natgillin/translations-raw huggingface dataset:
If it is suspected a patient has developed interstitial lung disease, Pravafenix therapy should be discontinued. 
Če obstaja sum, da se je pri bolniku razvila intersticijska pljučna bolezen, je treba zdravljenje z zdravilom Pravafenix prekiniti.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE FOR 14 AND 30 HARD CAPSULES 
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH PLASTENKA ZA 14 IN 30 TRDIH KAPSUL
If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment. 
Če je zdravljenje s fusidno kislino nujno, je treba prekiniti zdravljenje s pravastatinom za celotno obdobje zdravljenja s fusidno kislino.
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). 
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).
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. 
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.
There are no data from the combined use of pravastatin and fenofibrate in pregnant women. 
O kombinirani uporabi pravastatina in fenofibrata pri nosečnicah ni podatkov.
Pravastatin must not be co-administered with systemic fusidic acid. 
Pravastatin se ne sme uporabljati sočasno s sistemskim zdravljenjem s fusidno kislino.
If cholelithiasis is suspected, gallbladder studies are indicated. 
Če obstaja sum na holelitiazo, je treba opraviti preiskave žolčnika.
Mean (%)± SEb 
(%) ± SE
Mean percent changes from baseline to week 12 for patients treated with Pravafenix 40 mg/160 mg or Pravastatin 40 mg once daily 
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
- 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 
- 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).
A pharmacokinetic study after a single dose administration of Pravafenix has been performed in fed and fasting condition. 
Izvedena je bila farmakokinetična študija po enem odmerku zdravila Pravafenix pri teščih in neteščih bolnikih.
The bioavailability of fenofibric acid is lower in fasting conditions after a single dose administration of the Fenofibrate-Pravastatin 160/40 mg combination. 
Biološka uporabnost fenofibratne kisline na tešče je nižja po uporabi enega odmerka kombinacije fenofibrata in pravastatina 160/40 mg.
Venothromboembolic events 
Venski tromboembolični dogodki
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. 
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.
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. 
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.
Your doctor will monitor you while you are taking this medicine. 
Med jemanjem tega zdravila bo zdravnik pri vas opravljal spremljanje.
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. 
Pravastatin je kompetitiven zaviralec reduktaze 3-hidroksi-3-metilglutaril-koencima A (HMG-CoA), encima, ki katalizira zgodnjo stopnjo omejevanja hitrosti pri biosintezi holesterola.
- Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3 
- 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).
Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.). 
Zdravilo Pravafenix se ne priporoča pri bolnikih z zmerno okvaro jeter, pri bolnikih s hudo okvaro jeter pa je kontraindicirano (glejte poglavje 4.3).
Apo B (g/L) 
Apoprotein B (g/l)
If you are not sure, talk to your doctor or pharmacist before taking Pravafenix. 
Če niste prepričani, se preden začnete jemati zdravilo Pravafenix, posvetujte z zdravnikom ali farmacevtom.
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). 
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.
PRAVASTATIN 40 mg Na = 119 
PRAVASTATIN 40 mg
Fenofibric acid is not eliminated by haemodialysis. 
Fenofibratna kislina se ne odstrani s hemodializo.
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. 
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.
Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting. 
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
This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. 
• sladkorna bolezen: to je verjetneje, če imate visoke ravni sladkorjev in maščob v krvi, imate čezmerno telesno maso in visok krvi tlak.
Therefore, as far as pravastatin is contra indicated (see below), Pravafenix is contraindicated during pregnancy (see section 4.3). 
Ker je pravastatin kontraindiciran (glejte spodaj), je tudi zdravilo Pravafenix med nosečnostjo kontraindicirano (glejte poglavje 4.3).
There is no relevant use of Pravafenix in the paediatric population (< 18 years old) for the indication of mixed dyslipidaemia (see section 4.3). 
Pediatrična populacija (< 18 let) Zdravilo Pravafenix ni primerno za uporabo pri pediatrični populaciji z indikacijo mešane dislipidemije (glejte poglavje 4.3).
Over time, this plaque build-up can lead to a clogging of your arteries. 
Slednje lahko sčasoma pripeljejo do zožitve arterij.
Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and 
Pravafenix na prazen želodec slabše absorbira, ga je treba vedno vzeti skupaj s hrano (glejte poglavji 4.5 in 5.2).
Liver reactions: Marked and persistent increases of serum transaminases have been reported infrequently. 
Neželeni učinki na jetrih: redko so zabeležili izrazit in stalen porast serumskih transaminaz.
Patients should not be switched from a free co-administration of fenofibrate and pravastatin preparation to Pravafenix (see section 5.2. 
Bolniki ne smejo prehajati s sočasne uporabe zdravil s fenofibratom in pravastatinomna zdravilo Pravafenix (glejte poglavje 5.2).
This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred. 
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.
Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps. 
Na miopatijo je treba pomisliti pri kateremkoli bolniku, ki v mišicah čuti nepojasnjene simptome, na primer bolečino, občutljivost, oslabelost ali krče.
Do not take Pravafenix if - You are allergic to fenofibrate, pravastatin, or any of the other ingredients of this medicine (listed in section 6). 
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),
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. 
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,
Pancreatitis 
Pankreatiti
Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules. 
Neprozorne bele plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 14, 30, 60 in 90 trdih kapsul.
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. 
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),
Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3). 
Pri bolnikih, ki so jemali fenofibrat ali pravastatin, so poročali o pankreatitisu (glejte poglavje 4.3).
Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure 
Bolezni sečil povečan kreatinin v krvi, zmanjšan ledvični očistek kreatinina, povečan ledvični očistek kreatinina, odpoved ledvic občasni
No studies in lactating animals have been conducted with Pravafenix. 
Študij z zdravilom Pravafenix na doječih živalih niso opravili.
- 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. 
- Povejte mu, če pijete veliko alkohola (glejte spodnje poglavje Jemanje zdravila Pravafenix skupaj s hrano in pijačo) ali če ste kadarkoli imeli bolezen jeter.
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. 
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.
HDL cholesterol is often called ‘good' cholesterol because it helps keep the ‘bad' cholesterol from building up in the arteries and because it protects against heart disease. 
Holesterol HDL pogosto imenujemo „dobri“ holesterol, ker pomaga preprečevati kopičenje „slabega“
In the pivotal European multicenter 64-week clinical trial including 12 week randomised, doubleblind, double-dummy, 2-arm, parallel study period, 248 high vascular risk patients with mixed dyslipidaemia were randomised to one of the two treatment groups: Pravafenix 40 mg/160 mg or pravastatin 40 mg. Only patients who had not met their NCEP ATP III target LDL-C and Triglyceride goals (LDL >100 mg/dl and TG >150 mg/dl) after 8 weeks on pravastatin 40 mg (1 tablet, once daily) were randomized. 
12-tedensko randomizirano, dvojno slepo in dvojno zakrito paralelno študijo z dvema skupinama, je bilo 248 bolnikov z visokim tveganjem za vaskularne bolezni, ki so imeli mešano dislipidemijo, randomiziranih v eno od dveh skupin zdravljenja: zdravilo Pravafenix 40 mg/160 mg ali pravastatin 40 mg. Randomizirani so bili samo bolniki, ki po 8 tednih jemanja pravastatina 40 mg (ene tablete, enkrat dnevno) niso dosegli ciljnih vrednosti za holesterol LDL in trigliceride, ki jih priporoča ameriška skupina, zbrana v Odboru za zdravljenje odraslih Nacionalnega programa za izobraževanje o holesterolu (NCEP ATP III - National Cholesterol Education Program Adult Treatment Panel III) (LDL > 100 mg/dl in trigliceridi >150 mg/dl).
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. 
Pri bolnikih, ki so prejemali to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi).
- Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI>30kg/m2, raised triglycerides, history of hypertension). 
- izjemnih primerih intersticijske pljučne bolezni, posebej pri dolgotrajnem zdravljenju (glejte poglavje 4.4), - sladkorna bolezen: pogostnost bo odvisna od prisotnosti ali odsotnosti dejavnikov tveganja (glukoza v krvi na tešče ≥ 5,6 mmol/l, ITM > 30 kg/m2 , povišana raven trigliceridov, hipertenzija v anamnezi).
• Muscle inflammation (myositis), muscular cramps and weakness. 
• debelost, • vnetje mišic (miozitis), oslabelost mišic ali mišični krči.
ANNEX II 
Prilogi V.
• 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. 
LDL, zvišana koncentracija gama-glutamil transferaze (različnih jetrnih encimov), bolečine v jetrih (bolečine v zgornjem desnem predelu trebušne votline, ki jih bodisi spremlja bolečina v hrbtu ali ne), povečana telesna teža,
Patients receiving Pravafenix 40 mg/160 mg were compared to those receiving pravastatin 40 mg: Pravafenix significantly lowered non-HDL-C, LDL-C, TG and significantly increased HDL-C to a greater extent than pravastatin 40 mg (table). 
Bolniki, ki so prejemali zdravilo Pravafenix 40 mg/160 mg, so bili primerjani s tistimi, ki so prejemali pravastatin 40 mg: zdravilo Pravafenix je v večji meri kot pravastatin 40 mg pomembno znižal holesterol zaradi lipoproteinov nevisoke gostote, holesterol zaradi lipoproteinov nizke gostote in trigliceride ter pomembno zvišal holesterol lipoproteinov visoke gostote (tabela).
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate. 
Kadar se smole jemljejo sočasno, je treba fenofibrat vzeti eno uro prej ali od 4 do 6 ur kasneje kot smolo, tako da absorpcija fenofibrata ni ovirana.
Fenofibrate cannot be eliminated by haemodialysis. 
Fenofibrata iz telesa ni mogoče odstraniti s hemodializo.
- Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4). 
- Kronični ali akutni pankreatitis, razen akutnega pankreatitisa zaradi hude hipertrigliceridemije
Very rare side effects (may affect up to 1 in 10,000 people) 
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10 000 bolnikov)
Diabetes Mellitus 
Sladkorna bolezen
Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). 
Pred odločitvijo o začetku zdravljenja z zdravilom Pravafenix je treba oceniti ledvično funkcijo (glejte poglavje 4.4 Bolezni sečil).
Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system. 
S sistemom citokroma P450 pravastatin ni presnovljen v klinično pomembni meri.
Do not take Pravafenix if you are breast-feeding. 
Ne jemljite zdravila Pravafenix, če dojite.
In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074). 
V isti študiji so poročali o statistično pomembnem povečanju pogostosti pojavljanja pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p = 0,022) in o statistično nepomembnem povečanju pogostosti globoke venske tromboze (1,0 % v skupini, ki je prejemala placebo (48/4900 bolnikov), v primerjavi z 1,4 % v skupini, ki je prejemala fenofibrat (67/4895); p =
(see sections 4.2 and 5.2). 
(glejte poglavje 4.3).
Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of 
Prek tega mehanizma fenofibrat pospeši lipolizo in odstranjevanje delcev, bogatih s trigliceridi, iz plazme, tako da aktivira lipoproteinsko lipazo in zmanjša produkcijo apoproteina C-III. Aktivacija PPARα vzpodbudi tudi hitrejšo sintezo apoproteinov A-I in A-II ter holesterola HDL.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/679/001-007
• Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture. 
• razpad mišic (rabdomioliza), nekateri primeri težav s kitami, pri katerih včasih pride do zapleta s pretrganjem, • ščemenje in otrplost (periferna polinevropatija).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Pravafenix Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If a markedly elevated (> 5 times the ULN) CK level is detected and confirmed, Pravafenix therapy must be discontinued. 
Če je zaznana in potrjena izrazito zvišana vrednost kreatin-fosfokinaze (večja od petkratne zgornje meje normalnih vrednosti), je treba zdravljenje z zdravilom Pravafenix prekiniti.
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. 
Tveganje za toksične učinke na mišice je povečano, če se fibrat in inhibitor reduktaze 3-hidroksi-3
In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, < 5 times the ULN) was 1.92% for patients treated with Pravafenix. 
ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj kreatin fosfokinaze (KF ≥ 3-kratnika ZMN < 5-kratnika ZMN) znašala 1,92 %.
• Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances 
• učinki na živčevje: omotica (občutek nestabilnosti), glavobol, motnje spanja (vključno s težavami pri spanju in nočnimi morami), občutek zbadanja (parestezija),
Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.) 
Zdravilo Pravafenix je kontraindicirano pri bolnikih z zmerno do hudo okvaro ledvic (ki je določena z očistkom kreatinina < 60 ml/min.
No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3) 
V študijah vplivov na sposobnost razmnoževanja niso ne pri fenofibratu ne pri pravastatinu opazili učinkov na plodnost (glejte poglavje 5.3)
No modification of posology should be necessary in patients with mild renal impairment. 
Prilagoditev odmerjanja pri bolnikih z blago okvaro ledvic ni potrebna.
• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism) 
• neobičajen srčni utrip (palpitacije), nastanek krvnih strdkov v venah (globoka venska tromboza)
Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually. 
Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe samega pravastatina in samega fenofibrata.
Pravastatin sodium 
Natrijev pravastatinat
If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor. 
Ne prenehajte z jemanjem zdravila Pravafenix, dokler se ne posvetujete z zdravnikom.
Pravafenix 40 mg/160 mg Na = 120 
Pravafenix 40 mg/160 mg
PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules 
FARMACEVTSKA OBLIKA IN VSEBINA 60 trdih kapsul
Both are cholesterol/lipid modifying medicines. 
Obe učinkovini sta zdravili, ki vplivata na holesterol/lipide.
General disorders: 
Splošne težave:
Prolongation of the gestation period and difficulties during delivery were observed at high doses. 
Pri velikih odmerkih so opazili podaljšanje gestacijske dobe in težave med porodom.
Pravafenix versus PRAVASTATIN 
Pravafenix v primerjavi s PRAVASTATINOM
Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3). 
Zdravilo Pravafenix je pri zmerni do hudi okvari ledvic kontraindicirano (poglavje 4.3).
• 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. 
• simptomi vnetja jeter (hepatitisa), med katerimi so lahko rahlo porumenela koža in beločnice
It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood. 
- za znižanje ravni „slabega“ holesterola (holesterola LDL); zdravilo to doseže tako, da zniža raven skupnega holesterola in maščobnih snovi, imenovanih trigliceridi, v krvi,
Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level. 
Zdravnik vam lahko holesterol izmeri s preprosto preiskavo krvi.
Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps. 
Bolnike je treba opozoriti, da nemudoma sporočijo, če v mišicah pride do kakršnihkoli nepojasnjenih bolečin, občutljivosti, oslabelosti ali krčev.