FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Povprečni očistek (1,45 l/h/kg) je bil nekoliko večji očistek za pediatrično populacijo kot za odrasle bolnike (1,34 l/h/kg), medtem ko je bil povprečni volumen porazdelitve za pediatrične bolnike (0,705 l/kg) nižji kot pri odraslih (0,801 l/kg).
English: Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day.
Slovenian: Zdravilo Eurartesim je treba dajati tri zaporedne dni ob isti uri, torej skupno tri odmerke.
English: You or your child should not take a second course of Eurartesim within 2 months of the first course.
Slovenian: Vi ali vaš otrok ne smete prejeti drugega cikla zdravljenja z zdravilom Eurartesim v roku 2 mesecev od prvega zdravljenja.
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.
Slovenian: Pri zdravih moških prostovoljcih je bil razpon povprečnega Cmax in AUCINF za artenimol med 180-252 ng/ml oz. 516-684 ng/ml*h v pogojih na tešče.
English: 5 to <7
Slovenian: 5 do <7
English: When co-administered to healthy women, Eurartesim exerted only a minimum effect on an estrogen/progestinic combination oral contraceptive treatment increasing the ethynilestradiol rate of absorption (expressed by geometric mean Cmax) of about 28% but not significantly changing the exposure to ethynilestradiol and levonorgestrel and not influencing contraception activity as demonstrated by the similar plasma concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH) and progesterone observed after oral contraceptive treatment with or without concomitant Eurartesim administration.
Slovenian: Ko so sočasno dajali zdravilo Eurartesim zdravim ženskam, je le minimalno vplivalo na kombinirano peroralno kontracepcijsko terapijo z estrogenom in progestinom, tako da je zvečalo hitrost absorpcije etinilestradiola (izraženo z geometrično sredino Cmax) za okrog 28 %, a ni značilno spremenilo izpostavljenosti etinilestradiolu in levonorgestrelu in ni vplivalo na kontracepcijsko aktivnost, kot so pokazale podobne plazemske koncentracije folikle stimulirajočega hormona (FSH), luteinizirajočega hormona (LH) in progesterona, ki so jih ugotavljali po peroralni kontracepcijski terapiji s sočasnim dajanjem zdravila Eurartesim ali brez njega.
English: Piperaquine is also a substrate of CYP3A4.
Slovenian: Piperakin je tudi substrat CYP3A4.
English: Study DM040010 was conducted in Asian adult and paediatric patients with uncomplicated P. falciparum malaria.
Slovenian: Študija DM040010 je potekala z odraslimi in pediatričnimi bolniki azijskega porekla z nezapleteno malarijo P. falciparum.
English: White oblong biconvex film-coated tablet (dimension 11.5x5.5mm / thickness 4.4mm) with a break-line and marked on one side with the letters “S” and “T”.
Slovenian: Bele podolgovate bikonveksne filmsko obložene tablete (dimenzije 11,5 x 5,5 mm/debelina 4,4 mm) z razdelilno zarezo in oznako na eni strani s črkama „S“ in „T“.
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%.
Slovenian: Po drugi strani je bila zadnji dan zdravljenja z zdravilom Eurartesim največja koncentracija piperakina v plazmi višja pri ženskih kot pri moških zdravih prostovoljcih, pri čemer je razlika v razponu od 30 do 50 %.
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.
Slovenian: Če ste vi ali vaš otrok pozabili vzeti tretji (zadnji) odmerek ob pravem času, ga vzemite takoj, ko se spomnite.
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).
Slovenian: Zato je potrebna posebna pozornost, ko se zdravilo Eurartesim daje pri bolnikih, ki že jemljejo močne zaviralce CYP3A4 (npr. nekateri zaviralci proteaze [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodon ali verpamil), pomisliti pa je treba na spremljanje EKG zaradi tveganja višjih koncentracij piperakina v plazmi (glejte poglavje 4.4).
English: >5 to ≤12 years
Slovenian: > 5 do ≤ 12 let > 12 do ≤ 18 let
English: 24 to <36
Slovenian: 24 do <36
English: If you find out that you are pregnant within one month from taking Eurartesim, please inform your doctor.
Slovenian: Obvestite zdravnika, če v enem mesecu od jemanja zdravila Eurartesim ugotovite, da ste noseči.
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).
Slovenian: Na podlagi podatkov iz študij na živalih se sumi, da povzroča zdravilo Eurartesim hude prirojene okvare, če se daje v 1. trimesečju nosečnosti (glejte poglavji 4.4 in 5.3).
English: The 320 mg/40 mg tablets have two 'σ' letters on one side and come in blisters containing 3, 6, 9 or 12
Slovenian: Tablete 320 mg/40 mg imajo na eni strani dve črki „σ“ in so na voljo v pretisnih omotih s 3, 6, 9 ali 12 tabletami.
English: • has liver or kidney problems;
Slovenian: • imate vi ali vaš otrok težave z jetri ali ledvicami;
English: PCR-corrected cure rate (m-ITT) Eurartesim AS + MQ A + L
Slovenian: Stopnja ozdravljenja, popravljena za PCR (m-ITT) Zdravilo Eurartesim AS + MQ A + L
English: Malaria is caused by infection with a parasite called Plasmodium, spread by the bite of an infected mosquito.There are different types of Plasmodium parasite.
Slovenian: Malarijo povzroča okužba s parazitom, imenovanim plazmodij, ki se prenaša s pikom okuženega komarja.
English: Fax: +39 051 388689
Slovenian: Faks: +39 051 388689
English: These showed that QTc prolongation occurred more frequently and to a larger extent in association with Eurartesim therapy than with the comparators (see section 5.1 for details of the comparators).
Slovenian: Pokazali so, da se je interval QTc pogosteje in v večjem obsegu podaljšal v povezavi z zdravljenjem z zdravilom Eurartesim v primerjavi s primerjalnim zdravilom (za podrobnejše informacije o primerjalnih zdravilih glejte poglavje 5.1).
English: Pharmacotherapeutic group: Antiprotozoals, antimalarials, artemisinin and derivatives, combinations, ATC code: P01BF05
Slovenian: Farmakoterapevtska skupina: antiprotozoiki, antimalariki, artemizinin in derivati, kombinacije, oznaka ATC: P01BF05
English: An ECG should be obtained as early as possible during treatment with Eurartesim and ECG monitoring should be applied in patients who may have a higher risk of developing arrhythmia in association with QTc prolongation (see below).
Slovenian: EKG posnetek je treba pridobiti kar se da zgodaj med zdravljenjem z zdravilom Eurartesim in pa je treba uvesti nadziranje EKG pri bolnikih, pri katerih je tveganje za nastanek aritmije v povezavi s podaljšanjem intervala QTc večje (glejte spodaj).
English: Moreover, from in vitro and in vivo data in animals, piperaquine and artenimol tend to accumulate in RBC.
Slovenian: Poleg tega kažejo podatki in vitro in in vivo pri živalih, da se piperakin in artenimol nagibata h kopičenju v eritrocitih.
English: Contact your doctor immediately if you or your child develops one or more of the following symptoms after treatment with Eurartesim: pale skin, general weakness, headache, shortness of breath and rapid heartbeat; particularly with exercise, confusion, dizziness, or dark-coloured urine.
Slovenian: Takoj obvestite zdravnika, če se po zdravljenju z zdravilom Eurartesim pri vas ali vašem otroku pojavijo eden ali več od naslednjih simptomov: bleda koža, splošna oslabelost, glavobol, kratka sapa in hitro bitje srca (še posebej pri telesni aktivnosti), zmedenost, omotičnost ali temen urin.
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.
Slovenian: Verjetno je, da bodo zdravila, ki inducirajo encime, kot so rifampicin, karbamazepin, fenitoin, fenobarbital, šentjanževka (Hypericum perforatum), zmanjšala koncentracije piperakina v plazmi.
English: • Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
Slovenian: • nekatere nesedativne antihistaminike (npr. terfenadin, astemizol, mizolastin),
English: Study DM040011 was conducted in African paediatric patients with uncomplicated P. falciparum malaria.
Slovenian: Študija DM040011 je potekala z odraslimi in pediatričnimi bolniki afriškega porekla z nezapleteno malarijo P. falciparum.
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.
Slovenian: • Zaradi možnega tveganja teratogenosti se zdravila Eurartesim ne sme uporabljati v 1. trimesečju nosečnosti, če so na voljo drugi primerni in učinkoviti antimalariki.
English: In clinical trials with Eurartesim limited ECGs were obtained during treatment.
Slovenian: V kliničnih preskušanjih zdravila Eurartesim so med zdravljenjem pridobili malo EKG posnetkov.
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%).
Slovenian: Naslednje neželene učinke so opazili z incidenco ≥ 5,0 %: kašelj (32 %), pireksija (22,4 %), gripa (16,0 %), okužba s P. falciparum (14,1 %), driska (9,4 %), bruhanje (5,5 %) in anoreksija (5,2 %).
English: No reproduction toxicity studies have been performed with the combination of artenimol and piperaquine.
Slovenian: Študij vpliva na sposobnost razmnoževanja s kombinacijo artenimola in piperakina niso izvajali.
English: >1 to ≤ 2 years >2 to ≤5 years
Slovenian: ≤ 1 leto > 1 do ≤ 2 leti
English: No healthy subject dosed in fasting conditions showed a QTcF greater than 480 msec or an increase over baseline greater than 60 msec.
Slovenian: Pri nobenem zdravem prostovoljcu na tešče ni bil QTcF daljši od 480 msek in nobeno povečanje nad izhodiščno točko večje od 60 msek.
English: Email: antonietta.pazardjiklian@alfasigma.com
Slovenian: E-pošta: antonietta.pazardjiklian@alfasigma.com
English: • The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
Slovenian: • Obseg in uporabo seznama stanj in sočasnih zdravil, kjer je uporaba zdravila kontraindicirana.
English: You should try to take the dose at about the same time on each of the three days.
Slovenian: Vzemite en odmerek na dan. Poskusite vzeti odmerek vsak dan ob približno istem času.
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).
Slovenian: Zdravljenja z zdravilom Eurartesim ni dovoljeno ponoviti v roku 2 mesecev od prvega zdravljenja zaradi dolge razpolovne dobe piperakina (glejte poglavji 4.4 in 5.2).
English: Eurartesim is contraindicated in patients already taking other medicinal products that are known to prolong the QTc interval due to the risk of a pharmacodynamic interaction leading to an additive effect on the QTc interval (see sections 4.3 and 4.4).
Slovenian: Zdravilo Eurartesim je kontraindicirano pri bolnikih, ki že jemljejo druga zdravila, za katera je znano, da podaljšujejo interval QTc, zaradi tveganja farmakodinamičnega medsebojnega delovanja, ki bi vodilo v dodatni učinek na interval QTc (glejte poglavji 4.3 in 4.4).
English: Eurartesim should not be used during the 1st trimester of pregnancy in situations where other suitable and effective antimalarials are available (see section 4.6).
Slovenian: Zdravila Eurartesim se ne sme uporabljati v prvem trimesečju nosečnosti v situacijah, kjer so na voljo drugi ustrezni in učinkoviti antimalariki (glejte poglavje 4.6).
English: • has a malaria infection caused by a parasite other than Plasmodium falciparum;
Slovenian: • imate vi ali vaš otrok okužbo z malarijo, ki jo povzroča drug parazit, ne Plasmodium falciparum;
English: Piperaquine was mainly metabolised by CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19.
Slovenian: Piperakin presnavlja pretežno encim CYP3A4, manj pa encima CYP2C9 in CYP2C19.
English: In vitro drug-drug interaction studies revealed that artenimol is an inhibitor of CYP1A2; therefore, there is the potential for artenimol to increase plasma concentrations of CYP1A2 substrates (see section 4.5).
Slovenian: Študije medsebojnega delovanja zdravila z zdravili in vitro so pokazale, da je artenimol zaviralec encima CYP1A2, zato obstaja možnost, da artenimol zvišuje koncentracije substratov encima CYP1A2 v plazmi (glejte poglavje 4.5).
English: Artenimol pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Slovenian: Ugotovili so, da so parametri farmakokinetike artenimola podobni pri zdravih prostovoljcih azijskega porekla in belcih.
English: White oblong biconvex film-coated tablet (dimension 16x8mm / thickness 5.5mm) with a break-line and marked on one side with two “σ” letters.
Slovenian: Bele podolgovate bikonveksne filmsko obložene tablete (dimenzije 16 x 8 mm/debelina 5,5 mm) z razdelilno zarezo in oznako na eni strani z dvema črkama „σ“.
English: Therefore Eurartesim should not be used during the 1st trimester of pregnancy in situations where other suitable and effective anti-malarials are available (see section 4.4).
Slovenian: Zato se zdravila Eurartesim ne sme uporabljati v 1. trimesečju nosečnosti v situacijah, kjer so na voljo drugi ustrezni in učinkoviti antimalariki (glejte poglavje 4.4).
English: 7 to <13
Slovenian: 7 do <13
English: 13 to <24
Slovenian: 13 do <24
English: • Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase,
Slovenian: • zaviranjem kalcijeve ATPaze sarkoplazemskega-endoplazemskega retikuluma plazmodija falciparum,
English: No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated with artenimol.
Slovenian: Učinkov na profil presnovkov piperakina pri človeških hepatocitih pri sočasni inkubaciji piperakina z artenimolom niso opazili.
English: Piperaquine pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Slovenian: Ugotovili so, da so parametri farmakokinetike piperakina podobni pri zdravih prostovoljcih azijskega porekla in belcih.
English: In healthy volunteers, artenimol exposure was increased by 43% when administered with a high fat/high calorie meal.
Slovenian: Pri zdravih prostovoljcih se je izpostavljenost artenimolu pri dajanju z obroki z visoko vsebnostjo maščob/kalorij povečala za 43 %.
English: 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%.
Slovenian: Eurartesim največja koncentracija piperakina v plazmi višja pri ženskih kot pri moških zdravih prostovoljcih, pri čemer je razlika v razponu od 30 do 50 %.
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.
Slovenian: Pozornost je zato potrebna pri dajanju zdravila Eurartesim sočasno z zdravili, ki jih ta encim presnavlja, in imajo ozek terapevtski indeks, na primer teofilin.
English: 95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
Slovenian: 95-% dvostranski IZ razlike zdravljenja (zdravilo Eurartesimprimerjano zdravilo); vrednost p
English: Pharmacokinetics in special patient populations No specific pharmacokinetic studies have been performed in patients with hepatic or renal insufficiency, or in elderly people.
Slovenian: Specifičnih študij farmakokinetike pri bolnikih z jetrnim ali ledvičnim popuščanjem ter pri starejših bolnikih niso izvajali.
English: You can drive or use machines after taking Eurartesim once you have recovered from your illness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem zdravila Eurartesim lahko vozite in upravljate stroje, potem ko ste že okrevali po bolezni.
English: Piperaquine was found to be an inhibitor of CYP3A4 (also in a time-dependent way) and to a lesser extent of CYP2C19, while it stimulated the activity of CYP2E1.
Slovenian: Ugotovili so, da je piperakin zaviralec encima CYP3A4 (tudi v odvisnosti od časa) in manj encima CYP2C19, aktivnost encima CYP2E1 pa je stimuliral.
English: Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400
Slovenian: hipromeloza (E464) titanov dioksid (E171) makrogol 400
English: 95% two-sided CI on the treatment difference (Eurartesim - Comparator); p-value
Slovenian: 95-% dvostranski IZ razlike zdravljenja (zdravilo Eurartesim - primerjano zdravilo); vrednost p
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.
Slovenian: Večje število podatkov o uporabi artenimola/piperakina v 2. in 3. trimesečju nosečnosti (več kot 3.000 izpostavljenih nosečnosti) ne kaže na njegovo fetotoksičnost.
English: Artenimol is very rapidly absorbed, Tmax being approximately 1-2 hrs after single and multiple dosing.
Slovenian: Tmax je približno 1-2 uri po enkratnem in večkratnem odmerjanju.
English: There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1st trimester of pregnancy.
Slovenian: Nosečnost Podatki o uporabi artenimola in piperakina v 1. trimesečju nosečnosti so omejeni (n = 3).
English: • Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Slovenian: • cisaprid, droperidol, domperidon, bepridil, difemanil, probukol, levometadil, metadon, vinka alkaloide, arzenov trioksid.
English: There are no phototoxicity concerns with artenimol, as it does not absorb in the range of 290-700 nm. Piperaquine has an absorption maximum at 352 nm.
Slovenian: Ni pomislekov glede fototoksičnosti, povezane z artenimolom, saj se v razponu 290-700 nm ne absorbira.
English: In cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate, including ECG monitoring because of the possibility of QTc interval prolongation (see section 4.4).
Slovenian: V primeru suma na preveliko odmerjanje je treba nuditi ustrezno simptomatsko in podporno zdravljenje, vključno s spremljanjem EKG zaradi možnosti podaljšanja intervala QTc (glejte poglavje 4.4).
English: Therefore, particular attention should be paid when medicinal products that have a narrow therapeutic index (e.g. antiretroviral medicinal products and cyclosporine) are co-administered with Eurartesim.
Slovenian: Zato je potrebna posebna pozornost, kadar se sočasno z zdravilom Eurartesim dajejo zdravila, ki imajo ozek terapevtski indeks (npr. antiretrovirusna zdravila in ciklosporin).
English: These may increase the QTc-prolonging effect of Eurartesim (see section 4.3).
Slovenian: To lahko poveča učinke zdravila Eurartesim na podaljšanje intervala QTc (glejte poglavje 4.3).
English: The concurrent administration of oral Eurartesim with 7.5 mg oral midazolam, a CYP3A4 probe substrate, led to a modest increase (≤2-fold) in midazolam and its metabolites exposures in healthy adult subjects.
Slovenian: Sočasno peroralno dajanje zdravila Eurartesim s 7,5 mg peroralnega midazolama, ki je testni substrat CYP3A4, je povzročilo zmerno (≤ 2-kratno) zvečanje izpostavljenosti midazolamu in njegovim presnovkom pri zdravih odraslih preiskovancih.
English: Frequency of ADRs in paediatric patients participating in clinical studies with Eurartesim:
Slovenian: Pogostnost neželenih učinkov pri pediatričnih bolnikih, ki so bili vključeni v klinično preskušanje z zdravilom Eurartesim:
English: Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α-artenimol-G with no cytochrome P450-mediated metabolism.
Slovenian: Študije na mikrosomih človeških jeter so pokazale, da je artenimol presnavljala UDP-glukuronosiltransferaza (UGT1A9 in UGT2B7) v α-artenimol-G brez presnove, v kateri sodeluje citokrom P450.
English: You should take the Eurartesim tablets with water only.
Slovenian: Zdravilo Eurartesim skupaj s hrano in pijačo Zdravilo Eurartesim tablete vzemite samo z vodo.
English: - Family history of sudden death or of congenital prolongation of the QTc interval.
Slovenian: - Nenadna smrt ali prirojeno podaljšanje intervala QTc v družinski anamnezi.
English: Eurartesim are white film-coated tablets, embossed and with a break line along the middle.
Slovenian: Izgled zdravila Eurartesim in vsebina pakiranja Zdravilo Eurartesim so bele filmsko obložene tablete z vtisom in razdelilno zarezo na sredini.
English: A limited number of drug-drug pharmacokinetic interaction studies with Eurartesim have been performed in healthy adult subjects.
Slovenian: Pri zdravih odraslih preiskovancih so izvedli omejeno število študij farmakokinetičnega medsebojnega delovanja med zdravili in zdravilom Eurartesim.
English: DM04010 (n=1087) ≤5 years
Slovenian: DM040010 (n = 1.087) ≤ 5 let
English: • Disruption of parasite mitochondrial function
Slovenian: • prekinitvijo delovanja mitohondrija parazita.
English: Exposure to piperaquine may also be increased when co-administered with mild or moderate CYP3A4-inhibitors (e.g. oral contraceptives).
Slovenian: Izpostavljenost piperakinu se lahko zveča tudi, kadar ga dajemo sočasno z blagimi ali zmernimi zaviralci CYP3A4 (n.pr.
English: Frequency of ADRs in adult patients participating in clinical studies with Eurartesim:
Slovenian: Pogostnost neželenih učinkov pri odraslih bolnikih, ki so bili vključeni v klinično preskušanje z zdravilom Eurartesim:
English: The most frequent ADRs observed at an incidence ≥1.0% were: Headache (3.9%), Electrocardiogram QTc Prolonged (3.4%), P. falciparum infection (3.0%), Anaemia (2.8%), Eosinophilia (1.7%), Haemoglobin decreased (1.7%), Sinus tachycardia (1.7%), Asthenia (1.6%), Haematocrit [decreased] (1.6%), Pyrexia (1.5%), Red Blood Cell Count decreased (1.4%).
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili z incidenco ≥ 1,0 %, so bili: glavobol (3,9 %), podaljšanje QTc na elektrokardiogramu (3,4 %), okužba s P. falciparum (3,0 %), anemija (2,8 %), eozinofilija (1,7 %), znižanje hemoglobina (1,7 %), sinusna tahikardija (1,7 %), astenija (1,6 %), znižanje hematokrita (1,6 %), pireksija (1,5 %), znižanje števila eritrocitov (1,4 %).
English: In human studies, piperaquine was found to be a mild inhibitor of CYP3A4 enzyme while potent inhibitors of CYP3A4 activity caused mild inhibition of piperaquine metabolism (see section 4.5).
Slovenian: V študijah na ljudeh so ugotovili, da je piperakin blag zaviralec encima CYP3A4, medtem ko so močni zaviralci aktivnosti CYP3A4 blago zavirali presnovo piperakina (glejte poglavje 4.5).
English: The concurrent administration of a single dose of oral clarithromycin, (a strong CYP3A4 inhibitor probe) with a single dose of oral Eurartesim led to a modest increase (≤2-fold) in piperaquine exposure in healthy adult subjects.
Slovenian: Sočasno dajanje enkratnega peroralnega odmerka klaritromicina (ki je močan testni zaviralec CYP3A4) z enkratnim peroralnim odmerkom zdravila Eurartesim je pri zdravih odraslih preiskovancih povzročilo zmerno (≤ 2-kratno) zvečanje izpostavljenosti piperakinu.
English: How to take Eurartesim
Slovenian: Kako jemati zdravilo Eurartesim
English: P. falciparum infection
Slovenian: P. falciparum okužba dihal gripa