have not been observed in other species at comparable dose levels.
Croatian: Te su promjene specifične za glodavce i nisu opažene u usporedivim razinama doza u ostalih životinjskih vrsta.
English: This also concerns medicines obtained without a prescription including herbal medicines.
Croatian: To se odnosi i na lijekove koji se nabavljaju bez recepta, uključujući biljne lijekove.
English: Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Croatian: Fenofibrična kiselina snažno se veže za albumin u plazmi (više od 99%).
English: The tablets should not be crushed or chewed.
Croatian: Tablete se ne smiju zdrobiti ili žvakati.
English: In this case, symptomatic and supportive measures should be adopted.
Croatian: U tom slučaju, potrebno je primijeniti simptomatske i potporne mjere.
English: Measures to reduce the risk of myopathy caused by medicinal product interactions
Croatian: Mjere za smanjivanje rizika od miopatije uzrokovane interakcijama s drugim lijekovima
English: If you get pregnant while taking Cholib, stop taking it immediately and contact your doctor.
Croatian: Ako zatrudnite dok uzimate Cholib, prestanite ga odmah uzimati i obratite se liječniku.
English: In most people, there are no signs of cholesterol or triglycerides problems at first.
Croatian: U većine ljudi, najprije nema znakova problema s kolesterolom ili trigliceridima.
English: Treatment should be interrupted when creatinine level is 50% above the upper limit of normal.
Croatian: Liječenje se mora prekinuti kada je razina kreatinina 50% iznad gornje granice normale.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines (taking Cholib with any of these medicines can increase the risk of muscle problems):
Croatian: Osobito obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova (uzimanje Choliba s bilo kojim od sljedećih lijekova može povećati rizik od problema s mišićima):
English: Important information about some of the ingredients of Cholib
Croatian: Važne informacije o nekim sastojcima Choliba
English: Do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
Croatian: Nemojte uzimati fusidatnu kiselinu (lijek za bakterijske infekcije) dok uzimate ovaj lijek.
English: HDL-C levels are frequently increased.
Croatian: Razine HDL-C-a često su povišene.
English: Triglycerides are another fat in your blood.
Croatian: Trigliceridi su još jedna masnoća u Vašoj krvi.
English: (a medicine for bacterial infection)
Croatian: (lijek za bakterijsku infekciju)
English: What Cholib is and what it is used for What you need to know before you take Cholib How to take Cholib
Croatian: Što je Cholib i za što se koristi Što morate znati prije nego počnete uzimati Cholib Kako uzimati Cholib
English: • sexual difficulties
Croatian: • seksualne teškoće
English: What Cholib looks like and contents of the pack
Croatian: Kako Cholib izgleda i sadržaj pakiranja
English: Hydrolysis takes place mainly in the liver; the rate of hydrolysis in human plasma is very slow.
Croatian: Hidroliza se uglavnom odvija u jetri; a brzina hidrolize u ljudskoj plazmi je vrlo spora.
English: Contrarily to previous fenofibrate formulations, the maximum plasma concentration and overall exposure of this formulation is independent from food intake.
Croatian: Za razliku od prethodnih formulacija fenofibrata, maksimalna koncentracija u plazmi i ukupna izloženost te formulacije neovisni su od unosa hrane.
English: • numbness or weakness of the arms and legs
Croatian: • utrnulost ili slabost u rukama i nogama
English: < PC: {number} [product code]
Croatian: <PC: {broj} [oznaka lijeka]
English: • poor memory or memory loss
Croatian: • slabo pamćenje ili gubitak pamćenja
English: Do not consume grapefruit juice with Cholib as it may increase your risk of muscle problems.
Croatian: Nemojte piti sok od grejpa uz Cholib jer može povećati rizik od problema s mišićima.
English: Amiodarone Verapamil Diltiazem Amlodipine
Croatian: Amiodaron Verapamil Diltiazem Amlodipin
English: While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Croatian: Dok uzimate ovaj lijek, Vaš će Vas liječnik pažljivo pratiti ako imate šećernu bolest ili ako postoji rizik da razvijete šećernu bolest.
English: • you are due to have an operation.
Croatian: • ako se trebate podvrgnuti kirurškoj operaciji.
English: • feeling exhausted (astenia)
Croatian: • osjećaj iscrpljenosti (astenija)
English: Treatment with simvastatin must be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Croatian: Mora se obustaviti liječenje simvastatinom za vrijeme trajanja trudnoće ili dok se ne utvrdi da žena nije trudna.
English: Cholib contains soya lecithin.
Croatian: Cholib sadrži sojin lecitin.
English: The liver is the primary site of action of the active form.
Croatian: Jetra je primarno mjesto djelovanja aktivnog oblika lijeka.
English: In the majority of cases no overdose symptoms were reported.
Croatian: U većini slučajeva nisu prijavljeni simptomi predoziranja.
English: F145/S40 demonstrated statistically significant superiority on all parameters except on ApoA1 increase.
Croatian: F145/S40 pokazao je statistički značajnu superiornost u svim parametrima osim u povišenju ApoA1.
English: • Elderly ≥ 65 years
Croatian: • Starije osobe ≥65 godina
English: Fenofibrate also has a uricosuric effect leading to reduction in uric acid levels of approximately 25%.
Croatian: Fenofibrat ima također urikozurični učinak, koji dovodi do sniženja razina mokraćne kiseline za približno 25%.
English: Do not crush or chew the tablet.
Croatian: Nemojte drobiti ili žvakati tabletu.
English: This is of no relevance to therapeutic use in man.
Croatian: To nije od značenja za terapijsku primjenu u ljudi.
English: Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates') and simvastatin (belongs to the group called ‘statins').
Croatian: Cholib sadrži dvije različite djelatne tvari: fenofibrat (pripada skupini koja se zove ‘fibrati') i simvastatin (pripada skupini koja se zove ‘statini').
English: • increased sensitivity of your skin to sunlight, sun lamps and sunbeds
Croatian: • povećana osjetljivost kože na sunčevu svjetlost, UV lampe i solarij
English: Alopecia rare
Croatian: Alopecija rijetko
English: Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Croatian: Ispitivanja na miševima, štakorima i kunićima nisu pokazala nikakve teratogene učinke.
English: INR should be determined before starting Cholib and frequently enough during early therapy to ensure that no significant alteration of INR occurs.
Croatian: Potrebno je odrediti INR prije početka liječenja Cholibom i zatim dovoljno često tijekom početka terapije kako bi se osiguralo da nema značajne promjene INR-a.
English: Elderly patients (≥ 65 years old)
Croatian: Stariji bolesnici (≥65 godina starosti)
English: • sleep disturbances including nightmares
Croatian: • poremećaji sna uključujući noćne more
English: Swallow the tablet with a glass of water.
Croatian: Progutajte tabletu s čašom vode.
English: This leaflet was last revised in <{MM/YYYY}>.
Croatian: Ova uputa je zadnji put revidirana u {MM/GGGG}.
English: Other medicines and Cholib:
Croatian: Drugi lijekovi i Cholib
English: Concomitant food intake does not affect the absorption.
Croatian: Istodobno uzimanje s hranom ne utječe na apsorpciju.
English: • Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
Croatian: • Nemojte uzimati Cholib ako ste trudni, pokušavate zatrudnjeti ili mislite da biste mogli biti trudni.
English: It is recommended that the dose of those oral anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Croatian: Preporučuje se smanjenje doze tih peroralnih antikoagulansa za oko jednu trećinu na početku liječenja i zatim njena postepena prilagodba po potrebi prema praćenju Međunarodnog normaliziranog omjera (INR).
English: Adjust the dose of these oral anticoagulants according to INR monitoring
Croatian: Prilagodite dozu ovih peroralnih antikoagulansa prema praćenju INR-a
English: Once a stable INR has been documented, it can be monitored at the intervals usually recommended for patients on those oral anticoagulants.
Croatian: Jednom kada je stabilni INR dokumentiran, može se pratiti u razmacima koji se obično preporučuju kod bolesnika koji uzimaju te peroralne antikoagulanse.
English: The extraction in the liver is dependent on the hepatic blood flow.
Croatian: Ekstrakcija u jetri ovisi o prokrvljenosti jetre.
English: Following an oral dose of radioactive simvastatin to man, 13% of the radioactivity was excreted in the urine and 60% in the faeces within 96 hours.
Croatian: Nakon peroralne doze radioaktivnog simvastatina u ljudi, 13% radioaktivnosti je izlučeno mokraćom i 60% u stolici unutar 96 sati.
English: Statin type and dose used:
Croatian: Korištena vrsta i doza statina:
English: Glecaprevir Pibrentasvir
Croatian: Glekaprevir Pibrentasvir
English: If the dose of Cholib is changed or discontinued, the same procedure should be repeated.
Croatian: Ako se doza Choliba promijeni ili prekine liječenje, potrebno je ponoviti isti postupak.
English: It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.
Croatian: Preporučuje se mjeriti kreatinin tijekom prva 3 mjeseca nakon početka liječenja, i periodično nakon toga.
English: Compared to a fibrate or a statin alone, the risk of muscle breakdown is increased when you take these 2 medicines together, as in Cholib.
Croatian: U usporedbi sa samim fibratom ili statinom, rizik od razgradnje mišića povećan je kada uzimate ova 2 lijeka zajedno, kao u Cholibu.
English: However, it should be taken into account that some people get dizzy after taking Cholib.
Croatian: Međutim, treba voditi računa da su neki ljudi imali omaglicu nakon uzimanja Choliba.
English: The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), 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) and not known (cannot be estimated from the available data).
Croatian: Učestalosti nuspojava definirane su na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10000 i <1/1000); vrlo rijetko (<1/10000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Therapy with Cholib should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
Croatian: Terapiju Cholibom treba privremeno prekinuti nekoliko dana prije velikog elektivnog kirurškog zahvata i nakon svakog većeg medicinskog ili kirurškog stanja.
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: To nije opaženo u prethodno navedenoj podskupini bolesnika s dislipidemijom, ali također nije bilo jasnih dokaza koristi kod žena s dislipidemijom liječenih s fenofibratom plus simvastatin, a mogući štetan učinak u ovoj podskupini se ne može isključiti.
English: In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Croatian: Nadalje, obje povisuju razine "dobrog" kolesterola (HDL kolesterol).
English: • Active liver disease or unexplained persistent elevations of serum transaminases
Croatian: • Aktivna bolest jetre ili neobjašnjena stalna povišenja transaminaza u serumu
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi/rizika lijeka.
English: Grapefruit juice should be avoided (see section 4.5).
Croatian: Treba izbjegavati sok od grejpa (vidjeti dio 4.5).
English: For these reasons, simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Croatian: Iz tih razloga, simvastatin se ne smije primjenjivati u žena koje su trudne, pokušavaju zatrudnjeti ili sumnjaju da su trudne.
English: • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Croatian: • Poznata fotoalergija ili fototoksična reakcija tijekom liječenja fibratima ili ketoprofenom
English: If any of the previously listed serious side effects happen, stop taking Cholib and tell your doctor immediately or go to the emergency room at your nearest hospital - you may need urgent medical treatment.
Croatian: Ako se pojavi bilo koja od prethodno navedenih ozbiljnih nuspojava, prestanite uzimati Cholib i odmah obavijestite liječnika ili se uputite na hitnu pomoć u najbližu bolnicu - možda trebate hitnu medicinsku pomoć.
English: Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Croatian: Terapija statinom smije se ponovo nastaviti nakon sedam dana od zadnje doze fusidatne kiseline.
English: • If you have pancreatitis (inflamed pancreas which causes abdominal pain), which is not caused by high levels of fats in the blood
Croatian: • Ako imate pankreatitis (upalu gušterače koja uzrokuje bol u trbuhu), a koja nije uzrokovana visokim razinama masnoća u krvi
English: If myopathy is suspected for any other reason, treatment should be discontinued.
Croatian: Ako se iz bilo kojeg drugog razloga sumnja na miopatiju, potrebno je prekinuti liječenje.
English: • If you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6)
Croatian: • ako ste alergični na fenofibrat ili simvastatin ili bilo koje druge sastojke Choliba (navedeni u dijelu 6)
English: • Do not take Cholib if you are breast-feeding or plan to breast-feed your baby, because it is not known if the medicine passes into breast milk.
Croatian: • Nemojte uzimati Cholib ako dojite ili planirate dojiti Vaše dijete, jer nije poznato prelazi li lijek u majčino mlijeko.
English: In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
Croatian: U normalnih dobrovoljaca, izloženost simvastatinskoj kiselini u plazmi smanjena je za 93% kod istodobne primjene rifampicina.
English: If you have taken more Cholib than you should or if someone else has taken your medicine, tell your doctor or pharmacist or contact your nearest hospital
Croatian: Ako ste uzeli više Choliba nego što ste trebali ili ako je netko drugi uzeo Vaš lijek, obavijestite liječnika ili ljekarnika ili se obratite najbližoj bolnici.
English: Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
Croatian: Terapija Cholibom nije povezana s krvarenjem u bolesnika koji ne uzimaju antikoagulanse.
English: This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Croatian: Rizik je, međutim, manji od koristi statina u smanjivanju vaskularnog rizika, stoga to ne smije biti razlog za prekid liječenja statinom.
English: Cholib should be used with caution in patients who consume substantial quantities of alcohol.
Croatian: Cholib je potrebno primjenjivati s oprezom u bolesnika koji konzumiraju znatne količine alkohola.
English: You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Croatian: Postoji rizik da razvijete šećernu bolest ako imate visoke razine šećera i masnoća u krvi, ako imate prekomjernu tjelesnu težinu i povišeni krvni tlak.
English: The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites.
Croatian: Glavni metaboliti simvastatina prisutni u ljudskoj plazmi su beta-hidroksi kiselina i četiri dodatna aktivna metabolita.
English: Posology The recommended dose is one tablet per day.
Croatian: Doziranje Preporučena doza je jedna tableta dnevno.
English: Niacin (nicotinic acid) ≥ 1 g/day
Croatian: Niacin (nikotinska kiselina) ≥1 g/dan
English: The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Croatian: Rizik od miopatije povezane uz visoku dozu (80 mg) simvastatina iznosi općenito oko 1 %, bez genetskog testiranja.
English: • specific lung disease with difficulties breathing (called interstitial lung disease)
Croatian: • specifična bolest pluća s teškoćom pri disanju (zove se intersticijska bolest pluća)