FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Eurartesim se ne smije primjenjivati za liječenje teške malarije uzrokovane Plasmodium falciparum (vidjeti dio 4.3) te se, zbog nedostatnih podataka, ne smije primjenjivati za liječenje malarije uzrokovane Plasmodium vivax, Plasmodium malariae ili Plasmodium ovale.
English: If the second dose is vomited, alternative antimalarial therapy should be instituted.
Croatian: Ako i druga doza bude povraćena, potrebno je uvesti terapiju drugim antimalarikom.
English: Analysis of cardiac adverse events in clinical trials showed that these were reported more frequently in Eurartesim treated patients than in those treated with comparator antimalarial (see section 4.8).
Croatian: Analiza srčanih nuspojava u kliničkim ispitivanjima pokazala je da su češće bile zabilježene kod bolesnika liječenih Eurartesimom nego u onih koji su primali usporedni antimalarik (vidjeti dio 4.8).
English: Chloroquine binds to toxic haeme (derived from the patient's haemoglobin) within the malaria parasite, preventing its detoxification via a polymerisation step.
Croatian: Klorokin se veže za toksični hem (koji potječe iz hemoglobina bolesnika) unutar parazita malarije, sprječavajući njegovu detoksifikaciju putem polimerizacije.
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3 tablets.
Croatian: Eurartesim tablete su pakirane u PVC/PVDC/aluminij blisterima koji sadrže 3 tablete.
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.
Croatian: To može biti odraz oštećenja funkcije jetre povezanog s malarijom, koje uzrokuje povećanu bioraspoloživost artenimola (smanjenje učinka prvog prolaska kroz jetru) bez utjecaja na njegov prividni poluvijek eliminacije, koji je ograničen brzinom apsorpcije.
English: Animal data suggest excretion of piperaquine into breast milk but no data are available in humans.
Croatian: Podaci u životinja pokazuju da se piperakin izlučuje u mlijeko, ali nema dostupnih podataka za ljude.
English: Via Pontina Km 30.400 IT-00071 Pomezia (RM) Italy
Croatian: Via Pontina Km 30.400 IT-00071 Pomezia (RM)
English: In a second randomised trial, 1,038 children, aged between 6 months and 5 years, were exposed to Eurartesim and 71% were judged to have experienced an ADR.
Croatian: U drugom randomiziranom kliničkom ispitivanju, 1038 djece u dobi između 6 mjeseci i 5 godina primalo je Eurartesim i procijenjeno je da je 71% imalo neku nuspojavu.
English: If you notice anything different about your or your child's heart rhythm or have symptoms (such as palpitations or irregular heart beat) you should contact your doctor as soon as possible and before the next dose is due.
Croatian: Ako kod sebe ili svog djeteta primijetite bilo kakve promjene u srčanom ritmu ili imate simptome (kao što su osjećaj lupanja srca ili nepravilan rad srca), čim prije se obratite liječniku i prije nego što je vrijeme za sljedeću dozu.
English: Piperaquine, a highly lipophilic compound, is slowly absorbed.
Croatian: Piperakin, koji je izrazito lipofilni spoj, sporo se apsorbira.
English: Piperaquine has the potential to increase the rate of metabolism for CYP2E1 substrates resulting in a decrease in the plasma concentrations of substrates such as paracetamol or theophylline, and the anaesthetic gases enflurane, halothane and isoflurane.
Croatian: Piperakin može povećati brzinu metabolizma supstrata CYP2E1, što dovodi do smanjenja koncentracije u plazmi tih supstrata, kao što su paracetamol ili teofilin i anestetički plinovi enfluran, halotan i izofluran.
English: Do not give this medicine to infants under 6 months or below 5 kg in weight.
Croatian: Djeca Nemojte davati ovaj lijek dojenčadi mlađoj od 6 mjeseci ili tjelesne težine manje od 5 kg.
English: The bulky bisquinolone structure may be important for activity against chloroquine- resistant strains, and may act through the following mechanisms:
Croatian: Pozamašna struktura biskinolona može biti važna za djelovanje protiv sojeva rezistentnih na klorokin, a može djelovati putem sljedećih mehanizama:
English: In healthy volunteers, piperaquine exposure is increased approximately 3-fold when administered with a high fat/high calorie meal.
Croatian: U zdravih dobrovoljaca, izloženost piperakinu povećana je približno trostruko kad se primjenjuje uz visokomasni/visokokalorični obrok.
English: There was no evidence of artenimol-induced lesions in the specific nuclei in rats or dogs, even at lethal dose.
Croatian: Nije bilo dokaza da artenimol izaziva lezije u određenim nukleusima u štakora ili pasa, čak niti u letalnoj dozi.
English: 36 to <75
Croatian: 36 do <75
English: In healthy volunteers, artenimol exposure was increased by 43% when administered with a high fat/high calorie meal.
Croatian: U zdravih je dobrovoljaca izloženost artenimolu bila povećana za 43% kad se primjenjivao uz visokomasni/visokokalorični obrok.
English: Moreover, data obtained in animal studies show that fertility is unaffected by artenimol in both females and males.
Croatian: Nadalje, podaci dobiveni ispitivanjima na životinjama pokazuju da artenimol ne utječe na plodnost niti ženki niti mužjaka.
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.
Croatian: Eurartesim je indiciran za liječenje nekomplicirane malarije uzrokovane Plasmodium falciparum u odraslih, adolescenata, djece i dojenčadi u dobi od 6 ili više mjeseci i tjelesne težine 5 ili više kilograma.
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.
Croatian: Apsorpcija piperakina povećana je u prisutnosti masnih kiselina (vidjeti dijelove 4.4 i 5.2), što može pojačati njegov učinak na QTc interval.
English: Caution is therefore, advised when Eurartesim is administered concomitantly with medicinal products metabolised by this enzyme that have a narrow therapeutic index, such as theophylline.
Croatian: Stoga se savjetuje oprez kad se Eurartesim primjenjuje istovremeno s lijekovima koje taj enzim metabolizira, a koji imaju uzak terapijski indeks, kao što je teofilin.
English: Artenimol is very rapidly absorbed, Tmax being approximately 1-2 hrs after single and multiple dosing.
Croatian: Artenimol se vrlo brzo apsorbira, a Tmax postiže približno 1-2 sata nakon jednokratnog i višekratnog doziranja.
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).
Croatian: Međutim, prividni klirens bio je brži (1,30 naspram 1,14 l/h/kg) i prividni ukupni volumen distribucije bio je niži u pedijatrijske populacije (623 naspram 730 l/kg).
English: Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake ‘Rok valjanosti'.
English: The primary end-point was the PCR-corrected cure rate at Day 63.
Croatian: Primarni ishod bila je PCR-korigirana stopa izlječenja 63. dana.
English: Reactions such as cough, pyrexia, headache, P. falciparum infection, anaemia, asthenia, anorexia and the observed changes in blood cell parameters are consistent with those expected in patients with acute malaria.
Croatian: Reakcije kao što su kašalj, pireksija, glavobolja, infekcija P. falciparum, anemija, astenija, anoreksija i opažene promjene parametara krvnih stanica sukladne su onima koje se očekuju u bolesnika s akutnom malarijom.
English: • has a malaria infection caused by a parasite other than Plasmodium falciparum;
Croatian: • imate malariju uzrokovanu drugim parazitom a ne Plasmodium falciparum;
English: Eurartesim treatment was compared with Artesunate + Mefloquine (AS + MQ).
Croatian: Liječenje Eurartesimom bilo je uspoređeno s artesunatom + meflokin (AS + MQ).
English: You or your child should take each dose no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose of Eurartesim.
Croatian: Vi ili Vaše dijete svaku dozu trebate uzeti najmanje 3 sata nakon zadnjeg uzimanja hrane, a 3 sata nakon svake doze Eurartesima ne smijete uzimati nikakvu hranu.
English: Due to its long elimination half-life, piperaquine accumulates after multiple dosing.
Croatian: Zbog svog dugog poluvijeka eliminacije, piperakin se nakuplja nakon višekratnog doziranja.
English: • has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease;
Croatian: • imate srčani poremećaj, kao što su promjene ritma ili brzine rada srca, ili bolest srca;
English: How to take Eurartesim
Croatian: Kako uzimati Eurartesim
English: Side effects in adults
Croatian: Nuspojave u odraslih
English: • If you or your child gets another attack of malaria, you may take a second course of Eurartesim within one year if your doctor thinks this is a suitable treatment.
Croatian: • Ako Vi ili Vaše dijete dobijete drugi napad malarije, možete uzeti drugu kuru Eurartesima unutar godinu dana ako liječnik smatra da je to pogodno liječenje.
English: You or your child should not take a second course of Eurartesim within 2 months of the first course.
Croatian: Vi ili Vaše dijete ne smijete uzeti drugu kuru Eurartesima unutar 2 mjeseca od prve kure.
English: - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
Croatian: - Simptomatske srčane aritmije u anamnezi ili s klinički značajnom bradikardijom.
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Eurartesim, and in particular, those associated with a QT prolongation.
Croatian: • Da se bolesnicima treba savjetovati da se obrate liječniku u slučaju nuspojava i da liječnici/ljekarnici trebaju prijaviti sumnje na nuspojave Eurartesima, posebno one povezane s produljenjem QT intervala.
English: The age-specific PCR-corrected cure rates in the m-ITT populations are tabulated below for the Asian and African studies, respectively:
Croatian: Dobno specifične PCR-korigirane stope izlječenja u modificiranim populacijama s namjerom liječenja (m-ITT) u azijskom i afričkom ispitivanju prikazane su u sljedećim tablicama:
English: artenimol systemic exposure on the last day of treatment was higher in females than in males, the difference being within 30%.
Croatian: Sistemska izloženost artenimolu zadnjeg dana liječenja bila je viša u žena nego u muškaraca, uz razliku unutar 30%.
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.
Croatian: Vama ili Vašem djetetu liječnik može napraviti električni zapis rada srca (elektrokardiogram [EKG]) dok se liječite i nakon što uzmete zadnju dozu.
English: • Inhibition of the transporters that efflux chloroquine from the parasite food vacuole
Croatian: • inhibicija prijenosnika koji izbacuju klorokin iz prehrambene vakuole parazita
English: Central nervous system (CNS) toxicity
Croatian: Toksičnost za središnji živčani sustav (SŽS)
English: Data regarding artenimol excretion in humans are scarce.
Croatian: Podaci koji se odnose na izlučivanje artenimola u ljudi su šturi.
English: Compared to placebo, the maximum mean increases in QTcF on Day 3 of dosing with Eurartesim were 45.2, 35.5 and 21.0 msec under respective dosing conditions.
Croatian: U usporedbi s placebom, najveće prosječno povećanje QTcF 3. dana doziranja Eurartesima iznosilo je 45,2, 35,5 odnosno 21,0 ms u navedenim uvjetima doziranja.
English: No subject had a QTcF value greater than 500 msec in any of the dosing conditions.
Croatian: Niti jedan ispitanik nije imao vrijednost QTcF veću od 500 ms niti kod jednog načina doziranja.
English: The association of artenimol and piperaquine does not produce hERG inhibition greater than that of the single compounds.
Croatian: Povezanost artenimola i piperakina ne dovodi do inhibicije hERG koja je veća od one koju izaziva svaki spoj posebno.
English: This increase in exposure to the antimalarial combination may result in an exacerbation of the effect on QTc (see section 4.4).
Croatian: To povećanje izloženosti kombinaciji koja djeluje protiv malarije može rezultirati pogoršanim učinkom na QTc (vidjeti dio 4.4).
English: Delayed haemolytic anaemia has been observed up to one month following use of IV artesunate and oral artemisinin-based combination treatment (ACT) including reports involving Eurartesim.
Croatian: Odgođena hemolitička anemija opažena je do mjesec dana nakon i.v. primjene artesunata i peroralne primjene kombinirane terapije na bazi artemizinina, uključujući prijave koje su se odnosile na Eurartesim.
English: The number of subjects with QTcF greater than 480 msec after dosing with low fat meals was 3/64, while 10/64 had QTcF values over this threshold after dosing with high fat meals.
Croatian: Tri od 64 ispitanika imalo je QTcF dulji od 480 ms nakon uzimanja doze s niskomasnim obrocima, dok je 10 od 64 imalo vrijednosti QTcF veće od ovog praga nakon uzimanja doze s visokomasnim obrocima.
English: If you or your child forgets to take the second dose of Eurartesim at the right time, take it as soon as you remember.
Croatian: Ako ste Vi ili Vaše dijete zaboravili uzeti Eurartesim Ako Vi ili Vaše dijete zaboravite uzeti drugu dozu Eurartesima u pravo vrijeme, uzmite je čim se sjetite.
English: Artenimol was observed to have a small volume of distribution in humans (0.8 l/kg; CV 35.5%).
Croatian: Opaženo je da artenimol ima mali volumen distribucije u ljudi (0,8 l/kg; CV 35,5%).
English: Caution is recommended when co-administering Eurartesim with medicinal products exhibiting variable patterns of inhibition, induction or competition for CYP3A4 as the therapeutic and/or toxic effects of some co-administered medicinal products could be altered.
Croatian: Preporučuje se oprez kad se Eurartesim primjenjuje istovremeno s lijekovima koji pokazuju različite obrasce inhibicije, indukcije ili kompeticije za CYP3A4, jer terapijski i/ili toksični učinci nekih istovremeno primijenjenih lijekova mogu biti promijenjeni.
English: Eurartesim treatment was compared with Artemether + Lumefantrine (A + L).
Croatian: Liječenje Eurartesimom bilo je uspoređeno s artemeterom + lumefantrin (A + L).
English: A second course of Eurartesim should not be given within 2 months after the first course due to the long elimination half-life of piperaquine (see sections 4.4 and 5.2).
Croatian: Druga kura Eurartesima ne smije se dati unutar 2 mjeseca nakon prve kure zbog dugog poluvijeka eliminacije piperakina (vidjeti dijelove 4.4 i 5.2).
English: The mean oral clearance for adult patients with malaria was 1.34 l/h/kg.
Croatian: Prosječni oralni klirens za odrasle bolesnike s malarijom bio je 1,34 l/h/kg.
English: A large amount of data (more than 3000 exposed outcomes) from the use of artenimol/piperaquine during the 2nd and 3rd trimester indicate no fetotoxicity.
Croatian: Opsežni podaci (više od 3000 izloženih trudnoća) o primjeni artenimola/piperakina tijekom drugog i trećeg tromjesečja trudnoće ne ukazuju na fetotoksičnost.
English: These patients should not receive another dose of Eurartesim and alternative antimalarial therapy should be instituted.
Croatian: Ovi bolesnici ne smiju primiti drugu dozu Eurartesima i potrebno je uvesti terapiju drugim antimalarikom.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness, using the following convention: Very common (≥1/10), 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), not known
Croatian: Unutar svake skupine po učestalosti nuspojave su navedene slijedom prema sve manjoj ozbiljnosti, prema sljedećem dogovoru: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Due to the potential for higher plasma concentrations of piperaquine to occur, caution is advised if Eurartesim is administered to patients with jaundice and/or with moderate or severe renal or hepatic insufficiency, and ECG and blood potassium monitoring are advised.
Croatian: Zbog mogućnosti povišenja koncentracija piperakina u plazmi, savjetuje se oprez ako se Eurartesim primjenjuje bolesnicima sa žuticom i/ili umjerenom ili teškom insuficijencijom bubrega ili jetre te se savjetuje EKG nadzor i praćenje kalija u krvi.
English: The mean clearance (1.45 l/h/kg) was slightly faster in the paediatric patients than in the adult patients (1.34 l/h/kg), while the mean volume of distribution in the paediatric patients (0.705 l/kg) was lower than in the adults (0.801 l/kg).
Croatian: Prosječni klirens (1,45 l/h/kg) bio je nešto brži u pedijatrijskih bolesnika nego u odraslih bolesnika (1,34 l/h/kg), dok je prosječni volumen distribucije u pedijatrijskih bolesnika (0,705 l/kg) bio niži nego u odraslih (0,801 l/kg).
English: No food should be taken within 3 hours after each dose.
Croatian: Hrana se ne smije uzimati 3 sata nakon svake doze.
English: A total of 6 (0.8%) subjects had serious ADRs in the study.
Croatian: Ukupno je 6 (0,8%) ispitanika u ovom ispitivanju imalo ozbiljne nuspojave.
English: The QTcF prolongation observed under fasting conditions lasted between 4 and 11 hours after the last dose was administered on Day 3.
Croatian: Produljenje QTcF intervala opaženo natašte trajalo je između 4 i 11 sati nakon primjene zadnje doze 3. dana.
English: Delayed Haemolytic Anaemia
Croatian: Odgođena hemolitička anemija
English: - Family history of sudden death or of congenital prolongation of the QTc interval.
Croatian: - Iznenadna smrt u obiteljskoj anamnezi ili urođeno produljenje QTc intervala.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s ažuriranjem RMP-a, dokumenti mogu biti podneseni istodobno.
English: - Taking medicinal products that are known to prolong the QTc interval.
Croatian: - Uzimanje lijekova za koje se zna da produljuju QTc interval.
English: Artenimol is principally converted to α-artenimol-β-glucuronide (α-artenimol-G).
Croatian: Artenimol se prvenstveno konvertira u α-artenimol-β-glukuronid (α-artenimol-G).
English: Piperaquine was mainly metabolised by CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19.
Croatian: Piperakin je uglavnom metabolizirao CYP3A4 i u manjem opsegu CYP2C9 i CYP2C19.
English: Piperaquine did not induce malformation in rats and rabbits.
Croatian: Piperakin nije izazvao malformacije u štakora i kunića.
English: - Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval.
Croatian: - Poznato urođeno produljenje QTc intervala ili bilo koje kliničko stanje za koje se zna da produljuje QTc interval.
English: These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine
Croatian: Ti lijekovi uključuju meflokin, halofantrin, lumefantrin, klorokin ili kinin.
English: In the European Safety Registry 25 patients weighing ≥ 100 kg (range 100 -121 kg) were treated with 4 tablets 320/40 mg PQP/artenimol for 3 days.
Croatian: Prema Europskom registru podataka o sigurnosti primjene 25 bolesnika tjelesne težine ≥100 kg (raspon 100-121 kg) primalo je 4 tablete od 320/40 mg piperakina/artenimola tijekom 3 dana.
English: Enzyme inducing medicinal products such as rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort (Hypericum perforatum) are likely to lead to reduced piperaquine plasma concentrations.
Croatian: Lijekovi koji induciraju enzime, kao što su rifampicin, karbamazepin, fenitoin, fenobarbital, gospina trava (Hypericum perforatum), vjerojatno će dovesti do sniženja koncentracije piperakina u plazmi.
English: Artenimol administration may result in a slight decrease in CYP1A2 activity.
Croatian: Primjena artenimola može dovesti do blagog smanjenja aktivnosti CYP1A2.
English: Reproductive studies with artemisinin derivatives have demonstrated teratogenic potential with an increased risk during early gestation (see section 5.3).
Croatian: Ispitivanja učinka derivata artemizinina na reprodukciju pokazala su teratogeni potencijal, uz povećani rizik tijekom rane gestacije (vidjeti dio 5.3).
English: artenimol is eliminated by metabolism (mainly glucuroconjugation).
Croatian: Artenimol se eliminira metabolizmom (uglavnom glukurokonjugacijom).
English: General toxicity
Croatian: Opća toksičnost
English: The following ADRs were observed at an incidence of ≥5.0%: Cough (32%), Pyrexia (22.4%), Influenza (16.0%), P. falciparum infection (14.1%), Diarrhoea (9.4%), Vomiting (5.5%) and Anorexia (5.2%).
Croatian: Sljedeće opažene nuspojave imale su incidenciju od ≥5,0%: kašalj (32%), pireksija (22,4%), influenca (16,0%), infekcija P. falciparum (14,1%), proljev (9,4%), povraćanje (5,5%) i anoreksija (5,2%).
English: 5 to <7
Croatian: 5 do <7
English: Therefore, particular caution is required if Eurartesim is administered to patients taking potent CYP3A4 inhibitors (e.g. some protease inhibitors [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodone or verapamil), and ECG monitoring should be considered due to the risk of higher plasma concentrations of piperaquine (see section 4.4).
Croatian: Stoga je potreban poseban oprez ako se Eurartesim primjenjuje bolesnicima koji uzimaju jake inhibitore CYP3A4 (npr. neki inhibitori proteaze [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodon ili verapamil) i potrebno je razmotriti EKG nadzor zbog rizika od povišenih koncentracija piperakina u plazmi (vidjeti dio 4.4).
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C.
English: - Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Croatian: - Sklonost aritmiji zbog bilo kojeg srčanog stanja, kao što su teška hipertenzija, hipertrofija lijeve srčane klijetke (uključujući hipertrofičnu kardiomiopatiju) ili kongestivno zatajenje srca praćeno smanjenom ejekcijskom frakcijom lijeve srčane klijetke.
English: Study DM040011 was conducted in African paediatric patients with uncomplicated P. falciparum malaria.
Croatian: Ispitivanje DM040011 bilo je provedeno u afričkih pedijatrijskih bolesnika s nekompliciranom malarijom uzrokovanom P. falciparum.
English: The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.
Croatian: Ovaj lijek mogu uzimati odrasli, adolescenti, djeca i dojenčad starija od 6 mjeseci tjelesne težine 5 ili više kilograma.
English: Exposure to piperaquine may also be increased when co-administered with mild or moderate CYP3A4-inhibitors (e.g. oral contraceptives).
Croatian: Izloženost piperakinu može se također povećati kada se primjenjuje istovremeno s blagim ili umjerenim inhibitorima CYP3A4 (npr. oralnim kontraceptivima).
English: Study DM040010 was conducted in Asian adult and paediatric patients with uncomplicated P. falciparum malaria.
Croatian: Ispitivanje DM040010 bilo je provedeno u azijskih odraslih i pedijatrijskih bolesnika s nekompliciranom malarijom uzrokovanom P. falciparum.
English: In healthy male volunteers under fasting conditions, mean Cmax and AUCINF of artenimol ranged between 180-252 ng/ml and 516-684 ng/ml*h, respectively.
Croatian: U zdravih muških dobrovoljaca koji su bili natašte, raspon prosječnog Cmax artenimola iznosio je 180-252 ng/ml, a AUCINF 516-684 ng/ml*h.