natgillin/translations-raw huggingface dataset:
In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124). 
U prvom ispitivanju, oko 34 % bolesnika koji su uzimali 20 mg lijeka Nexium Control (41 od 121 bolesnika) više nije imalo simptome žgaravice u usporedbi s približno 14 % bolesnika koji su uzimali placebo (17 od 124).
In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118). 
U drugom ispitivanju, oko 42 % bolesnika koji su uzimali Nexium Control (47 od 113 bolesnika) više nije imalo simptome žgaravice, u usporedbi s 12 % bolesnika koji su uzimali placebo (14 od 118 bolesnika).
For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o korištenju lijeka Nexium Control bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju s Nexium Control pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor. 
Djelatna tvar u lijeku Nexium Control je esomeprazol, inhibitor protonske crpke.
Why is Nexium Control approved? 
Zašto je Nexium Control odobren?
What is Nexium Control and what is it used for? 
Što je Nexium Control i za što se koristi?
What are the risks associated with Nexium Control? 
Koji su rizici povezani s lijekom Nexium Control?
Nexium Control is a medicine that contains the active substance esomeprazole. 
Nexium Control je lijek koji sadrži djelatnu tvar esomeprazol.
For the full list of all side effects reported with Nexium Control, see the package leaflet. 
Potpuni popis nuspojava koje su zabilježene s Nexium Control potražite u uputi o lijeku.
What benefits of Nexium Control have been shown in studies? 
Koje su koristi lijeka Nexium Control dokazane u ispitivanjima?
How does Nexium Control work? 
Kako djeluje Nexium Control?
How is Nexium Control used? 
Kako se Nexium Control koristi?
This combination is, therefore, not recommended. 
Stoga se ova kombinacija ne preporučuje.
Practically all the drug is eliminated within 6 days. 
Praktički sav lijek se eliminira unutar 6 dana.
HDPE bottle 3 years. 
HDPE boca 3 godine.
The volume of distribution is about 0.5 l/kg. 
Volumen distribucije je oko 0,5 l/kg.
This is a very rare reaction which can be serious if it occurs. 
Ovo je vrlo rijetka reakcija koja, ako se dogodi, može biti ozbiljna.
The following two side effects are important and will require immediate action. 
Sljedeće dvije nuspojave su važne i zahtijevaju trenutno djelovanje.
These changes are specific to small rodents and have not been observed in other animal species. 
Ove su promjene specifične za male glodavce i nisu primijećene u drugih životinjskih vrsta.
- Tell your doctor about all your medical conditions including allergies. 
- Obavijestite liječnika o svim Vašim zdravstvenim stanjima uključujući alergije.
Swallow the capsule with water. 
Kapsulu progutajte s vodom.
- You should always keep your alcohol intake to a minimum. 
- Uzimanje alkohola morate svesti na minimum.
They may raise your risk of having heart problems. 
Oni mogu povisiti Vaš rizik za razvoj srčanih problema.
The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. 
Mehanizam ove interakcije (bilo da je farmakodinamička, farmakokinetička, ili oboje) još uvijek nije poznat.
If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor. 
Ako Vas brine koliko alkohola smijete popiti dok uzimate ovaj lijek, raspravite to sa svojim liječnikom.
Always take Pravafenix exactly as your doctor has told you. 
Uvijek uzimajte Pravafenix točno onako kako Vam je rekao liječnik.
The clinical significance of this is not clear. 
Klinički značaj navedenog još nije jasan.
This is of no relevance to therapeutic use in man. 
Ovo nema važnosti za terapijsku primjenu u čovjeka.
In most people, there are no signs of cholesterol problems at first. 
U većine ljudi u početku nema znakova problema uzrokovanih kolesterolom.
What should I know about cholesterol and triglycerides? 
Što trebam znati o kolesterolu i trigliceridima?
- Children and adolescents (age below 18 years). 
- Djeca i adolescenti (u dobi ispod 18 godina)
Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant. 
Nemojte uzimati Pravafenix ako ste trudni, nastojite zatrudnjeti ili mislite da biste mogli biti trudni.
The increase in AUC 
Povećanje AUC
For any information over this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
- Tell your doctor if you drink large amounts of alcohol (if you drink more than the recommended daily amount; ask your doctor or pharmacist if you are unsure) or have ever had liver disease. 
- Obavijestite liječnika ako pijete velike količine alkohola (ako pijete više od preporučene dnevne količine; pitajte svog liječnika ili ljekarnika ako niste sigurni) ili ste nekad imali bolest jetre.
This clogging can slow or block blood flow to vital organs such as the heart and brain. 
Ovo začepljenje može usporiti ili blokirati protok krvi do vitalnih organa kao što su srce i mozak.
If you are not sure about this, please follow your doctor's advice. 
Ako niste sigurni slijedite savjet liječnika.
∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively. 
∞, AUCt, i Cmax iznosi 111,88%, 114,06%, odnosno 115,28%.
This is due to the fat content of the meal. 
Tome je razlog sadržaj masti u obroku.
- You are under 18 years old. 
- ako ste mlađi od 18 godina,
Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%). 
Fenofibrična kiselina snažno se veže na albumine plazme (više od 99%).
Do not take Pravafenix if any of the above applies to you. 
Nemojte uzimati Pravafenix ako se bilo što od gore navedenog odnosi na Vas.
If you plan to become pregnant or become pregnant, inform your doctor immediately. 
Planirate li zatrudnjeti ili zatrudnite recite to odmah svom liječniku.
In clinical trials, over 1,566 patients received Pravafenix. 
U kliničkim ispitivanjima više od 1566 bolesnika primilo je Pravafenix.
The name of your medicine is Pravafenix. 
Naziv Vašeg lijeka je Pravafenix.
The risk of muscle breakdown is greater in certain patients. 
Rizik za pojavu razgradnje mišića veći je u nekih bolesnika.
Paediatric population (< 18 years old) 
Pedijatrijska populacija (< 18 godina)
- Fusidic acid: do not take fusidic acid (a medicine for bacterial infections) while using this medicine. 
- fusidatnom kiselinom: nemojte uzimati fusidatnu kiselinu (lijek za bakterijske infekcije) dok uzimate ovaj lijek.
Biotransformation and elimination 
Biotransformacija i eliminacija Pravastatin
The recommended dose is one capsule per day. 
Preporučena doza je jedna kapsula na dan.
It is recommended that the dose of 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. 
Preporučuje se smanjivanje doze antikoagulansa za oko jednu trećinu na početku liječenja i zatim njena postupna prilagodba, ako je potrebna, prema INR-u (International Normalised Ratio).
It is important to take the capsule with food, as it won't work as well if your stomach is empty. 
Važno je da kapsulu uzmete s hranom, jer inače neće djelovati jednako dobro ako je uzmete na prazan želudac.
What pravafenix is and what it is used for 
Što je pravafenix i za što se koristi
Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration. 
Maksimalne koncentracije u plazmi (Cmax) nastupju unutar 4 do 5 sati nakon peroralne primjene.
Polyamide-Aluminium-PVC/aluminium blister 2 years. 
Poliamid-aluminij-PVC/aluminij blister 2 godine.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011 
Datum prvog odobrenja: 14. travnja 2011.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid. 
Terapija statinom može se ponovno započeti sedam dana nakon posljednje doze fusidatne kiseline.
Your total cholesterol is made up mainly of LDL and HDL cholesterol. 
Vaš ukupni kolesterol sastoji se uglavnom od LDL i HDL kolesterola.
Based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity on reproduction, there are no other risks for the patient than those expected due to the pharmacological mechanism of action. 
Temeljeno na konvencionalnim ispitivanjima sigurnosne farmakologije, toksičnosti ponovljenih doza i toksičnosti na reprodukciju smatra se da nema drugih rizika za bolesnika osim onih očekivanih zbog farmakološkog mehanizma djelovanja.
Studies in mice, rats and rabbits did not reveal any teratogenic effect. 
Ispitivanja na miševima, štakorima i kunićima nisu otkrila bilo kakav teratogeni učinak.
In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect. 
Obzirom na ovaj znatan prvi prolaz kroz jetru, koncentracije pravastatina u plazmi imaju samo ograničenu vrijednost za predviđanje njegovog učinka na snižavanje lipida.
On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%. 
U prosjeku 34% peroralno primijenjene doze se apsorbira s apsolutnom bioraspoloživosti od 17%.
The food effect increases with the fat content: the larger the lipid content the larger the bioavailability of fenofibrate. 
Učinak hrane se pojačava sa sadržajem masti: što je veći udio lipida to je veća bioraspoloživost fenofibrata.
HDL cholesterol levels are frequently increased. 
Razine HDL kolesterola često su povišene.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal. 
Zahtjevi za podnošenje periodičnih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim Člankom 107c stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. 
Dok uzimate ovaj lijek liječnik će Vas pažljivo pratiti imate li šećernu bolest ili rizik za razvoj šećerne bolesti.
If you feel any of these symptoms you should stop taking Pravafenix and inform your doctor. 
Ako osjećate bilo koji od ovih simptoma morate odmah prekinuti uzimati Pravafenix i o tome obavijestiti liječnika.
If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so. 
Osjetite li bilo kakvu omaglicu, zamućen vid ili dvoslike tijekom liječenja, provjerite jeste li sposobni upravljati vozilima ili strojevima prije nego li to učinite.
The decreased in AUCt, AUC∞ and Cmax 
Smanjenje AUCt, AUC∞ i Cmax
Before treatment initiation 
Prije početka liječenja
Venothromboembolic events 
Venotromboembolijski događaji
See also below section “Taking Pravafenix with food and drink”. 
Vidjeti također dio u nastavku „Uzimanje Pravafenixa s hranom i pićem“.
14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules 
14 tvrdih kapsula 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula
About 50% of circulating pravastatin is bound to plasma proteins. 
Oko 50% cirkulirajućeg pravastatina veže se na proteine plazme.
Isolated cases of tendon disorders, sometimes complicated by rupture 
Izolirani slučajevi poremećaja tetiva, ponekad komplicirani rupturom
• Tingling and numbness (peripheral polyneuropathy). 
• Trnci i utrnulost (periferna polineuropatija).
Plasma concentrations are stable during continuous treatment in any given individual. 
Koncentracije u plazmi su stabilne tijekom kontinuirane primjene kod svakog pojedinca.
LDL and VLDL triglycerides are reduced. 
LDL i VLDL trigliceridi su sniženi.
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. 
Postoje dokazi da liječenje fibratima može smanjiti omjer koronarnih srčanih bolesti, ali nije dokazano da smanjuju smrtnost u primarnoj ili sekundarnoj prevenciji kardiovaskularnih bolesti.
Fenofibrate has a uricosuric effect and is therefore of additional benefit in such patients. 
Fenofibrat ima urikozurični učinak i stoga dodatno koristi ovim bolesnicima.
Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin. 
Iako su te promjene bile male nužan je oprez kada se pravastatin primjenjuje s eritromicinom ili klaritromicinom.
Studies on mutagenicity of fenofibrate have been negative. 
Ispitivanja mutagenosti fenofibrata bila su negativna.
Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease. 
Razine mokraćne kiseline u plazmi povišene su u približno 20% bolesnika s hiperlipidemijom, osobito u onih s bolešću tipa IV.
- To raise the level of your ‘good' cholesterol (HDL cholesterol). 
- za podizanje razine "dobrog" kolesterola (HDL kolesterol).
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. 
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.
In some patients, however, the increase in pravastatin exposure may be larger. 
Međutim u nekih bolesnika ovo povećanje izloženosti pravastatinu može biti veće.
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. 
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.
Response to therapy should be monitored by determination of serum lipid values. 
Odgovor na terapiju mora se nadzirati određivanjem vrijednosti lipida u serumu.
Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests. 
Prijavljeni slučajevi predoziranja bili su asimptomatski i nisu uzrokovali nenormalne rezultate laboratorijskih testova.
Adverse reactions have usually been mild and transient. 
Nuspojave su obično bile blage i prolazne.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, deficijencijom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
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. 
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.
• Problems with sight such as blurred or double vision. 
• Problemi s vidom poput zamućenog vida i dvoslika.
Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing. 
Iznenadne teške alergijske reakcije uključujući oticanje lica, usnice, jezika ili dušnika mogu uzrokovati velike teškoće pri disanju.
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). 
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).
Sleep disturbance including insomnia and nightmares 
Psihijatrijski poremećaji poremećaj spavanja uključujući nesanicu i noćne more
Co-administration of this combination may cause increased plasma concentrations of both agents. 
Istodobna primjena ove kombinacije može uzrokovati povišenje koncentracija u plazmi oba lijeka.
There are no data on the excretion of fenofibrate and/or its metabolites into human breast milk. 
Nema podataka o izlučivanju fenofibrata i/ili njegovih metabolita u majčino mlijeko u ljudi.
Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin) 
Moguće nuspojave koje su prijavljene s nekim statinima (iste vrste lijekova za snižavanje kolesterola kao i pravastatin)
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors. 
Povećan rizik od venskih trombotičkih događaja mogu biti povezani s povećanjem razine hemocisteina, faktora rizika za trombozu i drugih neutvrđenih faktora.
• Breathing problems including persistent cough/or shortness of breath or fever. 
• Problemi pri disanju uključujući stalni kašalj/ili nedostatak zraka ili vrućicu.
The combination has not been tested in reproductive toxicity studies. 
Ova kombinacija nije ispitana u ispitivanjima reproduktivne toksičnosti.
SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium 
SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgija
After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation. 
Nakon intravenske primjene 47% doze eliminira se izlučivanjem putem bubrega, a 53% izlučivanjem putem žuči i biotransformacijom.
No sign of any effect on fertility has been detected. 
Nije primijećen bilo kakav znak učinka na plodnost.
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. 
Pravastatin se ne metabolizira značajno putem citokroma P450 niti se čini da je supstrat ili inhibitor Pglikoproteina, već da je supstrat drugih transportnih proteina.
Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. 
Ispitivanjima kronične toksičnosti nisu dobivene značajne informacije o specifičnoj toksičnosti fenofibrata.
Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels). 
Prekid liječenja treba također razmotriti kada su mišićni simptomi teški i uzrokuju svakodnevnu nelagodu (bez obzira razine KF).
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. 
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.
In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation. 
U većini slučajeva razine jetrenih transaminaza vratile su se na početne vrijednosti bez potrebe prekidanja liječenja.
The plasma elimination half-life of fenofibric acid is approximately 20 hours. 
Poluvijek eliminacije fenofibrične kiseline iz plazme je približno 20 sati.
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. 
Ako bolesnica planira zatrudnjeti ili zatrudni mora o tome odmah obavijestiti liječnika a liječenje pravastatinom mora se odmah prekinuti zbog potencijalnog rizika za fetus.
Pravastatin is administered orally in the active form. 
Pravastatin se primjenjuje peroralno u aktivnom obliku.
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. 
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.
Concomitant administration resulted in approximately 40 to 50% decrease in the bioavailability of pravastatin. 
Istodobna primjena rezultirala je približno 40 do 50%-tnim smanjenjem bioraspoloživosti pravastatina.
- Before starting taking Pravafenix, you should be on a diet to lower your cholesterol. 
- Prije nego počnete uzimati Pravafenix morate biti na dijeti za snižavanje kolesterola.
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen. 
- Poznata fotoalergija ili fototoksična reakcija tijekom liječenja fibratima ili ketoprofenom.
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. 
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.
The absorption of fenofibrate is increased when administered with food. 
Apsorpcija fenofibrata je povećana kada se primjenjuje s hranom.
Colestyramine/Colestipol 
Kolestiramin/kolestipol
Alopecia, photosensitivity reactions 
Manje često alopecija, reakcije fotoosjetljivosti
Also see section 4.4 
Također vidjeti dio 4.4.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/. 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
Animal studies have not demonstrated any teratogenic effects. 
Ispitivanja na životinjama nisu pokazala bilo kakve teratogene učinke.
However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment. 
Ipak, prilikom upravljanja vozilima ili rada na strojevima treba uzeti u obzir da tijekom liječenja mogu nastupiti omaglica ili smetnje vida.
The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy. 
Početne razine CK mogu biti korisne kao referentne u slučaju kasnijeg povećanja tijekom kombinirane terapije.
Each hard capsule contains 19 mg of lactose. 
Svaka tvrda kapsula sadrži 19 mg laktoze.
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. 
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.