FrancophonIA/ELRC3.0 huggingface dataset:
English: If you or your child gets a rash, swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing, these may be signs of an allergic reaction.
Slovenian: Če se pri vas ali pri vašem otroku pojavijo izpuščaj, oteklina obraza, ustnic, jezika ali žrela s težavami požiranja ali dihanja, so lahko to znaki alergijske reakcije.
English: Based on animal data Eurartesim is suspected to harm the unborn child when used during the first three months of pregnancy.
Slovenian: Na podlagi podatkov pri živalih se sumi, da zdravilo Eurartesim škoduje nerojenemu otroku, če se uporablja v prvih treh mesecih nosečnosti.
English: Total number of tablets for treatment
Slovenian: Skupno število tablet na zdravljenje
English: Some medicines can affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that extra checks are needed while you or your child is taking the medicines which could cause possible interactions.
Slovenian: Nekatera zdravila lahko vplivajo na način delovanja zdravila Eurartesim in vaš zdravnik se bo morda odločil, da jemanje zdravila Eurartesim ni ustrezno ali da je treba vas ali vašega otroka dodatno pregledovati med jemanjem zdravil, ki bi lahko povzročila medsebojno delovanje.
English: Re-dosing with Eurartesim should not be attempted more than once.
Slovenian: Zdravila Eurartesim ne poskušajte dajati ponovno več kot enkrat.
English: Special precaution is advised in young children when vomiting, as they are likely to develop electrolyte disturbances.
Slovenian: Posebna pozornost se priporoča pri majhnih otrocih, ki bruhajo, saj obstaja večja možnost, da se razvijejo motnje elektrolitov.
English: The safety of Eurartesim has been evaluated in two phase III open-label studies involving 1,239 paediatric patients up to 18 years and 566 adult patients >18 years treated with Eurartesim.
Slovenian: Varnost zdravila Eurartesim so ocenili v dveh odprtih študijah faze III, ki sta vključevali 1.239 pediatričnih bolnikov, starih do 18 let, in 566 odraslih bolnikov, starih več kot 18 let, zdravljenih z zdravilom Eurartesim.
English: Effects on blood pressure and on PR and QRS duration were observed at high piperaquine doses.
Slovenian: Učinke na krvni tlak in trajanje PR in QRS so opazili samo pri visokih odmerkih piperakina.
English: Pharmacokinetic profiles of artenimol and piperaquine have been investigated in animal models and in different human populations (healthy volunteers, adult patients and paediatric patients).
Slovenian: Farmakokinetična profila artenimola in piperakina so preučili na živalskih modelih in pri različnih populacijah ljudi (zdravi prostovoljci, odrasli bolniki in pediatrični bolniki).
English: However, there was no delay in neonatal development following exposure in utero or via milk (see section 5.3).
Slovenian: Vendar pa ni bilo zakasnitve v neonatalnem razvoju po izpostavitvi in utero ali z mlekom (glejte poglavje 5.3).
English: Its clearance was found to be slightly lower in female than in male healthy volunteers.
Slovenian: Ugotovili so, da je očistek nekoliko manjši pri ženskih zdravih prostovoljkah kot pri moških zdravih prostovoljcih.
English: Adverse event data collected in clinical trials suggest that Eurartesim has no influence on the ability to drive and operate machines once the patient has recovered from the acute infection.
Slovenian: Podatki o neželenih učinkih, zbrani v kliničnih preskušanjih, kažejo, da zdravilo Eurartesim nima vpliva na sposobnost vožnje in upravljanja strojev, ko enkrat bolnik okreva od akutne okužbe.
English: If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed.
Slovenian: Če bolnik izpusti odmerek, ga mora vzeti takoj, ko se to opazi, nato pa naj s priporočenim režimom jemanja nadaljuje do zaključka celotnega poteka zdravljenja.
English: This pharmacokinetic effect is accompanied by an increased effect on prolongation of the QT interval.
Slovenian: Ta farmakokinetični učinek spremlja večji učinek na podaljšanje intervala QT.
English: Very common (may affect more than 1 in 10 people) Influenza, cough, fever.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): gripa, kašelj, zvišana telesna temperatura.
English: However, it is reported in the literature that the excretion of unchanged active substance in human urine and faeces is negligible for artemisinin derivatives.
Slovenian: Vendar pa viri navajajo, da je izločanje nespremenjene učinkovine v človeškem urinu in blatu zanemarljivo za derivative artemizinina.
English: What Eurartesim is and what it is used for
Slovenian: Kaj je zdravilo Eurartesim in za kaj ga uporabljamo
English: Data regarding artenimol excretion in humans are scarce.
Slovenian: Podatki o izločanju artenimola pri ljudeh so redki.
English: The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue.
Slovenian: Natančen mehanizem delovanja piperakina ni znan, vendar verjetno posnema delovanje klorokina, bližnjega analoga po zgradbi.
English: In a perinatal and postnatal development study (segment III) in female rats treated with 80 mg/kg, some animals had a delay of delivery inducing mortality of the neonates.
Slovenian: V študijah perinatalnega in ponatalnega razvoja (segment III) pri podganjih samicah, ki so jim dajali 80 mg/kg, se je pri nekaterih živalih pojavila zakasnitev kotenja, kar je induciralo smrtnost rojenih goličev.
English: Before the third dose of Eurartesim, in one of the two Phase III studies 3/767 patients (0.4%) were reported to have a QTcF value of >500 ms versus none in the comparator group.
Slovenian: Pred tretjim odmerkom zdravila Eurartesim so v eni od dveh študij 3. faze pri 3/767 bolnikov (0,4 %) poročali o vrednosti QTcF > 500 ms v primerjavi z nobenim v primerjalni skupini.
English: Examples are listed below (but there are several others): - some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,
Slovenian: Primeri so našteti spodaj (vendar obstaja še veliko drugih): - nekatera zdravila za zdravljenje visokega holesterola v krvi (kot so atorvastatin, cerivastatin,
English: A total of 6 (0.8%) subjects had serious ADRs in the study.
Slovenian: Skupaj 6 (0,8 %) oseb je imelo v študiji hude neželene učinke.
English: A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose.
Slovenian: Težave s srcem, imenovane podaljšanje intervala QT, se lahko pojavijo pri jemanju zdravila Eurartesim in še nekaj dni po zadnjem odmerku.
English: Eurartesim kills the Plasmodium falciparum parasite.
Slovenian: Zdravilo Eurartesim ubije parazita Plasmodium falciparum.
English: The potential for Eurartesim to prolong the QTc interval was investigated in parallel groups of healthy volunteers who took each dose with high (~1000 Kcal) or low (~400 Kcal) fat/calorie meals or in fasting conditions.
Slovenian: Potencial zdravila Eurartesim, da podaljša interval QTc, so preučili v vzporednih skupinah zdravih prostovoljcev, ki so vzeli vsak odmerek z visoko (~1000 Kcal) ali nizko (~400 Kcal) vsebnostjo maščob/kalorij ali na tešče.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Your doctor should have prescribed a dose that is appropriate for your weight or your child's weight as follows:
Slovenian: Vaš zdravnik bi moral predpisati odmerek, ki je ustrezen za vašo ali otrokovo telesno maso, kot sledi.
English: No subject had a QTcF value greater than 500 msec in any of the dosing conditions.
Slovenian: Nobena od oseb ni imela vrednosti QTcF nad 500 msek pod nobenimi pogoji odmerjanja.
English: If any of the above applies to you or your child or if you are unsure, tell your doctor or pharmacist before taking or giving Eurartesim.
Slovenian: Če kar koli od zgoraj navedenega velja za vas ali vašega otroka ali če ste negotovi, obvestite zdravnika ali farmacevta, preden vzamete ali daste otroku zdravilo Eurartesim.
English: Tell your doctor if you are in the 1st trimester of pregnancy, think you may be pregnant or become pregnant, or if you are breast-feeding.
Slovenian: Obvestite zdravnika, če ste v 1. trimesečju nosečnosti, menite, da bi lahko bili noseči, načrtujete zanositev ali dojite.
English: Artenimol bioavailability appears to be higher in malaria patients than in healthy volunteers, possibly because malaria per se has an effect on artenimol disposition.
Slovenian: Kaže, da je biološka razpoložljivost artenimola višja pri bolnikih z malarijo kot pri zdravih prostovoljcih, morda zato, ker ima malarija sama po sebi učinek na razporeditev artenimola.
English: Therefore the assessment of the potential for drug-drug interactions to occur is based on either in vivo or in vitro studies.
Slovenian: Zato ocene pojava možnosti medsebojnega delovanja med zdravili temeljijo tako na študijah in vivo kot na študijah in vitro.
English: In each case the results confirmed that Eurartesim was not inferior to the comparator medicinal product.
Slovenian: V obeh primerih so rezultati potrdili, da zdravljenje z zdravilom Eurartesim ni slabše kot s primerjanim zdravilom.
English: The piperaquine major metabolites were a carboxyl acid cleavage product, and a mono-N-oxidated product.
Slovenian: Glavni presnovki piperakina so bili produkt cepljenja karboksilne kisline in mono-N-oksidiran produkt.
English: Therefore, caution is advised when administering Eurartesim to these patients (see section 4.4).
Slovenian: Zato je potrebna previdnost pri dajanju zdravila Eurartesim tem bolnikom (glejte poglavje 4.4).
English: In females delivering normally the development, behaviour and growth of the surviving progeny was normal following exposure in utero or via milk.
Slovenian: Pri samicah, ki so normalno kotile, so razvoj, vedenje in rast preživele zalege po izpostavljenosti in utero ali z mlekom potekali normalno.
English: Eurartesim should be taken orally with water and without food.
Slovenian: Zdravilo Eurartesim se jemlje z vodo in brez hrane.
English: There is no data on a second course of treatment.
Slovenian: Ni podatkov o ponovitvi zdravljenja.
English: You should not take Eurartesim with grapefruit juice due to possible interactions.
Slovenian: Zdravila Eurartesim ne smete jemati s sokom grenivke zaradi možnega medsebojnega delovanja.
English: This inhibitory effect was no longer evident one week after last administration of Eurartesim.
Slovenian: Ta zaviralni učinek en teden po zadnjem odmerku zdravila Eurartesim ni bil več viden.
English: • If you or your child is infected more than twice in a year, your doctor will prescribe an alternative treatment.
Slovenian: • Če se vi ali vaš otrok okužite več kot dvakrat v letu, bo vaš zdravnik predpisal drugo zdravljenje.
English: Absorption of piperaquine is increased in the presence of fatty food (see sections 4.4 and 5.2) which may increase its effect on QTc interval.
Slovenian: Absorpcija piperakina se poveča v prisotnosti mastne hrane (glejte poglavji 4.4 in 5.2), kar lahko poveča njegov učinek na interval QTc.
English: In vitro metabolism studies demonstrated that piperaquine is metabolised by human hepatocytes (approximately 85% of piperaquine remained after 2 hours incubation at 37°C).
Slovenian: Študije presnove in vitro so pokazale, da piperakin človeški hepatociti presnavljajo (približno 85 % piperakina se po 2 urah inkubacije pri 37 °C ohrani).
English: You or your child must not take more than two courses within one year.
Slovenian: Vi ali vaš otrok ne smete prejeti več kot dveh ciklov zdravljenja v enem letu.
English: Cardiovascular toxicity
Slovenian: Kardiovaskularna toksičnost
English: Eurartesim should not be taken with grapefruit juice as it is likely to lead to increased piperaquine plasma concentrations.
Slovenian: Zdravila Eurartesim se ne sme dajati s sokom grenivke, saj lahko to povzroči višje koncentracije piperakina v plazmi.
English: Your doctor may take electrical recordings of the heart (electrocardiogram, ECG) while you or your child is being treated and after the last dose is given.
Slovenian: Zdravnik lahko naredi električni posnetek delovanja srca (elektrokardiogram, EKG) med vašim zdravljenjem ali zdravljenjem vašega otroka in po zadnjem odmerku.
English: In humans, piperaquine has a Tmax of approximately 5 hours following a single and repeated dose.
Slovenian: Pri ljudeh ima piperakin Tmax približno 5 ur po enkratnem in ponavljajočem odmerku.
English: The mean QTcF prolongation compared to placebo decreased to 11.8 msec at 24 hours and to 7.5 msec at 48 hours.
Slovenian: Povprečno podaljšanje QTcF v primerjavi s placebom se je zmanjšalo na 11,8 msek po 24 urah in na 7,5 msek po 48 urah.
English: There are no specific data relating to the effects of piperaquine on fertility, however, to date no adverse events have been reported during clinical use.
Slovenian: Ni posebnih podatkov o učinkih piperakina na plodnost, vendar pa v klinični uporabi niso poročali o neželenih učinkih.
English: Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo med nosečnostjo ali dojenjem.
English: No single type of ADR occurred at an incidence of ≥5%.
Slovenian: Nobeni neželeni učinki posamezne vrste se niso pojavili z incidenco ≥ 5 %.
English: Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more.
Slovenian: Zdravilo Eurartesim je indicirano za zdravljenje nezapletene malarije Plasmodium falciparum pri odraslih, mladostnikih, otrocih in dojenčkih, starih 6 mesecev in več in težkih 5 kg ali več.
English: Effects on cardiac repolarization
Slovenian: Učinki na repolarizacijo srca
English: It is used to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.
Slovenian: Uporablja se za zdravljenje nezapletene malarije, ko je peroralno dajanje zdravila ustrezno.
English: Therefore, they may be more sensitive to the effects of QTc-prolonging medications such as Eurartesim so that special caution is required.
Slovenian: Zato so morda bolj občutljivi na učinke zdravil, ki podaljšujejo interval QTc, kot je zdravilo Eurartesim, zaradi česar je potrebna posebna pozornost.
English: When clinically appropriate, consideration should be given to obtaining an ECG from all patients before the last of the three daily doses is taken and approximately 4-6 hours after the last dose, since the risk of QTc interval prolongation may be greatest during this period (see section 5.2).
Slovenian: Če je klinično ustrezno, je treba razmisliti o pridobitvi EKG posnetka od vseh bolnikov pred uporabo zadnjega od treh dnevnih odmerkov in v približno 4-6 urah po zadnjem odmerku, saj je lahko tveganje za podaljšanje intervala QTc v tem obdobju največje (glejte poglavje 5.2).
English: Therefore Eurartesim must not be used in the 1st trimester of pregnancy if your doctor can give you an alternative medicine.
Slovenian: Zato se zdravila Eurartesim ne sme uporabljati v 1. trimesečju nosečnosti, če vam zdravnik lahko predpiše drugo zdravilo.
English: Eurartesim should not be used to treat severe falciparum malaria (see section 4.3) and, due to insufficient data, should not be used to treat malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale.
Slovenian: Zdravila Eurartesim se ne sme uporabljati za zdravljenje hude oblike malarije, ki jo povzroča plazmodij P. falciparum (glejte poglavje 4.3), zaradi nezadostnih podatkov pa se ga prav tako ne sme uporabljati za zdravljenje malarije, povzročene s plazmodiji Plasmodium vivax, Plasmodium malariae ali Plasmodium ovale.
English: Tablet strength and number of tablets per dose
Slovenian: Jakost tablete in število tablet na odmerek
English: This may reflect malaria-associated impairment of hepatic function, causing an increase in artenimol bioavailability (reduction of first hepatic effect) without affecting its apparent elimination half-life, which is absorption rate limited.
Slovenian: To se lahko odraža z malarijo povezano okvaro delovanja jeter, ki povzroči povečanje biološke razpoložljivosti artenimola (zmanjšanje prvega jetrnega učinka), ne da bi to vplivalo na navidezno razpolovno dobo izločanja, ki je omejena z absorpcijsko stopnjo.
English: Due to its slow elimination, piperaquine accumulates in plasma after multiple doses with an accumulation factor of approximately 3.
Slovenian: Zaradi počasnega izločanja se piperakin kopiči v plazmi po večkratnem odmerjanju s faktorjem akumulacije približno 3.
English: There is potential for neurotoxicity of artemisinin derivatives in man and animals, which is strongly related to the dose, route and formulations of the different artenimol pro-drugs.
Slovenian: Obstaja možnost za nevrotoksičnost derivatov artemizinina pri ljudeh in živalih, ki je močno odvisen od odmerka, poti uporabe in formulacije različnih predzdravil artenimola.
English: In a paediatric pharmacokinetic study, and based on very limited sampling, minor differences were observed for artenimol pharmacokinetics between the paediatric and adult populations.
Slovenian: V pediatrični študiji farmakokinetike in na podlagi majhnega vzorca so opazili manjše razlike za farmakokinetiko artenimola med pediatrično in odraslo populacijo.
English: A course of Eurartesim lasts 3 consecutive days.
Slovenian: Zdravljenje z zdravilom Eurartesim traja tri zaporedne dni.
English: • The need to counsel patients on important risks associated with Eurartesim therapy and appropriate precautions when using the medicine.
Slovenian: • Bolnikom je treba svetovati o pomembnih tveganjih, povezanih z zdravljenjem z zdravilom Eurartesim, in o ustreznih previdnostnih ukrepih med uporabo zdravila.
English: The safety and efficacy of Eurartesim in infants aged less than 6 months and in children weighing less than 5 kg has not been established.
Slovenian: Varnost in učinkovitost zdravila Eurartesim pri dojenčkih, starih manj kot 6 mesecev, in pri otrocih s telesno maso, manjšo kot 5 kg, nista bili dokazani.
English: Since piperaquine is present in the skin (about 9% in the non-pigmented rat and only 3% in the pigmented rat), slight phototoxic reactions (swelling and erythema) were observed 24 hours after oral treatment in mice exposed to UV radiation.
Slovenian: Ker je piperakin prisoten v koži (približno 9 % v nepigmentiranih podganah in le 3 % v pigmentiranih podganah), so opazili rahle fototoksične reakcije (oteklost in eritem) 24 ur po peroralnem dajanju mišim, izpostavljenim UV-žarkom.
English: The most important nonclinical safety findings after repeated dosing were the infiltration of macrophages with intracytoplasmic basophilic granular material consistent with phospholipidosis and degenerative lesions in numerous organs and tissues.
Slovenian: Najpomembnejši predklinični izsledek o varnosti po ponavljajočem se odmerjanju je bila infiltracija makrofagov z intracitoplazemskim bazofilnim granularnim materialom, konsistentna s fosfolipidozo in degenerativnimi lezijami številnih organov in tkiva.
English: There was no evidence of artenimol-induced lesions in the specific nuclei in rats or dogs, even at lethal dose.
Slovenian: Ni dokazov o lezijah, induciranih z artenimolom, v specifičnih jedrih podgan ali psov, tudi ob smrtnih odmerkih.
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: QTc intervals of more than 500 ms are associated with a pronounced risk for potentially life-threatening ventricular tachyarrhythmias.
Slovenian: Intervali QTc, višji od 500 ms, so povezani z izrazitim tveganjem ventrikularne tahiaritmije, ki so lahko življenjsko nevarne.
English: In humans, the potential neurotoxicity of orally administered artenimol can be considered highly unlikely, given the rapid clearance ofartenimol, and its short exposure (3 days of treatment for malaria patients).
Slovenian: Pri ljudeh je možnost nevrotoksičnosti peroralno uporabljenega artenimola zelo malo verjetna, ob upoštevanju hitrega očistka artenimola in kratke izpostavljenosti (3 dni za zdravljenje bolnikov z malarijo).
English: In a randomised trial in which 767 adults and children with uncomplicated P. falciparum malaria were exposed to Eurartesim, 25% of subjects were judged to have experienced an adverse drug reaction
Slovenian: V randomizirani študiji, v kateri je bilo 767 odraslih in otrok z nezapleteno malarijo P. falciparum izpostavljenih zdravilu Eurartesim, so ocenili, da je imelo 25 % oseb neželene učinke na zdravilo Eurartesim.
English: In perinatal and postnatal studies in rats, piperaquine was associated with delivery complications.
Slovenian: V perinatalnih in postnatalnih študijah pri podganah so piperakin povezali z zapleti med kotenjem.
English: If you or your child is not able to do this, talk to your doctor or pharmacist.
Slovenian: Če vi ali vaš otrok tega niste sposobni, se pogovorite z zdravnikom ali farmacevtom.
English: Pharmacokinetic parameters observed for piperaquine in humans indicate that this active substance has a large volume of distribution (730 l/kg; CV 37.5%).
Slovenian: Farmakokinetični parametri, ki so jih opazili za piperakin pri ljudeh, kažejo, da ima ta učinkovina velik volumen porazdelitve (730 l/kg; CV 37,5 %).
English: The effect on prolongation of the QTc interval was observed on Day 2, and had resolved by Day 7 (the next time point at which ECGs were performed).
Slovenian: Učinek na podaljšanje intervala QTc so opazili 2. dan, do 7. dne pa so izzveneli (naslednja časovna točka izvajanja EKG).
English: Literature data concerning chronic toxicity of piperaquine in dogs and monkeys indicate some hepatotoxicity and mild reversible depression of total white cell and neutrophil counts.
Slovenian: Podatki iz literature glede kronične toksičnosti piperakina pri psih in opicah kažejo na hepatotoksičnost in blago reverzibilno depresijo skupnega števila levkocitov in nevtrofilcev.
English: The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Slovenian: Pri pediatrični populaciji je treba upoštevati zgoraj omenjena medsebojna delovanja pri odraslih in opozorila v poglavju 4.4.
English: Each dose should be taken no less than 3 hours after the last food intake.
Slovenian: Vsak odmerek je treba vzeti vsaj 3 ure po zadnjem zaužitju hrane.
English: The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.
Slovenian: Zdravilo lahko jemljejo odrasli, mladostniki, otroci in dojenčki, stari več kot 6 mesecev, s telesno maso 5 kilogramov ali več.
English: There is the potential for reducing the rate of metabolism of other substrates of this enzyme, such as omeprazole, with consequent increase of their plasma concentration, and therefore, of their toxicity.
Slovenian: Ima potencial za zmanjšanje stopnje presnavljanja drugih substratov tega encima, na primer omeprazola, s posledičnim zvišanjem njihovih koncentracij v plazmi in s tem njihove toksičnosti.
English: Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
Slovenian: Prevladuje mnenje, da je njegov endoperoksidni most bistven za njegovo antimalarično aktivnost, ker s prostimi radikali poškoduje membranski sistem parazita, vključno s/z:
English: However, the apparent clearance was faster (1.30 versus 1.14 l/h/kg) and the apparent total volume of distribution was lower in the paediatric population (623 versus 730 l/kg).
Slovenian: Vendar pa je bil navidezni očistek hitrejši (1,30 v primerjavi z 1,14 l/h/kg) in navidezni skupni volumen porazdelitve nižji v pediatrični populaciji (623 v primerjavi s 730 l/kg).