FrancophonIA/ELRC3.0 huggingface dataset:
English: No sign of any effect on fertility has been detected.
Slovenian: Zaznali niso nobenega učinka na plodnost.
English: Pravafenix is used if you are an adult with an elevated risk for heart disease and need to improve cholesterol and triglycerides fat levels in your blood when your ‘bad' cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine).
Slovenian: Zdravilo Pravafenix ste dobili, če ste bolnik z zvišanim tveganjem za bolezni srca in morate izboljšati raven holesterola in trigliceridnih maščob v krvi in če je vaš „slabi“ holesterol ustrezno nadzorovan samo s pravastatinom (statinom, zdravilom za zniževanje ravni holesterola).
English: Apo A1 (g/L)
Slovenian: Apoprotein A1 (g/l)
English: Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
Slovenian: občasni rabdomioliza, ki je lahko zelo redki povezana z akutno odpovedjo ledvic po mioglobinuriji, miopatija (glejte poglavje 4.4); miozitis, polimiozitis.
English: Pravafenix contains a sugar called lactose.
Slovenian: Zdravilo Pravafenix vsebuje sladkor, imenovan laktoza.
English: The recommended dose is one capsule taken daily during the evening meal.
Slovenian: Priporočeni odmerek je ena kapsula na dan, ki se zaužije med večernim obrokom.
English: Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.
Slovenian: Po zdravljenju z zdravilom Pravafenix se vrednosti serumskih lipidov običajno naglo znižajo, če pa v treh mesecih ni ustreznega odziva, je treba zdravljenje prekiniti.
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Slovenian: Izjemoma so pri nekaterih statinih, še posebej pri dolgotrajnem zdravljenju, opisovali primere intersticijske pljučne bolezni (glejte poglavje 4.8).
English: Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
Slovenian: Skeletna mišičnina: redko so zabeležili izrazit in stalen porast kreatin-fosfokinaze (KF).
English: Fenofibrate
Slovenian: Fenofibrat
English: In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
Slovenian: Tako pri zdravih osebah kot pri bolnikih s hiperholesterolemijo pravastatin znižuje naslednje vrednosti lipidov: skupni holesterol, holesterol LDL, apolipoprotein B, holesterol VLDL in trigliceride.
English: - You should keep to this diet while taking Pravafenix
Slovenian: - Te diete se morate držati tudi med jemanjem zdravila Pravafenix.
English: • Hypersensitivity.
Slovenian: • preobčutljivost,
English: INFORMATION IN BRAILLE Pravafenix
Slovenian: PODATKI V BRAILLOVI PISAVI Pravafenix
English: In rats a 2-year carcinogenicity study demonstrates at a dose of 100 mg/kg/day (125 times the maximum human mg/kg/dose) a statistically significant increase in the incidence of hepatocellular carcinomas in males only.
Slovenian: Pri podganah je dveletna študija kancerogenosti pri odmerkih 100 mg/kg/dan (125-kratnik največjega odmerka pri človeku v mg/kg) pokazala statistično pomembno povečanje incidence hepatocelularnih karcinomov samo pri samcih.
English: There are no data from the use of fenofibrate in pregnant women.
Slovenian: O uporabi fenofibrata pri nosečnicah ni podatkov.
English: Do not use Pravafenix after the expiry date which is stated on the carton and the blister/bottle after EXP.
Slovenian: Zdravila Pravafenix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu/steklenički poleg oznake „Uporabno do“.
English: HDPE bottle 3 years.
Slovenian: Polietilena visoke gostote (HDPE) 3 leti
English: Secondly, pravastatin inhibits LDL production by inhibiting the hepatic synthesis of VLDLcholesterol, the LDL-cholesterol precursor.
Slovenian: Drugič, pravastatin zavira produkcijo LDL, tako da zavira sintezo holesterola VLDL, ki je predhodnik holesterola LDL, v jetrih.
English: Pravafenix does not usually affect your ability to drive or use machines.
Slovenian: Zdravilo Pravafenix ponavadi ne vpliva na sposobnost upravljanja vozil in strojev.
English: • Breathing problems including persistent cough/or shortness of breath or fever.
Slovenian: • težave z dihanjem, vključno z dolgotrajnim kašljem/ali oteženo dihanje ali zvišana telesna temperatura,
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Slovenian: Tem bolnikom je treba naročiti, naj se takoj posvetujejo z zdravnikom, če se pri njih pojavijo kakršni koli simptomi mišične oslabelosti, bolečin ali preobčutljivosti.
English: In clinical trials, over 1,566 patients received Pravafenix.
Slovenian: 4.8 Neželeni učinki V kliničnih študijah je zdravilo Pravafenix prejelo 1566 bolnikov.
English: Therefore the fixed dose combination (Pravafenix) could not be considered interchangeable with the free co-administration of fenofibrate and pravastatin mono-component drug products.
Slovenian: Zato fiksna kombinacija odmerkov (zdravilo Pravafenix) ne more veljati za medsebojno zamenljivo s sočasno uporabo enokomponentnih zdravil s fenofibratom in pravastatinom brez omejitev.
English: 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
Slovenian: Lastnost fenofibrata, da znižuje koncentracijo lipidov, ki je bila opažena v klinični praksi, je bila pojasnjena in vivo pri transgenskih miših in s kulturami humanih hepatocitov z aktivacijo s peroksisomskim proliferatorjem aktiviranega receptorja α (PPARα).
English: 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.
Slovenian: 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 tudi absorpcijo zdravila Pravafenix.
English: If you forget to take Pravafenix
Slovenian: Če ste pozabili vzeti zdravilo Pravafenix
English: Four multicenter studies with either Pravafenix 40 mg/160 mg or Pravastatin 40 mg or Simvastatin 20 mg were conducted: 3 studies included a 12 week randomized, double-blind, active controlled period with an open-label extension phase and one was a 24-week open-label study.
Slovenian: 40 mg ali s simvastatinom 20 mg: 3 študije so vključevale 12-tedensko randomizirano, dvojno slepo, aktivno nadzorovano študijo z odprto podaljšano fazo, ena pa je bila 24-tedenska odprta študija.
English: Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
Slovenian: Koncentracija sečne kisline v plazmi je povečana pri približno 20 % bolnikov s hiperlipidemijo, še posebej pri tistih z boleznijo tipa IV. Fenofibrat ima urikozurični učinek in zato takim bolnikom dodatno koristi.
English: The effects of Pravafenix 40 mg/160 mg were confirmed in a similar multicenter, 64-week trial including a 12 week randomized, double-blind phase in a study performed in the USA and comparing Pravafenix 40 mg/160 mg to Fenofibrate 160 mg monotherapy and Pravastatin 40 mg monotherapy in patients with mixed dyslipidaemia.
Slovenian: Učinki zdravila Pravafenix 40 mg/160 mg so bili potrjeni v podobnem multicentričnem 64-tedenskem preskušanju, ki je vključevalo 12-tedensko randomizirano, dvojno slepo študijo, ki je potekala v ZDA in je primerjala zdravilo Pravafenix 40 mg/160 mg z monoterapijo s fenofibratom 160 mg in monoterapijo s pravastatinom 40 mg pri bolnikih z mešano dislipidemijo.
English: If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
Slovenian: Če pri teh bolnikih obstaja sum na dedno bolezen mišic, začenjanje ponovnega zdravljenja z zdravilom Pravafenix ni priporočljivo.
English: The absorption of fenofibrate is increased when administered with food.
Slovenian: Fenofibrat se bolje absorbira, če se jemlje skupaj s hrano.
English: Pravafenix with food, drink and alcohol - Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
Slovenian: Zdravilo Pravafenix skupaj s hrano in pijačo - Zdravilo Pravafenix vedno vzemite skupaj s hrano, saj se na tešče slabše absorbira.
English: You should tell your doctor immediately if it happens.
Slovenian: Če se to zgodi, o tem takoj obvestite zdravnika.
English: This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol.
Slovenian: Zato se poveča število receptorjev za LDL na površinah celic, pospeši se receptorsko posredovani katabolizem, krožeči holesterol LDL pa očisti.
English: Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Slovenian: Pretisni omoti iz poliamida-aluminija-PVC/aluminija, ki vsebujejo 30, 60 in 90 trdih kapsul.
English: Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Slovenian: Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgija
English: What Pravafenix looks like and contents of the pack
Slovenian: Izgled zdravila Pravafenix in vsebina pakiranja
English: Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Slovenian: Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Bruselj Belgija
English: Since current safety and efficacy data are based upon administration with food and with dietary restrictions, it is recommended that Pravafenix is administered with food.
Slovenian: Ker trenutni podatki o varnosti in učinkovitosti temeljijo na jemanju skupaj s hrano in upoštevanju dietnih omejitev, se priporoča jemanje zdravila Pravafenix skupaj s hrano (glejte poglavji 4.2 in 5.2).
English: If it is suspected a patient has developed interstitial lung disease, Pravafenix therapy should be discontinued.
Slovenian: Če obstaja sum, da se je pri bolniku razvila intersticijska pljučna bolezen, je treba zdravljenje z zdravilom Pravafenix prekiniti.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE FOR 14 AND 30 HARD CAPSULES
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH PLASTENKA ZA 14 IN 30 TRDIH KAPSUL
English: If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment.
Slovenian: Če je zdravljenje s fusidno kislino nujno, je treba prekiniti zdravljenje s pravastatinom za celotno obdobje zdravljenja s fusidno kislino.
English: Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031).
Slovenian: Preiskave povečana količina sečnine v krvi redki * V študiji FIELD (študiji o fenofibratu), randomiziranem, s placebom nadzorovanem preskušanju, ki je bilo izvedeno pri 9795 bolnikih s sladkorno boleznijo tipa 2, so pri bolnikih, ki so prejemali fenofibrat, opazili statistično pomembno povečanje primerov pankreatitisa v primerjavi s tistimi, ki so prejemali placebo (0,8 % v primerjavi z 0,5 %; p = 0,031).
English: In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Slovenian: Pri bolnikih, pri katerih se oceni, da je sistemska uporaba fusidne kisline nujna, je treba prekiniti zdravljenje s statini za celotno obdobje zdravljenja s fusidno kislino.
English: There are no data from the combined use of pravastatin and fenofibrate in pregnant women.
Slovenian: O kombinirani uporabi pravastatina in fenofibrata pri nosečnicah ni podatkov.
English: Pravastatin must not be co-administered with systemic fusidic acid.
Slovenian: Pravastatin se ne sme uporabljati sočasno s sistemskim zdravljenjem s fusidno kislino.
English: If cholelithiasis is suspected, gallbladder studies are indicated.
Slovenian: Če obstaja sum na holelitiazo, je treba opraviti preiskave žolčnika.
English: Mean (%)± SEb
Slovenian: (%) ± SE
English: Mean percent changes from baseline to week 12 for patients treated with Pravafenix 40 mg/160 mg or Pravastatin 40 mg once daily
Slovenian: Povprečne spremembe od izhodiščne vrednosti do 12. tedna v odstotkih za bolnike, zdravljene z zdravilom Pravafenix 40 mg/160 mg ali pravastatinom 40 mg enkrat dnevno
English: - Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the ULN under previous statin treatment
Slovenian: - Miopatija in/ali rabdomioliza ob jemanju statinov in/ali fibratov v osebni anamnezi ali potrjeno zvišanje kreatin-fosfokinaze, ki je bilo med prejšnjim zdravljenjem s statini višje od petkratne zgornje meje normalnih vrednosti (ZMN) (glejte poglavje 4.4).
English: A pharmacokinetic study after a single dose administration of Pravafenix has been performed in fed and fasting condition.
Slovenian: Izvedena je bila farmakokinetična študija po enem odmerku zdravila Pravafenix pri teščih in neteščih bolnikih.
English: The bioavailability of fenofibric acid is lower in fasting conditions after a single dose administration of the Fenofibrate-Pravastatin 160/40 mg combination.
Slovenian: Biološka uporabnost fenofibratne kisline na tešče je nižja po uporabi enega odmerka kombinacije fenofibrata in pravastatina 160/40 mg.
English: Venothromboembolic events
Slovenian: Venski tromboembolični dogodki
English: The bioavailability of pravastatin is higher after a single dose administration of the test product Fenofibrate/Pravastatin 160/40 mg in fasting conditions than after a single dose of the product in fed conditions.
Slovenian: Biološka uporabnost pravastatina je višja po uporabi enega odmerka testnega zdravila fenofibrat/pravastatin 160/40 mg na tešče v primerjavi z enim odmerkom zdravila pri neteščih bolnikih.
English: 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.
Slovenian: Pri miših je dveletna študija kancerogenosti 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.
English: Your doctor will monitor you while you are taking this medicine.
Slovenian: Med jemanjem tega zdravila bo zdravnik pri vas opravljal spremljanje.
English: 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.
Slovenian: Pravastatin je kompetitiven zaviralec reduktaze 3-hidroksi-3-metilglutaril-koencima A (HMG-CoA), encima, ki katalizira zgodnjo stopnjo omejevanja hitrosti pri biosintezi holesterola.
English: - Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3
Slovenian: - Huda okvara jeter, v katero sta všteti 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).
English: Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.).
Slovenian: Zdravilo Pravafenix se ne priporoča pri bolnikih z zmerno okvaro jeter, pri bolnikih s hudo okvaro jeter pa je kontraindicirano (glejte poglavje 4.3).
English: Apo B (g/L)
Slovenian: Apoprotein B (g/l)
English: If you are not sure, talk to your doctor or pharmacist before taking Pravafenix.
Slovenian: Če niste prepričani, se preden začnete jemati zdravilo Pravafenix, posvetujte z zdravnikom ali farmacevtom.
English: Certain predisposing factors such as age > 70, renal impairment, hepatic impairment, hypothyroidism, personal history of muscular toxicity with a statin or fibrate, personal or familial history of hereditary muscular disorders or alcohol abuse may increase the risk of muscular toxicity and therefore CK measurement is indicated before starting the combination therapy in these patients (see below).
Slovenian: Nekateri predispozicijski dejavniki, na primer starost nad 70 let, okvara ledvic, okvara jeter, hipotiroidizem, toksični učinki statina ali fibrata na mišice v osebni anamnezi, dedne mišične motnje v osebni ali družinski anamnezi ali zloraba alkohola, lahko povečajo tveganje za toksične učinke na mišice.
English: PRAVASTATIN 40 mg Na = 119
Slovenian: PRAVASTATIN 40 mg
English: Fenofibric acid is not eliminated by haemodialysis.
Slovenian: Fenofibratna kislina se ne odstrani s hemodializo.
English: Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
Slovenian: Razvije se lahko kadarkoli med zdravljenjem, zanjo pa je značilen masiven razkroj mišic, povezan z znatnim zvišanjem kreatin-fosfokinaze (ponavadi > 30- ali 40-kratnik ZMN), ki vodi v mioglobinurijo.
English: Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Slovenian: Bolezni prebavil napihnjenost trebuha, bolečina v trebuhu, bolečina v zgornjem delu trebuha, zaprtost, driska, suha usta, dispepsija, kolcanje, napenjanje, navzea, neugodje v trebuhu, bruhanje pogosti
English: This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Slovenian: • sladkorna bolezen: to je verjetneje, če imate visoke ravni sladkorjev in maščob v krvi, imate čezmerno telesno maso in visok krvi tlak.
English: Therefore, as far as pravastatin is contra indicated (see below), Pravafenix is contraindicated during pregnancy (see section 4.3).
Slovenian: Ker je pravastatin kontraindiciran (glejte spodaj), je tudi zdravilo Pravafenix med nosečnostjo kontraindicirano (glejte poglavje 4.3).
English: There is no relevant use of Pravafenix in the paediatric population (< 18 years old) for the indication of mixed dyslipidaemia (see section 4.3).
Slovenian: Pediatrična populacija (< 18 let) Zdravilo Pravafenix ni primerno za uporabo pri pediatrični populaciji z indikacijo mešane dislipidemije (glejte poglavje 4.3).
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Slovenian: Slednje lahko sčasoma pripeljejo do zožitve arterij.
English: Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and
Slovenian: Pravafenix na prazen želodec slabše absorbira, ga je treba vedno vzeti skupaj s hrano (glejte poglavji 4.5 in 5.2).
English: Liver reactions: Marked and persistent increases of serum transaminases have been reported infrequently.
Slovenian: Neželeni učinki na jetrih: redko so zabeležili izrazit in stalen porast serumskih transaminaz.
English: Patients should not be switched from a free co-administration of fenofibrate and pravastatin preparation to Pravafenix (see section 5.2.
Slovenian: Bolniki ne smejo prehajati s sočasne uporabe zdravil s fenofibratom in pravastatinomna zdravilo Pravafenix (glejte poglavje 5.2).
English: This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Slovenian: To morate storiti, ker so težave z mišicami v zelo redkih primerih (mednje spada razpadanje mišic, ki povzroča poškodbe ledvic) lahko resne; v zelo redkih primerih je prišlo do smrti.
English: Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps.
Slovenian: Na miopatijo je treba pomisliti pri kateremkoli bolniku, ki v mišicah čuti nepojasnjene simptome, na primer bolečino, občutljivost, oslabelost ali krče.
English: Do not take Pravafenix if - You are allergic to fenofibrate, pravastatin, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PRAVAFENIX Ne jemljite zdravila Pravafenix - če ste alergični (preobčutljivi) na fenofibrat, pravastatin ali katerokoli sestavino zdravila Pravafenix (navedeno v poglavju 6),
English: Check with your doctor or pharmacist before taking Pravafenix if you have severe respiratory failure, e.g. you have breathing problems including, persistent non-productive cough, deterioration in general health like fatigue (tiredness), weight loss and/or shortness of breath or fever.
Slovenian: Pred jemanjem zdravila Pravafenix se posvetujte z zdravnikom ali farmacevtom, če imate hudo respiracijsko insuficienco, npr. težave z dihanjem, vključno z neproduktivnim kašljem, ki ne poneha,
English: Pancreatitis
Slovenian: Pankreatiti
English: Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Slovenian: Neprozorne bele plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 14, 30, 60 in 90 trdih kapsul.
English: It is important that you inform your doctor if you are already being treated with any of the following: - Bile acid resins such as colestyramine/colestipol (a medicine for lowering cholesterol), because it affects the way Pravafenix works.
Slovenian: Pomembno je, da zdravnika obvestite, če vas že zdravijo s čimerkoli od naštetega: - 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),
English: Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3).
Slovenian: Pri bolnikih, ki so jemali fenofibrat ali pravastatin, so poročali o pankreatitisu (glejte poglavje 4.3).
English: Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure
Slovenian: Bolezni sečil povečan kreatinin v krvi, zmanjšan ledvični očistek kreatinina, povečan ledvični očistek kreatinina, odpoved ledvic občasni
English: No studies in lactating animals have been conducted with Pravafenix.
Slovenian: Študij z zdravilom Pravafenix na doječih živalih niso opravili.
English: - 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.
Slovenian: - Povejte mu, če pijete veliko alkohola (glejte spodnje poglavje Jemanje zdravila Pravafenix skupaj s hrano in pijačo) ali če ste kadarkoli imeli bolezen jeter.
English: 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.
Slovenian: 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.