FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
Bulgarian: tip 1500, hidroksipropilceluloza, makrogol 20 000.
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Bulgarian: FARMACEVTSKA OBLIKA IN VSEBINA 30 trdih kapsul
English: 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.
Bulgarian: Če ravni aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT) presežejo trikratno
English: Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Bulgarian: S sistemom citokroma P450 pravastatin ni presnovljen v klinično pomembni meri.
English: Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Bulgarian: Zdravilo Pravafenix je kontraindicirano pri bolnikih z zmerno do hudo okvaro ledvic (ki je določena z očistkom kreatinina < 60 ml/min).
English: Do not take Pravafenix if you are breast-feeding.
Bulgarian: Ne jemljite zdravila Pravafenix, če dojite.
English: Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Bulgarian: Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgija
English: Very rare side effects (may affect up to 1 in 10,000 people)
Bulgarian: Zelo redki neželeni učinki (pojavijo se lahko največ pri 1 od 10.000 bolnikov)
English: 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.
Bulgarian: 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).
English: 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.
Bulgarian: Nekateri dokazi kažejo, da statini kot razred zdravil povišajo raven glukoze in lahko pri nekaterih bolnikih z velikim
English: 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.
Bulgarian: 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.
English: Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Bulgarian: Zdravilo Pravafenix je pri zmerni do hudi okvari ledvic kontraindicirano (poglavje 4.3).
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Bulgarian: Ravni trigliceridov LDL in VLDL se znižajo. Skupni učinek je zmanjšano razmerje med lipoproteini nizke in zelo nizke gostote ter lipoproteini visoke gostote.
English: PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
Bulgarian: FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul
English: 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.
Bulgarian: 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.
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.
Bulgarian: 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: Diabetes Mellitus
Bulgarian: Sladkorna bolezen
English: • Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances
Bulgarian: učinki na živčevje: omotica (občutek nestabilnosti), glavobol, motnje spanja (vključno s težavami pri spanju in nočnimi morami), občutek zbadanja (parestezija),
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
Bulgarian: 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: Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Bulgarian: Kinetične raziskave po uporabi enkratnega odmerka in neprekinjenem zdravljenju
English: 60 hard capsules
Bulgarian: 60 trdih kapsul
English: 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.
Bulgarian: Kapsule so na voljo v pretisnih omotih iz poliamidaaluminija-PVC/aluminija, ki vsebujejo 30, 60 in 90 trdih kapsul, in v neprozornih belih plastenkah
English: Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually.
Bulgarian: Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe samega pravastatina in samega fenofibrata.
English: 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.
Bulgarian: 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.
English: If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor.
Bulgarian: Ne prenehajte z jemanjem zdravila Pravafenix, dokler se ne posvetujete z zdravnikom.
English: The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Bulgarian: Tveganje za miopatijo, vključno z rabdomiolizo, se lahko poveča pri sistemskem zdravljenju
English: 90 hard capsules
Bulgarian: 90 trdih kapsul
English: 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.
Bulgarian: Tveganje za toksične učinke na mišice je povečano, če se fibrat in inhibitor reduktaze 3-hidroksi-3
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Bulgarian: to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi).
English: 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%).
Bulgarian: 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 %).
English: In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation.
Bulgarian: transaminaz padle na izhodiščno vrednost, ne da bi bilo
English: Pravastatin sodium
Bulgarian: Natrijev pravastatinat
English: 30 hard capsules
Bulgarian: 30 trdih kapsul
English: 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).
Bulgarian: Fenofibrat je derivat fibrične kisline (fibrat), katerega vpliv na lipide, o katerem poročajo pri ljudeh, se posreduje z aktivacijo
English: Uncommon side effects (may affect up to 1 in 100 people)
Bulgarian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps.
Bulgarian: Bolnike je treba opozoriti, da nemudoma sporočijo, če v mišicah pride do kakršnihkoli nepojasnjenih bolečin, občutljivosti, oslabelosti ali krčev.
English: Both are cholesterol/lipid modifying medicines.
Bulgarian: Obe učinkovini sta zdravili, ki vplivata na holesterol/lipide.
English: The frequencies of adverse reactions are ranked according to the following: Very common ( ≥ 1/10),
Bulgarian: Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
English: 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.
Bulgarian: Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih
English: • Muscle inflammation (myositis), muscular cramps and weakness.
Bulgarian: vnetje mišic (miozitis), oslabelost mišic ali mišični krči.
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
Bulgarian: Lastnost fenofibrata, da znižuje koncentracijo lipidov, ki je bila opažena v klinični praksi, je bila pojasnjena in vivo pri transgenskih miših in
English: Clinical efficacy and safety
Bulgarian: Z VARNO IN UČINKOVITO UPORABO
English: In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Bulgarian: s klaritromicinom so opazili statistično pomembno zvišanje površine pod krivuljo (110 %) in
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.
Bulgarian: 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
English: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
Bulgarian: V plazmi, v kateri je glavni metabolit fenofibratna kislina, ni zaznati nobenega nespremenjenega fenofibrata.
English: • 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.
Bulgarian: simptomi vnetja jeter (hepatitisa), med katerimi so lahko rahlo porumenela koža in beločnice
English: Mean percent changes from baseline to week 12 for patients treated with Pravafenix 40 mg/160 mg or Pravastatin 40 mg once daily
Bulgarian: tedna v odstotkih za bolnike, zdravljene z zdravilom Pravafenix 40 mg/160 mg ali pravastatinom 40 mg enkrat dnevno
English: - Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol
Bulgarian: - 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,
English: 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.
Bulgarian: Zato je mogoče zdravila, ki jih sistem citokroma P450 presnavlja ali pa so njegovi zaviralci, dodajati stabilni
English: Other Side effects
Bulgarian: Drugi neželeni učinki
English: • Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
Bulgarian: neobičajen srčni utrip (palpitacije), nastanek krvnih strdkov v venah (globoka venska tromboza)
English: • 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.
Bulgarian: LDL, zvišana koncentracija gama-glutamil transferaze (različnih jetrnih encimov), bolečine v jetrih (bolečine v zgornjem desnem predelu
English: It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
Bulgarian: - za znižanje ravni „slabega“ holesterola (holesterola LDL); zdravilo to doseže tako, da zniža raven skupnega holesterola in maščobnih snovi, imenovanih trigliceridi, v krvi,
English: If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
Bulgarian: sum na dedno bolezen mišic, začenjanje ponovnega zdravljenja z zdravilom Pravafenix ni priporočljivo.
English: • Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Bulgarian: 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,
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.
Bulgarian: Pri bolnikih, pri katerih se oceni, da je sistemska uporaba fusidne kisline nujna, je treba prekiniti zdravljenje
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Bulgarian: NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Bulgarian: IME IMETNIKA DOVOLJENJA
English: Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
Bulgarian: Pri bolnikih, starejših od 75 let, so na voljo le omejeni podatki o varnosti,
English: 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.
Bulgarian: 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
English: Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Bulgarian: Vsaka trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
English: Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
Bulgarian: Zdravilo Pravafenix je v študiji enkratnega odmerka bioekvivalenten sočasno uporabljenima fenofibratu in pravastatinu.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Bulgarian: DODATEK II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN
English: 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.
Bulgarian: Pravastatin je učinkovitejši pri zniževanju holesterola LDL in skupnega holesterola, na trigliceride in holesterol HDL pa ima le zmeren učinek.
English: - Ciclosporin (a medicine often used in organ transplant patients).
Bulgarian: - 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: Hepatobiliary disorders Transaminases increased.
Bulgarian: so povečanje vrednosti transaminaz in bolezni prebavil.
English: 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).
Bulgarian: Analiza druge predhodno določene podskupine, opredeljene kot statistično značilna interakcija med zdravljenjem in spolom (p = 0,01), kaže na možne koristi zdravljenja
English: Fenofibric acid is not eliminated by haemodialysis.
Bulgarian: Fenofibratna kislina se ne odstrani
English: Pravafenix has no or negligible influence on the ability to drive and use machines.
Bulgarian: ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
Bulgarian: se pojavi v 4 do 5 urah po peroralni uporabi.
English: • Obesity.
Bulgarian: debelost,
English: The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet.
Bulgarian: Kapsule so iz trde želatine z olivno zelenim zgornjim in s svetlozelenim
English: Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of
Bulgarian: s trigliceridi, iz plazme, tako da aktivira lipoproteinsko lipazo
English: Interactions relevant to pravastatin
Bulgarian: Interakcije, povezane
English: Renal impairment
Bulgarian: Okvara ledvic
English: Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Bulgarian: Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
English: If you get any side effects, talk to your doctor or pharmacist.
Bulgarian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
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.
Bulgarian: Pravastatin je kompetitiven zaviralec reduktaze 3-hidroksi-3-metilglutaril-koencima A (HMG-CoA),
English: 6.6 Special precautions for disposal
Bulgarian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: • The active substances are fenofibrate and pravastatin.
Bulgarian: Zdravilni učinkovini sta fenofibrat in pravastatin.
English: Driving and using machines
Bulgarian: Med vožnjo motornih vozil ali delom
English: 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.
Bulgarian: 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.
English: A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3).
Bulgarian: Pravastatin se v majhnih količinah izloča v materino mleko, zato je med dojenjem kontraindiciran
English: In clinical studies, the incidence of important elevations in serum transaminases (ALT
Bulgarian: Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3-kratnika
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Bulgarian: IME ZDRAVILA Pravafenix 40 mg/160 mg trde kapsule
English: CK levels should be measured prior to initiation of therapy.
Bulgarian: Pred začetkom zdravljenja je treba izmeriti vrednosti kreatin-fosfokinaze.
English: Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Bulgarian: Preiskava zvišana koncentracija holesterola v krvi, zvišana koncentracija trigliceridov v krvi, zvišana koncentracija lipoproteinov majhne gostote, povečana telesna masa.
English: Triglycerides are another fat in your blood.
Bulgarian: Druga vrsta maščob v krvi so trigliceridi.
English: 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%).
Bulgarian: smrtnega izida in kardiovaskularni smrtji (razmerje tveganja [RT] 0,92, 95 % IZ 0,79-1,08, p = 0,32; absolutno zmanjšanje tveganja: 0,74 %).
English: Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion.
Bulgarian: Kadar se zdravilo Pravafenix uporablja pri bolnikih, ki imajo v anamnezi obolenje jeter ali čezmerno uživajo alkohol, je potrebna previdnost.
English: Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
Bulgarian: Koncentracija sečne kisline v plazmi je povečana pri približno 20 % bolnikov
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Bulgarian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
English: General disorders:
Bulgarian: Splošne težave:
English: Pravafenix
Bulgarian: Zdravilo Pravafenix
English: Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Bulgarian: Prvič, z reverzibilnim in specifičnim kompetitivnim zaviranjem reduktaze
English: Pravafenix contains lactose
Bulgarian: Zdravilo Pravafenix vsebuje laktozo
English: • Hypersensitivity.
Bulgarian: preobčutljivost,
English: Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I,
Bulgarian: Aktivacija PPARα vzpodbudi tudi hitrejšo sintezo apoproteinov A-I in A-II ter holesterola HDL.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Bulgarian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo
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.
Bulgarian: Zato fiksna kombinacija odmerkov (zdravilo Pravafenix) ne more veljati za medsebojno zamenljivo
English: Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
Bulgarian: Če je ocenjeni očistek kreatinina < 60 ml/min, je treba zdravljenje prekiniti.
English: No posology adjustment is required in patients with mild hepatic impairment.
Bulgarian: Prilagoditev odmerjanja pri bolnikih z blago okvaro jeter ni potrebna.
English: Dizziness, headache, paraesthesia
Bulgarian: Bolezni živčevja omotica, glavobol, parestezija občasni
English: Patients should not be switched from a free co-administration of fenofibrate and pravastatin preparation to Pravafenix (see section 5.2.
Bulgarian: s fenofibratom in pravastatinom na zdravilo Pravafenix (glejte poglavje 5.2).