FrancophonIA/ELRC3.0 huggingface dataset:
English: - capsule shell: gelatine, indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).
Croatian: natrijev škroboglikolat, magnezijev stearat, talk, triacetin, natrijev hidrogenkarbonat, makrogolglicerollaurat, hidroksipropilceluloza, makrogol 20.000. - ovojnica kapsule: želatina, indigo karmin (E132), crni željezov oksid (E172), titanijev dioksid (E171), žuti željezov oksid (E172).
English: There are no data on fertility from the combined use of fenofibrate and pravastatin
Croatian: Nema podataka o učinku na plodnost kombinirane primjene fenofibrata i pravastatina.
English: If you are not sure, talk to your doctor or pharmacist before taking Pravafenix.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Pravafenixa.
English: Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps.
Croatian: Bolesnike treba savjetovati da odmah prijave neobjašnjivu mišićnu bol, osjetljivost, slabost ili grčeve.
English: Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
Croatian: Sadržaj kapsule laktoza hidrat celuloza, mikrokristalična askorbilpalmitat povidon K29-32 natrijev škroboglikolat magnezijev stearat talk triacetin natrijev hidrogenkarbonat makrogolglicerollaurat tipa 1500 hidroksipropilceluloza makrogol 20 000
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.
Croatian: Bioraspoloživost pravastatina je viša nakon primjene jednokratne doze ispitivanog lijeka fenofibrat/pravastatin 160/40 mg natašte nego li je to nakon primjene jednokratne doze lijeka na pun želudac.
English: • The active substances are fenofibrate and pravastatin.
Croatian: • Djelatne tvari su fenofibrat i pravastatin.
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.
Croatian: Važno je da obavijestite svog liječnika ako se već liječite bilo kojim od sljedećih lijekova: - smolama žučnih kiselina poput kolestiramina/kolestipola (lijeka za snižavanje kolesterola), jer utječe na način djelovanja Pravafenixa, - ciklosporinom (lijek često korišten u bolesnika s presađenim organima), - lijekovima koji sprečavaju zgrušavanje krvi, poput varfarina, flunidiona, fenoprokumona ili acenokumarola (antikoagulansi),
English: PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
Croatian: OBLIK I SADRŽAJ 14 tvrdih kapsula
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Croatian: Bolesnicima treba savjetovati da odmah potraže liječnički pomoć ako osjete bilo kakve simptome mišićne slabosti,
English: Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Croatian: Poremećaji probavnog sustava distenzija abdomena, bol u abdomenu, bol u gornjem abdomenu, konstipacija, proljev, suha usta, dispepsija, podrigivanje, vjetrovi,
English: Very rare side effects (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti kod manje od 1 od 10 000 osoba)
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.
Croatian: Rutinsko praćenje CK sistematski se preporučuje svaka 3 mjeseca tijekom prvih 12 mjeseci kombinirane terapije, a nakon toga odluku o daljnjim kontrolama treba prepustiti liječniku specijalisti.
English: (see sections 4.2 and 5.2).
Croatian: 4.2 i 5.2).
English: Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
Croatian: Pravafenixa u bolesnika >75 godina starosti, stoga je nužan oprez.
English: In the FIELD 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 thrombosis (placebo 1.0% 48/4,900 patients) versus fenofibrate 1.4% (67/4,895); p=0.074.
Croatian: U ispitivanju FIELD prijavljeno je statistički značajano povećanje incidencije plućne embolije (0,7% u placebo skupini naspram 1,1% u skupini na fenofibratu; p=0,022) i statistički neznačajno povećanje duboke venske tromboze (placebo 1,0% 48/4900 bolesnika) naspram fenofibrata 1,4% (67/4895);
English: Pravafenix must be taken with food, as food enhances the bioavailability of fenofibrate (see sections 4.2 and 5.2).
Croatian: Pravafenix se mora uzimati s hranom, jer hrana pojačava bioraspoloživost fenofibrata (vidjeti dijelove
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.
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Kao i ostali lijekovi koji snizuju lipide, pravastatin ili fenofibrat bili su povezani s nastupom mialgije, miopatije i vrlo rijetko rabdomiolizom, s ili bez sekundarne insuficijencije bubrega.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA BOCE
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5).
Croatian: Postoje izvješća o rabdomiolizi (uključujući nekoliko smrtnih ishoda) u bolesnika koji su primali ovu kombinaciju lijekova.
English: - Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4).
Croatian: - Kronični ili akutni pankreatitis s izuzetkom akutnog pankreatitisa zbog teške hipertrigliceridemije
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.
Croatian: Pravafenixa 40 mg/160 mg na glavne parametre lipida naspram Pravastatina 40 mg i fenofibrata 160 mg.
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.
Croatian: U kliničkim ispitivanjima incidencija značajnih povišenja kreatin fosfokinaze (KF ≥ 3 puta GGN, < 5 puta GGN) bila je kod 1,92% bolesnika liječenih Pravafenixom.
English: Distribution
Croatian: Distribucija Pravastatin
English: Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija, bol u leđima, povišena kreatinin fosfokinaza u krvi, mišićni grčevi, mišićnokoštana bol, mialgija, bol u ekstremitetima
English: Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Croatian: Pravafenix je kontraindiciran kod umjerenog do teškog oštećenja bubrega (dio 4.3).
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.
Croatian: Preporučuje se praćenje razina transaminaza svaka 3 mjeseca tijekom prvih 12 mjeseci liječenja, a nakon toga odluku o daljnjim kontrolama treba prepustiti liječniku specijalisti.
English: This is to check how well your liver and your kidneys are working.
Croatian: To se čini da bi se provjerilo koliko dobro rade
English: Mean (%)± SEb p-valuec
Croatian: SEb p-vrijednostc
English: - You should keep to this diet while taking Pravafenix
Croatian: Te se dijete morate pridržavati i dok uzimate Pravafenix.
English: Do not take Pravafenix if you are breast-feeding.
Croatian: Nemojte uzimati Pravafenix ako dojite.
English: Hepatic pain, gammaglutamyl transferase increased.
Croatian: Često bol u jetri, povišenje gamaglutamil transferaze
English: No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
Croatian: 5.2 Farmakokinetička svojstva Nisu opažene značajne farmakokinetičke interakcije kada se fenofibrat primjenjivao istodobno s pravastatinom.
English: CK levels should be measured prior to initiation of therapy.
Croatian: Prije početka terapije potrebno je izmjeriti razine KF.
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).
Croatian: - iznimni slučajevi intersticijske bolesti pluća naročito nakon dugotrajne terapije (vidjeti dio 4.4). - šećerna bolest: učestalost će ovisiti o prisutnosti ili odsutnosti faktora rizika (glukoza u krvi natašte ≥ 5.6 mmol/l, BMI>30kg/m2, povišeni trigliceridi, hipertenzija u anamnezi).
English: Diabetes mellitus aggravated, Obesity
Croatian: Poremećaji metabolizma i prehrane pogoršanje šećerne bolesti, prekomjerna debljina
English: If cholelithiasis is suspected, gallbladder studies are indicated.
Croatian: Ako se sumnja na kolelitijazu indicirano je učiniti pretrage žučnog mjehura.
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Croatian: OBLIK I SADRŽAJ 60 tvrdih kapsula
English: Fusidic acid
Croatian: Fusidatna kiselina
English: No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Croatian: U ispitivanjima reproduktivne toksičnosti nije primijećen učinak fenofibrata niti pravastatina na plodnost (vidjeti dio 5.3).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Croatian: Tijekom ili nakon liječenja nekim statinima vrlo rijetko je prijavljena imunološki posredovana nekrotizirajuća miopatija (IMNM, engl. immune-mediated necrotizing myopathy).
English: Skin rash, Scalp/hair abnormality (including alopecia)
Croatian: Poremećaji kože i potkožnog tkiva kožni osip, poremećaji vlasišta (uključujući alopeciju)
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.
Croatian: Na pročetku liječenja preporučuje se učiniti sustavnu procjenu klirensa kreatinina, te njegovu kontrolu svaka 3 mjeseca tijekom prvih 12 mjeseci kombinirane terapije, a nakon toga odluku o daljnjim kontrolama treba prepustiti liječniku specijalisti.
English: If you forget to take Pravafenix
Croatian: Ako prestanete uzimati Pravafenix
English: You should tell your doctor immediately if it happens.
Croatian: Ako se dogodi, odmah se obratite liječniku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/001-007
English: Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, < 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Croatian: Klinički značajna povišenja kreatin fosfokinaze (KF ≥ 5 puta GGN, < 10 puta GGN bez mišićnih simptoma) viđena su kod 0,38% bolesnika liječenih Pravafenixom.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke vrste šećera,
English: • Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances
Croatian: • Učinci na živčani sustav: omaglica (osjećaj nestabilnosti), glavobolja, poremećaji spavanja (uključujući teškoće pri spavanju i noćne more), osjećaj bockanja i iglica (parestezije).
English: Jaundice, complications of cholelithiasis (e.g cholecystitis, cholangitis, biliary colic, etc).
Croatian: Vrlo rijetko žutica, komplikacije kolelitijaze (npr. kolecistitis, kolangitis,
English: Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Croatian: Pravafenix 40 mg/160 mg tvrde kapsule pravastatin/fenofibrat
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Croatian: NAZIV LIJEKA Pravafenix 40 mg/160 mg tvrde kapsule
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.
Croatian: kod kojih postoji visoki rizik za nastanak šećerne bolesti u budućnosti, mogu uzrokovati razinu hiperglikemije koja zahtijeva odgovarajuće liječenje šećerne bolesti.
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%).
Croatian: U unaprijed određenoj podskupini oboljelih od dislipidemije, koji su definirani kao oni u najnižoj tercili HDL-C (≤34 mg/dl ili 0,88 mmol/L) i najvišoj tercili TG (≥204 mg/dl ili 2,3 mmol/L) na početku liječenja, terapija fenofibratom uz simvastatin pokazala je relativno smanjenje od 31% u odnosu na monoterapiju simvastatinom za kompozitni primarni ishod (omjer hazarda [HR] 0,69, 95% CI 0,49-0,97, p = 0,03; apsolutno smanjenje rizika: 4,95%).
English: Pravafenix with food, drink and alcohol - Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
Croatian: - Uvijek uzimajte Pravafenix s hranom jer se Pravafenix inače slabije apsorbira na prazan želudac.
English: Meditrina Pharmaceuticals Ltd Τηλ: +30 210 67 26 260
Croatian: Τηλ: +30 210 67 26 260
English: Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness.
Croatian: Odmah se obratite svom liječniku ako osjetite neobjašnjive bolove u mišićima, osjetljivost ili slabost mišića.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti kod manje od 1 od 100 osoba)
English: Diabetes Mellitus
Croatian: Šećerna bolest
English: Therefore, as far as pravastatin is contra indicated (see below), Pravafenix is contraindicated during pregnancy (see section 4.3).
Croatian: Stoga, budući da je pravastatin kontraindiciran (vidi dolje), kontraindiciran je i Pravafenix tijekomm trudnoće (vidjeti dio 4.3).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva svrbež, urtikarija
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15.
Croatian: Lijek se izdaje na recept. 15. UPUTE ZA UPORABU
English: Jaundice, fulminant hepatic necrosis
Croatian: Manje često žutica, fulminantna nekroza jetre
English: • Obesity.
Croatian: • Debljina.
English: As with other lipid lowering medicinal products, moderate increases in transaminase levels have been reported in some patients treated with pravastatin or fenofibrate.
Croatian: Poremećaji jetre i žuči Kao i s drugim lijekovima za snižavanje lipida u nekih bolesnika liječenih pravastatinom ili fenofibratom prijavljeno je blago povišenje razina transaminaza.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 40 mg pravastatinnatrija i 160 mg fenofibrata.
English: Tell your doctor if any of the following applies to you: - Liver or kidney problems - Thyroid problems - You are more than 70 years old - You have ever had muscle problems during a treatment with cholesterol-lowering medicines such as a statin or fibrate - You are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection - You or your close family members have a hereditary muscle disorder - You have alcohol problems (regularly drinking large amounts of alcohol)
Croatian: - imali ste ranije probleme s mišićima tijekom liječenja lijekovima za snižavanje kolesterola poput statina ili fibrata - uzimate, ili ste u zadnjih 7 dana uzeli ili Vam je dan lijek koji nazivamo fusidatna kiselina (lijek za bakterijske infekcije)
English: Pravafenix 40 mg/160 mg Na = 120
Croatian: Pravafenixom 40 mg/160 mg ili Pravastatinom 40 mg jedanput dnevno Pravafenix 40 mg/160 mg na = 120
English: 6.6 Special precautions for disposal
Croatian: 6.6 Posebne mjere pri čuvanju lijeka
English: Tell your doctor straight away if you have any unexplained muscular pain or cramps, tenderness, or weakness.
Croatian: Smjesta se obratite liječniku ako osjetite neobjašnjivu bol u mišićima ili grčeve, osjetljivost ili slabost mišića.
English: Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Croatian: Jedna tvrda kapsula sadrži 40 mg pravastatinnatrija i 160 mg fenofibrata.
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.
Croatian: 12-tjedno randomizirano, dvostruko slijepo, dvostrukim placebom kontrolirano, paralelno ispitivanje 2 ispitnih skupina, 248 bolesnika s visokim vaskularnim rizikom s miješanom dislipidemijom bilo je randomizirano u jednu ili dvije liječene skupine: skupinu koja je primala Pravafenix 40 mg/160 mg ili skupinu koja je primala pravastatin 40 mg.
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).
Croatian: U istom ispitivanju prijavljeno je statistički značajno povećanje incidencije plućne embolije (0,7% u placebo skupini naspram 1,1% u skupini na fenofibratu; p=0,022) i statistički neznačajno povećanje duboke venske tromboze (placebo: 1,0%
English: There are no data from the combined use of pravastatin and fenofibrate in pregnant women.
Croatian: Pravafenix Nema podataka o kombiniranoj primjeni pravastatina i fenofibrata u trudnica.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava snižen hemoglobin, smanjen broj leukocita
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
Croatian: između početnih vrijednosti izmjerenih nakon 8 tjedana na Pravastatinu 40 mg i 12 dodatnih tjedana primjene Pravafenixa 40 mg/160 mg ili Pravastatina 40 mg c p-vrijednost parnog testa je značajna ako je <0,05
English: Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
Croatian: Klinički značajno povišenje kreatin fosfokinaze (KF ≥ 10 puta GGN bez mišićnih simptoma) viđeno je kod 0,06% bolesnika liječenih Pravafenixom. (vidjeti dio 4.4).
English: How to take pravafenix
Croatian: Kako uzimati Pravafenix
English: Adverse reaction (Pravastatin)
Croatian: Nuspojava (pravastatin)
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.
Croatian: Klinički značajno povišenje transaminaza u serumu (ALT i/ili AST ≥ 5 puta GGN) viđen je kod 0,38% bolesnika liječenih
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki seksualna disfunkcija seksualna disfunkcija
English: bladder problems (painful or frequent urination, having to pass water at night), sexual dysfunction.
Croatian: • Problemi s bubrezima (povišene ili snižene razine određenih enzima unutar tijela u krvnim nalazima), problemi s mokraćnim mjehurom (bolno ili učestalo mokrenje, potreba za mokrenjem noću), poremećaj seksualne funkcije.
English: EU/1/11/679/004 30 hard capsules
Croatian: EU/1/11/679/004 30 tvrdih kapsula
English: • The other ingredients are: - capsule content: lactose monohydrate, cellulose microcrystalline, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000.
Croatian: • Pomoćne tvari su: - sadržaj kapsule: laktoza hidrat, mikrokristalična celuloza, askorbilpalmitat, povidon,
English: (eructation)).
Croatian: žučne kolike itd.).
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Druge nuspojave Česte nuspojave (mogu se javiti kod manje od 1 od 10 osoba)
English: Muscle disorder (e.g. myositis, muscular weakness)
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva poremećaji mišića (npr. miozitis, mišićna slabost)
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/007 14 tvrdih kapsula
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula sadrži 40 mg pravastatinnatrija i 160 mg fenofibrata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001 30 hard capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/001 30 tvrdih kapsula
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/005 60 hard capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/679/005 60 tvrdih kapsula
English: Respiratory, thoracic and mediastinal disorders
Croatian: prsišta i sredoprsja intersticijska pneumopatija
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.
Croatian: smanjenje tjelesne težine), za liječenje mješovite hiperlipidemije u odraslih bolesnika s visokim kardiovaskularnim rizikom s ciljem smanjenja triglicerida i povećanja kolesterola visoke gustoće
English: Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
Croatian: U ispitivanju jednokratne doze Pravafenix je bioekvivalentan istodobno primijenjenom fenofibratu i pravastatinu.
English: - You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) - You are pregnant or breast-feeding.
Croatian: - ako bolujete od bolesti žučnog mjehura, - ako bolujete od pankreatitisa (upale gušterače koja dovodi do boli u trbuhu),
English: Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Croatian: Pretrage povišenje kolesterola u krvi, povišenje triglicerida u krvi,
English: EU/1/11/679/002 60 hard capsules
Croatian: EU/1/11/679/002 60 tvrdih kapsula
English: Abiogen Pharma S.p.A. Tel: +39 050 3154 101
Croatian: Tel: +39 050 3154 101
English: Laboratoires SMB S.A. Tlf: + 32.2.411.48.28.
Croatian: Tlf: + 32.2.411.48.28.
English: Tel: +40 21 211 71 83
Croatian: Solartium Group S.r.l. Tel: +40 21 211 71 83
English: Receptor type α (PPARα).
Croatian: PPARα receptora.