natgillin/translations-raw huggingface dataset:
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.
V primerjavi s placebom so bila največja povprečna podaljšanja v QTcF 3. dan po dajanju zdravila Eurartesim 45,2, 35,5 in 21,0 msek pod opisanimi pogoji odmerjanja.
Food interaction
Medsebojno delovanje s hrano
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
- Anamneza simptomatskih srčnih aritmij, klinično pomembne bradikardije.
− macrolides (e.g. erythromycin, clarithromycin),
− makrolidi (npr. eritromicin, klaritromicin),
If the second dose is vomited, alternative antimalarial therapy should be instituted.
Če bolnik drugi odmerek izbruha, je treba uvesti zdravljenje z alternativnim antimalarikom.
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.
Tablete zdravila Eurartesim so pakirane v pretisne omote iz PVC/PVDC/aluminija, ki vsebujejo 3, 6, 9 ali 12 tablet.
- 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.
- Kakršna koli bolezen srca, ki povečuje dovzetnost za razvoj aritmij, kot je huda hipertenzija, hipertrofija levega prekata (vključno s hipertrofično kardiomiopatijo) ali kongestivno srčno popuščanje, ki ga spremlja zmanjšan iztisni delež levega prekata.
EU/1/11/716/001 3 film-coated tablets EU/1/11/716/002 6 film-coated tablets EU/1/11/716/003 9 film-coated tablets EU/1/11/716/004 12 film-coated tablets
EU/1/11/716/001 3 filmsko obložene tablete EU/1/11/716/002 6 filmsko obloženih tablet EU/1/11/716/003 9 filmsko obloženih tablet EU/1/11/716/004 12 filmsko obloženih tablet
If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.
Če jemljete folate kot dopolnilno zdravljenje za preprečevanje morebitnih okvar nevralne cevi, lahko s tem nadaljujete med jemanjem zdravila Eurartesim.
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.
Če opazite kakršno koli spremembo v svojem ali otrokovem srčnem ritmu ali če imate vi ali vaš otrok simptome (kot so palpitacije ali nepravilen srčni utrip), se obrnite na zdravnika takoj, ko je to mogoče in še preden morate vi ali vaš otrok vzeti naslednji odmerek.
If this happens, talk to your doctor.
V tem primeru se pogovorite z zdravnikom.
The primary end-point was PCR-corrected cure rate at Day 28.
Primarni končni opazovani dogodek je bila stopnja ozdravljenja, popravljena za PCR, na 28. dan.
In the hERG test, the IC50 was 0.15 µmol for piperaquine and 7.7 µmol forartenimol.
V testu hERG je bil IC50 0,15 µmol za piperakin in 7,7 µmol za artenimol.
Artenimol causes embryolethality and teratogenicity in rats and rabbits.
Artenimol povzroča smrtnost zarodkov in teratogenost pri podganah in kuncih.
Delayed Haemolytic Anaemia
Zakasnjena hemolitična anemija
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.
Zaradi možnosti višjih koncentracij piperakina v plazmi je potrebna previdnost pri dajanju zdravila Eurartesim bolnikom z zlatenico in/ali zmerno ali hudo ledvično ali jetrno insuficienco, priporoča pa se tudi spremljanje EKG in kalija v krvi.
• 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.
• Bolnike je treba opozoriti, da se o neželenih učinkih posvetujejo z zdravnikom, in da mora zdravnik/farmacevt poročati domnevne neželene učinke z zdravilom Eurartesim, še zlasti tiste, ki so povezani s podaljšanjem intervala QT.
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).
Ustrezno je treba zdravilo Eurartesim dajati z vodo vsaj 3 ure po zadnjem vnosu hrane, nato pa se hrane ne sme uživati 3 ure po vsakem obroku (glejte poglavje 4.2).
Central nervous system (CNS) toxicity
Toksičnost za osrednji živčni sistem (OŽS)
Artenimol is principally converted to α-artenimol-β-glucuronide (α-artenimol-G).
Artenimol se v glavnem pretvori v α-artenimol-β-glukuronid (α-artenimol-G).
SPECIAL STORAGE CONDITIONS Do not store above 30°C
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
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
Znotraj vsake pogostnostne skupine so neželeni učinki navedeni po padajoči resnosti v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3 tablets.
Tablete zdravila Eurartesim so pakirane v pretisne omote iz PVC/PVDC/aluminija, ki vsebujejo 3 tablete.
• That Eurartesim has a potential to prolong the QTc interval that may lead to potentially lethal arrhythmias.
• Zdravilo Eurartesim lahko podaljša interval QTc, kar lahko povzroči aritmije, ki so lahko smrtne.
Eurartesim treatment was compared with Artesunate + Mefloquine (AS + MQ).
Zdravljenje z zdravilom Eurartesim so primerjali z zdravljenjem s kombinacijo artesunat + meflokin (AS + MQ).
• Inhibition of the transporters that efflux chloroquine from the parasite food vacuole
• zaviranje transporterjev, ki izlivajo klorokine iz vakuole hrane parazita,
• That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
• Absorpcija piperakina se poveča v prisotnosti hrane, zato je treba bolnikom svetovati, da zdravilo vzamejo z vodo in brez hrane vsaj tri ure po zadnjem zaužitju hrane, da tako zmanjšajo tveganje podaljšanja intervala QTc.
Clinical studies of Eurartesim did not include patients aged 65 years and over, therefore no dosing recommendation can be made.
Bolniki, stari 65 let in več, niso bili vključeni v klinične študije z zdravilom Eurartesim, zato priporočil za odmerjanje ni mogoče dati.
The mean oral clearance for adult patients with malaria was 1.34 l/h/kg.
Povprečni peroralni očistek za odrasle bolnike z malarijo je bil 1,34 l/h/kg.
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.
Previdnost je potrebna pri kombiniranju zdravila Eurartesim z zdravili, ki kažejo različne vzorce zaviranja, induciranja ali tekmovanja za encim CYP3A4, saj se lahko s tem spremenijo terapevtski in/ali toksični učinki nekaterih sočasno uporabljenih zdravil.
artenimol systemic exposure on the last day of treatment was higher in females than in males, the difference being within 30%.
Sistemska izpostavljenost artenimolu zadnji dan zdravljenja je bila višja pri ženskah kot pri moških, pri čemer je bila razlika 30 %.
Moreover, data obtained in animal studies show that fertility is unaffected by artenimol in both females and males.
Podatki, zbrani iz študij na živalih, kažejo, da artenimol ne vpliva na plodnost niti pri ženskah niti pri moških.
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.
Vsak odmerek vzemite (vi ali vaš otrok) vsaj 3 ure po zadnjem vnosu hrane, nato pa hrane ne smete uživati 3 ure po vsakem odmerku zdravila Eurartesim.
The mean oral clearance for adult patients with malaria was 2.09 l/h/kg, while in paediatric patients was 2.43 l/h/kg.
Povprečni peroralni očistek za odrasle bolnike z malarijo je bil 2,09 l/h/kg, medtem ko je bil za pediatrične bolnike 2,43 l/h/kg.
This leaflet was last revised in month YYYY
Navodilo je bilo nazadnje revidirano dne meseca LLLL
Therefore, ECG monitoring during the following 24-48 hours should be applied for patients found to have a prolongation to this extent.
Zato je treba pri bolnikih, pri katerih so ugotovili podaljšanje v taki meri, uvesti nadziranje z EKG v obdobju naslednjih 24-48 ur.
• 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.
• Če vi ali vaš otrok dobite ponovni napad malarije, lahko jemljete ponoven cikel zdravila Eurartesim v roku enega leta, če zdravnik meni, da je to ustrezno zdravljenje.
In healthy volunteers, piperaquine exposure is increased approximately 3-fold when administered with a high fat/high calorie meal.
Pri zdravih prostovoljcih se izpostavljenost piperakinu poveča približno za 3-krat, če se daje z obrokom z visoko vsebnostjo maščob/visokokaloričnim obrokom.
Take at least 3 hours before or after food.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vzemite vsaj 3 ure pred obrokom hrane ali po njem.
- Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial medicinal products) taking into account their elimination half-life.
- Nedavno zdravljenje z zdravili, za katera je znano, da podaljšujejo interval QTc, ki lahko še vedno cirkulirajo v času uvedbe zdravila Eurartesim (npr. meflokin, halofantrin, lumefantrin, klorokinin, kinin in drugi antimalariki), ob upoštevanju njihovega razpolovnega časa izločanja.
The primary end-point was the PCR-corrected cure rate at Day 63.
Primarni končni opazovani dogodek je bila stopnja ozdravljenja, popravljena za PCR, na 63. dan.
− fluoroquinolones (e.g. moxifloxacin, sparfloxacin),
− fluorokinoloni (npr. moksifloksacin, sparfloksacin),
These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine
Ta zdravila vključujejo: meflokin, halofantrin, lumefantrin, klorokin ali kinin.
Piperaquine did not induce malformation in rats and rabbits.
Piperakin ni induciral malformacij pri podganah in kuncih.
• That Eurartesim is contraindicated in patients with severe malaria according to WHO definition and in patients with a history of clinical conditions that may lead to QTc interval prolongation, and in patients taking drugs that are known to prolong the QTc interval.
• Zdravilo Eurartesim je kontraindicirano pri bolnikih s hudo obliko malarije po opredelitvi SZO in pri bolnikih z anamnezo kroničnih stanj, ki lahko povzročijo podaljšanje intervala QTc, ter pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QTc.
This increase in exposure to the antimalarial combination may result in an exacerbation of the effect on QTc (see section 4.4).
To zvečanje izpostavljenosti protimalarični kombinaciji zdravil lahko poslabša učinek na interval QTc (glejte poglavje 4.4).
Eurartesim treatment was compared with Artemether + Lumefantrine (A + L).
Zdravljenje z zdravilom Eurartesim so primerjali z zdravljenjem s kombinacijo artemeter + lumefantrin (A + L).
Patients and caregivers should be advised to be vigilant for signs and symptoms of post-treatment haemolysis such as pallor, jaundice, dark-coloured urine, fever, fatigue, shortness of breath, dizziness and confusion.
Bolnikom in negovalcem je treba naročiti, da morajo biti pozorni na znake in simptome hemolize po zdravljenju, kot so bledica, zlatenica, temen urin, zvišana telesna temperatura, utrujenost, kratka sapa, omotičnost in zmedenost.
- Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval.
- Znano prirojeno podaljšanje intervala QTc ali katero koli klinično stanje, za katerega je znano, da podaljšuje interval QTc.
The 160 mg/20 mg tablets have the letters ‘S' and ‘T' on one side and come in blisters containing 3 tablets.
Tablete 160 mg/20 mg imajo na eni strani črki „S“ in „T“ in so na voljo v pretisnih omotih s 3 tabletami.
Due to its long elimination half-life, piperaquine accumulates after multiple dosing.
Zaradi svoje dolge razpolovne dobe izločanja se piperakin po večkratnem odmerjanju kopiči.
tacrolimus); - sex hormones, including those contained in hormonal contraceptives (such as gestodene,
takrolimus), - spolni hormoni, vključno s tistimi v hormonskih kontraceptivih (kot so gestoden, progesteron,
Artenimolwas observed to have a small volume of distribution in humans (0.8 l/kg; CV 35.5%).
Opazili so, da ima artenimol majhen volumen porazdelitve pri ljudeh (0,8 l/kg; CV 35,5 %).
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).
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).
Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day.
Zdravilo Eurartesim je treba dajati tri zaporedne dni ob isti uri, torej skupno tri odmerke.
You or your child should not take a second course of Eurartesim within 2 months of the first course.
Vi ali vaš otrok ne smete prejeti drugega cikla zdravljenja z zdravilom Eurartesim v roku 2 mesecev od prvega zdravljenja.
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.
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.
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.
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.
Piperaquine is also a substrate of CYP3A4.
Piperakin je tudi substrat CYP3A4.
Study DM040010 was conducted in Asian adult and paediatric patients with uncomplicated P. falciparum malaria.
Študija DM040010 je potekala z odraslimi in pediatričnimi bolniki azijskega porekla z nezapleteno malarijo P. falciparum.
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”.
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“.
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%.
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 %.
If you or your child forgets to take the second dose of Eurartesim at the right time, take it as soon as you remember.
Če ste vi ali vaš otrok pozabili vzeti tretji (zadnji) odmerek ob pravem času, ga vzemite takoj, ko se spomnite.
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).
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).
>5 to ≤12 years
> 5 do ≤ 12 let > 12 do ≤ 18 let
If you find out that you are pregnant within one month from taking Eurartesim, please inform your doctor.
Obvestite zdravnika, če v enem mesecu od jemanja zdravila Eurartesim ugotovite, da ste noseči.
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 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).
The 320 mg/40 mg tablets have two 'σ' letters on one side and come in blisters containing 3, 6, 9 or 12
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.
• has liver or kidney problems;
• imate vi ali vaš otrok težave z jetri ali ledvicami;
PCR-corrected cure rate (m-ITT) Eurartesim AS + MQ A + L
Stopnja ozdravljenja, popravljena za PCR (m-ITT) Zdravilo Eurartesim AS + MQ A + L
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.
Malarijo povzroča okužba s parazitom, imenovanim plazmodij, ki se prenaša s pikom okuženega komarja.
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).
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).
Pharmacotherapeutic group: Antiprotozoals, antimalarials, artemisinin and derivatives, combinations, ATC code: P01BF05
Farmakoterapevtska skupina: antiprotozoiki, antimalariki, artemizinin in derivati, kombinacije, oznaka ATC: P01BF05
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).
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).
Moreover, from in vitro and in vivo data in animals, piperaquine and artenimol tend to accumulate in RBC.
Poleg tega kažejo podatki in vitro in in vivo pri živalih, da se piperakin in artenimol nagibata h kopičenju v eritrocitih.
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.
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.
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.
Verjetno je, da bodo zdravila, ki inducirajo encime, kot so rifampicin, karbamazepin, fenitoin, fenobarbital, šentjanževka (Hypericum perforatum), zmanjšala koncentracije piperakina v plazmi.
• Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
• nekatere nesedativne antihistaminike (npr. terfenadin, astemizol, mizolastin),
Study DM040011 was conducted in African paediatric patients with uncomplicated P. falciparum malaria.
Študija DM040011 je potekala z odraslimi in pediatričnimi bolniki afriškega porekla z nezapleteno malarijo P. falciparum.
• 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.
• Zaradi možnega tveganja teratogenosti se zdravila Eurartesim ne sme uporabljati v 1. trimesečju nosečnosti, če so na voljo drugi primerni in učinkoviti antimalariki.
In clinical trials with Eurartesim limited ECGs were obtained during treatment.
V kliničnih preskušanjih zdravila Eurartesim so med zdravljenjem pridobili malo EKG posnetkov.
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%).
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 %).
No reproduction toxicity studies have been performed with the combination of artenimol and piperaquine.
Študij vpliva na sposobnost razmnoževanja s kombinacijo artenimola in piperakina niso izvajali.
>1 to ≤ 2 years >2 to ≤5 years
≤ 1 leto > 1 do ≤ 2 leti
No healthy subject dosed in fasting conditions showed a QTcF greater than 480 msec or an increase over baseline greater than 60 msec.
Pri nobenem zdravem prostovoljcu na tešče ni bil QTcF daljši od 480 msek in nobeno povečanje nad izhodiščno točko večje od 60 msek.
Email: antonietta.pazardjiklian@alfasigma.com
E-pošta: antonietta.pazardjiklian@alfasigma.com
• The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
• Obseg in uporabo seznama stanj in sočasnih zdravil, kjer je uporaba zdravila kontraindicirana.
You should try to take the dose at about the same time on each of the three days.
Vzemite en odmerek na dan. Poskusite vzeti odmerek vsak dan ob približno istem času.
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).
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).