natgillin/translations-raw huggingface dataset:
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. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, vzemite le običajno količino zdravila Pravafenix naslednji dan ob istem času kot običajno.
The results of this study show that food has effect on the rate and extent of absorption in the fixed dose combination. 
Rezultati te študije kažejo, da hrana vpliva na hitrost in količino absorpcije fiksne kombinacije odmerkov.
Animal studies have not demonstrated any teratogenic effects. 
Študije na živalih niso pokazale nobenih teratogenih učinkov.
• Memory loss 
• izguba spomina,
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. 
Priporočljivo je, da se odmerek antikoagulantov na začetku zdravljenja zniža za eno tretjino in se nato po potrebi postopoma prilagodi v skladu s spremljanjem internacionalnega normaliziranega razmerja
Studies on mutagenicity of fenofibrate have been negative. 
Študije o mutagenosti fenofibrata so bile negativne.
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). 
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10 000 do < 1/1.000), zelo redki (< 1/10.000).
About 50% of circulating pravastatin is bound to plasma proteins. 
Okoli 50 % krožečega pravastatina se veže na plazemske beljakovine.
∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively. 
Povečanje vrednosti AUC∞, AUCt in Cmax znaša 111,88 %, 114,06 % in 115,28 %.
Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing. 
Nenadne hude alergijske reakcije, vključno z otekanjem obraza, ustnic, jezika ali sapnika, ki lahko močno otežijo dihanje.
Also see section 4 of this leaflet. 
Glejte tudi poglavje 4 v tem navodilu.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. 
Ko jemljete to zdravilo, vas bo zdravnik skrbno spremljal, če imate sladkorno bolezen ali ste izpostavljeni tveganju za razvoj sladkorne bolezni.
The drug is excreted mainly in the urine. 
Zdravilo se izloča pretežno z urinom.
The risk of muscle breakdown is greater in certain patients. 
Pri nekaterih bolnikih je tveganje za razpad mišic večje.
Before you take Pravafenix you should tell your doctor if you have or have had any medical problems. 
Pred zdravljenjem z zdravilom Pravafenix morate zdravniku povedati, če imate ali ste imeli kakršnekoli zdravstvene težave.
Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. 
Študije o kronični toksičnosti niso odkrile relevantnih podatkov o specifični toksičnosti fenofibrata.
Plasma concentrations are stable during continuous treatment in any given individual. 
Koncentracija v plazmi je med neprekinjenim zdravljenjem pri katerem koli danem posamezniku stabilna.
A small quantity of pravastatin passes into the human breast milk. 
Majhna količina pravastatina preide v materino mleko.
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors. 
Povečano tveganje za venske trombotične dogodke je morda povezano z zvišano ravnijo homocisteina, ki je dejavnik tveganja za trombozo, in z drugimi neopredeljenimi dejavniki.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid. 
Zdravljenje s statini se lahko ponovno uvede sedem dni po zadnjem odmerku fusidne kisline.
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. 
Pomembnost tega tveganja pa je manjša od pomembnosti zmanjšanja vaskularnega tveganja pri uporabi statinov, zato to ne sme biti razlog za prekinitev zdravljenja.
Co-administration of this combination may cause increased plasma concentrations of both agents. 
Sočasno uvajanje te kombinacije lahko povzroči povečano koncentracijo obeh zdravil v plazmi.
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. 
Glede na ta pomemben prvi prehod prek jeter ima koncentracija pravastatina v plazmi le omejeno vrednost pri predvidevanju vpliva na zniževanje koncentracije lipidov.
- To raise the level of your ‘good' cholesterol (HDL cholesterol). 
- za zvišanje ravni „dobrega“ holesterola (holesterola HDL).
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. 
Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja za bolnika ni drugih tveganj razen tistih, ki so zaradi farmakološkega mehanizma delovanja pričakovana.
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen. 
- Znana fotoalergija ali fototoksična reakcija med zdravljenjem s fibrati ali ketoprofenom.
Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin) 
Možni neželeni učinki, o katerih so poročali pri nekaterih statinih (isti vrsti zdravil za zniževanje holesterola kot je pravastatin)
In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation. 
Pri podganah in miših so pri visokih odmerkih našli tumorje na jetrih, ki jih gre pripisati proliferaciji peroksisomov.
Polyamide-Aluminium-PVC/aluminium blister 2 years. 
Pretisni omoti iz poliamida-aluminija-PVC/aluminija 2 leti
Studies in mice, rats and rabbits did not reveal any teratogenic effect. 
Študije na miših, podganah in kuncih niso odkrile nobenih teratogenih učinkov.
On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%. 
V povprečju se absorbira 34 % peroralno zaužitega odmerka, pri čemer absolutna biološka uporabnost znaša 17 %.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. 
Zdravniku ali farmacevtu prav tako povejte, če se vam pojavi stalna oslabelost mišic.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells. 
Študije in vitro so pokazale, da se pravastatin prenaša v hepatocite, pri čemer je vnos v druge celice znatno manjši.
What pravafenix is and what it is used for 
KAJ JE ZDRAVILO PRAVAFENIX IN ZA KAJ GA UPORABLJAMO
Special caution is recommended in women of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy. 
Pri ženskah v rodni dobi se priporoča posebna previdnost, s čimer naj se zagotovi, da pravilno razumejo možno tveganje, povezano z zdravljenjem s pravastatinom med nosečnostjo.
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. 
Po absorpciji se 66 % pravastatina izloči s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL.
The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins. 
Skupni učinek je zmanjšano razmerje med lipoproteini nizke in zelo nizke gostote ter lipoproteini visoke gostote.
Fibrates and statins in combination have also been shown to synergistically increase the transcriptional activities of PPARα receptors. 
Dokazano je tudi, da kombinacija fibratov in statinov sinergijsko krepi transkripcijske dejavnosti receptorjev PPARα.
It is important to take the capsule with food, as it won't work as well if your stomach is empty. 
Pomembno je, da kapsulo vzamete s hrano, saj na tešče ne bo tako dobro delovala.
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. 
Zato je mogoče zdravila, ki jih sistem citokroma P450 presnavlja ali pa so njegovi zaviralci, dodajati stabilni shemi odmerjanja pravastatina, ne da bi se pri tem pomembno spremenile ravni pravastatina v plazmi, kot je bilo opaženo pri drugih statinih.
The plasma elimination half-life of fenofibric acid is approximately 20 hours. 
Plazemska razpolovna doba izločanja fenofibratne kisline traja približno 20 ur.
There have been no formal interaction studies for Pravafenix; however the concomitant use of the active substances in patients in clinical studies has not resulted in any unexpected interactions. 
Študije o interakcijah zdravila Pravafenix niso bile narejene, vendar sočasno jemanje zdravilnih učinkovin pri bolnikih v kliničnih študijah ni povzročilo nobenih nepričakovanih interakcij.
Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests. 
Primeri prevelikega odmerjanja, o katerih so poročali, so bili asimptomatski in niso povzročili nenormalnih izvidov laboratorijskih preiskav.
However in a multiple dose study, the results showed that the product is not bioequivalent because its bioavailability after multiple dosing is a 20% lower for the fenofibrate component of the combination. 
Vendar pa so rezultati v študiji večkratnega odmerka pokazali, da zdravilo ni bioekvivalentno, ker je njegova biološka uporabnost po večkratnem odmerjanju zaradi fenofibratne komponente kombinacije 20 % nižja.
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. 
Če ste med zdravljenjem omotični ali če imate zamegljen ali dvojni vid, se najprej prepričajte, da ste sposobni voziti in upravljati stroje, šele nato se tega lahko lotite.
After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation. 
Po intravenski uporabi se 47 % odmerka izloči prek ledvic, 53 % pa biliarno in z biotransformacijo.
Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate. 
Fenofibrat se v glavnem izloča v obliki fenofibratne kisline in njenega glukuronidnega konjugata.
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. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
(eructation)). 
(pravastatin)
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 s citokromom P450 ne presnavlja znatno, niti ni substrat ali zaviralec P-glikoproteina, ampak prej substrat za druge transportne proteine.
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. 
V te študije so v Evropi in ZDA zajeli skupno 1637 bolnikov, ki se niso dobro odzvali na zdravljenje z monoterapijo s pravastatinom 40 mg ali s simvastatinom 20 mg.
Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate. 
Kinetične raziskave po uporabi enkratnega odmerka in neprekinjenem zdravljenju so pokazale, da se zdravilo ne kopiči.
Children and adolescents Do not take Pravafenix if you are under 18 years old 
Ne jemljite zdravila Pravafenix, če ste mlajši od 18 let.
Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. 
Fenofibrat okrepi učinek peroralnih antikoagulantov in lahko poveča tveganje za krvavitev.
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. 
Zato je treba pri teh bolnikih skrbno spremljati ledvično funkcijo in pri veliki spremembi laboratorijskih parametrov zdravljenje s fenofibratom prekiniti.
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. 
Če bolnica načrtuje nosečnost ali če zanosi, mora biti zdravnik o tem takoj obveščen, zdravljenje s pravastatinom pa zaradi možnega tveganja za plod prekinjeno.
This is a very rare reaction which can be serious if it occurs. 
To je zelo redek neželeni učinek, ki pa je lahko nevaren.
The decreased in AUCt, AUC∞ and Cmax 
Znižanje vrednosti AUCt, AUC∞
In most people, there are no signs of cholesterol problems at first. 
Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
In some patients, however, the increase in pravastatin exposure may be larger. 
Pri nekaterih bolnikih pa je povečanje sistemske izpostavljenosti pravastatinu lahko večje.
Alopecia, photosensitivity reactions 
občasni alopecija, fotosenzitivnostne reakcije redki
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
Also see section 4.4 
Glejte tudi poglavje 4.4.
However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment. 
Med vožnjo motornih vozil ali delom s stroji pa se je treba zavedati, da se lahko med zdravljenjem pojavijo vrtoglavica ali motnje vida.
Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels). 
O prekinitvi zdravljenja je treba razmisliti tudi v primeru, če so simptomi v mišicah hudi in motijo dnevne dejavnosti (ne glede na to, kakšne so vrednosti kreatin-fosfokinaze).
The European Medicines Agency has waived the obligation to submit the results of studies with Pravafenix in all subsets of the paediatric population in disorders of lipoprotein metabolism and other hyperlipidaemias (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Pravafenix za vse skupine pediatrične populacije pri motnjah metabolizma lipoproteinov in drugih hiperlipidemijah (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential. 
Genetske toksikološke študije in vitro in in vivo niso našle dokazov za mutageni potencial.
The following statements reflect the pharmacodynamic/pharmacokinetic properties of the individual active substances of Pravafenix. 
Naslednje trditve opisujejo farmakodinamične/farmakokinetične lastnosti posameznih zdravilnih učinkovin zdravila Pravafenix.
Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol. 
Prvič, z reverzibilnim in specifičnim kompetitivnim zaviranjem reduktaze HMG-CoA vpliva na zmerno upočasnitev sinteze znotrajceličnega holesterola.
Pravastatin is administered orally in the active form. 
Pravastatin Pravastatin se jemlje peroralno v aktivni obliki.
Pravastatin is contraindicated during pregnancy and should be administered to women of childbearing potential only when such patients are unlikely to conceive and have been informed of the potential risk. 
Pravastatin je med nosečnostjo kontraindiciran in se lahko daje ženskam v rodni dobi le, če je malo verjetno, da bodo te bolnice zanosile, in če so bile obveščene o možnem tveganju.
In all clinical trials, patients were instructed to take Pravafenix daily during the evening meal and dietary restrictions instituted before therapy should be continued. 
V vseh kliničnih študijah je bilo bolnikom dano navodilo, da jemljejo zdravilo Pravafenix vsak dan med večernim obrokom in da še naprej upoštevajo dietne omejitve, vpeljane pred zdravljenjem.
Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU. 
Kategorije pogostnosti temeljijo na informacijah iz Povzetka glavnih značilnosti zdravila za pravastatin in fenofibrat, ki je na voljo v EU.
If you take indigestion remedies (used to neutralise acid in your stomach), take Pravafenix 1 hour after. 
Če jemljete zdravila za prebavne težave (za nevtralizacijo kisline v želodcu), vzemite zdravilo Pravafenix eno uro kasneje.
Interaction between pravastatin and fusidic acid can lead to an increased risk of rhabdomyolysis. 
Medsebojno delovanje pravastatina in fusidne kisline lahko privede do povečanega tveganja za rabdomiolizo.
If you are not sure about this, please follow your doctor's advice. 
Če ste v dvomu, upoštevajte nasvet zdravnika.
Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Pravafenix are listed below. 
Dodatni neželeni učinki, povezani z uporabo zdravil, ki vsebujejo pravastatin ali fenofibrat, ki so jih opazili v kliničnih študijah in pri izkušnjah z zdravilom po začetku trženja in do katerih lahko pride pri uporabi zdravila Pravafenix, so našteti spodaj.
In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation. 
Pri večini primerov so ravni jetrnih transaminaz padle na izhodiščno vrednost, ne da bi bilo treba zdravljenje prekiniti.
Additionally, fibrates have the properties to modify the size and density of LDL-C particles to make them less atherogenic. 
Poleg tega imajo fibrati lastnosti, s katerimi lahko spreminjajo velikost in gostoto delcev holesterola LDL in jih tako spreminjajo v manj aterogene.
Sleep disturbance including insomnia and nightmares 
Psihiatrične motnje motnje spanja, vključno z nespečnostjo in nočnimi morami občasni
Clinical and biochemical monitoring of patients receiving this combination is recommended. 
Pri bolnikih, ki prejemajo to kombinacijo, je priporočeno spremljanje kliničnih in biokemičnih parametrov.
Thromboembolism (pulmonary embolism, deep vein thrombosis)* 
Žilne bolezni tromboembolija (pljučna embolija, globoka venska tromboza)*
Pravafenix has no or negligible influence on the ability to drive and use machines. 
Zdravilo Pravafenix nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Following oral administration, 20% of the initial dose is eliminated in the urine and 70% in the faeces. 
Po peroralni uporabi se 20 % začetnega odmerka izloči z urinom, 70 % pa z blatom.
The medicine must be discontinued because of the potential risk to the foetus. 
Jemanje zdravila je treba zaradi možnega tveganja za plod prekiniti.
Each hard capsule contains 19 mg of lactose. 
Ena trda kapsula vsebuje 19 mg laktoze.
Do not take Pravafenix if any of the above applies to you. 
Ne vzemite zdravila Pravafenix, če kaj od naštetega velja za vas.
Abnormal urination (including dysuria, frequency, nocturia) 
nenormalno uriniranje (vključno z dizurijo, pogostim uriniranjem, nikturijo)
14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules 
14 trdih kapsul 30 trdih kapsul 60 trdih kapsul 90 trdih kapsul
Interactions relevant to fenofibrate 
Interakcije, povezane s fenofibratom
• Tiredness, weakness, influenza-like illness. 
• utrujenost, oslabelost, gripi podobno bolezensko stanje,
Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). 
Med simptomi in znaki so lahko dispneja, neproduktiven kašelj in poslabšanje splošnega zdravstvenega stanja (utrujenost, hujšanje in vročina).
Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration. 
Najvišja koncentracija v plazmi se pojavi v 4 do 5 urah po peroralni uporabi.
Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure. 
Sočasna uporaba pravastatina in ciklosporina vodi k približno štirikratnemu povečanju sistemske izpostavljenosti pravastatina.
The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy. 
Izhodiščne vrednosti kreatin-fosfokinaze so lahko uporabne tudi kot referenčne, če do zvišanja pride kasneje, med kombiniranim zdravljenjem.
If you feel any of these symptoms you should stop taking Pravafenix and inform your doctor. 
Če imate kateregakoli od teh simptomov, morate z jemanjem zdravila Pravafenix prenehati in o tem obvestiti zdravnika.
This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct medicinal product effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct. 
To lahko kaže na neučinkovitost zdravila pri bolnikih s hudo hipertrigliceridemijo, kar je neposredna posledica zdravila, ali pa gre za sekundarni pojav, ki nastane zaradi kamna ali usedline v biliarnem traktu, ki ovira žolčevod.
In the event of an overdose, symptomatic and supportive measures should be employed. 
V primeru prevelikega odmerjanja je potrebno začeti simptomatsko in podporno zdravljenje.
In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed. 
V podobni študiji s klaritromicinom so opazili statistično pomembno zvišanje površine pod krivuljo (110 %) in Cmax (127 %).
Prior to initiating Pravafenix, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment. 
Pred začetkom zdravljenja z zdravilom Pravafenix je treba izključiti sekundarne vzroke za kombinirano dislipidemijo, bolnikom pa mora biti predpisana standardna dieta za zniževanje vrednosti holesterola in trigliceridov, ki se je morajo držati tudi med zdravljenjem.
The major degradation product of pravastatin is the 3-αhydroxy isomeric metabolite. 
Glavni produkt razgradnje pravastatina je izomerni metabolit 3-α-hidroksi.
In such cases CK levels should be measured (see below). 
V takih primerih je treba izmeriti vrednosti kreatin-fosfokinaze (glejte spodaj).
Pravafenix must be taken with food, as food enhances the bioavailability of fenofibrate (see sections 4.2 and 5.2). 
Zdravilo Pravafenix je treba jemati s hrano, saj hrana zviša biološko uporabnost fenofibrata (glejte poglavji 4.2 in 5.2).
Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin. 
Čeprav gre za manjše spremembe, je pri sočasnem jemanju pravastatina z eritromicinom ali klaritromicinom potrebna previdnost.
- Before starting taking Pravafenix, you should be on a diet to lower your cholesterol. 
- Pred začetkom jemanja zdravila Pravafenix morate biti na dieti za zniževanje holesterola.