FrancophonIA/ELRC3.0 huggingface dataset:
English: AFSTYLA 2000 IU powder and solvent for solution for injection Powder (2000 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a purple disc (plastic), and a green striped cap (aluminium).
Slovenian: AFSTYLA 2000 i.e. prašek in vehikel za raztopino za injiciranje Prašek (2000 i.e.) v 10 ml viali (steklo tipa I) z zamaškom (gumijast), vijolično okroglo ploščico (plastična) in zeleno črtasto zaporko (aluminijasta).
English: powder and solvent for solution for injection 1 vial with powder: 2000 IU lonoctocog alfa (400 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 2000 i.e. lonoktokoga alfa (400 i.e./ml po rekonstituciji) 1 viala s 5 ml vode za injekcije
English: After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 200 i.e./ml enoverižnega rVIII.
English: AFSTYLA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Slovenian: AFSTYLA 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
English: AFSTYLA 1000 IU powder and solvent for solution for injection
Slovenian: AFSTYLA 1000 i.e. prašek in vehikel za raztopino za injiciranje
English: 3000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 600 IU/ml of lonoctocog alfa.
Slovenian: 3000 i.e na vialo; po pripravi s 5 ml vode za injekcije raztopina vsebuje približno 600 i.e./ml lonoktokoga alfa.
English: AFSTYLA 2000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 2000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 100 i.e./ml enoverižnega rVIII.
English: When reconstituted with 5 ml water for injections the solution contains 600 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 600 i.e./ml enoverižnega rVIII.
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Slovenian: 2000 i.e. na vialo; po pripravi s 5 ml vode za injekcije raztopina vsebuje približno 400 i.e./ml lonoktokoga alfa.
English: 1 disposable 10 ml syringe
Slovenian: 1 injekcijska brizga (10 ml) za enkratno uporabo 1 komplet za punkcijo vene
English: AFSTYLA 2000 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 2000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Slovenian: 1000 i.e na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 400 i.e./ml lonoktokoga alfa.
English: AFSTYLA 500 IU powder and solvent for solution for injection
Slovenian: AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje
English: AFSTYLA 3000 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 3000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of lonoctocog alfa.
Slovenian: 500 i.e. na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 200 i.e./ml lonoktokoga alfa.
English: powder and solvent for solution for injection 1 vial with powder: 3000 IU lonoctocog alfa (600 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 3000 i.e. lonoktokoga alfa (600 i.e./ml po rekonstituciji) 1 viala s 5 ml vode za injekcije
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of lonoctocog alfa.
Slovenian: 250 i.e na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 100 i.e./ml lonoktokoga alfa.
English: AFSTYLA 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Slovenian: AFSTYLA 2500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2500 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
English: AFSTYLA 250 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 250 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: AFSTYLA 1500 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 1500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 400 i.e./ml enoverižnega rVIII.
English: 2500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 500 IU/ml of lonoctocog alfa.
Slovenian: 2500 i.e. na vialo; po pripravi s 5 ml vode za injekcije raztopina vsebuje približno 500 i.e./ml lonoktokoga alfa.
English: AFSTYLA 3000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 3000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 250 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 250 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: powder and solvent for solution for injection 1 vial with powder: 1500 IU lonoctocog alfa (300 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 1500 i.e. lonoktokoga alfa (300 i.e./ml po rekonstituciji) 1 viala s 5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 1000 IU lonoctocog alfa (400 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 1000 i.e. lonoktokoga alfa (400 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 2500 IU lonoctocog alfa (500 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 2500 i.e. lonoktokoga alfa (500 i.e./ml po rekonstituciji) 1 viala s 5 ml vode za injekcije
English: When reconstituted with 5 ml water for injections the solution contains 500 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 500 i.e./ml enoverižnega rVIII.
English: When reconstituted with 5 ml water for injections the solution contains 300 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 300 i.e./ml enoverižnega rVIII.
English: AFSTYLA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Slovenian: AFSTYLA 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
English: AFSTYLA 2500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 2500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 2500 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 2500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: AFSTYLA 1000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 1000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: When reconstituted with 5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Slovenian: Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 400 i.e./ml enoverižnega rVIII.
English: AFSTYLA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Slovenian: AFSTYLA 1500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1500 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
English: AFSTYLA 1500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 1500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Slovenian: AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
English: AFSTYLA 500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Slovenian: AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: Inhibitors
Slovenian: Zaviralci
English: AFSTYLA 1000 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 1000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: AFSTYLA 500 IU powder for solution for injection Lonoctocog alfa
Slovenian: AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
English: Nervous system disorders
Slovenian: Bolezni živčevja omotica pogosti parestezija pogosti
English: powder and solvent for solution for injection 1 vial with powder: 250 IU lonoctocog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 250 i.e. lonoktokoga alfa (100 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 500 IU lonoctocog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 500 i.e. lonoktokoga alfa (200 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
English: The reconstituted solution should be clear to slightly opalescent, yellow to colourless i.e., it might sparkle when held up to the light but must not contain any obvious particles.
Slovenian: Pripravljena raztopina mora biti bistra do rahlo svetlikajoča, rumena do brezbarvna t.j.
English: United Kingdom Hikma Farmacêutica (Portugal), S.A.
Slovenian: Hikma Farmacêutica (Portugal), S.A.
English: Solution For Injection Intramuscular Use | Intravenous Use
Slovenian: Raztopina za injiciranje Intramuskularna uporaba | intravenska uporaba
English: Metilprednisolon Teva Methylprednisolone 40mg/Ml
Slovenian: Metilprednisolon Teva Metilprednizolon 40 mg/ml
English: Metylprednizolón Hikma Methylprednisolone 53mg Vial
Slovenian: Metylprednizolón Hikma Metilprednizolon 53 mg viala
English: Powder And Solvent For Solution For Injection/Infusion
Slovenian: Prašek in vehikel za raztopino za injiciranje/infundiranje
English: Metilprednizolon Teva Methylprednisolone 40mg/Ml
Slovenian: Metilprednizolon Teva Metilprednizolon 40 mg/ml
English: Lyophilisate And Solvent For Solution For Injection
Slovenian: Liofilizat in vehikel za raztopino za injiciranje
English: Methylprednisolone Hemisuccinate 50.7mg Vial
Slovenian: Metilprednizolon hemisukcinat 50,7 mg viala
English: Methylprednisolone Hemisuccinate 50.68mg Bottle
Slovenian: Metilprednizolon hemisukcinat 50,68 mg steklenička
English: Methylprednisolone Hemisuccinate 25.35mg Vial
Slovenian: Metilprednizolon hemisukcinat 25,35 mg viala
English: Metilprednizolon Teva Methylprednisolone Sodium Succinate 40mg Vial
Slovenian: Metilprednizolon Teva Metilprednizolon natrijev sukcinat 40 mg viala
English: Methylprednisolone Sodium Succinate 53.03mg/Ml
Slovenian: Metilprednizolon natrijev sukcinat 53,03 mg/ml
English: Methylprednisolone Hemisuccinate 25.34mg Bottle
Slovenian: Metilprednizolon hemisukcinat 25,34 mg steklenička
English: Methylprednisolone 40mg Tablet
Slovenian: Metilprednizolon 40 mg tableta
English: Metilprednisolon Teva Methylprednisolone Sodium Succinate 53mg Vial
Slovenian: Metilprednisolon Teva Metilprednizolon natrijev sukcinat 53 mg viala
English: Methylprednisolone 120mg Bottle
Slovenian: Metilprednizolon 120 mg steklenička
English: Methylprednisolone Sodium Succinate 53.2mg/Ml
Slovenian: Metilprednizolon natrijev sukcinat 53,2 mg/ml
English: The patient's blood should be monitored regularly to see how the medicine is working.
Slovenian: Redno je treba spremljati bolnikovo kri, da se preveri delovanje zdravila.
English: The recommended dose is one capsule a day taken during the evening meal.
Slovenian: Priporočeni odmerek je ena kapsula na dan, ki se zaužije med večernim obrokom.
English: It must not be given to women who are pregnant or breastfeeding.
Slovenian: Ne smejo ga uporabljati ženske, ki so noseče ali dojijo.
English: Pravafenix pravastatin/fenofibrate
Slovenian: Pravafenix pravastatin/fenofibrat
English: The medicine should always be taken with food as it is less well absorbed from an empty stomach.
Slovenian: Zdravilo je vedno treba jemati skupaj s hrano, saj se iz praznega želodca slabše absorbira.
English: Fenofibrate is a ‘PPAR agonist'.
Slovenian: Fenofibrat je „agonist PPAR“.
English: It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.
Slovenian: Na voljo je v obliki zelenih in olivno zelenih kapsul, ki vsebujejo 40 mg pravastatina in 160 mg fenofibrata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pravafenix, veljavno po vsej Evropski uniji, odobrila družbi Laboratoires SMB s.a. dne 14. aprila 2011.
English: Pravastatin belongs to the group called ‘statins'.
Slovenian: Pravastatin spada v skupino, imenovano „statini“.
English: Because pravastatin and fenofibrate have been used in medicines for a number of years, the company presented information from the scientific literature in addition to results from its own studies.
Slovenian: Ker se pravastatin in fenofibrat v zdravilih uporabljata že vrsto leto, je družba poleg rezultatov lastnih študij predstavila tudi informacije iz znanstvene literature.
English: The full EPAR for Pravafenix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pravafenix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Pravafenix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pravafenix.
English: The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks (excluding HDL or ‘good' cholesterol).
Slovenian: Glavno merilo učinkovitosti je bilo znižanje ravni holesterola po 12 tednih (brez holesterola HDL ali „dobrega“ holesterola).
English: The doctor should stop treatment if an adequate response is not seen within three months.
Slovenian: Če zadosten odziv ni dosežen v treh mesecih, mora zdravnik zdravljenje prekiniti.
English: For more information about treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pravafenix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Committee therefore decided that Pravafenix's benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Pravafenix večje od z njim povezanih tveganj pri tej skupini bolnikov, in priporočil, da se zanj odobri dovoljenje za promet.
English: The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal novo objavljene podatke o koristih kombinacije statinov in fenofibrata.
English: It activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha', which is involved in breaking down fat from the diet, especially triglycerides.
Slovenian: Aktivira vrsto receptorjev, imenovanih „peroksisomski proliferator aktiviranega receptorja alfa“, ki vpliva na razgradnjo maščob iz prehrane, zlasti trigliceridov.
English: Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient's abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.
Slovenian: Pred začetkom zdravljenja z zdravilom Pravafenix mora zdravnik najprej proučiti vse možne vzroke za bolnikove nenormalne ravni holesterola in trigliceridov ter bolniku predpisati ustrezno dieto.
English: Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate.
Slovenian: Pravafenix je zdravilo, ki vsebuje zdravilni učinkovini pravastatin in fenofibrat.
English: The cholesterol drawn out of the blood in this way is the LDL, or ‘bad' cholesterol.
Slovenian: Holesterol, ki se iz krvi odstrani na tak način, je holesterol LDL ali „slabi“ holesterol.
English: The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.
Slovenian: Zdravilni učinkovini v zdravilu Pravafenix, pravastatin in fenofibrat, delujeta različno, njuni učinki pa se med seboj dopolnjujejo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pravafenix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pravafenix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Slovenian: Ker jetra holesterol potrebujejo za proizvajanje žolča, znižana raven holesterola v krvi povzroča, da celice jeter proizvajajo receptorje, ki črpajo holesterol iz krvi in tako njegovo raven še bolj znižujejo.
English: Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients.
Slovenian: Zdravila Pravafenix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilni učinkovini ali katero koli drugo sestavino zdravila.
English: The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes.
Slovenian: Najpogostejši neželeni učinki zdravila Pravafenix (opaženi pri 1 do 10 bolnikih izmed 100) so napihnjenost trebuha, bolečina v trebuhu, zaprtost, driska, suha usta, dispepsija (zgaga), kolcanje (spahovanje), napenjanje (plini), navzeja (slabost), neugodje v trebuhu, bruhanje in povečana koncentracija jetrnih encimov v krvi.
English: The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats.
Slovenian: Družba je izvedla eno glavno študijo, v kateri so zdravilo Pravafenix primerjali z monoterapijo s pravastatinom pri 248 bolnikih z visokim tveganjem za bolezen srca, ki so imeli nenormalno raven holesterola in trigliceridnih maščob.
English: What benefit has Pravafenix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pravafenix izkazalo med študijami?
English: Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.
Slovenian: Raven holesterola zaradi lipoproteinov nevisoke gostote se je v povprečju znižala za okoli 14 % pri bolnikih, ki so jemali zdravilo Pravafenix, v primerjavi s 6 % pri bolnikih, ki so jemali samo pravastatin.
English: Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).
Slovenian: Zdravilo Pravafenix se uporablja za zdravljenje odraslih bolnikov z visokim tveganjem za bolezen srca, pri katerih so vrednosti holesterola zaradi „lipoproteinov nizke gostote“ (holesterol LDL ali slabi holesterol) že nadzirane z monoterapijo s pravastatinom, vendar morajo kljub temu še izboljšati raven holesterola in zmanjšati raven trigliceridov (vrsta maščob).
English: For the full list of all side effects reported with Pravafenix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pravafenix, glejte navodilo za uporabo.
English: Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen.
Slovenian: Ne smejo ga uporabljati bolniki, mlajši od 18 let, ali bolniki s hudimi težavami z jetri, zmernimi do hudimi težavami z ledvicami, s fotoalergijo ali fototoksičnimi reakcijami (alergijskimi reakcijami ali poškodbami kože zaradi izpostavljenosti svetlobi) pri zdravljenju s fibrati ali ketoprofenom.
English: It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate.
Slovenian: Prav tako ga ne smejo uporabljati bolniki z boleznijo žolčnika, s kroničnim ali akutnim pankreatitisom (vnetjem trebušne slinavke) ali bolniki z anamnezo miopatije (mišične motnje) ali rabdomiolize (razpadanjem mišičnih vlaken) po zdravljenju s statinom ali fibratom.
English: What is the risk associated with Pravafenix?
Slovenian: Kakšna tveganja so povezana z zdravilom Pravafenix?