natgillin/translations-raw huggingface dataset:
s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL. 
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.
To morate narediti, ker holestiramin ali druge smole, ki vežejo žolčno kislino, pogosto poslabšajo absorpcijo zdravil, če med njihovim zaužitjem in zaužitjem zdravil preteče premalo časa, in tako motijo 
This is because colestyramine or other bile acid binding resins frequently reduce the absorption of medicines when taken too closely together and so may impede the absorption of Pravafenix.
ZA PROMET EU/1/11/679/001-007 
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
s pretrganjem zelo redki rabdomioliza imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.) 
Immune-mediated necrotizing myopathy (see section 4.4).
Pred odločitvijo o začetku zdravljenja z zdravilom Pravafenix je treba oceniti ledvično funkcijo (glejte poglavje 4.4 Bolezni sečil). 
Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders).
Vpliv kombinacije na sposobnost razmnoževanja v študijah ni bil raziskan. 
The combination has not been tested in reproductive toxicity studies.
občasni rabdomioliza, ki je lahko povezana z akutno odpovedjo ledvic po mioglobinuriji, miopatija (glejte poglavje 4.4); miozitis, polimiozitis. posamezni primeri okvar kit, pri katerih včasih pride do zapleta 
Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
V študijah vplivov na sposobnost razmnoževanja niso ne pri fenofibratu ne pri pravastatinu opazili učinkov na plodnost (glejte poglavje 5.3) 
No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Bolezni mišično-skeletnega sistema in vezivnega tkiva 
Musculoskeletal and connective tissue disorders
Skeletna mišičnina: redko so zabeležili izrazit in stalen porast kreatin-fosfokinaze (KF). Med bolniki, 
Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
tip 1500, hidroksipropilceluloza, makrogol 20 000. 
Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
FARMACEVTSKA OBLIKA IN VSEBINA 30 trdih kapsul 
PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Če ravni aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT) presežejo trikratno 
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.
S sistemom citokroma P450 pravastatin ni presnovljen v klinično pomembni meri. 
Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Zdravilo Pravafenix je kontraindicirano pri bolnikih z zmerno do hudo okvaro ledvic (ki je določena z očistkom kreatinina < 60 ml/min). 
Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Ne jemljite zdravila Pravafenix, če dojite. 
Do not take Pravafenix if you are breast-feeding.
Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgija 
Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Zelo redki neželeni učinki (pojavijo se lahko največ pri 1 od 10.000 bolnikov) 
Very rare side effects (may affect up to 1 in 10,000 people)
Študije o interakcijah zdravila Pravafenix niso bile narejene, vendar sočasno jemanje zdravilnih učinkovin pri bolnikih v kliničnih študijah ni povzročilo nobenih nepričakovanih interakcij. Spodnje navedbe odražajo dostopne podatke o posameznih zdravilnih učinkovinah (fenofibratu in pravastatinu). 
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.
Nekateri dokazi kažejo, da statini kot razred zdravil povišajo raven glukoze in lahko pri nekaterih bolnikih z velikim 
Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate.
se odmerkih kažejo, da lahko pravastatin sproži različne stopnje hepatotoksičnosti in miopatije; v splošnem so bili znatni učinki na ta tkiva opazni šele pri odmerkih, ki so znašali 50-kratnik največjega odmerka pri človeku v mg/kg ali več. Genetske toksikološke študije in vitro in in vivo niso našle dokazov za mutageni potencial. 
Repeated dose studies indicate that pravastatin may induce varying degrees of hepatotoxicity and myopathy; in general, substantive effects on these tissues were only evident at doses 50 or more times the maximum human mg/kg dose.
Zdravilo Pravafenix je pri zmerni do hudi okvari ledvic kontraindicirano (poglavje 4.3). 
Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Ravni trigliceridov LDL in VLDL se znižajo. Skupni učinek je zmanjšano razmerje med lipoproteini nizke in zelo nizke gostote ter lipoproteini visoke gostote. 
The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul 
PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
s katerokoli drugo smolo, ki veže žolčno kislino (zdravilom za zniževanje holesterola), vzemite zdravilo Pravafenix eno uro pred smolo ali 4 do 6 ur po njej. 
When your doctor has prescribed Pravafenix along with colestyramine or any other bile acid binding resins (medicines for lowering cholesterol), take Pravafenix 1 hour before, or 4 to 6 hours after the resin.
s pravastatinom v odmerkih 250 in 500 mg/kg/dan (> 310-kratnika največjega odmerka pri človeku v mg/kg) pokazala statistično pomembno povečanje incidence hepatocelularnih karcinomov pri samcih in samicah ter adenomov pljuč samo pri samicah. 
In mice, a 2-year carcinogenicity study with pravastatin demonstrates at doses of 250 and 500 mg/kg/day (> 310 times the maximum human mg/kg dose), statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only.
Sladkorna bolezen 
Diabetes Mellitus
učinki na živčevje: omotica (občutek nestabilnosti), glavobol, motnje spanja (vključno s težavami pri spanju in nočnimi morami), občutek zbadanja (parestezija), 
• Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances
tudi biliarna ciroza in aktivna jetrna bolezen, vključno z nepojasnjenimi trajno zvišanimi vrednostmi parametrov pri testih jetrne funkcije (vključno z zvišano serumsko transaminazo), ki so višje od trikratne zgornje meje normalnih vrednosti (ZMN) (glejte poglavje 4.4). 
- Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3
Kinetične raziskave po uporabi enkratnega odmerka in neprekinjenem zdravljenju 
Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
60 trdih kapsul 
60 hard capsules
Kapsule so na voljo v pretisnih omotih iz poliamidaaluminija-PVC/aluminija, ki vsebujejo 30, 60 in 90 trdih kapsul, in v neprozornih belih plastenkah 
The capsules are supplied in Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing either 14, 30, 60 or 90 capsules.
Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe samega pravastatina in samega fenofibrata. 
Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually.
V prvih 12 mesecih kombiniranega zdravljenja je sistematično priporočljivo rutinsko spremljanje kreatin-fosfokinaze na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku. 
Routine monitoring of CK is systematically recommended every 3 months during the first 12 months of the combination therapy and let to the appreciation of the clinician beyond this initial period.
Ne prenehajte z jemanjem zdravila Pravafenix, dokler se ne posvetujete z zdravnikom. 
If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor.
Tveganje za miopatijo, vključno z rabdomiolizo, se lahko poveča pri sistemskem zdravljenju 
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
90 trdih kapsul 
90 hard capsules
Tveganje za toksične učinke na mišice je povečano, če se fibrat in inhibitor reduktaze 3-hidroksi-3 
The risk of muscle toxicity is increased when a fibrate and a 3-hydroxy-3-methyl-glutarylCoenzyme A (HMG-CoA) reductase inhibitor are administered together.
to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi). 
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
s simvastatinom v monoterapiji za sestavljen primarni izid (razmerje tveganja [RT] 0,69, 95 % IZ 0,49-0,97, p = 0,03; absolutno zmanjšanje tveganja: 4,95 %). 
mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%).
transaminaz padle na izhodiščno vrednost, ne da bi bilo 
In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation.
Natrijev pravastatinat 
Pravastatin sodium
30 trdih kapsul 
30 hard capsules
Fenofibrat je derivat fibrične kisline (fibrat), katerega vpliv na lipide, o katerem poročajo pri ljudeh, se posreduje z aktivacijo 
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) 
Uncommon side effects (may affect up to 1 in 100 people)
Bolnike je treba opozoriti, da nemudoma sporočijo, če v mišicah pride do kakršnihkoli nepojasnjenih bolečin, občutljivosti, oslabelosti ali krčev. 
Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps.
Obe učinkovini sta zdravili, ki vplivata na holesterol/lipide. 
Both are cholesterol/lipid modifying medicines.
Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do 
The frequencies of adverse reactions are ranked according to the following: Very common ( ≥ 1/10),
Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih 
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.
vnetje mišic (miozitis), oslabelost mišic ali mišični krči. 
• Muscle inflammation (myositis), muscular cramps and weakness.
Lastnost fenofibrata, da znižuje koncentracijo lipidov, ki je bila opažena v klinični praksi, je bila pojasnjena in vivo pri transgenskih miših in 
The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated
Z VARNO IN UČINKOVITO UPORABO 
Clinical efficacy and safety
s klaritromicinom so opazili statistično pomembno zvišanje površine pod krivuljo (110 %) in 
In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Pravastatin in fenofibrat sta, tako kot druge učinkovine za zniževanje lipidov, povezana z nastankom mialgije, miopatije, zelo redko pa tudi rabdomiolize, ki lahko ali pa ne vodi k zmanjšanemu delovanju ledvic. Rabdomioliza je akutno in potencialno 
As with other lipid lowering substances, pravastatin or fenofibrate have been associated with the onset of myalgia, myopathy and very rarely rhabdomyolysis with or without secondary renal insufficiency.
V plazmi, v kateri je glavni metabolit fenofibratna kislina, ni zaznati nobenega nespremenjenega fenofibrata. 
No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
simptomi vnetja jeter (hepatitisa), med katerimi so lahko rahlo porumenela koža in beločnice 
• Inflammation of the liver (hepatitis), symptoms of which may be mild yellowing of the skin and whites of the eyes (jaundice), abdominal pain and itching.
tedna v odstotkih za bolnike, zdravljene z zdravilom Pravafenix 40 mg/160 mg ali pravastatinom 40 mg enkrat dnevno 
Mean percent changes from baseline to week 12 for patients treated with Pravafenix 40 mg/160 mg or Pravastatin 40 mg once daily
- z zdravili za preprečevanje krvnih strdkov, kot so varfarin, fluindion, fenprokomon ali acenokumarol (antikoagulanti), - z antibiotikom, kot sta eritromicin ali klaritromicin, ki se uporabljata za zdravljenje okužb, ki jih povzročajo bakterije, 
- Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol
Zato je mogoče zdravila, ki jih sistem citokroma P450 presnavlja ali pa so njegovi zaviralci, dodajati stabilni 
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.
Drugi neželeni učinki 
Other Side effects
neobičajen srčni utrip (palpitacije), nastanek krvnih strdkov v venah (globoka venska tromboza) 
• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
LDL, zvišana koncentracija gama-glutamil transferaze (različnih jetrnih encimov), bolečine v jetrih (bolečine v zgornjem desnem predelu 
• Increased blood cholesterol, increased blood triglycerides, increased LDL, increased gamma glutamyl transferase (various liver enzymes), liver pain (upper right abdominal pain with or without pain in the back), increased weight.
- za znižanje ravni „slabega“ holesterola (holesterola LDL); zdravilo to doseže tako, da zniža raven skupnega holesterola in maščobnih snovi, imenovanih trigliceridi, v krvi, 
It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
sum na dedno bolezen mišic, začenjanje ponovnega zdravljenja z zdravilom Pravafenix ni priporočljivo. 
If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
bolečine v mišicah (mialgija, artralgija), bolečina v hrbtu, spremembe v nekaterih laboratorijskih krvnih preiskavah delovanja mišic, • težave z vidom, kot je zamegljen ali dvojni vid, 
• Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Pri bolnikih, pri katerih se oceni, da je sistemska uporaba fusidne kisline nujna, je treba prekiniti zdravljenje 
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept. 
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
IME IMETNIKA DOVOLJENJA 
NAME OF THE MARKETING AUTHORISATION HOLDER
Pri bolnikih, starejših od 75 let, so na voljo le omejeni podatki o varnosti, 
Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
telovadba, zmanjšanje telesne mase) za zdravljenje odraslih bolnikov z mešano hiperlipidemijo in visokm tveganjem za kardiovaskularne bolezni, za zmanjševanje vrednosti trigliceridov in višanje vrednosti holesterola HDL, v primeru, ko so vrednosti holesterola LDL ustrezno nadzirane z monoterapijo 
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.
Vsaka trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata. 
Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Zdravilo Pravafenix je v študiji enkratnega odmerka bioekvivalenten sočasno uporabljenima fenofibratu in pravastatinu. 
Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
DODATEK II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Pravastatin je učinkovitejši pri zniževanju holesterola LDL in skupnega holesterola, na trigliceride in holesterol HDL pa ima le zmeren učinek. 
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.
- s holestiraminom/holestipolom (zdravilom za zniževanje holesterola), saj vpliva na to, kako zdravilo Pravafenix deluje, - s ciklosporinom (zdravilom, ki se pogosto uporablja pri bolnikih po presaditvi organa), 
- Ciclosporin (a medicine often used in organ transplant patients).
so povečanje vrednosti transaminaz in bolezni prebavil. 
Hepatobiliary disorders Transaminases increased.
Analiza druge predhodno določene podskupine, opredeljene kot statistično značilna interakcija med zdravljenjem in spolom (p = 0,01), kaže na možne koristi zdravljenja 
Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Fenofibratna kislina se ne odstrani 
Fenofibric acid is not eliminated by haemodialysis.
ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji. 
Pravafenix has no or negligible influence on the ability to drive and use machines.
se pojavi v 4 do 5 urah po peroralni uporabi. 
Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
debelost, 
• Obesity.
Kapsule so iz trde želatine z olivno zelenim zgornjim in s svetlozelenim 
The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet.
s trigliceridi, iz plazme, tako da aktivira lipoproteinsko lipazo 
Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of
Interakcije, povezane 
Interactions relevant to pravastatin
Okvara ledvic 
Renal impairment
Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat 
Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. 
If you get any side effects, talk to your doctor or pharmacist.
Pravastatin je kompetitiven zaviralec reduktaze 3-hidroksi-3-metilglutaril-koencima A (HMG-CoA), 
Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid-lowering effect in two ways.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom 
6.6 Special precautions for disposal
Zdravilni učinkovini sta fenofibrat in pravastatin. 
• The active substances are fenofibrate and pravastatin.
Med vožnjo motornih vozil ali delom 
Driving and using machines
Če se zdravilo Pravafenix vzame med obrokom, ki vsebuje maščobe, ali med postenjem, njegove farmakokinetične lastnosti niso popolnoma enake kot pri sočasni uporabi obstoječih monoterapij. 
The pharmacokinetics properties of Pravafenix are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state.
Pravastatin se v majhnih količinah izloča v materino mleko, zato je med dojenjem kontraindiciran 
A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3).
Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3-kratnika 
In clinical studies, the incidence of important elevations in serum transaminases (ALT
IME ZDRAVILA Pravafenix 40 mg/160 mg trde kapsule 
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Pred začetkom zdravljenja je treba izmeriti vrednosti kreatin-fosfokinaze. 
CK levels should be measured prior to initiation of therapy.
Preiskava zvišana koncentracija holesterola v krvi, zvišana koncentracija trigliceridov v krvi, zvišana koncentracija lipoproteinov majhne gostote, povečana telesna masa. 
Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Druga vrsta maščob v krvi so trigliceridi. 
Triglycerides are another fat in your blood.
smrtnega izida in kardiovaskularni smrtji (razmerje tveganja [RT] 0,92, 95 % IZ 0,79-1,08, p = 0,32; absolutno zmanjšanje tveganja: 0,74 %). 
Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%).
Kadar se zdravilo Pravafenix uporablja pri bolnikih, ki imajo v anamnezi obolenje jeter ali čezmerno uživajo alkohol, je potrebna previdnost. 
Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion.
Koncentracija sečne kisline v plazmi je povečana pri približno 20 % bolnikov 
Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Splošne težave: 
General disorders:
Zdravilo Pravafenix 
Pravafenix
Prvič, z reverzibilnim in specifičnim kompetitivnim zaviranjem reduktaze 
Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Zdravilo Pravafenix vsebuje laktozo 
Pravafenix contains lactose
preobčutljivost, 
• Hypersensitivity.
Aktivacija PPARα vzpodbudi tudi hitrejšo sintezo apoproteinov A-I in A-II ter holesterola HDL. 
Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I,
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo 
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Zato fiksna kombinacija odmerkov (zdravilo Pravafenix) ne more veljati za medsebojno zamenljivo 
Therefore the fixed dose combination (Pravafenix) could not be considered interchangeable with the free co-administration of fenofibrate and pravastatin mono-component drug products.
Če je ocenjeni očistek kreatinina < 60 ml/min, je treba zdravljenje prekiniti. 
Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.