FrancophonIA/ELRC3.0 huggingface dataset:
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Croatian: - Poremećaj elektrolita, osobito hipokalijemija, hipokalcijemija ili hipomagnezijemija.
English: Talk to your doctor or pharmacist before taking this medicine if you or your child:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek ako Vi ili Vaše dijete:
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.
Croatian: Obratite se svom liječniku ako ste u prvom tromjesečju trudnoće, mislite da biste mogli biti trudni ili zatrudnjeti, ili ako dojite.
English: The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue.
Croatian: Točan mehanizam djelovanja piperakina nije poznat, ali vjerojatno je sličan mehanizmu djelovanja klorokina, bliskom strukturnom analogu.
English: Artenimol is able to reach high concentrations within the parasitized erythrocytes.
Croatian: Artenimol može postići visoke koncentracije unutar eritrocita u kojima se nalaze paraziti.
English: It is used to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.
Croatian: Primjenjuje se za liječenje nekomplicirane malarije kad je primjereno primijeniti lijek koji se daje na usta.
English: Tablet strength and number of tablets per dose
Croatian: Jačina tablete i broj tableta po dozi
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.
Croatian: Ako Vi ili Vaše dijete dobijete osip, otečenost lica, usana, jezika ili grla s otežanim gutanjem ili disanjem, to mogu biti znakovi alergijske reakcije.
English: Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products.
Croatian: Potrebno je uzeti u obzir službene smjernice za odgovarajuću primjenu antimalarika.
English: This can cause a life-threatening abnormality of the heart rhythm.
Croatian: To može uzrokovati životno opasni poremećaj srčanog ritma.
English: The concentration of artenimol may also be reduced.
Croatian: Koncentracija artenimola također može biti snižena.
English: In clinical trials, nine patients received double the cumulative intended dose of Eurartesim.
Croatian: U kliničkim ispitivanjima, 9 je bolesnika primilo dvostruko veću dozu od kumulativne planirane doze Eurartesima.
English: The systemic exposure to artenimol was slightly lower following the last dose of Eurartesim (lower than after the first dose by up to 15%).
Croatian: Sistemska izloženost artenimolu bila je nešto niža nakon zadnje doze Eurartesima (niža do 15% nego nakon prve doze).
English: Twenty-two of these patients were shown to be parasitic free at the last microscopic analysis of the blood sample; three patients did not complete parasitological blood analysis.
Croatian: 22 od tih bolesnika pokazalo se da nemaju parazite na posljednjoj mikroskopskoj analizi krvnog uzorka, a 3 bolesnika nisu dovršila analizu krvi na parazite.
English: Examples are listed below (but there are several others): - some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,
Croatian: Primjeri su navedeni u nastavku (ali postoji još nekoliko drugih): - neki lijekovi za liječenje visokog kolesterola u krvi (kao što su atorvastatin, lovastatin,
English: Therefore, they may be more sensitive to the effects of QTc-prolonging medications such as Eurartesim so that special caution is required.
Croatian: Stoga mogu biti osjetljiviji na učinke lijekova koji produljuju QTc, kao što je Eurartesim, pa je potreban poseban oprez.
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.
Croatian: Sigurnost primjene Eurartesima procijenjena je u dva otvorena ispitivanja faze III koja su uključila 1239 pedijatrijskih bolesnika u dobi do 18 godina i 566 odraslih bolesnika u dobi od >18 godina liječenih Eurartesimom.
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).
Croatian: Farmakokinetički profili artenimola i piperakina ispitani su na životinjskim modelima i u različitim populacijama ljudi (zdravi dobrovoljci, odrasli bolesnici i pedijatrijski bolesnici).
English: Therefore Eurartesim must not be used in the 1st trimester of pregnancy if your doctor can give you an alternative medicine.
Croatian: Stoga se Eurartesim ne smije uzimati u prvom tromjesečju trudnoće ako Vam liječnik može dati neki drugi lijek.
English: Both piperaquine and artenimol are highly bound to human plasma proteins: the protein binding observed in in vitro studies was 44-93% for artenimol and >99% for piperaquine.
Croatian: I piperakin i artenimol u visokom su postotku vezani za proteine ljudske plazme: vezanje za proteine opaženo u ispitivanjima in vitro iznosilo je 44-93% za artenimol i >99% za piperakin.
English: A course of Eurartesim lasts 3 consecutive days.
Croatian: Liječenje Eurartesimom traje 3 uzastopna dana.
English: However, there was no delay in neonatal development following exposure in utero or via milk (see section 5.3).
Croatian: Međutim, nije bilo zaostajanja u neonatalnom razvoju nakon izloženosti in utero ili putem mlijeka (vidjeti dio 5.3).
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.
Croatian: U ispitivanju perinatalnog i postnatalnog razvoja (segment III) u ženki štakora liječenih s 80 mg/kg, neke su se životinje kasnije okotile što je izazvalo mortalitet novorođenog potomstva.
English: If you or your child vomit also the second dose, do not take or give your child another dose.
Croatian: Ako Vi ili Vaše dijete povratite i drugu dozu, nemojte uzeti ili djetetu dati drugu dozu.
English: Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek tijekom trudnoće ili dojenja.
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.
Croatian: Podaci o štetnim događajima prikupljeni u kliničkim ispitivanjima pokazuju da Eurartesim ne utječe na sposobnost upravljanja vozilima i rada sa strojevima nakon što se bolesnik oporavi od akutne infekcije.
English: Drug-drug interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija lijekova provedena su samo u odraslih.
English: • If you or your child is infected more than twice in a year, your doctor will prescribe an alternative treatment.
Croatian: • Ako Vi ili Vaše dijete budete zaraženi više od dvaput u godinu dana, liječnik će propisati drugo liječenje.
English: Therefore, caution is advised when administering Eurartesim to these patients (see section 4.4).
Croatian: Stoga se savjetuje oprez kad se Eurartesim primjenjuje u ovih bolesnika (vidjeti dio 4.4).
English: The mean oral clearance was slightly higher for paediatric patients, however the differences were minor in magnitude (<20%).
Croatian: Prosječni oralni klirens bio je nešto viši za pedijatrijske bolesnike, međutim, razlike su bile manjeg reda veličine (<20%).
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.
Croatian: Bioraspoloživost artenimola čini se viša u bolesnika s malarijom nego u zdravih dobrovoljaca, možda zato što malarija sama po sebi utječe na raspoloživost artenimola.
English: QTc intervals of more than 500 ms are associated with a pronounced risk for potentially life-threatening ventricular tachyarrhythmias.
Croatian: QTc intervali dulji od 500 ms povezani su s izrazitim rizikom od mogućih životno opasnih ventrikularnih tahiaritmija.
English: If you or your child is not able to do this, talk to your doctor or pharmacist.
Croatian: Ako Vi ili Vaše dijete ne možete to učiniti, obratite se svom liječniku ili ljekarniku.
English: • The need to counsel patients on important risks associated with Eurartesim therapy and appropriate precautions when using the medicine.
Croatian: • Potreba da se bolesnike obavijesti o važnim rizicima povezanima s terapijom Eurartesimom i odgovarajućim mjerama opreza kad uzimaju lijek.
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.
Croatian: Sigurnost i djelotvornost Eurartesima u dojenčadi u dobi manjoj od 6 mjeseci i djece tjelesne težine manje od 5 kg nisu ustanovljene.
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.
Croatian: Mogućnost da Eurartesim produlji QTc interval bila je ispitana na usporednim skupinama zdravih dobrovoljaca koji su svaku dozu uzimali s visokomasnim visokokaloričnim (~1000 Kcal) ili niskomasnim niskokaloričnim (~400 Kcal) obrocima ili natašte.
English: There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1st trimester of pregnancy.
Croatian: Postoje samo ograničeni podaci (n=3) o primjeni artenimola/piperakina u prvom tromjesečju trudnoće.
English: Eurartesim are white film-coated tablets, embossed and with a break line along the middle.
Croatian: Eurartesim su bijele filmom obložene tablete, označene i s razdjelnom crtom po sredini.
English: A limited number of drug-drug pharmacokinetic interaction studies with Eurartesim have been performed in healthy adult subjects.
Croatian: Proveden je ograničeni broj ispitivanja farmakokinetičkih interakcija lijekova s Eurartesimom u zdravih odraslih ispitanika.
English: If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered.
Croatian: Ako bolesnik povrati unutar 30 minuta nakon uzimanja Eurartesima, potrebno je ponovno primijeniti cijelu dozu; ako bolesnik povrati unutar 30-60 minuta, potrebno je ponovno primijeniti polovicu doze.
English: Women taking Eurartesim should not breast-feed during their treatment.
Croatian: Žene koje uzimaju Eurartesim ne smiju dojiti za vrijeme liječenja.
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.
Croatian: Ako se nešto od gore navedenog odnosi na Vas ili Vaše dijete ili niste sigurni, obavijestite svog liječnika ili ljekarnika prije uzimanja ili davanja Eurartesima.
English: If you find out that you are pregnant within one month from taking Eurartesim, please inform your doctor.
Croatian: Ako ustanovite da ste trudni kada od uzimanja Eurartesima još nije prošlo mjesec dana, obavijestite o tome svoga liječnika.
English: Therefore, ECG monitoring during the following 24-48 hours should be applied for patients found to have a prolongation to this extent.
Croatian: Stoga je potreban EKG nadzor tijekom sljedećih 24-48 sati kod svih bolesnika u kojih se pronađe ovako veliko produljenje.
English: Effects on cardiac repolarization
Croatian: Učinci na repolarizaciju srca
English: No single type of ADR occurred at an incidence of ≥5%.
Croatian: Ni za jedan tip nuspojava incidencija nije bila ≥5%.
English: In humans, piperaquine has a Tmax of approximately 5 hours following a single and repeated dose.
Croatian: Piperakin u ljudi ima Tmax od približno 5 sati nakon jednokratne i ponovljenih doza.
English: These adverse reactions were seen in animals at exposure levels similar to clinical exposure levels, and with possible relevance to clinical use.
Croatian: Ove nuspojave bile su zapažene u životinja pri razinama izloženosti sličnima razinama izloženosti u ljudi i s mogućom važnošću za kliničku primjenu.
English: 30.400 00071 Pomezia (Rome) Italy
Croatian: 30,400 00071 Pomezia (Rome)
English: Total number of tablets for treatment
Croatian: Ukupni broj tableta za liječenje
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.
Croatian: Budući da je piperakin prisutan u koži (oko 9% u nepigmentiranog štakora i samo 3% u pigmentiranog štakora), u miševa izloženih UV zračenju bile su opažene blage fototoksične reakcije (oticanje i eritem) 24 sata nakon peroralnog liječenja.
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%).
Croatian: Farmakokinetički parametri opaženi za piperakin u ljudi pokazuju da ova djelatna tvar ima veliki volumen distribucije (730 l/kg; CV 37,5%).
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.
Croatian: U pedijatrijskom farmakokinetičkom ispitivanju, a na temelju vrlo malog uzorka, opažene su manje razlike u farmakokinetici artenimola između pedijatrijske i odrasle populacije.
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).
Croatian: Ispitivanja metabolizma in vitro pokazala su da piperakin metaboliziraju ljudski hepatociti (približno 85% piperakina ostalo je nakon 2 sata inkubacije na 37°C).
English: The piperaquine major metabolites were a carboxyl acid cleavage product, and a mono-N-oxidated product.
Croatian: Glavni metaboliti piperakina bili su produkt cijepanja karboksilatne kiseline i mono-N-oksidirani produkt.
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).
Croatian: U ljudi se moguća neurotoksičnost peroralno primijenjenog artenimola može smatrati krajnje nevjerojatnom s obzirom na brzi klirens artenimola i kratkotrajnu izloženost (3 dana liječenja za bolesnike s malarijom).
English: A total of 15 (1.5%) subjects had serious ADRs in the study.
Croatian: Ukupno je 15 (1,5%) ispitanika u ovom ispitivanju imalo ozbiljne nuspojave.
English: • is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the other ingredients of this medicine (listed in section 6);
Croatian: • ako ste alergični na djelatne tvari, piperakintetrafosfat ili artenimol, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: Artenimol and piperaquine were not genotoxic/clastogenic based on in vitro and in vivo testing.
Croatian: Artenimol i piperakin nisu bili genotoksični/klastogeni na temelju in vitro i in vivo ispitivanja.
English: In the absence of carcinogenicity study data, and due to lack of clinical experience with repeated courses of treatment in humans, no more than two courses of Eurartesim should be given in a 12-month period (see sections 4.2 and 5.3).
Croatian: U odsutnosti podataka ispitivanja kancerogenosti, a zbog nedostatka kliničkog iskustva s ponavljanjem kura liječenja u ljudi, ne smije se dati više od dvije kure Eurartesima u razdoblju od 12 mjeseci (vidjeti dijelove 4.2 i 5.3).
English: The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Croatian: Sigurnosni profil ovih bolesnika nije se razlikovao od profila bolesnika koji su primili preporučenu dozu, s time da nijedan bolesnik nije prijavio ozbiljnu nuspojavu.
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).
Croatian: Učinak na produljenje QTc intervala bio je opažen 2. dana i povukao se 7. dana (sljedeća vremenska točka u kojoj je učinjen EKG).
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.
Croatian: Eurartesim tablete su pakirane u PVC/PVDC/aluminij blisterima koji sadrže 3, 6, 9 ili 12 tableta.
English: On the other hand, on the last day of Eurtartesim treatment, the piperaquine maximum plasma concentration was higher in female than in male healthy volunteers, the difference being in the order of 30 to 50%.
Croatian: S druge strane, zadnjeg dana liječenja Eurtartesimom, najviša koncentracija piperakina u plazmi bila je viša u ženskih nego u muških zdravih dobrovoljaca, uz razliku reda veličine od 30 do 50%.
English: • has a severe type of malaria infection which has affected parts of the body such as the brain, lungs or kidneys;
Croatian: • imate teški oblik malarije koja je zahvatila dijelove tijela poput mozga, pluća ili bubrega;
English: Resistance to piperaquine (when used as monotherapy) has been reported.
Croatian: Zabilježena je rezistencija na piperakin (kad se primjenjuje kao monoterapija).
English: The primary end-point was PCR-corrected cure rate at Day 28.
Croatian: Primarni ishod bila je PCR-korigirana stopa izlječenja 28. dana.
English: Therefore the assessment of the potential for drug-drug interactions to occur is based on either in vivo or in vitro studies.
Croatian: Stoga se procjena mogućnosti pojave interakcija lijekova temelji na ili in vivo ili in vitro ispitivanjima.
English: In perinatal and postnatal studies in rats, piperaquine was associated with delivery complications.
Croatian: U perinatalnim i postnatalnim ispitivanjima u štakora, piperakin je bio povezan s komplikacijama pri okotu.
English: • That there is a potential risk of teratogenicity and so Eurartesim should not be used in the 1st trimester of pregnancy in situations where other suitable and effective anti-malarials are available.
Croatian: • Da postoji mogući rizik od teratogenosti pa se Eurartesim ne smije primjenjivati tijekom prvog tromjesečja trudnoće u situacijama kad su dostupni drugi pogodni i učinkoviti antimalarici.
English: This pharmacokinetic effect is accompanied by an increased effect on prolongation of the QT interval.
Croatian: Ovaj farmakokinetički učinak popraćen je pojačanim učinkom na produljenje QT intervala.
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.
Croatian: Najvažniji neklinički nalazi o sigurnosti primjene ponovljenih doza bili su infiltracija makrofaga intracitoplazmatskim bazofilnim granularnim materijalom sukladno fosfolipidozi i degenerativne lezije u brojnim organima i tkivima.
English: This leaflet was last revised in month YYYY
Croatian: Ova uputa je zadnji puta revidirana u mjesec GGGG.
English: Based on animal data, Eurartesim is suspected to cause serious birth defects when administered during the first trimester of pregnancy (see sections 4.4 and 5.3).
Croatian: Na temelju podataka prikupljenih na životinjama, sumnja se da Eurartesim uzrokuje ozbiljne urođene mane kad se primjenjuje tijekom prvog tromjesečja trudnoće (vidjeti dijelove 4.4 i 5.3).
English: No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated with artenimol.
Croatian: Nije opažen učinak na profil metabolita piperakina u ljudskim hepatocitima kad se piperakin inkubirao zajedno s artenimolom.
English: Each dose should be taken no less than 3 hours after the last food intake.
Croatian: Svaku dozu treba uzeti najmanje 3 sata nakon zadnjeg uzimanja hrane.
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.
Croatian: Prije treće doze Eurartesima, u jednom od dva ispitivanja faze III, zabilježeno je da je 3/767 bolesnika (0,4%) imalo vrijednost QTcF >500 ms naspram nijednog bolesnika u usporednoj skupini.
English: No reproduction toxicity studies have been performed with the combination of artenimol and piperaquine.
Croatian: Nisu provedena ispitivanja reproduktivne toksičnosti kombinacije artenimola i piperakina.
English: Accordingly, Eurartesim should be administered with water no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose (see section 4.2).
Croatian: Sukladno tome, Eurartesim treba primjenjivati s vodom najmanje 3 sata nakon zadnjeg uzimanja hrane i hrana se ne smije uzimati tijekom 3 sata nakon svake doze (vidjeti dio 4.2).
English: The mean QTcF prolongation compared to placebo decreased to 11.8 msec at 24 hours and to 7.5 msec at 48 hours.
Croatian: Prosječno produljenje QTcF intervala u usporedbi s placebom smanjilo se na 11,8 ms nakon 24 sata i na 7,5 ms nakon 48 sati.
English: Considering the possibility of age-associated decrease in hepatic and renal function, as well as a potential for heart disorders (see sections 4.3 and 4.4), caution should be exercised when administering the product to the elderly.
Croatian: S obzirom na mogućnost smanjene funkcije jetre i bubrega povezane s dobi, kao i na mogućnost srčanih poremećaja (vidjeti dijelove 4.3 i 4.4), potreban je oprez kad se ovaj lijek primjenjuje u starijih bolesnika.
English: 95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
Croatian: 95% dvostrani CI za razliku liječenja (Eurartesim - usporedni lijek); p-vrijednost
English: • Interference with parasite transport proteins
Croatian: • ometanje prijenosnih proteina parazita
English: Due to its slow elimination, piperaquine accumulates in plasma after multiple doses with an accumulation factor of approximately 3.
Croatian: Zbog spore eliminacije, piperakin se nakuplja u plazmi nakon višekratnih doza uz faktor nakupljanja od približno 3.
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).
Croatian: Kad je to klinički primjereno, potrebno je razmotriti pregled EKG-om u svih bolesnika prije uzimanja zadnje od tri dnevne doze i približno 4-6 sati nakon zadnje doze, budući da rizik od produljenja QTc intervala može biti najveći upravo tijekom tog razdoblja (vidjeti dio 5.2).
English: Piperaquine is a bisquinoline, and this class has shown good antimalarial activity against chloroquineresistant Plasmodium strains in vitro.
Croatian: Piperakin je biskinolin, a ta je skupina pokazala dobro antimalarijsko djelovanje protiv sojeva Plasmodium rezistentnih na klorokin in vitro.
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
Croatian: U randomiziranom kliničkom ispitivanju u kojem je 767 odraslih i djece s nekompliciranom malarijom uzrokovanom P. falciparum primalo Eurartesim, procijenjeno je da je 25% ispitanika imalo nuspojavu.
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.
Croatian: Postoji mogućnost smanjenja brzine metabolizma drugih supstrata ovog enzima, kao što je omeprazol, s posljedičnim povećanjem njihovih koncentracija u plazmi, a time i njihove toksičnosti.