natgillin/translations-raw huggingface dataset:
30.400 00071 Pomezia (Rome) Italy
30,400 00071 Pomezia (Rome)
Total number of tablets for treatment
Ukupni broj tableta za liječenje
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.
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.
Pharmacokinetic parameters observed for piperaquine in humans indicate that this active substance has a large volume of distribution (730 l/kg; CV 37.5%).
Farmakokinetički parametri opaženi za piperakin u ljudi pokazuju da ova djelatna tvar ima veliki volumen distribucije (730 l/kg; CV 37,5%).
In a paediatric pharmacokinetic study, and based on very limited sampling, minor differences were observed for artenimol pharmacokinetics between the paediatric and adult populations.
U pedijatrijskom farmakokinetičkom ispitivanju, a na temelju vrlo malog uzorka, opažene su manje razlike u farmakokinetici artenimola između pedijatrijske i odrasle populacije.
In vitro metabolism studies demonstrated that piperaquine is metabolised by human hepatocytes (approximately 85% of piperaquine remained after 2 hours incubation at 37°C).
Ispitivanja metabolizma in vitro pokazala su da piperakin metaboliziraju ljudski hepatociti (približno 85% piperakina ostalo je nakon 2 sata inkubacije na 37°C).
The piperaquine major metabolites were a carboxyl acid cleavage product, and a mono-N-oxidated product.
Glavni metaboliti piperakina bili su produkt cijepanja karboksilatne kiseline i mono-N-oksidirani produkt.
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).
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).
A total of 15 (1.5%) subjects had serious ADRs in the study.
Ukupno je 15 (1,5%) ispitanika u ovom ispitivanju imalo ozbiljne nuspojave.
• is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the other ingredients of this medicine (listed in section 6);
• ako ste alergični na djelatne tvari, piperakintetrafosfat ili artenimol, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
Artenimol and piperaquine were not genotoxic/clastogenic based on in vitro and in vivo testing.
Artenimol i piperakin nisu bili genotoksični/klastogeni na temelju in vitro i in vivo ispitivanja.
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).
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).
The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Sigurnosni profil ovih bolesnika nije se razlikovao od profila bolesnika koji su primili preporučenu dozu, s time da nijedan bolesnik nije prijavio ozbiljnu nuspojavu.
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).
Učinak na produljenje QTc intervala bio je opažen 2. dana i povukao se 7. dana (sljedeća vremenska točka u kojoj je učinjen EKG).
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.
Eurartesim tablete su pakirane u PVC/PVDC/aluminij blisterima koji sadrže 3, 6, 9 ili 12 tableta.
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%.
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%.
• has a severe type of malaria infection which has affected parts of the body such as the brain, lungs or kidneys;
• imate teški oblik malarije koja je zahvatila dijelove tijela poput mozga, pluća ili bubrega;
Resistance to piperaquine (when used as monotherapy) has been reported.
Zabilježena je rezistencija na piperakin (kad se primjenjuje kao monoterapija).
The primary end-point was PCR-corrected cure rate at Day 28.
Primarni ishod bila je PCR-korigirana stopa izlječenja 28. dana.
Therefore the assessment of the potential for drug-drug interactions to occur is based on either in vivo or in vitro studies.
Stoga se procjena mogućnosti pojave interakcija lijekova temelji na ili in vivo ili in vitro ispitivanjima.
In perinatal and postnatal studies in rats, piperaquine was associated with delivery complications.
U perinatalnim i postnatalnim ispitivanjima u štakora, piperakin je bio povezan s komplikacijama pri okotu.
• 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.
• 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.
This pharmacokinetic effect is accompanied by an increased effect on prolongation of the QT interval.
Ovaj farmakokinetički učinak popraćen je pojačanim učinkom na produljenje QT intervala.
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.
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.
This leaflet was last revised in month YYYY
Ova uputa je zadnji puta revidirana u mjesec GGGG.
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).
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).
No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated with artenimol.
Nije opažen učinak na profil metabolita piperakina u ljudskim hepatocitima kad se piperakin inkubirao zajedno s artenimolom.
Each dose should be taken no less than 3 hours after the last food intake.
Svaku dozu treba uzeti najmanje 3 sata nakon zadnjeg uzimanja hrane.
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.
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.
No reproduction toxicity studies have been performed with the combination of artenimol and piperaquine.
Nisu provedena ispitivanja reproduktivne toksičnosti kombinacije artenimola i piperakina.
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).
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).
The mean QTcF prolongation compared to placebo decreased to 11.8 msec at 24 hours and to 7.5 msec at 48 hours.
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.
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.
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.
95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
95% dvostrani CI za razliku liječenja (Eurartesim - usporedni lijek); p-vrijednost
• Interference with parasite transport proteins
• ometanje prijenosnih proteina parazita
Due to its slow elimination, piperaquine accumulates in plasma after multiple doses with an accumulation factor of approximately 3.
Zbog spore eliminacije, piperakin se nakuplja u plazmi nakon višekratnih doza uz faktor nakupljanja od približno 3.
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).
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).
Piperaquine is a bisquinoline, and this class has shown good antimalarial activity against chloroquineresistant Plasmodium strains in vitro.
Piperakin je biskinolin, a ta je skupina pokazala dobro antimalarijsko djelovanje protiv sojeva Plasmodium rezistentnih na klorokin in vitro.
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
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.
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.
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.
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.
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.
If the second dose is vomited, alternative antimalarial therapy should be instituted.
Ako i druga doza bude povraćena, potrebno je uvesti terapiju drugim antimalarikom.
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).
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).
Chloroquine binds to toxic haeme (derived from the patient's haemoglobin) within the malaria parasite, preventing its detoxification via a polymerisation step.
Klorokin se veže za toksični hem (koji potječe iz hemoglobina bolesnika) unutar parazita malarije, sprječavajući njegovu detoksifikaciju putem polimerizacije.
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3 tablets.
Eurartesim tablete su pakirane u PVC/PVDC/aluminij blisterima koji sadrže 3 tablete.
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.
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.
Animal data suggest excretion of piperaquine into breast milk but no data are available in humans.
Podaci u životinja pokazuju da se piperakin izlučuje u mlijeko, ali nema dostupnih podataka za ljude.
Via Pontina Km 30.400 IT-00071 Pomezia (RM) Italy
Via Pontina Km 30.400 IT-00071 Pomezia (RM)
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.
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.
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.
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.
Piperaquine, a highly lipophilic compound, is slowly absorbed.
Piperakin, koji je izrazito lipofilni spoj, sporo se apsorbira.
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.
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.
Do not give this medicine to infants under 6 months or below 5 kg in weight.
Djeca Nemojte davati ovaj lijek dojenčadi mlađoj od 6 mjeseci ili tjelesne težine manje od 5 kg.
The bulky bisquinolone structure may be important for activity against chloroquine- resistant strains, and may act through the following mechanisms:
Pozamašna struktura biskinolona može biti važna za djelovanje protiv sojeva rezistentnih na klorokin, a može djelovati putem sljedećih mehanizama:
In healthy volunteers, piperaquine exposure is increased approximately 3-fold when administered with a high fat/high calorie meal.
U zdravih dobrovoljaca, izloženost piperakinu povećana je približno trostruko kad se primjenjuje uz visokomasni/visokokalorični obrok.
There was no evidence of artenimol-induced lesions in the specific nuclei in rats or dogs, even at lethal dose.
Nije bilo dokaza da artenimol izaziva lezije u određenim nukleusima u štakora ili pasa, čak niti u letalnoj dozi.
36 to <75
36 do <75
In healthy volunteers, artenimol exposure was increased by 43% when administered with a high fat/high calorie meal.
U zdravih je dobrovoljaca izloženost artenimolu bila povećana za 43% kad se primjenjivao uz visokomasni/visokokalorični obrok.
Moreover, data obtained in animal studies show that fertility is unaffected by artenimol in both females and males.
Nadalje, podaci dobiveni ispitivanjima na životinjama pokazuju da artenimol ne utječe na plodnost niti ženki niti mužjaka.
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.
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.
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.
Apsorpcija piperakina povećana je u prisutnosti masnih kiselina (vidjeti dijelove 4.4 i 5.2), što može pojačati njegov učinak na QTc interval.
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.
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.
Artenimol is very rapidly absorbed, Tmax being approximately 1-2 hrs after single and multiple dosing.
Artenimol se vrlo brzo apsorbira, a Tmax postiže približno 1-2 sata nakon jednokratnog i višekratnog doziranja.
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).
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).
Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake ‘Rok valjanosti'.
The primary end-point was the PCR-corrected cure rate at Day 63.
Primarni ishod bila je PCR-korigirana stopa izlječenja 63. dana.
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.
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.
• has a malaria infection caused by a parasite other than Plasmodium falciparum;
• imate malariju uzrokovanu drugim parazitom a ne Plasmodium falciparum;
Eurartesim treatment was compared with Artesunate + Mefloquine (AS + MQ).
Liječenje Eurartesimom bilo je uspoređeno s artesunatom + meflokin (AS + MQ).
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.
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.
Due to its long elimination half-life, piperaquine accumulates after multiple dosing.
Zbog svog dugog poluvijeka eliminacije, piperakin se nakuplja nakon višekratnog doziranja.
• has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease;
• imate srčani poremećaj, kao što su promjene ritma ili brzine rada srca, ili bolest srca;
How to take Eurartesim
Kako uzimati Eurartesim
Side effects in adults
Nuspojave u odraslih
• 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.
• 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.
You or your child should not take a second course of Eurartesim within 2 months of the first course.
Vi ili Vaše dijete ne smijete uzeti drugu kuru Eurartesima unutar 2 mjeseca od prve kure.
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
- Simptomatske srčane aritmije u anamnezi ili s klinički značajnom bradikardijom.
• 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.
• 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.
The age-specific PCR-corrected cure rates in the m-ITT populations are tabulated below for the Asian and African studies, respectively:
Dobno specifične PCR-korigirane stope izlječenja u modificiranim populacijama s namjerom liječenja (m-ITT) u azijskom i afričkom ispitivanju prikazane su u sljedećim tablicama:
artenimol systemic exposure on the last day of treatment was higher in females than in males, the difference being within 30%.
Sistemska izloženost artenimolu zadnjeg dana liječenja bila je viša u žena nego u muškaraca, uz razliku unutar 30%.
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.
Vama ili Vašem djetetu liječnik može napraviti električni zapis rada srca (elektrokardiogram [EKG]) dok se liječite i nakon što uzmete zadnju dozu.
• Inhibition of the transporters that efflux chloroquine from the parasite food vacuole
• inhibicija prijenosnika koji izbacuju klorokin iz prehrambene vakuole parazita
Central nervous system (CNS) toxicity
Toksičnost za središnji živčani sustav (SŽS)
Data regarding artenimol excretion in humans are scarce.
Podaci koji se odnose na izlučivanje artenimola u ljudi su šturi.
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.
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.
No subject had a QTcF value greater than 500 msec in any of the dosing conditions.
Niti jedan ispitanik nije imao vrijednost QTcF veću od 500 ms niti kod jednog načina doziranja.
The association of artenimol and piperaquine does not produce hERG inhibition greater than that of the single compounds.
Povezanost artenimola i piperakina ne dovodi do inhibicije hERG koja je veća od one koju izaziva svaki spoj posebno.
This increase in exposure to the antimalarial combination may result in an exacerbation of the effect on QTc (see section 4.4).
To povećanje izloženosti kombinaciji koja djeluje protiv malarije može rezultirati pogoršanim učinkom na QTc (vidjeti dio 4.4).
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.
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.
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.
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.
If you or your child forgets to take the second dose of Eurartesim at the right time, take it as soon as you remember.
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.
Artenimol was observed to have a small volume of distribution in humans (0.8 l/kg; CV 35.5%).
Opaženo je da artenimol ima mali volumen distribucije u ljudi (0,8 l/kg; CV 35,5%).