FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
Slovenian: V drugi študiji so pri bolnikih, ki so prejemali zdravilo Nexium Control, simptomi zgage izginili pri približno 42 % bolnikov (pri 47 od 113) v primerjavi s približno 12 % bolnikov, ki so prejemali placebo (14 od 118).
English: What are the risks associated with Nexium Control?
Slovenian: Kakšna tveganja so povezana z zdravilom Nexium Control?
English: Why is Nexium Control approved?
Slovenian: Zakaj je bilo zdravilo Nexium Control odobreno?
English: The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Nexium Control je esomeprazol, ki je zaviralec protonske črpalke.
English: It is not intended to provide practical advice on how to use Nexium Control.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Nexium Control can be obtained without a prescription.
Slovenian: Izdaja zdravila Nexium Control je brez recepta.
English: How does Nexium Control work?
Slovenian: Kako zdravilo Nexium Control deluje?
English: How is Nexium Control used?
Slovenian: Kako se zdravilo Nexium Control uporablja?
English: Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients).
Slovenian: Najpogostejši neželeni učinki zdravila Nexium Control (opaženi pri največ 1 od 10 bolnikov) so glavobol, bolečine v trebuhu, driska in navzea.
English: The clinical significance of this is not clear.
Slovenian: Klinični pomen tega ni jasen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 14. april 2011
English: The volume of distribution is about 0.5 l/kg.
Slovenian: Volumen porazdelitve je približno 0,5 l/kg.
English: Practically all the drug is eliminated within 6 days.
Slovenian: Skoraj vsa količina zdravila se izloči v 6 dneh.
English: - You should always keep your alcohol intake to a minimum.
Slovenian: - Pitje alkohola morate vedno omejiti na najmanjšo možno mero.
English: These changes are specific to small rodents and have not been observed in other animal species.
Slovenian: Te spremembe so specifične za male glodavce in jih pri drugih živalskih vrstah niso opazili.
English: Swallow the capsule with water.
Slovenian: Kapsulo pogoltnite z vodo.
English: The following two side effects are important and will require immediate action.
Slovenian: Naslednji neželeni učinki so pomembni in zahtevajo takojšnje ukrepanje.
English: This combination is, therefore, not recommended.
Slovenian: Kombinacija zato ni priporočljiva.
English: - Children and adolescents (age below 18 years).
Slovenian: - Otroci in mladostniki (mlajši od 18 let).
English: B-1080 Brussels
Slovenian: B-1080 Bruselj
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Slovenian: Mehanizem tega medsebojnega delovanja (bodisi da gre za farmakodinamiko ali farmakokinetiko, ali pa oboje) še ni znan.
English: - Tell your doctor about all your medical conditions including allergies.
Slovenian: - Opišite mu vaše celotno zdravstveno stanje, vključno z alergijami.
English: Elderly patients (≥ 65 years old)
Slovenian: Posebne skupine Starejši bolniki (≥ 65 let)
English: Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant.
Slovenian: Zdravila Pravafenix ne jemljite, če ste noseči, če skušate zanositi ali če menite, da bi lahko bili noseči.
English: Adverse reactions have usually been mild and transient.
Slovenian: Neželeni učinki so bili običajno blagi in prehodni.
English: They may raise your risk of having heart problems.
Slovenian: Ti lahko povečajo vaše tveganje za bolezni srca.
English: This is of no relevance to therapeutic use in man.
Slovenian: Za terapevtsko uporabo pri človeku to ni pomembno.
English: If confirmed, the treatment should definitively not be initiated (see section 4.3).
Slovenian: Če so potrjeni, se zdravljenje vsekakor ne sme začeti (glejte poglavje 4.3).
English: This is due to the fat content of the meal.
Slovenian: Do tega pride zaradi maščob, ki jih vsebuje obrok.
English: If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Slovenian: Če vas skrbi, koliko alkohola lahko med jemanjem tega zdravila popijete, se o tem posvetujte z zdravnikom.
English: This is to check how well your liver and your kidneys are working.
Slovenian: S tem bo preveril, ali vaša jetra in ledvice dobro delujejo.
English: Response to therapy should be monitored by determination of serum lipid values.
Slovenian: Odziv na terapijo je treba spremljati z določanjem vrednosti serumskih lipidov.
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Slovenian: Zožitve lahko upočasnijo ali prekinejo dotok krvi v življenjsko pomembne organe, kot sta srce in možgani.
English: Before treatment initiation
Slovenian: Pred začetkom zdravljenja
English: HDL cholesterol levels are frequently increased.
Slovenian: Ravni holesterola HDL se pogosto zvišajo.
English: The food effect increases with the fat content: the larger the lipid content the larger the bioavailability of fenofibrate.
Slovenian: Vpliv hrane se povečuje z vsebnostjo maščob: večja kot je vsebnost lipidov, večja je biološka uporabnost fenofibrata.
English: If you plan to become pregnant or become pregnant, inform your doctor immediately.
Slovenian: Če načrtujete nosečnost ali če ste zanosili, o tem takoj obvestite zdravnika.
English: For any information over this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Slovenian: Fenofibratna kislina je močno vezana na plazemske albumine (več kot 99-odstotno).
English: Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, vzemite le običajno količino zdravila Pravafenix naslednji dan ob istem času kot običajno.
English: The results of this study show that food has effect on the rate and extent of absorption in the fixed dose combination.
Slovenian: Rezultati te študije kažejo, da hrana vpliva na hitrost in količino absorpcije fiksne kombinacije odmerkov.
English: Animal studies have not demonstrated any teratogenic effects.
Slovenian: Študije na živalih niso pokazale nobenih teratogenih učinkov.
English: • Memory loss
Slovenian: • izguba spomina,
English: It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Slovenian: Priporočljivo je, da se odmerek antikoagulantov na začetku zdravljenja zniža za eno tretjino in se nato po potrebi postopoma prilagodi v skladu s spremljanjem internacionalnega normaliziranega razmerja
English: Studies on mutagenicity of fenofibrate have been negative.
Slovenian: Študije o mutagenosti fenofibrata so bile negativne.
English: Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Slovenian: < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10 000 do < 1/1.000), zelo redki (< 1/10.000).
English: About 50% of circulating pravastatin is bound to plasma proteins.
Slovenian: Okoli 50 % krožečega pravastatina se veže na plazemske beljakovine.
English: ∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Slovenian: Povečanje vrednosti AUC∞, AUCt in Cmax znaša 111,88 %, 114,06 % in 115,28 %.
English: Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing.
Slovenian: Nenadne hude alergijske reakcije, vključno z otekanjem obraza, ustnic, jezika ali sapnika, ki lahko močno otežijo dihanje.
English: Also see section 4 of this leaflet.
Slovenian: Glejte tudi poglavje 4 v tem navodilu.
English: While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Slovenian: Ko jemljete to zdravilo, vas bo zdravnik skrbno spremljal, če imate sladkorno bolezen ali ste izpostavljeni tveganju za razvoj sladkorne bolezni.
English: The drug is excreted mainly in the urine.
Slovenian: Zdravilo se izloča pretežno z urinom.
English: The risk of muscle breakdown is greater in certain patients.
Slovenian: Pri nekaterih bolnikih je tveganje za razpad mišic večje.
English: Before you take Pravafenix you should tell your doctor if you have or have had any medical problems.
Slovenian: Pred zdravljenjem z zdravilom Pravafenix morate zdravniku povedati, če imate ali ste imeli kakršnekoli zdravstvene težave.
English: Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Slovenian: Študije o kronični toksičnosti niso odkrile relevantnih podatkov o specifični toksičnosti fenofibrata.
English: Plasma concentrations are stable during continuous treatment in any given individual.
Slovenian: Koncentracija v plazmi je med neprekinjenim zdravljenjem pri katerem koli danem posamezniku stabilna.
English: A small quantity of pravastatin passes into the human breast milk.
Slovenian: Majhna količina pravastatina preide v materino mleko.
English: The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Slovenian: Povečano tveganje za venske trombotične dogodke je morda povezano z zvišano ravnijo homocisteina, ki je dejavnik tveganja za trombozo, in z drugimi neopredeljenimi dejavniki.
English: Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Slovenian: Zdravljenje s statini se lahko ponovno uvede sedem dni po zadnjem odmerku fusidne kisline.
English: This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Slovenian: Pomembnost tega tveganja pa je manjša od pomembnosti zmanjšanja vaskularnega tveganja pri uporabi statinov, zato to ne sme biti razlog za prekinitev zdravljenja.
English: Co-administration of this combination may cause increased plasma concentrations of both agents.
Slovenian: Sočasno uvajanje te kombinacije lahko povzroči povečano koncentracijo obeh zdravil v plazmi.
English: In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Slovenian: Glede na ta pomemben prvi prehod prek jeter ima koncentracija pravastatina v plazmi le omejeno vrednost pri predvidevanju vpliva na zniževanje koncentracije lipidov.
English: Technimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
Slovenian: Tecnimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
English: - To raise the level of your ‘good' cholesterol (HDL cholesterol).
Slovenian: - za zvišanje ravni „dobrega“ holesterola (holesterola HDL).
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.
Slovenian: Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja za bolnika ni drugih tveganj razen tistih, ki so zaradi farmakološkega mehanizma delovanja pričakovana.
English: - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
Slovenian: - Znana fotoalergija ali fototoksična reakcija med zdravljenjem s fibrati ali ketoprofenom.
English: Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)
Slovenian: Možni neželeni učinki, o katerih so poročali pri nekaterih statinih (isti vrsti zdravil za zniževanje holesterola kot je pravastatin)
English: In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
Slovenian: Pri podganah in miših so pri visokih odmerkih našli tumorje na jetrih, ki jih gre pripisati proliferaciji peroksisomov.
English: Polyamide-Aluminium-PVC/aluminium blister 2 years.
Slovenian: Pretisni omoti iz poliamida-aluminija-PVC/aluminija 2 leti
English: Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Slovenian: Študije na miših, podganah in kuncih niso odkrile nobenih teratogenih učinkov.
English: On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
Slovenian: V povprečju se absorbira 34 % peroralno zaužitega odmerka, pri čemer absolutna biološka uporabnost znaša 17 %.
English: Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Slovenian: Zdravniku ali farmacevtu prav tako povejte, če se vam pojavi stalna oslabelost mišic.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells.
Slovenian: Študije in vitro so pokazale, da se pravastatin prenaša v hepatocite, pri čemer je vnos v druge celice znatno manjši.
English: What pravafenix is and what it is used for
Slovenian: KAJ JE ZDRAVILO PRAVAFENIX IN ZA KAJ GA UPORABLJAMO
English: Special caution is recommended in women of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy.
Slovenian: Pri ženskah v rodni dobi se priporoča posebna previdnost, s čimer naj se zagotovi, da pravilno razumejo možno tveganje, povezano z zdravljenjem s pravastatinom med nosečnostjo.
English: After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
Slovenian: Po absorpciji se 66 % pravastatina izloči s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL.
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Slovenian: Skupni učinek je zmanjšano razmerje med lipoproteini nizke in zelo nizke gostote ter lipoproteini visoke gostote.
English: Fibrates and statins in combination have also been shown to synergistically increase the transcriptional activities of PPARα receptors.
Slovenian: Dokazano je tudi, da kombinacija fibratov in statinov sinergijsko krepi transkripcijske dejavnosti receptorjev PPARα.
English: It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Slovenian: Pomembno je, da kapsulo vzamete s hrano, saj na tešče ne bo tako dobro delovala.
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.
Slovenian: Zato je mogoče zdravila, ki jih sistem citokroma P450 presnavlja ali pa so njegovi zaviralci, dodajati stabilni shemi odmerjanja pravastatina, ne da bi se pri tem pomembno spremenile ravni pravastatina v plazmi, kot je bilo opaženo pri drugih statinih.
English: The plasma elimination half-life of fenofibric acid is approximately 20 hours.
Slovenian: Plazemska razpolovna doba izločanja fenofibratne kisline traja približno 20 ur.
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.
Slovenian: Študije o interakcijah zdravila Pravafenix niso bile narejene, vendar sočasno jemanje zdravilnih učinkovin pri bolnikih v kliničnih študijah ni povzročilo nobenih nepričakovanih interakcij.
English: Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests.
Slovenian: Primeri prevelikega odmerjanja, o katerih so poročali, so bili asimptomatski in niso povzročili nenormalnih izvidov laboratorijskih preiskav.
English: However in a multiple dose study, the results showed that the product is not bioequivalent because its bioavailability after multiple dosing is a 20% lower for the fenofibrate component of the combination.
Slovenian: Vendar pa so rezultati v študiji večkratnega odmerka pokazali, da zdravilo ni bioekvivalentno, ker je njegova biološka uporabnost po večkratnem odmerjanju zaradi fenofibratne komponente kombinacije 20 % nižja.
English: If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so.
Slovenian: Če ste med zdravljenjem omotični ali če imate zamegljen ali dvojni vid, se najprej prepričajte, da ste sposobni voziti in upravljati stroje, šele nato se tega lahko lotite.
English: After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation.
Slovenian: Po intravenski uporabi se 47 % odmerka izloči prek ledvic, 53 % pa biliarno in z biotransformacijo.
English: Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Slovenian: Fenofibrat se v glavnem izloča v obliki fenofibratne kisline in njenega glukuronidnega konjugata.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: (eructation)).
Slovenian: (pravastatin)
English: Pravastatin is not significantly metabolised by cytochrome P450 nor does it appear to be a substrate or an inhibitor of P-glycoprotein but rather a substrate of other transport proteins.
Slovenian: Pravastatin se s citokromom P450 ne presnavlja znatno, niti ni substrat ali zaviralec P-glikoproteina, ampak prej substrat za druge transportne proteine.
English: In total, these studies enrolled 1,637 patients who have not had an adequate response to treatment with pravastatin 40 mg monotherapy or simvastatin 20 mg in Europe and in the USA.
Slovenian: V te študije so v Evropi in ZDA zajeli skupno 1637 bolnikov, ki se niso dobro odzvali na zdravljenje z monoterapijo s pravastatinom 40 mg ali s simvastatinom 20 mg.
English: Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Slovenian: Kinetične raziskave po uporabi enkratnega odmerka in neprekinjenem zdravljenju so pokazale, da se zdravilo ne kopiči.
English: Children and adolescents Do not take Pravafenix if you are under 18 years old
Slovenian: Ne jemljite zdravila Pravafenix, če ste mlajši od 18 let.
English: Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding.
Slovenian: Fenofibrat okrepi učinek peroralnih antikoagulantov in lahko poveča tveganje za krvavitev.
English: The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.
Slovenian: Zato je treba pri teh bolnikih skrbno spremljati ledvično funkcijo in pri veliki spremembi laboratorijskih parametrov zdravljenje s fenofibratom prekiniti.
English: If a patient plans to become pregnant or becomes pregnant, the physician has to be informed immediately and pravastatin should be discontinued because of the potential risk to the foetus.
Slovenian: Če bolnica načrtuje nosečnost ali če zanosi, mora biti zdravnik o tem takoj obveščen, zdravljenje s pravastatinom pa zaradi možnega tveganja za plod prekinjeno.
English: This is a very rare reaction which can be serious if it occurs.
Slovenian: To je zelo redek neželeni učinek, ki pa je lahko nevaren.
English: The decreased in AUCt, AUC∞ and Cmax
Slovenian: Znižanje vrednosti AUCt, AUC∞
English: In most people, there are no signs of cholesterol problems at first.
Slovenian: Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
English: In some patients, however, the increase in pravastatin exposure may be larger.
Slovenian: Pri nekaterih bolnikih pa je povečanje sistemske izpostavljenosti pravastatinu lahko večje.
English: Alopecia, photosensitivity reactions
Slovenian: občasni alopecija, fotosenzitivnostne reakcije redki
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: Also see section 4.4
Slovenian: Glejte tudi poglavje 4.4.
English: However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment.
Slovenian: Med vožnjo motornih vozil ali delom s stroji pa se je treba zavedati, da se lahko med zdravljenjem pojavijo vrtoglavica ali motnje vida.
English: Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels).
Slovenian: O prekinitvi zdravljenja je treba razmisliti tudi v primeru, če so simptomi v mišicah hudi in motijo dnevne dejavnosti (ne glede na to, kakšne so vrednosti kreatin-fosfokinaze).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pravafenix in all subsets of the paediatric population in disorders of lipoprotein metabolism and other hyperlipidaemias (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Pravafenix za vse skupine pediatrične populacije pri motnjah metabolizma lipoproteinov in drugih hiperlipidemijah (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential.
Slovenian: Genetske toksikološke študije in vitro in in vivo niso našle dokazov za mutageni potencial.
English: The following statements reflect the pharmacodynamic/pharmacokinetic properties of the individual active substances of Pravafenix.
Slovenian: Naslednje trditve opisujejo farmakodinamične/farmakokinetične lastnosti posameznih zdravilnih učinkovin zdravila Pravafenix.
English: Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Slovenian: Prvič, z reverzibilnim in specifičnim kompetitivnim zaviranjem reduktaze HMG-CoA vpliva na zmerno upočasnitev sinteze znotrajceličnega holesterola.
English: Pravastatin is administered orally in the active form.
Slovenian: Pravastatin Pravastatin se jemlje peroralno v aktivni obliki.