FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Holesterol HDL pogosto imenujemo „dobri“ holesterol, ker pomaga preprečevati kopičenje „slabega“
English: 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.
Slovenian: 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).
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Slovenian: Pri bolnikih, ki so prejemali to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi).
English: - 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).
Slovenian: - 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).
English: • Muscle inflammation (myositis), muscular cramps and weakness.
Slovenian: • debelost, • vnetje mišic (miozitis), oslabelost mišic ali mišični krči.
English: ANNEX II
Slovenian: Prilogi V.
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.
Slovenian: 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,
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Fenofibrate cannot be eliminated by haemodialysis.
Slovenian: Fenofibrata iz telesa ni mogoče odstraniti s hemodializo.
English: - Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4).
Slovenian: - Kronični ali akutni pankreatitis, razen akutnega pankreatitisa zaradi hude hipertrigliceridemije
English: Very rare side effects (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10 000 bolnikov)
English: Diabetes Mellitus
Slovenian: Sladkorna bolezen
English: Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders).
Slovenian: Pred odločitvijo o začetku zdravljenja z zdravilom Pravafenix je treba oceniti ledvično funkcijo (glejte poglavje 4.4 Bolezni sečil).
English: Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Slovenian: S sistemom citokroma P450 pravastatin ni presnovljen v klinično pomembni meri.
English: Do not take Pravafenix if you are breast-feeding.
Slovenian: Ne jemljite zdravila Pravafenix, če dojite.
English: 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).
Slovenian: 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 =
English: (see sections 4.2 and 5.2).
Slovenian: (glejte poglavje 4.3).
English: Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of
Slovenian: 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/679/001-007
English: • Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.
Slovenian: • razpad mišic (rabdomioliza), nekateri primeri težav s kitami, pri katerih včasih pride do zapleta s pretrganjem, • ščemenje in otrplost (periferna polinevropatija).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: 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.
English: If a markedly elevated (> 5 times the ULN) CK level is detected and confirmed, Pravafenix therapy must be discontinued.
Slovenian: Če je zaznana in potrjena izrazito zvišana vrednost kreatin-fosfokinaze (večja od petkratne zgornje meje normalnih vrednosti), je treba zdravljenje z zdravilom Pravafenix prekiniti.
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.
Slovenian: Tveganje za toksične učinke na mišice je povečano, če se fibrat in inhibitor reduktaze 3-hidroksi-3
English: 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.
Slovenian: ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj kreatin fosfokinaze (KF ≥ 3-kratnika ZMN < 5-kratnika ZMN) znašala 1,92 %.
English: • Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances
Slovenian: • učinki na živčevje: omotica (občutek nestabilnosti), glavobol, motnje spanja (vključno s težavami pri spanju in nočnimi morami), občutek zbadanja (parestezija),
English: Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Slovenian: Zdravilo Pravafenix je kontraindicirano pri bolnikih z zmerno do hudo okvaro ledvic (ki je določena z očistkom kreatinina < 60 ml/min.
English: No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Slovenian: V študijah vplivov na sposobnost razmnoževanja niso ne pri fenofibratu ne pri pravastatinu opazili učinkov na plodnost (glejte poglavje 5.3)
English: No modification of posology should be necessary in patients with mild renal impairment.
Slovenian: Prilagoditev odmerjanja pri bolnikih z blago okvaro ledvic ni potrebna.
English: • Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
Slovenian: • neobičajen srčni utrip (palpitacije), nastanek krvnih strdkov v venah (globoka venska tromboza)
English: Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually.
Slovenian: Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe samega pravastatina in samega fenofibrata.
English: Pravastatin sodium
Slovenian: Natrijev pravastatinat
English: If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor.
Slovenian: Ne prenehajte z jemanjem zdravila Pravafenix, dokler se ne posvetujete z zdravnikom.
English: Pravafenix 40 mg/160 mg Na = 120
Slovenian: Pravafenix 40 mg/160 mg
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 trdih kapsul
English: Both are cholesterol/lipid modifying medicines.
Slovenian: Obe učinkovini sta zdravili, ki vplivata na holesterol/lipide.
English: General disorders:
Slovenian: Splošne težave:
English: Prolongation of the gestation period and difficulties during delivery were observed at high doses.
Slovenian: Pri velikih odmerkih so opazili podaljšanje gestacijske dobe in težave med porodom.
English: Pravafenix versus PRAVASTATIN
Slovenian: Pravafenix v primerjavi s PRAVASTATINOM
English: Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Slovenian: Zdravilo Pravafenix je pri zmerni do hudi okvari ledvic kontraindicirano (poglavje 4.3).
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.
Slovenian: • simptomi vnetja jeter (hepatitisa), med katerimi so lahko rahlo porumenela koža in beločnice
English: It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
Slovenian: - za znižanje ravni „slabega“ holesterola (holesterola LDL); zdravilo to doseže tako, da zniža raven skupnega holesterola in maščobnih snovi, imenovanih trigliceridi, v krvi,
English: Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level.
Slovenian: Zdravnik vam lahko holesterol izmeri s preprosto preiskavo krvi.
English: Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps.
Slovenian: Bolnike je treba opozoriti, da nemudoma sporočijo, če v mišicah pride do kakršnihkoli nepojasnjenih bolečin, občutljivosti, oslabelosti ali krčev.
English: - You have had photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain) - You suffer from gallbladder disease.
Slovenian: - če imate jetrno bolezen, - če ste mlajši od 18 let, - če imate ledvično bolezen, - če je znano, da imate med zdravljenjem s fibrati (zdravili, ki znižujejo koncentracijo lipidov) ali s ketoprofenom (protivnetno zdravilo, ki ga za težave z mišicami in kostmi lahko uporabljate peroralno ali na koži, za protin in bolečine med menstruacijo pa peroralno) fotoalergijo (alergijsko reakcijo, ki jo povzroča sončna svetloba ali izpostavljenost UV-svetlobi) ali fototoksične reakcije (poškodbe kože, ki jih povzroča izpostavljenost soncu ali UV-svetlobi), - če imate bolezen žolčnika, - če imate težave s pankreatitisom (vnetjem trebušne slinavke, ki povzroča bolečine v trebuhu), - če ste noseči ali dojite, - če imate v anamnezi med zdravljenjem z zdravili za nadzor holesterola, ki se imenujejo „statini“
English: • Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Slovenian: • 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: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Pravafenix Vsebina pakiranja in dodatne informacije
English: It is recommended to systematically assess the estimated creatinine clearance at the initiation of the treatment and every 3 months during the first 12 months of the combination therapy then let to the appreciation of the clinician beyond this period.
Slovenian: V prvih 12 mesecih kombiniranega zdravljenja je priporočljivo sistematično ocenjevanje očistka kreatinina na začetku zdravljenja in na vsake 3 mesece, po tem obdobju pa je odločitev o tem prepuščena zdravniku.
English: - Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol
Slovenian: - 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: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
Slovenian: V plazmi, v kateri je glavni metabolit fenofibratna kislina, ni zaznati nobenega nespremenjenega fenofibrata.
English: It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment and let to the appreciation of the clinician beyond this initial period.
Slovenian: V prvih 12 mesecih kombiniranega zdravljenja je priporočljivo spremljanje ravni transaminaz na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku.
English: The incremental benefit of Pravafenix 40 mg/160 mg on main lipid parameters versus Pravastatin 40 mg and Fenofibrate 160 mg monotherapy was also established.
Slovenian: Ugotovljeno je bilo tudi, da je zdravilo Pravafenix 40 mg/160 mg v primerjavi z monoterapijo s pravastatinom 40 mg in fenofibratom 160 mg dodatno koristno za uravnavanje glavnih parametrov lipidov.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov)
English: Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Slovenian: Preiskava zvišana koncentracija holesterola v krvi, zvišana koncentracija trigliceridov v krvi, zvišana koncentracija lipoproteinov majhne gostote, povečana telesna teža.
English: PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul
English: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m 2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Slovenian: 2 , povišana raven trigliceridov, hipertenzija) je treba klinično in biokemično spremljati skladno z nacionalnimi smernicami.
English: • Rashes, skin rash, itching, hives or reactions to sunlight or exposure to UV light (photosensitivity reactions), scalp/hair abnormality (including hair loss)
Slovenian: • izpuščaji, kožni izpuščaj, srbenje, koprivnica ali reakcija na sončno svetlobo ali izpostavljenost
English: Pravafenix
Slovenian: Zdravilo Pravafenix
English: Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Slovenian: Vsaka trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
English: Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
Slovenian: Pri bolnikih, starejših od 75 let, so na voljo le omejeni podatki o varnosti,
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.
Slovenian: Pravastatin je učinkovitejši pri zniževanju holesterola LDL in skupnega holesterola, na trigliceride in holesterol HDL pa ima le zmeren učinek.
English: Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
Slovenian: Zdravilo Pravafenix je v študiji enkratnega odmerka bioekvivalenten sočasno uporabljenima fenofibratu in pravastatinu.
English: bladder problems (painful or frequent urination, having to pass water at night), sexual dysfunction.
Slovenian: • težave z ledvicami (zvišane ali znižane ravni določenih encimov v telesu, ki so vidne pri preiskavi), težave s sečnim mehurjem (boleče ali pogosto uriniranje, potrebna po odvajanju vode ponoči), spolne motnje,
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.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Pravafenix je indiciran za zdravljenje odraslih bolnikov z visokim tveganjem za koronarno bolezen srca in mešano dislipidemijo (za katero so značilne visoke vrednosti trigliceridov in nizke vrednosti holesterola HDL), pri katerih so vrednosti holesterola LDL ustrezno nadzirane z monoterapijo s 40 mg pravastatina.
English: Therefore, taking into account the contra indication of pravastatin during lactation, Pravafenix is contraindicated during breastfeeding (see section 4.3).
Slovenian: Ob upoštevanju kontraindikacije za pravastatin med dojenjem je tudi zdravilo Pravafenix med dojenjem kontraindicirano (glejte poglavje
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.
Slovenian: Če ravni aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT) presežejo trikratno zgornjo mejo normalnih vrednosti in se ne znižajo, je treba zdravljenje prekiniti.
English: Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion.
Slovenian: Kadar se zdravilo Pravafenix uporablja pri bolnikih, ki imajo v anamnezi obolenje jeter ali čezmerno uživajo alkohol, je potrebna previdnost.
English: The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet.
Slovenian: Kapsule so iz trde želatine z olivno zelenim zgornjim in s svetlozelenim spodnjim delom.
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišično skeletnega sistema, vezivnega tkiva in kosti bolezen mišic (npr.
English: Hs-CRP (mg/L) a Number of patients b Mean percent change (least square mean ± standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if <0.05
Slovenian: a Število bolnikov b Povprečna sprememba v odstotkih (povprečje najmanjših kvadratov ± standardna napaka) med izhodiščno vrednostjo, izmerjeno po 8 tednih jemanja pravastatina 40 mg, in vrednostjo po 12
English: Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
Slovenian: kratnika ZMN brez simptomov v mišicah) je prišlo pri 0,06 % bolnikov, ki so prejemali zdravilo Pravafenix (glejte poglavje 4.4).
English: Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Slovenian: Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
English: Clinically important elevations in serum transaminases (ALT and/or AST ≥ 5 times the ULN) were seen in 0.38% of the patients treated with Pravafenix.
Slovenian: Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3-kratnika ZMN < 5-kratnika ZMN) znašala 0,83 %.
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.
Slovenian: 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: Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Slovenian: Farmakoterapevtska skupina: Učinkovine, ki vplivajo na lipide, zaviralci reduktaze hidroksimetilglutaril koencima A v kombinaciji z drugimi učinkovinami, ki vplivajo na lipide, oznaka
English: Diabetes mellitus aggravated, Obesity
Slovenian: Presnovne in prehranske motnje poslabšanje sladkorne bolezni, debelost občasni
English: In clinical studies, the incidence of important elevations in serum transaminases (ALT
Slovenian: Do klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 5-kratnika ZMN) je prišlo pri
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Slovenian: IME ZDRAVILA Pravafenix 40 mg/160 mg trde kapsule
English: A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3).
Slovenian: Pravastatin se v majhnih količinah izloča v materino mleko, zato je med dojenjem kontraindiciran
English: Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
Slovenian: Če je ocenjeni očistek kreatinina < 60 ml/min, je treba zdravljenje prekiniti.
English: CK levels should be measured prior to initiation of therapy.
Slovenian: Pred začetkom zdravljenja je treba izmeriti vrednosti kreatin-fosfokinaze.
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.
Slovenian: 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: Dizziness, headache, paraesthesia
Slovenian: Bolezni živčevja omotica, glavobol, parestezija občasni